(52 days)
No
The device description details a standard mechanical wheelchair with no mention of AI/ML components or functionalities.
No
The device is described as a wheelchair for transportation, which is a mobility aid, not a therapeutic device. Its predicate devices are also wheelchairs.
No
Explanation: The "Intended Use / Indications for Use" states the device is "For transportation of disabled persons," which indicates a functional support device rather than a diagnostic tool. The device description also details components for mobility, not diagnosis.
No
The device description clearly outlines physical hardware components (steel frame, wheels, seat, etc.), indicating it is a physical medical device, not software-only.
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 diagnosis, monitoring, or screening.
- 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)
- Indicated Patient Age Range (while some IVDs have age ranges, it's not a defining factor, but its absence here supports the non-IVD nature)
- Intended User / Care Setting (IVDs are often used in laboratories or clinical settings)
- Description of training/test sets, performance studies, and key metrics (these are crucial for validating the analytical performance of IVDs)
The device described is clearly a mechanical wheelchair, which falls under the category of medical devices used for mobility assistance. The predicate devices listed (K945175, K35398, K915262) are also all mechanical wheelchairs, further confirming its classification.
N/A
Intended Use / Indications for Use
For transportation of disabled persons.
Product codes
IOR
Device Description
The device consists of a chromed steel frame with cross bars, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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).
0
JAN 1 3 2000
510(k) SUMMARY
This is an Initial 510(k) Summary in accordance with 21 CFR 807.92 (a)
- Submitted by: Sigma Distribution & Supply, Inc. (1) 701 West Harvard Street Glendale, CA 91204 Phone (818) 246-4624 Contact: Arthur Keshishyan Prepared 10/28/1999
- SIGMA MANUAL WHEELCHAIR (2) Propriety Name: Common Name: Manual Wheelchair Classification Name: Manual, wheelchair
(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 Wheelchairs, K35398 Bantex Brand Wheelchairs, K915262
The device consists of a chromed steel frame with cross bars, slung fabric seat (4) 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 FOSHAN DONGFANG MEDICAL EQUIPMENT MANUFACTORY compared with the dimensions 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. Furhter the fabric of the subited whhelchair mcets the NFPA 701-89 Flame Resistant Textile and Films test.
| Our Submitted Wheelchair | Invacare Tracer Wheelchair (510(k) #K93539 | |
|---|---|---|
| 1. Seat Ht. | 20" | 20" |
| 2. Widths | 14"-22" | 14"-22" |
| 3. Rear Wheels | 24" | 24" |
| 4. Front Casters | 8" | 8" |
| Product Wt. | 43lbs | 44lbs |
| 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 consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2000
Mr. Arthur Keshishyan Sigma Distribution & Supply, Inc. 701 West Harvard Street Glendale, California 91204
Re: K993963 Trade Name: Sigma Manual Wheelchair Regulatory Class: I Product Codc: IOR Dated: November 8, 1999 Received: November 22, 1999
Dear Mr. Keshishyan:
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 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 (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 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.
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.
2
Page 2 - Mr. John T. Mogensen
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) 594-4595. 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.gov/cdrh/dsmamain.html".
Sincerely yours,
Mark. .1 Mull...
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
KG143963 510(k) Number ::K992389-Device Namc: SIGMA MANUAL WHEELCHAIR
Indication For Use:
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)
Prescription Use __
OR
Over the Counter Use
Monk n Milken
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K993963