(627 days)
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No
The description focuses on voice command recognition and control, which can be achieved with traditional signal processing and pattern matching techniques without necessarily employing AI/ML. There is no mention of learning, adaptation, or complex decision-making beyond interpreting predefined voice commands.
No.
The device is a voice-operated control system for electric wheelchairs, enhancing mobility for users who can control their chairs with voice commands. It is an assistive technology, but it does not treat or diagnose any medical condition, nor does it restore a damaged function of the body.
No
The device is described as an integrated voice-operated control system for electric wheelchairs, allowing the occupant to control movement using voice commands. There is no mention of it being used for diagnosis, disease detection, or medical assessment.
No
The device description explicitly refers to an "Integrated Voice Operated Control Unit (IVOC-1)", implying a physical hardware component that integrates with the wheelchair controllers. The summary does not indicate this is purely software running on existing hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control the movement of an electric wheelchair using voice commands. This is a functional device for mobility assistance.
- Device Description: The device is described as an "Integrated Voice Operated Control Unit (IVOC-1) for Powered Wheelchairs." This description aligns with a control system for a physical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or treatment based on biological markers.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device does not fit that description.
N/A
Intended Use / Indications for Use
Integrated Voice Operated Control system for electric wheelchairs, allows the occupant to control movement of their chair by using voice commands.
Controllers. The user's wheelchair must have one of the following controllers:
A. Invacare MK IV controller.
B. Everest and Jennings Z-51 or Z-61 controller.
C. Quickie P100, P200, or P300 controller.
D. Dynamic Controls Ltd. DX-Power controller.
Vocal Capability. The User must have the ability to consistently reproduce a series commands or sounds.
Emergency Stop Switch. The User must have the capability to activate a manual Emergency Stop Switch.
Product codes (comma separated list FDA assigned to the subject device)
LFF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 890.3920 Wheelchair component.
(a)
Identification. A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
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Image /page/0/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 with three human profiles incorporated into the design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 1998
Mr. Ken Hollenbeck President Interactive Living Systems, Inc. 14901 East Hampden Avenue, Suite 310 Aurora, Colorado 80014
Re: K964977 Integrated Voice Operated Control Unit (IVOC-1) for Powered Wheelchairs Requlatory Class: II Product Code: LFF Dated: July 31, 1998 Received: August 6, 1998
Dear Mr. Hollenbeck:
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 Regulations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 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. Ken Hollenbeck
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.gov/cdrh/dsmamain.html".
Sincerely yours,
Ph.D., M.D. a M. Witten, Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if known): K964977
Device Name:
Indications For Use: Integrated Voice Operated Control system for electric wheelchairs, allows the occupant to control movement of their chair by using voice commands.
Controllers. The user's wheelchair must have one of the following controllers:
A. Invacare MK IV controller. B. Everest and Jennings Z-51 or Z-61 controller. C. Quickie P100, P200, or P300 controller. D. Dynamic Controls Ltd. DX-Power controller. Vocal Capability. The User must have the ability to consistently reproduce a series commands or sounds.
Emergency Stop Switch. The User must have the capability to activate a manual Emergency Stop Switch.
(Please do not write below this line-continue on another page if needed)
Concurrence of CDRH,Office of Device Evaluation (ODE)
Signature
(Division Sigh-Off) Division of General Restorative Devices צו GC 497 510(k) Number
Prescription Use (21 CFR 801.109) OR
Over-the- Counter Use X
(Optional Format 1-2-96)
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