(53 days)
ComfortCare Compression Support with Magnets is designed to provide relief of minor physical discomforts that have their origin in stress and strain of repetitive actors associated with athletic, workplace and at-home activities. Device provides support for unprotected vulnerable anatomical areas and for recovery from minor physical injuries.
ComfortCare Absortek fabric construction provides for absorption and venting of perspiration thereby minimizing potential for skin irritation.
ComfortCare Magnetic Insoles provide foot comfort while layered absorptive fabric vents moisture and minimizes damp layer conducive to bacterial and fungal growth.
(a) Elasticized material to support and compress a part of the body. (b) Insole provides magnetic Magnets encased in breathable fabric reader comers (a) (ents moisture to keep feet dry.
This document describes a Special 510(k) Pre-Market Notification for modifications to an existing device, not a new device requiring a comprehensive performance study with acceptance criteria. Therefore, much of the requested information regarding performance metrics, sample sizes, and expert adjudication for a study proving acceptance criteria will not be present.
Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, despite the addition of magnets.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This section is largely not applicable in the traditional sense for this type of 510(k) submission. The "acceptance criteria" here relate to the regulatory standards for substantial equivalence, rather than specific performance metrics of the device itself that would require a study to "prove".
The fundamental "acceptance criteria" for this Special 510(k) were to demonstrate that the modifications (adding magnets) did not alter the fundamental technology, safety, or intended use of the predicate devices. The "reported device performance" is the claim of substantial equivalence.
| Acceptance Criteria (Regulatory) | Reported Device Performance (Claimed by Med Gen Inc.) |
|---|---|
| 1. Modifications do not alter the intended use of 'compression support and insole products' as identified in Section 880.5075 (Elastic Bandages) and Section 880.6280 (Medical Insoles). | ComfortCare's enhancements (addition of magnets) do not alter the intended use. The intended uses are "relief of minor discomfort that may have resulted from a simple accident, sports-related or intense workplace activities" for compression support, and "provides magnetic magnets encased in breathable fabric...vents moisture to keep feet dry" for insoles, minimizing bacterial/fungal growth. The final "Indications for Use" approved by the FDA aligns with this: "relief of minor physical discomforts that have their origin in stress and strain of repetitive actors associated with athletic, workplace and at-home activities. Device provides support for unprotected vulnerable joints and muscles to prevent serious physical injuries." for compression support, and "provide foot comfort while layered absorptive fabric vents perspiration thereby minimizing potential for bacterial and fungal growth" for insoles. |
| 2. The addition of static magnets at present levels of commercial use does not present any history of adverse effects and is within safety limits. | No history of adverse effects reported by the World Health Organization. Numerous studies support safety limits of 20,000 Gauss, determined not to produce detrimental health effects. The letter does not specify the Gauss of the ComfortCare magnets, only that they are "at present levels of commercial use." |
| 3. Modifications do not affect the fundamental technology and science behind similar legally marketed devices. The risk posed by the medical device and reasonable equivalency in technological characteristics are maintained. (This is the core of substantial equivalence for a Special 510(k) for device modification). | Similarities exist in 9 of 11 basic technical characteristics between ComfortCare and legally marketed products. Dominant marketers with magnets (e.g., Homeones, Pinsters) use neoprene for compression, but ComfortCare's non-neoprene elastic fabric without magnet use doesn't differ significantly in properties. The company asserts that the "technology character" is essentially the same as predicates. "ComfortCare's modifications do not affect the fundamental technology and science behind similar legally marketed devices." The FDA concurred that the device is "substantially equivalent." |
| 4. Labeling and claims are appropriate and do not make unsupportable structure/function claims or specific indications that deviate from predicate devices' allowed claims for basic compression supports and insoles. Emphasis is on compression/support and perspiration control, with magnets de-emphasized. (This is important when adding a component like a magnet with perceived therapeutic effects). | ComfortCare's packaging makes no structure/function claims, provides no specific indications, and minimally uses magnetic references. The copy emphasis is on 'compression and support' for fitments and 'perspiration control' for insoles. This addresses a potential concern about making unsubstantiated claims related to magnet therapy. The Indications for Use provided and accepted by the FDA align with these claims for support and moisture control, not direct therapeutic claims for magnets. |
2. Sample Size Used for the Test Set and the Data Provenance
- Not applicable. This submission does not describe a clinical performance study with a test set. The evidence provided is primarily based on regulatory comparison and literature review regarding magnet safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. No test set or expert ground truth was established for the device's efficacy in this submission. The FDA's review process inherently involves regulatory experts (e.g., those in the Division of Dental, Infection Control and General Hospital Devices) evaluating the substantial equivalence claim.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-enabled device or a diagnostic device where MRMC studies would typically be conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the established regulatory framework for similar existing devices (predicate devices) and scientific consensus/literature regarding the safety of static magnets.
- For the compression component: Established regulatory classifications (Section 880.5075) for elastic bandages and common use/characteristics of legally marketed products (e.g., Ace, Decam).
- For the insole component: Established regulatory classifications (Section 880.6280) for medical insoles and common use/characteristics of legally marketed products.
