(126 days)
The Caddy is a transportable / foldable electric scooter. The Caddy Scooter has been developed especially for those people with Mobility problems are generally problems with walking or with the stamina. wanting or was as a suite for the use of elderly persons and physically disabled persons. The Caddy scooter was developed especially for use in and around the house and to be taken along for trips. For this purpose the scooter can be folded and disassembled easily and the separate parts can be handled with ease.
The Caddy is a transportable / foldable electric scooter.
The provided text is a 510(k) premarket notification letter from the FDA regarding a powered wheelchair named "CADDY." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter explicitly states: "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..."
Substantial equivalence (SE) is a regulatory pathway that allows a new device to be marketed if it is as safe and effective as a legally marketed predicate device. It does not typically require the submission of clinical trials with specific acceptance criteria and detailed study results as would be the case for a premarket approval (PMA) application or certain novel devices.
Therefore, I cannot provide the requested information based on the given text. The text does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method.
- MRMC comparative effectiveness study or its effect size.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an eagle or bird with three wave-like lines beneath it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 9 2004
Avner Fishbein Afikim Electric Vehicles Kibbutz Afikim 15148 Israel
Re: K041186 Trade/Device Name: CADDY Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: August 6, 2004 Received: August 13, 2004
Dear Mr. Fishbein:
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 for ass been a lor 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.
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Page 2 – Avner Fishbein
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotel with at a so the finding of substantial equivalence of your device to a legally premailer notification. The 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 If you desire specific as no and (301) 594-4659. Also, please note the regulation entitled, Connect the Ories of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micromational 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 yours,
Mark A. Milken
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
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Indications for Use
510(k) Number (if known): K041186
CADDY Device Name:
Indications for Use:
The Caddy is a transportable / foldable electric scooter.
The Caddy Scooter has been developed especially for those people with The Caddy Books. Mobility problems are generally problems with walking or with the stamina.
wanting or was as a suite for the use of elderly persons and physically disabled persons.
The Caddy scooter was developed especially for use in and around the house and to be taken along for trips. For this purpose the scooter can be folded and disassembled easily and the separate parts can be handled with ease.
Mark N. Millman
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K041186
mber
510(k) Number_
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).