CLASS II 510(k) EXEMPTION PETITION

Transcription

1 Adaptive Engineering Inc. A EB U6 CLASS II 510(k) EXEMPTION PETITION 6 Feb.13/2014 Division of Dockets Management Branch Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, rm Rockville, MD ATTN: Karen Kennard, Director Dear Ms. Kennard, Further to our phone conversation of Feb. 10/14, our application of Dec. 2, 2013, and your letter of Jan. 22/2014; the attached was prepared in accordance with your instructions. We submit that this is unusual and urgent because disabled travelers across the US are dependent on it. Please phone us at (403) ext. 104 if you see any problems or delay in issuing the Docket Number. Thank you, Adaptive Engineering Inc. 04/Le/kr cc Corrina Sullivan Finance Manager Adaptive Engineering Inc th Ave. S.E. Calgary, AB T2G lv 1 Canada Phone: (403) ext. 104 Fax: (403) FAA-- 201e( P- ov5 ( ze ley - 5Y th Avenue S.E., Calgary AB, Canada T2G 1V1,(403) , , Fax:(403) ,

2 Adaptive Engineering Inc. A 7 CLASS II 510(k) EXEMPTION PETITION Feb.13/2014 Division of Dockets Management Branch Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, rm Rockville, MD Citizen Petition The undersigned submits this petition under regulation 21 CFR # , Class 2 of the CDRH to request the Commissioner of Food and Drugs to exempt the manually operated portable wheelchair lift from the 510(k) pre-market notification. A. Action Requested The following is an application by Adaptive Engineering Inc. for exemption from the Pre-market notification 510 (k) requirements for our manually operated portable wheelchair lift currently falling under (21 CFR # , class 2) listed below: Sec Wheelchair elevator. (a) Permanently mounted wheelchair platform lift--(1)identification. A permanently mounted wheelchair platform lift is a motorized vertical or inclined pdatform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided pdatform to move a person from one level to another, with or without a wheelchair. (2)Classification. Class II. The permanently mounted wheelchair pdatform lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to and the following conditions for exemption: (i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must demonstrate that the safety controls are adequate to prevent a free fall of the pdatform in the event of a device failure; (ii)appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety; (iii)appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must demonstrate the ability of the enclosures to prevent the user from falling from the device; and (iv)appropriate analysis and nonclinical testing (such as that outlined in the currently zoiq P - oa--5( Page I of4 cv" is- 17

3 FDA-recognized editions of AAMI/ANSI/IEC , "Medical Electrical Equipment--Part 1-2: General Requirements for Safety--Collateral Standard: Electromagnetic Compatibility- -Requirements and Tests," and ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must validate electromagnetic compatibility and electrical safety. (b) Portable wheelchair elevators--(1)identification. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable pdatform lifts, attendant-operated stair climbing devices for wheelchairs). (2)Classification. Class II. (78 FR 14015, Mar. 4, Adaptive Engineering Inc. is requesting section (b) Portable wheelchair elevators inclusion in the pre-market exemption under (2)Classification. Class II as it meets the specified conditions for this exemption. B. Statement of Grounds The following are statements in which Adaptive Engineering Inc.'s mobile manual wheelchair lift meets or exceeds the specified conditions for exemption: Section (i) ( Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must demonstrate that the safety controls are adequate to prevent a free fall of the pdatform in the event of a device failure;) This lift meets ASME A18.1 (2.8.8). It should be noted that portable manual lifts are not specifically covered by ASME. The lift meets the specification of ADA part (4) which include, safety factors and requires that no single component could fail and result in a fall. Section (ii)(appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety;) Every lift has a Professional Engineer certified load test to 5 times the working load which meets the ASME A18.1(2.6.1). This test also confirms all workmanship, materials and fasteners. This exceeds the safety factor of 3 requirement under ADA 49 CFR 38 (2B). Section (iii) (Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must demonstrate the ability of the enclosures to prevent the user from falling from the device; and This lift meets the enclosure requirements of ADA 49 CFR (13). The ASME code applies only to fixed lifts. Section (iv) (Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC , "Medical Electrical Equipment-- Part 1-2: General Requirements for Safety--Collateral Standard: Electromagnetic Compatibility-- Requirements and Tests," and'asme A18.1 "Safety Standard for Platform Lifts and Stairway Chair Lifts") must validate electromagnetic compatibility and electrical safety.) Page 2 of 4

