(608 days)
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No
The description focuses on mechanical and electrical components for converting a manual wheelchair to a powered one, with no mention of AI or ML.
No
This device is described as a powered wheelchair conversion kit, designed to assist with mobility, not to treat or diagnose a medical condition.
No
The device converts manually operated wheelchairs to powered wheelchairs, which is a functional enhancement, not a diagnostic purpose.
No
The device description clearly outlines numerous hardware components, including a central disc structure, cosmetic covers, a direct gear drive, a pancake motor with a rare earth magnet, and components for power source, power conversion, and power electronics. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to convert manually operated wheelchairs to powered wheelchairs. This is a mechanical function related to mobility and transportation.
- Device Description: The description focuses on the mechanical and electrical components of a powered wheel designed for a wheelchair. It describes motors, gears, power sources, and electronics related to driving the wheel.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Providing information about a person's health status, diagnosis, or treatment.
- Any form of in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic, monitoring, or screening purposes. This device clearly falls outside of that category.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The features described in the section of the Premarket Notification 510(k) entitled, SAFETY AND EFFECTIVENESS OF THE SPRW, are as follows: 1.) All the components for driving the wheels are rigidly supported in a central disc structure forming the wheel cavity; 2.) The cavity is fully enclosed by cosmetic covers; 3.) The components have been chosen for longevity to outlast two or more wheelchair frames; 4.) The resulting wheels can be quickly interchanged with the standard wheels of a manually operated wheelchair; 5.) A direct gear drive; 6.) The pancake motor with a state of the art rare earth neodymium-Iron-Boron magnet, makes this motor one of the most powerful for it's size; 7.) The SPRW is the first time that, a wheel used for transportation, has rotating within it: it's own power source, power conversion means (electrical to mechanical), power electronics photo-optic signal transmission at the hub between rotating and non-rotating components.
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/0 description: The image shows the text "DataTran Inc." followed by a black square, a right arrow, and an empty square. The text is in a simple, sans-serif font and is the main focus of the image. The symbols are aligned horizontally with the text.
Kg50025
Man/Machine System Innovators
December 26, 1994
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Bld. Rockville, Maryland 20850
Re: 510(k) Self Propelled Robotic Wheel(SPRW), Owner / Operator No. 9011753
Attention: Document Mail Clerk
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requrements of the Safe Medical Device Act of 1990 and 21 CFR 807.92." With this letter DataTran Inc., the developer of the Self Propelled Robotic Wheel (SPRW) requests that the Office of Device Evaluation (ODE) review the enclosed Premarket Notification 510(k) submission.
SEP
3 1996
This 510k will show that the SPRW has a "predicate device" which was sold by SOLO PRODUCTS INC., on the interstate market, during the years 1975 to 1983. It began to be sold prior to May 28, 1976; and in accordance with the Federal Food, Drug and Cosmetic Act, 513(i)(1)(A),(1)(2), if ODE agrees, it is requested that they transmit to DataTran, a "Substantially Equivalent 510(k) letter."
DataTran has determined that the SPRW, when mounted on a wheelchair frame, converts manually operated wheelchairs to powered wheelchairs, and falls under class II as defined by 21 CFR 807. DataTran has "Taken action to assure performance", by having made arrangements with the University of Pittsburgh to verify our assertion that the SPRW device/system is in compliance with the ANSI/RESNA 1991 Wheelchair Standard.
The features described in the section of the Premarket Notification 510(k) entitled, SAFETY AND EFFECTIVENESS OF THE SPRW, are as follows: 1.) All the components for driving the wheels are rigidly supported in a central disc structure forming the wheel cavity; 2.) The cavity is fully enclosed by cosmetic covers; 3.) The components have been chosen for longevity to outlast two or more wheelchair frames; 4.) The resulting wheels can be quickly interchanged with the standard wheels of a manually operated wheelchair; 5.) A direct gear drive; 6.) The pancake motor with a state of the art rare earth neodymium-Iron-Boron magnet, makes this motor one of the most powerful for it's size; 7.) The SPRW is the first time that, a wheel used for transportation, has rotating within it: it's own power source, power conversion means (electrical to mechanical), power electronics photo-optic signal transmission at the hub between rotating and non-rotating components.
Notwithstanding that there is at least one "predicate device" that the SPRW is "substantially equivalent" to, the SPRW system includes innovations such as the infrared transmission link. These features are subject of a patent application which has been formally allowed for filing by the US Patent Office, to issue in mid 1995. This link is at least as safe and reliable as any signal transmission path used by the "predicate devices" for controlling speed and direction of the wheelchair. In no way do the innovations alter the "intended use" or the technologies used for the "predicate devices." The prime motivation for introducing the innovations is safety and effectiveness for the SPRW system.
Within the enclosed 510(k) there is information which is proprietary to DataTran Inc., It is requested that those who review the contents of the 510(k) maintain this confidentiality.
E.A. Avakian, President
Emik A. Avakian, President Contact person
12-26-94
Date
67 Applewood Drive · Chicopee, MA 01022 · (413) 593-9574