(197 days)
SuperSkin® helps to protect skin exposed to irritation from moisture such as sweat, urine, and digestive juices.
SuperSkin® can also be used on unbroken skin surfaces that are exposed to friction and shear.
Do not apply over broken skin.
SuperSkin® is a topically-applied skin protectant for use on unbroken skin. The patient applies between 2-4 drops of SuperSkin® to the intact skin. The liquid polymerizes to form a thin, flexible coating.
The provided document is a 510(k) summary for a skin protectant device called SuperSkin®. It describes the device, its intended use, and technological characteristics, as well as the types of data submitted to the FDA to demonstrate substantial equivalence to predicate devices. However, it does not explicitly detail specific acceptance criteria or a dedicated study report comparing its performance against such criteria. The document focuses on demonstrating that SuperSkin® provides equivalent performance to predicate devices in areas like moisture barrier, vapor penetration, shear protection, friction reduction, and chronic irritation.
Therefore, much of the requested information cannot be directly extracted from this document. I will fill in what can be inferred and state when information is not present.
Here's an attempt to answer the questions based on the provided text, while acknowledging limitations:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a table of explicit, quantified acceptance criteria in the format typically used for medical device performance studies alongside reported device performance. Instead, it states that the device provides "equivalent performance" to predicate products across several characteristics.
| Acceptance Criteria (Implied) | Reported (Equivalent) Device Performance |
|---|---|
| Biocompatibility (Appropriate for intended use) | Demonstrated appropriate biocompatibility and non-toxicity for its intended use; Biological testing performed satisfactorily in accordance with ISO 10993. |
| Non-toxicity (Appropriate for intended use) | Demonstrated appropriate biocompatibility and non-toxicity for its intended use. |
| Moisture Barrier Performance (Equivalent to predicate) | Provides equivalent performance in terms of moisture barrier to the predicate product. |
| Vapor Penetration Performance (Equivalent to predicate) | Provides equivalent performance in terms of vapor penetration to the predicate product. |
| Shear Protection Performance (Equivalent to predicate) | Provides equivalent performance in terms of shear protection to the predicate product; performance characteristics for friction reduction and moisture protection evaluated in a clinical model. |
| Friction Reduction Performance (Equivalent to predicate) | Provides equivalent performance in terms of friction reduction to the predicate product; performance characteristics for friction reduction and moisture protection evaluated in a clinical model. |
| Chronic Irritation (Equivalent to predicate) | Provides equivalent performance in terms of chronic irritation to the predicate product; product evaluated for safety in a chronic irritation setting. |
| Non-sterile aseptic application suitability | Product is intended for application to skin in a nonsterile aseptic format. (Implies performance supports this). |
| Bioburden (Acceptable levels) | Bioburden assays were performed. (Implies acceptable levels were found to support non-sterile aseptic application). |
Note: The "acceptance criteria" listed above are inferred from the technological characteristics and data submitted, which state the device "demonstrates appropriate..." and "provides equivalent performance..." to predicate devices. No specific quantitative thresholds are provided for these equivalency claims.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the sample size used for the clinical model for friction reduction, moisture protection, or chronic irritation. It only states these were "evaluated in a clinical model" or "in a chronic irritation setting."
- Data Provenance: The country of origin of the data is not specified. The study appears to be prospective, given it describes "clinical model" and "chronic irritation setting" evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies mentioned (e.g., chronic irritation setting, clinical model for friction reduction and moisture protection) do not describe an expert-based ground truth establishment process, nor the number or qualifications of any experts involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for establishing ground truth for a test set. This type of detail is typically found in studies involving expert interpretation, which is not the primary focus of this 510(k).
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a physical skin protectant, not an AI-assisted diagnostic or interpretive tool.
- Effect size of human readers with/without AI: This is not applicable as the device is not an AI-based system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical product, not an algorithm. Its performance is inherent to its physical properties and interaction with the skin.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The term "ground truth" as typically understood in AI/imaging studies does not directly apply here. Instead, the performance evaluations relied on:
- ISO 10993 guidelines: For biological testing of medical materials (for biocompatibility and non-toxicity).
- Clinical model evaluations: For friction reduction and moisture protection.
- Chronic irritation setting: For safety and irritation potential.
These likely involved objective measurements based on established standards and clinical observation/assessment rather than expert consensus on interpretive data or pathology. Outcomes data specific to patients (beyond irritation assessment) are not mentioned.
8. The sample size for the training set
This is not applicable. The device is a physical product, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for a physical device.
{0}------------------------------------------------
大972081
DEC I 7 1997
510(k) Summarv
Michael Byram, CEO, MedLogic Global Corporation, Ste 111, 4815 Applicant: List Drive, Colorado Springs, CO 80919
1-719-540-8200 (telephone) 1-719-535-8999 (facsimile)
June 3, 1997 Date:
SuperSkin® Name:
Classification: Skin Protectant; 21 CFR § 880.5090.
3M No Sting Barrier Film; Bard Protective Barrier Film Predicate:
SuperSkin® is a topically-applied skin protectant for use on unbroken Description: skin. The patient applies between 2-4 drops of SuperSkin® to the intact skin. The liquid polymerizes to form a thin, flexible coating.
Intended Use: SuperSkin® helps to protect skin exposed to irritation from moisture such as sweat, urine, and digestive juices.
SuperSkin® can also be used on unbroken skin surfaces that are exposed to friction and shear.
Do not apply over broken skin.
Technological
Characteristic: SuperSkin® demonstrates appropriate biocompatability and non-toxicity for its intended use; the product is intended for application to skin in a nonsterile aseptic format; and, the product provides equivalent performance in terms of moisture barrier, vapor penetration, shear protection, friction reduction, and chronic irritation to the predicate product.
Data
Biological testing of medical materials was performed satisfactorily in Submitted: accordance with the guidelines found in ISO 10993; bioburden assays were performed; and, the product was evaluated for safety in a chronic irritation setting and for performance characteristics for friction reduction and moisture protection in a clinical model.
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a river or stream. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
OCT 1 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medlogic Global Corporation % Mr. Jur Strobos Greenberg & Traurig 1300 Connecticut Avenue, N.W. Suite 1000 Washington, D. C. 20036
Re: K972081 Trade/Device Name: SuperSkin® Regulation Number: 21 CFR 880.5090 Regulation Name: Bandage, liquid, skin protectant liquid bandage Regulatory Class: I (exempt) Product Code: NEC Dated: September 29, 1997 Received: September 29, 1997
Dear Mr. Strobos:
This letter corrects our substantially equivalent letter of December 17, 1997.
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 (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 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
{2}------------------------------------------------
Page 2 - Mr. Jur Strobos
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 continue 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), please contact the Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
erely yours,
arbare Buchner
for
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
| 510(k) Number (if known): | |
|---|---|
| Device Name: | SuperSkin |
| Indications For Use: |
SuperSkir® helps to protect skin exposed to irritation from moisture such as sweat, urine,
and digestive juices.
SuperSkin® can also be used on unbroken skin surfaces that are exposed to friction and the
shear. shear.
Do not apply over broken skin
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
-t
Division of General Restorative Device
510(k) Number
Prescription Use (Per 21 CFR 801.109)
ଠନ୍ନ
: !
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.