The Petit Silma Elastic Bandage with Germanium/Titanium Oxide is designed to provide relief of minor physicial discomforts that have their origin in stress and strain of repetitive actions associated with athletic, workplace and at-home activities. The device provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injuries.

Device Description

The Petit Silma Elastic Bandage is a simple device to provide relief of minor physical discomforts arising from stress or strain of repetitive actions including athletic, workplace and at-home activities. It consists of an elastic compression bandage, containing the element Germanium in a circular pellet. The product is worn on the injured portion of the body (elbow, knee, wrist) as appropriate. Alternatively, a second version of the the product would contain a Titanium Oxide pellet, instead of Germanium.

AI/ML Overview

The provided document is a 510(k) summary for the "Petit Silma Elastic Bandage With Germanium/Titanium Oxide". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through new clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not typically included or required in a 510(k) summary for a Class I device like an elastic bandage.

Here's the breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Not applicable. The 510(k) summary does not define specific performance acceptance criteria for the "Petit Silma Elastic Bandage" itself, as it relies on demonstrating substantial equivalence to a predicate device. Performance is generally assumed to be similar to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. A dedicated test set for evaluating specific performance metrics of the device is not described in this 510(k) summary. The submission relies on a comparison to a predicate device, not new performance data from a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set involving adjudication is described.

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 a simple elastic bandage, not an AI-powered diagnostic device. An MRMC study is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No new data requiring ground truth establishment is presented. The basis for approval is substantial equivalence to a predicate device, which implies that the predicate device's established safety and effectiveness serve as the "ground truth" for the new device's intended use.

8. The sample size for the training set

Not applicable. There is no mention of machine learning or an algorithm requiring a training set in this 510(k) summary.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of available information from the K040936 document:

The 510(k) summary for the "Petit Silma Elastic Bandage With Germanium/Titanium Oxide" focuses on demonstrating substantial equivalence to a predicate device: "Comfort Care™ Compression Support With Magnets, 510(k) # K013239".

The study that "proves" the device meets acceptance criteria, in the context of a 510(k) for this type of device, is essentially the comparison to the predicate device. The fundamental "acceptance criteria" here is that the device is as safe and effective as a legally marketed device.

Device Description and Intended Use:

Trade Name: Petit Silma Elastic Bandage With Germanium/Titanium Oxide
Common Name: Elastic Bandage or Compression Bandage
Classification Name: Elastic Bandage (21 C.F.R. § 880.5075), Product Code: FQM
Device Description: An elastic compression bandage containing either a Germanium or Titanium Oxide pellet. It is worn on injured body parts (elbow, knee, wrist) to provide relief of minor physical discomforts.
Intended Use/Indications for Use: To provide relief of minor physical discomforts arising from stress and strain of repetitive actions (athletic, workplace, at-home). It provides support for unprotected vulnerable body parts and post-injury impact induced by overexertion in self-limiting physical injuries.
Predicate Device: Comfort Care™ Compression Support With Magnets, 510(k) # K013239, manufactured by Med Gen, Inc.

The conclusion of the 510(k) summary is based on the belief that the "Petit Silma Elastic Bandage is substantially equivalent to its claimed predicates under conditions of intended use." This statement is the core of how the device "meets acceptance criteria" in this regulatory context. No new clinical studies demonstrating specific performance metrics were required or conducted.

Summary

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K040936

MAY - 3 2004

APPENDIX E

510(k) SUMMARY Petit Silma Elastic Bandage Bio-Lipid, Inc.

This 510(k) summary of safety and effectiveness for Petit Silma Elastic Bandage is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant:	Bio-Lipid, Inc.
Address:	7000 SW 97 AvenueSuite 213Miami, FL 33173
Contact Person:	David J. BlochRegulatory Counsel
Telephone:	(202) 414-9209 (telephone)(202) 414-9209 (fax)
Preparation Date:	March 2004
Device Trade Name:	Petit Silma Elastic Bandage With Germanium/TitaniumOxide
Common Name:	Elastic Bandage or Compression Bandage
Classification Name:	Elastic Bandage (see 21 C.F.R. § 880.5075)
	Product Code: FQM
Predicate Devices:	Comfort Care™ Compression Support With Magnets, 510(k)# K013239, manufactured by Med Gen, Inc.
Device Description:	The Petit Silma Elastic Bandage is a simple device toprovide relief of minor physical discomforts arising fromstress or strain of repetitive actions including athletic,workplace and at-home activities. It consists of an elasticcompression bandage, containing the element Germaniumin a circular pellet. The product is worn on the injured portionof the body (elbow, knee, wrist) as appropriate.Alternatively, a second version of the the product wouldcontain a Titanium Oxide pellet, instead of Germanium.

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Intended Use:	Petit Silma Elastic Bandage is an elastic bandage to providerelief of minor physical discomforts that have their origin instress and strain of repetitive actions associated withathletic, workplace and at-home activities. The deviceprovides support for unprotected vulnerable body parts andpost-injury impact induced by overexertion in self-limitingphysical injuries.
CONCLUSIONS:	Based on the foregoing and other information in thisapplication, Bio-Lipid, Inc. believes that the Petit SilmaElastic Bandage is substantially equivalent to its claimedpredicates under conditions of intended use.

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Image /page/2/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 symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 3 2004

Leda Company Limited C/O Mr. David J. Bloch Regulatory Counsel Reed Smith, L.L.P. 1301 K Street, N.W. Suite 1100-East Tower Washington, D.C. 20005-3373

Re: K040936

Trade/Device Name: Petit Selma Elastic Bandage with Germanium/Titanium Oxide Regulation Number: 880.5075 Regulation Name: Elastic Bandage Regulatory Class: I Product Code: FQM Dated: April 9, 2004 Received: April 9, 2004

Dear Mr. Bloch:

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.

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Page 2 - Mr. Bloch

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 (OS) 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K040936 510(k) Number (if known):

Device Name: Petit Selma Elastic Bandage with Germanium/Titanium Oxide

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arene Ramera for ADW 4/29/04

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K040936

Regulation Number and Section

§ 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.