- For the magnet component: World Health Organization reports and "numerous studies" supporting the safety limits of 20,000 Gauss, and the historical use of magnets.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that would have a "training set." The product's development would likely incorporate design verification and validation testing, but these are not described as "training" in the context of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no "training set" for this type of device.
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Special 510(k): Device Modification Pre-Market Notification
Section G 510(k) Summary
NOV 2 0 2001
| Submitters Name | Paul S. Mitchell, President |
|---|---|
| Corporate Name | Med Gen Inc. |
| Address: 7284 W. Palmetto Park Rd., Boca Raton, Florida 33433 | Ph. 561-750-1100Fax 561-750-6239 |
| Consulant | Theodore Barash561-750-1100 |
| Date of This Summary Preparation | September 21, 2001 |
| Trade Name: | ComfortCare Compression Support with MagnetsComfortCare Magnetic Insoles |
| Common Name | Elastic Bandage and Medical Insole |
| Class Under Section 513 | ComfortCare Products Not Classified |
Device Description - (a) Elasticized material to support and compress a part of the body. Device Description – (a) Elasticized inaterial to support. (b) Insole provides magnetic Magnets encased in breadlable labric reader comers (a) (ents moisture to keep feet dry.
Intended Use – (a) The compression support line with magnets is designed for the relief of Intended Use = (a) The compression supportune simple accident, encreatic sports-related or
minor discomfort that may have resulted from a simple accident targeted intense workplace activities. Absorption and venting of perspiration keeps targeted intense workplace actrines: "Fiborphile for skin irritation. (b) Magnetic insoles with analomical area ury minimizing posture from soles of feet, thereby minimizing damp layer co absol prive inwe to breeding bacterial and fungal growth.
Technological Character -- Among the leading brands, similarities exist in 9 of 1 1 basic I echnical characteristics between ComfortCare and legally marketed products. General technical characteristics between Obickinson and Ace) differ only to the extent that Suppression support mail keters (10 Decam 200und elastic fabrics respectively, without the they use neoplene compression and weap are . Among dominant marketers with magnets use of magicus. Fuller of dood not afferences exist in their use of neoprene for compression. Such as Homeones and Pinsters, in properties as compared to ComfortCare. In all cases, Support without fabric absorphous profibutes and safety of products in this classification, with or without magnets, are essentially the same as ComfortCare products.
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Special 510(k): Device Modification Pre-Market Notification
Section G 510(k) Summary (continued)
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.
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- 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 880.5075 and Section 880.6280 respectively.
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- The addition of static magnets at present levels of commercial use, do not present any history of adverse effects as reported by the World Health Organization. Numerous studies, support the safety limits of 20,000 Gauss which have been determined not to produce any detrimental effect on health.
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- Magnets have been in use for thousands of years and provide testimony to some level of therapeutic effect that impel its continued life span, placebo effect not withstanding.
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- Although the existence of placebo effect has been challenged recently, other studies suggest that placebo effect may be a factor in the same physical response induced by ethical drugs for certain conditions. Some reports indicate that placebo may well represent up to 35% of the desired effect in the administration of certain approved ethical drugs. If magnets work at some placebo level, magnets may be a non-invasive drug-free option for minor discomfort, particularly for 9 of 10 symptoms of the selflimiting variety.
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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 and support' for ComfortCare's fitments and 'perspiration control' for its insole. Magnets have been de-emphasized.
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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 880.6280 for medical insoles.
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Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an abstract symbol. The symbol appears to be a stylized representation of a human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Mr. Theodore Barash Consultant Med Gen Incorporated 7284 W. Palmetto Park Road Boca Raton, Florida 33433-3406
Re: K013239
Trade/Device Name: ComfortCare Compression Support with Magnets ComfortCare Magnetic Insole Regulation Number: 880.5075 and 880.6280 Regulation Name: Elastic Bandage and Medical Insole Regulatory Class: I Product Code: FMQ and KYS Dated: September 25, 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 requirements
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Page 2 -- Mr. Barash
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
Timo 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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K 013257
NOV 2 0 2001
Page 1 of 1
510(k) Number K013239
Device Name: ComfortCare Compression Support with Magnets. ComfortCare Magnetic Insole
Revision of October 30, 2001
Indications for Use:
ComfortCare Compression Support with Magnets is designed to provide relief of minor physical Comforts that have their origin in stress and strain of repetitive actors associated with discomforts mark their ongin in sucss and subscription support for upprotected wulnerable
athletic, workplace and at-home activities. Device provides support for universal in athletic, workplace and al-nome achvittes. Dovies support of the artistical injuries.
ComfortCare Absortek fabric construction provides for absorption and venting of perspiration Councorcale rosofted innimizing potential for skin irritation.
ComfortCare Magnetic Insoles provide foot comfort while layered absorptive fabric vents Comfort Care Magnetic insoles provide toor connects was a release of the consisterial and fungal growth.
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(Division Sign-Off) Division of Dental, Infection Control. and General Hospital Devices 0323 110(k) Number __
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(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.