4 This section does not apply as the mobile manual wheelchair lift does not have any electrical components. Although there is no ASME code on portable manual lifts. Our mechanical components cables, drums, pulleys meet or exceed the codes ASME A18.1 (2.5.2). Other relevant information for consideration as the safety and effective performance has been well established: We have sold over 3000 of the lifts in the US over the last 25 years with no known safety incidents. The effectiveness is confirmed by the fact that this lift is the standard for rail travel throughout North America (AMTRAK, Caltrain, MBTA, MTA, Boston Tourist Rail and VIA Rail Canada). We are the "sole supplier" to the railways and they have no known alternative. We have worked with the railways to satisfy their preferences for "Buy America", "Disadvantaged Business Enterprises- DBE" and their concerns about "Sole Supplier". This can be confirmed with the commuter railways listed above. The "Effectiveness" of this patented lift results directly from the "manual operation", because of the almost 100 percent reliability required. A "stranded" traveler with a disability is an embarrassment to everyone, and can also lead to legal action because carriers are required under US Federal Law, (Americans with Disabilities Act) to provide access. Motorized lifts were investigated and tested, but were found to be not "effective" because of unreliability resulting from dead batteries, extension cord hazards and complexity. The end use of these lifts is unusual in that they may not be used for weeks then must work safely regardless of weather or operator training. This record can be verified with the legal or disabled access departments of Amtrak, New Jersey Transit, Alaska Rail, Caltrain, MBTA, Maryland Dept. of Transportation, and Tourist railways (complete list available on request). There has never been any question of renewal of our US product Liability Insurance (Rogers Insurance Ltd., contact: Nathan Klein, , nklein@rogersinsurance.ca ) The lift drive has a twin braking system with an automatic final mechanical backup with no known failure. There have been no changes in the basic simple manual lift for 20 years other than cosmetics or colors requested by some users. Information regarding misleading claims or risks associated with the characteristics of the device: Risk concern is discussed above and we know of no "misleading claims" (see ). Additional information: The lift was developed in collaboration with AMTRAK, Caltrain, Via Rail and the Americans with Disabilities Act over 20 years ago. An interruption in the availability of the lift would be a major concern to rail operators and disabled travelers. As noted above, there is no known alternative to this patented lift that they have all standardized on. The lifts have become the standard over 25 years and we submit that it would be in the public interest of railways and disabled travelers that we are able to continue supplying them. US railways are the biggest users of the lift, but they have been service around the world for decades with CE acceptance in Europe. Page 3 of 4

5 C. Environmental Impact There is no significant environmental impact of the mobile manual wheelchair lift. It is not motorized and the stainless steel and aluminum components are 90% recyclable after 20 years of use. Carbon footprint is limited to manufacturing only and there is no environmental impact for commercial/customer uses. No lubricants or oils are required for maintenance. D. Economic Impact Adaptive Engineering's mobile manual wheelchair lift is the standard lift used by the Rail industry throughout North America and is designated as "sole source". The economic impact of not obtaining this product for future or replacement units will be very costly, not only to individual operators but to government funded commuter rail. Amtrak alone has over 500 units in operation in various stages of aging. Some were recently replaced with new units, some still needing replacing and some are required for new stations. Without this product and its' maintenance parts not only will the rail companies feel the effects but also the consumer, especially those in the disabled community. At this time there is no comparable product sufficient to fulfill the highly specialize accessibility needs of the rail industry. Amtrak can be contacted through Gail Secan at (additional contacts available on request). E. Certification The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information know to the petitioner which are unfavorable to the petition. If you require a meeting or any additional information on this application, please do not hesitate to contact us at Adaptive Engineering Inc., (403) , info@adaptivelifts.com. Sincerely, Adaptive Engineering Dave Smith P.Eng., President, Chief Engineer. Adaptive Engineering Inc th Ave. S.E. Calgary, AB T2G 1V1 Canada Phone: (403) Fax: (403)

6 Page 1 of 2 From: (403) Dave Smith ADAPTIVE ENGINEERING INC AVE SE CALGARY, AB T2G1V1 CANADA SHIP TO (301) Origin ID: YYCB Fedym BILL SENDER Karen Kennard Division of Docket Management, FDA Depart. of Health & Human Services 5630 Fishers Lane, rm Rockville, MD us Express. J These commodities, technology. or software were exported from Canada in accordance with the export administration regulations Diversion contrary to Canadian law prohibited The Warsaw Convention may apply and will govern and in rnost cases limit the liability of Federal Express for loss or delay of or damage to your shipment Subject to the conditions of the contract. 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