(70 days)
Not Found
Not Found
No
The summary describes a compression support and insoles with magnets and anti-bacterial properties, focusing on physical support, moisture wicking, and odor control. There is no mention of AI or ML in the intended use, device description, or any of the other sections.
Yes
The device is described as providing "relief of minor physical discomforts" and "relief of discomfort in self-limiting physical injuries," which are therapeutic claims.
No
The device is described as providing support and relief for physical discomforts and injuries, absorbing moisture, and resisting bacterial growth. It does not mention any capabilities related to identifying, analyzing, or determining the nature or cause of a condition or disease, which are characteristics of a diagnostic device.
No
The device description explicitly details physical components like elasticized material, magnets encased in fabric, and insoles made of layered fabric, indicating it is a hardware device with physical properties and functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device Description and Intended Use: The description of the ComfortCare Compression Support with Magnets & Anti-Bacterial Agent clearly indicates it is a physical support and comfort device applied to the body. Its intended uses are for providing relief of physical discomfort, support for injuries, and foot comfort by managing moisture and potentially using magnets.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens from the body.
Therefore, this device falls under the category of a physical support or comfort device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ComfortCare Compression Support with Magnets & Anti-Becterial Agent is designed to provide relief of minor physical discomforts that have their origin in sprains, strains or contusions associated with athletic, workplace and at-home activities. Device provides support for relief of minor physical discomforts and for creation in self-limiting physical injuries.
ComfortCare Absortek fabric construction provides for absorption and venting of perspiration in compressed areas, minimizing potential for skin irritation.
ComfortCare Magnetic Insoles with Anti-Bacterial Agent provide foot comfort while layered absorptive fabric vents moisture from soles of feet, thereby minimizing damp environment conducive to breeding bacterial and fungal growth.
Product codes
FQM, KYS
Device Description
(a) Elasticized material to support and compress a part of the body. Magnets encased in breathable fabric reader comfort. (b) Insole provides magnetic coverage of full foot insole and layered fabric absorbs and vents moisture to keep feet dry. (c) resists the growth of odor-causing bacteria and mildew
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
part of the body, feet, soles of feet
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
§ 880.5075 Elastic bandage.
(a)
Identification. An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.(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 § 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Special 510(k): Device Modification Pre-Market Notification
DEC 0 7 2001
Section G 510(k) Summary - K013244
| Submitters Name | Paul S. Mitchell, President |
|---|---|
| Corporate Name | Med Gen Inc. |
| Address: 7284 W. Palmetto Park Rd., Boca Raton, Florida 33433 | Ph. 561-750-1100 |
| Fax 561-750-6239 | |
| Consultant | Theodore Barash |
| 561-750-1100 | |
| Date of This Summary Revision | December 5, 2001 |
| Trade Name: | ComfortCare Compression Support with |
| Magnets & Anti-Bacterial Agent | |
| ComfortCare Magnetic Insoles with Anti-Bacterial Agent |
Common Name ..................................................................................................................................................................
Class Under Section 513 ......ComfortCare Products Not Classified as of Initial Submission
Device Description - (a) Elasticized material to support and compress a part of the body. Magnets encased in breathable fabric reader comfort. (b) Insole provides magnetic coverage of full foot insole and layered fabric absorbs and vents moisture to keep feet dry. (c) resists the growth of odor-causing bacteria and mildew
Intended Use - (a) The compression support line with magnets is designed for the relief of minor discomfort that may have resulted from a simple accident, energetic sports-related or intense workplace activities. Absorption and venting of perspiration keeps targeted anatomical area dry minimizing potential for skin irritation. (b) Magnetic insoles provide comfort, with layered absorptive fabric venting moisture from soles of feet, thereby minimizing damp environment conducive to breeding bacterial and fungal growth.
Technological Character - Among the leading brands, similarities cxist in 9 of 12 basic technical characteristics between ComfortCare and legally marketed products, General suppression support marketers (ie Becton-Dickinson and Ace) differ only to the extent that they use neoprene compression and wrap-around clastic fabrica respectively, without the use of magnets or anti-microbials. Among dominant marketers with magnets such as Homedics and Nikken, differences exist in their use of neoprene for compression support without fabric absorption properties and without anti-microbial agents as compared to Without Care, In all cases, however, the intended use, technical and safety attributes with or without magnets are essentially the same as ComfortCare products.
1
510(k) Summary (continued) K013244 Section G
Summary - In the absence of a classification ruling, Med Gen Inc. has referenced similar compression support products and insoles as comparative bases for substantial equivalence.
-
- Such type products are in broad common use in the USA and throughout the world.
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- ComfortCare's enhancements do not alter the intended use of 'compression support and insole products' as identified in Section 880.6075 and Section 880.6280 respectively.
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- ComfortCare's modifications do not affect the fundamental technology and science behind similar legally marketed devices.
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- ComfortCare's packaging makes no structure/function claims, provides no specific indications and minimally uses magnetic references.
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- The copy emphasis on each product's packaging of ComfortCare is on 'compression I he copy chipface on care care's fitments and 'perspiration control' for its insole, with anti-microbial agent.
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- The standard that any proposed device be substantially equivalent relies on the premise that any change does not effect or alter the fundamental science and safety of legally marketed devices, the risk posed by the medical device and reasonable equivalency in technological characteristics and, not necessarily identical.
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- Given the above, Med Gen Inc. respectfully submits that this application qualifies for classification of its products into Section 880.5075 for Elastic Bandages and Section 880.628() for medical insoles.
2
Image /page/2/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 symbol that resembles an abstract human figure with three wavy lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 7 2001
Mr. Thedore Barash Consultant Med Gen, Incorporated 7284 W. Palmetto Park Road Boca Raton, Florida 33433-3406
Re: K013244
Trade/Device Name: ComfortCare Compression Support with Magnets and Anti-Bacterial Agent; ComfortCare Magnets Insoles and Anti-Bacterial Agent Regulation Number: 880.5075 and 880.6280 Regulation Name: Elastic Bandage and Medical Insole Regulatory Class: I Product Code: FQM and KYS Dated: September 24, 2001 Received: September 28, 2001
Dear Mr. Barash:
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 (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
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Page 2 - Mr. Barash
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.
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) 594-4618. 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 yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number K013244
Trade Name: ComfortCare Compression Support with Magnets & Anti-Bacterial Agent.
Agent. ComfortCare Compretic Insole with Anti-Bacterial Agent
Revision of December 5, 2001
Indications for Use:
ComfortCare Compression Support with Magnets & Anti-Becterial Agent is designed to provide ComfortCare Compression Support with Magness or intributions of register actions
relief of minor physical discomforts that have their origin in strenger for relief of minor physical discollubris and at-home actives. Device provides support for associated with athletic, workplace and at-nome activities: Doviet of creation in self-limiting physical injuries.
ComfortCare Absortek fabric construction provides for absorption and venting of perspiration in Comforceded areas, minimizing potential for skin irritation.
ComfortCare Magnetic Insoles with Anti-Bacterial Agent provide foot comfort while layered ComfortCare Magnetic Insoles with Anti-Dacterial Right provironment conducive to breeding bacterial and fungal growth.
Patricia Cucuriti
vision Sign-Off Division of Dental, Infection Control, and General Hospital Devices K013244 510(k) Number.