(145 days)
The Bruno Powerbase Model 2200 is designed to assist those Homecare Patients whose afflictions or disabilities require them to use motorized assistance for daily mobility. Typically these users would not be able to maintain independence with a manual wheelchair. The Bruno Powerbase is intended to be used in a primarily indoor environments with limited use on hard relatively level outdoor surfaces such as sidewalks, ramps and hard packed garden plots.
Power Wheelchair Model 2200
The provided document is a 510(k) clearance letter from the FDA for a power wheelchair, Model PSB-2200 (also referred to as Model 2200). It focuses on the substantial equivalence of the device to a predicate device and its indications for use. The document does not contain any information regarding acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for testing or training, ground truth establishment, or details of specific studies proving the device meets acceptance criteria.
Therefore, I cannot answer the questions directly from the provided text. The output of the desired information would be:
- A table of acceptance criteria and the reported device performance: Not provided in the document.
- Sample sized used for the test set and the data provenance: Not provided in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided as there's no mention of a ground truth for a test set.
- Adjudication method for the test set: Not provided in the document.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical medical device (power wheelchair), not an AI/imaging diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable/provided.
- The sample size for the training set: Not provided in the document.
- How the ground truth for the training set was established: Not applicable/provided.
The document is a regulatory clearance letter, not a clinical study report or technical specification detailing performance metrics.
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Image /page/0/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" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov - 2 1999
Mr. William W. Belson III Director of Engineering Bruno Independent Living Aids, Inc. 1780 Executive Drive Oconomoc, Wisconsin 53066
Re: K991954 The Bruno Powerbase, Model PSB-2200 Trade Name: Requlatory Class: II Product Code: ITI Dated: September 20, 1999 Received: September 21, 1999
Dear Mr. Belson:
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 reguirements 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 Regulation (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 regulations.
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Page 2 - Mr. William W. Belson III
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 premarket notification" (21 CFR 807.97). 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.qov/cdrh/dsmamain.html".
Sincerely yours,
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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Image /page/2/Picture/0 description: The image shows the logo for Bruno Independent Living Aids. The logo features a stylized image to the left of the word "BRUNO" in large, bold letters. Below "BRUNO" is the text "INDEPENDENT LIVING AIDS" in a smaller font. Underneath that, it says "ISO 9001 CERTIFIED".
FDA 510(k) INDICATIONS FOR USE
510(k) Number: Device Name:
K991954 Power Wheelchair Model 2200
Indications For Use:
The Bruno Powerbase Model 2200 is designed to assist those Homecare Patients whose afflictions or disabilities require them to use motorized assistance for daily mobility. Typically these users would not be able to maintain independence with a manual wheelchair.
The Bruno Powerbase is intended to be used in a primarily indoor environments with limited use on hard relatively level outdoor surfaces such as sidewalks, ramps and hard packed garden plots.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of General Restorative Devices |
510(k) Number .
Prescription Use (PER 21 CFR 801.109) OR
Over-The-Counter Use X
(Optional format 1-2-96)
510(k) K991954 Response letter
§ 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).