(35 days)
No
The device description details a standard mechanical wheelchair with no mention of AI or ML components.
No
The device is a wheelchair used for transportation, not for treating or diagnosing a medical condition.
No
This device is a wheelchair, used for transportation of disabled persons. It does not perform any diagnostic functions.
No
The device description clearly outlines a physical wheelchair with a steel frame, fabric seat, wheels, and other hardware components. It does not describe software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For transportation of disabled persons." This describes a physical aid for mobility, not a device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details the physical components of a wheelchair, which is a mechanical device for transportation. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document explicitly states "Not Found" for key indicators typically associated with IVDs, such as:
- Mentions image processing
- Mentions AI, DNN, or ML (often used in analyzing biological data)
- Input Imaging Modality
- Anatomical Site (IVDs often target specific anatomical sites for sample collection)
- Description of training/test sets and performance studies (crucial for validating the accuracy and reliability of IVDs)
- Key Metrics (Sensitivity, Specificity, etc., which are performance measures for diagnostic tests)
In summary, the device's purpose and description clearly align with a mobility aid, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
For transportation of disabled persons.
Product codes
IOR
Device Description
The device consists of a folding chromed steel frame with cross braces, slung fabric seat and back, fixed or removable armrests, fixed or removable foot/legrests, front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K945175, K35398, K915262, K930411
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).
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1 CI S R D FAITH CALL F τ
Image /page/0/Picture/1 description: The image shows the logo for G. Hirsch and Company Inc. The logo is in black and white, with the words "G. HIRSCH" in large, bold letters on a black background. Below that, the words "AND COMPANY INC." are in smaller letters on a white background.
AUG 3 1 1998
KG82607
510(k) SUMMARY
(a) This is an Initial 510(k) Summary in accordance with 21 CFR 807.92.
(1) Submitted by: G. Hirsch and Company, Inc. 1815 Rollins Road Burlingame, CA 94010-2204 Phone (650) 692-8770 Contact: Garv Hirsch Prepared 07/24/98
- (2) Proprietary Name: Manual Wheelchair Common Name: Manual Wheelchair Classification Name: Wheelchair, Mechanical
(3) Examples of four legally marketed devices of substantial equivalence, together with their 510(k) numbers are as follows:
Mechanical Wheelchair 980.3850, K945175 Tracer Series Manual Wheelchairs, K35398 Bantex Brand Wheelchairs, K915262 Universal Wheelchair, K930411
(4) The device consists of a folding chromed steel frame with cross braces, slung fabric seat and back, fixed or removable armrests, fixed or removable foot/legrests, front caster wheels for steering, rear push handles for attendant-assisted propulsion, rear drive wheels with handrims for self-propulsion, and lever-style wheel locks.
(5) The wheelchair is to be used for transportation of disabled persons.
(6) The wheelchair exhibits no material differences from the predicate devices listed in number (3) above. Please see the enclosed catalog pages of Invacare Tracer Series wheelchairs (510(k) #K935398) for a comparison of design features, which we believe to be equivalent to our submitted wheelchair. Some items for comparison are listed below.
| Our submitted wheelchair | Invacare Tracer Wheelchair (510(k)#K935398) | |
|---|---|---|
| 1. Seat Ht. | 20" | 20" |
| 2. Widths | 14" – 22" | 14" - 20" |
| 3. Rear Wheels | 24" | 24" |
| 4. Front Casters | 8" | 8" |
| 3. Product Wt. | 42 lbs. | 44 lbs. |
| 4. Weight Limit: | 250 lbs. | 250 lbs. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 1998
Mr. Gary Hirsch President G. Hirsch and Company, Inc. 1815 Rollins Road 94010 Burlingame, California
Re: K982607 Manual Wheelchair Trade Name: Regulatory Class: I Product Code: IOR Dated: July 24, 1998 Received: July 27, 1998
Dear Mr. Hirsch:
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 Requlations, Title 21, Parts 800 to 895. ಡಿ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements 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.
2
Page 2 - Mr. Gary Hirsch
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 1 its internet address "http://www.fda.gov/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
3
510(k) Number (if known):_
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
ン
For transportation of disabled persons.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
te colly
(Division Sign-Off) Division of General Restorative Devices 16982607 510(k) Number.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
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(Optional Format 1-2-96)