(8 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices.
Yes
The device is described as being for "Persons who are unable to walk or who have a walking impediment," which implies it is intended to provide a therapeutic benefit by helping individuals with mobility issues.
No
The intended use statement describes the device for persons who are unable to walk or have a walking impediment, implying a functional or assistive purpose rather than diagnosing a medical condition.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is 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 "Persons who are unable to walk or who have a walking impediment." This describes a physical condition and a functional limitation, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (biomarkers, pathogens, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions based on laboratory results.
The intended use strongly suggests a device designed to assist with mobility, such as a wheelchair, walker, or other assistive device. These are not considered IVDs.
N/A
Intended Use / Indications for Use
- Persons who are unable to walk or who have a walking impediment.
Product codes
IOR
Device Description
Start Family of Manual Wheelchairs (Basic, Plus, Multi and Hemi)
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)
Not Found
Reference Device(s)
Not Found
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).
0
OCT 6 - 2005
Otto Bock®
Ko52681/
QUALITY FOR LIFE
510(k) SUMMARY of SAFETY and EFFECTIVENESS
A. General Information
一次,第二次
| 1. | Submitter's Name: | OTTO BOCK Health Care, LP |
|---|---|---|
| 2. Address: | Two Carlson Parkway North, Suite 100 | |
| Minneapolis, Minnesota USA 55447-4467 | ||
| 3. | Telephone: | 763-553-9464 |
| 4. | Contact Person: | Bert Harman |
| 5. | Date Prepared: | August 1, 2005 |
| 6. | Registration Number: | 2182293 |
| B. Device | ||
| 1. | 1. Name: | Start Family of Manual Wheelchairs (Basic, Plus, |
| Multi and Hemi | ||
| 2. | 2. Trade Name: | Start Family of Manual Wheelchairs (Basic, Plus, |
| Multi and Hemi | ||
| 3. Common Name: | Manual Wheelchair | |
| 4. | 4. Classification Name: | Manual Wheelchair |
| 5. | 5. Product Code: | IOR |
| 6. | 6. Class: | I |
| 7. | 7. Regulation Number: | 890.3850 |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the upper portion of the circular border.
OCT 6 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bert Harman President OTTO BOCK Health Carc, LP Two Carlson Parkway North, Suite 100 Minneanolis, Minnesota 55447-4467
Re: K052681
Trade/Device Name: Start Family of Manual Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: 1 Product Code: IOR Dated: August 1, 2005 Received: September 28, 2005
Dear Mr. Harman:
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 (PM), 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 complics 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.
2
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 (240) 276-0120. 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.1da.gov/cdrl/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): To be determined
Device Name: Start Family of Manual Wheelchairs
Indications for Use:
- Persons who are unable to walk or who have a walking impediment. .
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(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, and Neurological Devices
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