(38 days)
The FR168W Powered Wheelchair provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
The FR168W Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The product has a base with six wheels, an adjustable seat with armrests, an adjustable footrest, and a controller attached to one armrest. The controller allows the rider to control the movement of the chair. The chair can be disassembled for transport and is provided with a battery charger.
The provided text is a 510(k) summary for the FR168W Powered Wheelchair. It describes the device, its intended use, and its substantial equivalence to a predicate device (Jazzy Power Chair).
However, the documentation explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
Therefore, based on the provided text, I cannot describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner requested (i.e., with performance metrics, sample sizes, ground truth establishment, or expert involvement). The submission relies on establishing substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results.
Given the constraints of the provided document, here's an answer that states what is available and explains what is not available:
Acceptance Criteria and Device Performance Study (Based on Provided Document)
1. Table of Acceptance Criteria and Reported Device Performance:
The 510(k) summary for the FR168W Powered Wheelchair does not provide a table of specific quantitative acceptance criteria or reported device performance metrics from a formal study. The submission establishes substantial equivalence through a comparison of technological characteristics and intended use with a predicate device.
The "Testing conducted" section states: "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission." However, the specific acceptance criteria and results of these tests are not detailed in this public 510(k) summary.
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided regarding a sample size for a test set, as comparative performance testing and clinical evaluations were not submitted as part of this 510(k). The submission focuses on demonstrating substantial equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. As no comparative performance or clinical evaluations were submitted, there was no ground truth to establish by experts in the context of device performance.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring expert adjudication was described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or submitted. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, there is no information on the effect size of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The device is a powered wheelchair; it does not involve algorithms or AI that would require a standalone performance study in the way this question implies for software or diagnostic devices.
7. Type of Ground Truth Used:
Not applicable. The submission for this traditional medical device (powered wheelchair) did not involve a "ground truth" in the context of expert consensus, pathology, or outcomes data for a diagnostic or AI-driven device. Substantial equivalence was demonstrated by comparing features and intended use to an existing predicate device.
8. Sample Size for the Training Set:
Not applicable. This device is a powered wheelchair, not an AI/ML algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This question is irrelevant for the type of device and submission described.
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K033370
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510(k) SUMMARY
Submitter's Name:
FreeRider Corporation No. 181, Ta-Te 18t Road Kang Shan Town, Kaohsiung Taiwan R.O.C. 886-7-622-3093
October 6, 2003 Date summary prepared:
Device name:
Proprietary name: Common or usual name: Classification name:
FR168W Powered Wheelchair Power chair. Powered wheelchair, Class II, 21 CFR 890.3860.
Legally marketed device for substantial equivalence comparison:
Jazzy Power Chair submitted by Pride Health Care, Inc. and cleared for marketing under 510(k) *K945936.
Description of the device:
The FR168W Powered Wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The product has a base with six wheels, an adjustable seat with armrests, an adjustable footrest, and a controller attached to one armrest. The controller allows the rider to control the movement of the chair. The chair can be disassembled for transport and is provided with a battery charger.
Intended use of device:
The FR168W Powered Wheelchair provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
Technological characteristics:
The device features and use parameters of the FR168W Powered Wheelchair and the Jazzy Power Chair are very similar. Both are battery operated, have two motors, and have automatic braking systems. The controllers regulate similar features for both wheelchairs. Battery chargers and instructions for their use are supplied with both chairs. Use parameters are very similar as well, with minor variations in such areas as turning radius and maximum speed.
Testing conducted:
Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results included in the subject 510(k) submission.
Performance testing:
Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).
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SECTION 3 - INTENDED USE
Intended use of device:
The FR168W Powered Wheelchair provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
Intended use of predicate device:
The intended use of the Jazzy Power Chair is given in the Owner's Manual "Your power chair is a state-of-the-art life-enhancement device designed to increase mobility."
Comparison:
The intended uses of the two products are identical.
Labeling:
The intended use of the FR168W Powered Wheelchair is on page 4 of the Owner's Manual found in Appendix II. The intended use of the Jazzy Power Chair is on page 6 of the Owner's Manual found in Appendix V.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
NOV 28 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FreeRider Corporation C/o Mr. Robert S. McQuate R.S. McQuate and Associates, Inc. 3636 E. Columbine Drive Phoenix. Arizona 85032
Re: K033370
Trade/Device Name: FR168W Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: October 16, 2003 Received: October 21, 2003
Dear Mr. McQuate:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Robert S. McQuate
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Mark N. Milkeson
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number ( if known):
Device name: FR168W Powered Wheelchair
Indications for Use: The FR168W Powered Wheelchair provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR .
Over-The-Counter Use √
for Mark A. Millbern
or, Off) visio Teneral, Restorative Divisio: and Net logical Devices
"10(k) Number --
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).