(29 days)
Predicate manual wheelchair use is stated to allow user, or user assistant to propel or push chair in order to maneuver seated individual in a safe, controlled environment. Also must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality.
Wheelchair to be a manual transport device, with 8" fron swivel casters on the front, and 24" mag style wheels on the rear. Wheelchair will be foldable for storage, will be chrom- plate Finnish. Armrests will be padded or plastic and wil have padded embossed upholstery for user comfort. Wheelchair will be equipped with wheel locks to prevent rolling while transferring patient. Push handles will be of a non-slip vinyl material. Standard color available will be dark blue. Chairs to have rear extensions to prevent tip-over. Wheelchairs to be available in models with swing away footrests or elevating legrests as shown in pictures.
This document is a 510(k) summary for the Transport Plus and Transport Deluxe manually propelled transport wheelchairs. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study demonstrating acceptance criteria met by the device itself. Therefore, many of the requested elements for a study showing device performance are not available in this type of document.
Here's an analysis based on the provided text, highlighting where information is missing due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific acceptance criteria in the way one would for a diagnostic algorithm (e.g., minimum sensitivity/specificity thresholds). Instead, it aims to demonstrate substantial equivalence to predicate devices based on design, materials, and intended use. The "performance" is implicitly tied to meeting the functionality described for a manual wheelchair.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (from "Device Description" and "Intended Use") |
|---|---|
| Functionality for Maneuvering: | Allows user or user assistant to propel/push chair to maneuver seated individual in a safe, controlled environment. |
| Braking/Locking Mechanism: | Must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality. Equipped with wheel locks to prevent rolling while transferring patient. |
| Portability/Storage: | Foldable for storage. |
| Material/Construction: | Chrome-plate Finnish (frame). Armrests: padded or plastic. Upholstery: padded embossed. Push handles: non-slip vinyl. Rear extensions to prevent tip-over. |
| Wheel Configuration: | 8" front swivel casters, 24" mag style wheels on the rear. |
| User Comfort/Features: | Padded embossed upholstery, padded or plastic armrests. Models with swing away footrests or elevating legrests. |
| Safety: | Rear extensions to prevent tip-over. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This is a 510(k) premarket notification for a physical medical device (wheelchair), not a software or AI/ML device requiring a test set of data. The "test" here refers to the design and features satisfying the requirements for a wheelchair, often through engineering analysis and potentially mechanical testing, though no details are provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. As above, this isn't a diagnostic device where "ground truth" is established by experts interpreting data. The "ground truth" for a wheelchair's safety and effectiveness is established through compliance with established standards for medical devices of its type, and comparison to legally marketed predicate devices.
4. Adjudication Method for the Test Set
- Not Applicable. No data adjudication is described as this is not a study involving human interpretation of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This type of study is not relevant for a manual wheelchair. MRMC studies are typically performed for imaging or diagnostic devices where human readers interpret medical cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- For the purpose of this 510(k) submission, the "ground truth" is the established functionality and safety profile of already legally marketed predicate manual wheelchairs (Everest & Jennings model Universal wheelchair – K930411 and Invacare model Rolls 2000 wheelchair - K881762). The manufacturer asserts that the new device shares the same intended use and fundamental technological characteristics as these predicates.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above, no training set is involved.
Summary of the Study (or Basis for Clearance):
The document you provided is a 510(k) Summary for a medical device (manual wheelchair). The "study" in this context is the comparison to legally marketed predicate devices to demonstrate substantial equivalence. The manufacturer asserts that the Transport Plus and Transport Deluxe wheelchairs have the same intended use and similar technological characteristics as the identified predicate devices (Everest & Jennings model Universal wheelchair – K930411 and Invacare model Rolls 2000 wheelchair - K881762).
The core of this submission is not a performance study in the clinical trial sense, but rather a regulatory submission where the "acceptance criteria" are the regulatory requirements for showing equivalence, which are met by detailing the device's design, materials, and intended use, and showing how these align with existing cleared devices. The FDA's letter (K973418) acknowledges receipt and states that the device is "substantially equivalent," allowing it to be marketed.
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Assembly Required Distributors Inc.
3 Crabapple Lane Commack, NY 11725-2405 Phone/fax 516-864-9575
14973418
September
September 5, 1997
510K Summary
-7 -
| Submitter: | Assembly Required Distributors Inc.3 Crabapple LaneCommack, NY 11725516-864-9575 |
|---|---|
| Contact Person: | Doreen Murphy |
| Date of Preparation: | 9/8/97 |
| Trade/Proprietary Name: | Transport Plus and Transport Deluxe |
| Common/Usual Name: | Manually Propelled Transport Wheelchair |
| Legally Marketed Device:For Equivalence | Everest & Jennings model Universal wheelchair – K930411Invacare model Rolls 2000 wheelchair - K881762 |
| Device Description: | Wheelchair to be a manual transport device, with 8" fronswivel casters on the front, and 24" mag style wheels on therear. Wheelchair will be foldable for storage, will be chrom-plate Finnish. Armrests will be padded or plastic and wilhave padded embossed upholstery for user comfort.Wheelchair will be equipped with wheel locks to preventrolling while transferring patient. Push handles will be of anon-slip vinyl material. Standard color available will be darkblue. Chairs to have rear extensions to prevent tip-over.Wheelchairs to be available in models with swing awayfootrests or elevating legrests as shown in pictures. |
| Intended Use: | Predicate manual wheelchair use is stated to allow user, oruser assistant to propel or push chair in order to maneuverseated individual in a safe, controlled environment. Alsomust be able to lock rear wheels for patient transfer. Subjectwheelchair is to have same functionality. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping lines that suggest a face and neck. The figure is oriented to the right. Encircling the figure is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 9 1997
Ms. Doreen Murphy Compliance Officer Assembly Required Distributors, Inc. 3 Crabapple Lane Commack, New York 11725-2405
K973418 Re: Transport Plus and Transport Deluxe Trade Name: Requlatory Class: I Product Code: IOR September 8, 1997 Dated: Received: September 10, 1997
Dear Ms. Murphy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Doreen Murphy
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regaracion enereroa, "hibbianany "}} Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Assembly Required Distributors Inc.
3 Crabapple Lane Commack, NY 11725-2405 Phone/fax 516-864-9575
September 5, 1997
Intended Use:
Predicate manual wheelchair use is stated to allow user, or user assistant to propel or push chair in order to maneuver seated individual in a safe, controlled environment. Also must be able to lock rear wheels for patient transfer. Subject wheelchair is to have same functionality.
Acoello
Over-the-Counter Use X
N/A