(44 days)
Dynamic Systems PHC-2, PHC-3, Adaptive Switch Laboratories Inc.'s ASL Head Array, Invacare's Sip and Puff head array, Invacare's Remote Joystick
Not Found
No
The summary describes a head movement commanded driving control for wheelchairs and does not mention any AI or ML terms or concepts.
No
The device is a control module for operating powered wheelchairs, providing mobility rather than diagnosing, treating, or preventing a disease or condition.
No
The device is described as a "head movement commanded driving control" for powered wheelchairs, indicating it is an assistive control device, not one used to identify or analyze a disease or condition.
No
The description explicitly states "head movement commanded driving control" and lists predicate devices that are hardware-based head arrays and joysticks, strongly implying a hardware component is involved in detecting and translating head movements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "non-contact, fully proportional, head movement commanded driving control intended to provide mobility to persons restricted to a seated position while operating a variety of powered wheelchairs." This describes a device used for controlling a physical object (a wheelchair) based on a user's physical movement (head movement).
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens or any diagnostic purpose.
- Anatomical Site: While the anatomical site is listed as "head," this refers to the part of the body being used to control the device, not a site from which a specimen is being collected for analysis.
Therefore, the Escape Control Module falls under the category of a medical device used for mobility assistance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Escape Control Module is a non-contact, fully proportional, head movement commanded driving control intended to provide mobility to persons restricted to a seated position while operating a variety of powered wheelchairs.
Product codes
ITI
Device Description
The Escape Control Module is a non-contact, fully proportional, head movement commanded driving control.
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)
Dynamic Systems PHC-2, PHC-3, Adaptive Switch Laboratories Inc.'s ASL Head Array, Invacare's Sip and Puff head array, Invacare's Remote Joystick
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
AUG 01 2002
510(k) Summary
Specialty Drive Technologies, Inc.'s Escape Control Module
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Specialty Control Technologies, Inc. 509 Pleasant Hill Church Rd. Winder, GA 30680 Phone: 770 363-7398 Fax: 770 586-0917
Contact Person: Scott Kersey
Date Prepared:June 17, 2002
Name of Device and Name/Address Of Sponsor
Escape Control Module Specialty Control Technologies, Inc. 509 Pleasant Hill Church Rd. Winder, GA 30680 Phone: 770 363-7398 770 586-0917 Fax:
Common or Usual Name
Escape Control Module
Classification Name
Power Wheelchair Control Unit
Predicate Devices
The Escape Control Module is substantially equivalent to Dynamic Systems PHC-2 and PHC-3, Adaptive Switch Laboratories Inc.'s ASL Head Array, Invacare's Sip and Puff head array and Invacare's Remote Joystick.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a cascading manner. The profiles are connected by flowing lines that resemble a ribbon or banner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 01 2002
Specialty Drives Technologies, Inc. Scott Kersey 509 Pleasant Hill Church Road Winder. Georgia 30680
Re: K021995
Trade Name: Escape Control Module Regulation Number: 890.3860 Regulation Name: Wheelchair, powered (accessory) Regulatory Class: II Product Code: ITI Dated: June 17, 2002 Received: June 18, 2002
Dear Mr. Kersey:
We have reviewed your Section 510(k) premarket 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) 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
2
Page 2 - Mr. Scott Kersey
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Sincerely yours,
Mark H. Milkman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
510(k) Number: _ KO21995
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Device Name:
Indications for Use: The Escape Control Module is a non-contact, fully proportional, head movement commanded driving control intended to provide mobility to persons restricted to a seated position while operating a variety of powered wheelchairs.
PLEASE DO NOT WRITE BELOW THIS LINE (CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-the-Counter Use ✓
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | ----------------------------------------------------------------------------------------------------- |
|---|
for
| (Division Sign-Off) | (Division Sign-Off) |
|---|---|
| Division of General, Restorative | |
| and Neurological Devices | Division of General Restorative Devices |
| 510(k) Number | 510(k) Number |
| K021995 |
Mark N. Melleur