CENTURION SORBAVIEW OTC

• K Number: K080524
• Device Name: CENTURION SORBAVIEW OTC
• Manufacturer: TRI-STATE HOSPITAL SUPPLY CORP.
• Date Cleared: 2008-04-23 ( 57 days)
• Product Code: FRO , KGX
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K945977 , K811291
• Predicate For: N/A

Intended Use

Centurion® SorbaView® OTC dressings are intended for medical purposes to cover and protect wounds, hold together the skin edges of a wound, support an injured part of the body, or to secure objects to the skin.

This device is intended for lay or prescription use by pediatric or adult patients.

Device Description

Sorba View® dressings are highly permeable, self-adhesive, transparent film dressings that are of multi-layer construction. The multi-layer construction consists of:

• Polyurethane film, .
• . Solvent-spun cellulose,
• . Medical grade adhesive,
• ◆ Non-woven fabric, and
• Kraft liner with silicone release coating. .

AI/ML Overview

This is a 510(k) premarket notification for a medical device (dressing), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and human/AI performance is not applicable.

The provided document describes the Centurion® SorbaView® OTC dressing and its substantial equivalence to predicate devices (Centurion® SiteGuard® Transparent Dressing K945977 and 3M Tegaderm™ + Pad K811291).

Here's a summary of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance: This section is designed for AI/ML performance metrics. For this device, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various tests.

   Acceptance Criteria (Implied)	Reported Device Performance
   Biocompatibility: Non-cytotoxic, non-sensitizing, negligible irritant	Results of testing validate SorbaView® is non-cytotoxic, non-sensitizing, and a negligible irritant.
   Barrier effectiveness against viral contaminants	Effective against penetration of viral contaminants (ASTM F 1671-97b).
   Barrier effectiveness against blood contaminants	Effective against penetration of blood contaminants (ASTM F 1671-97b and 107098).

2. Sample Size and Data Provenance: Not applicable for a non-AI/ML device. The testing conducted was for biocompatibility and barrier effectiveness, likely using standardized laboratory samples.

3. Number of Experts and Qualifications: Not applicable. Human experts are not involved in establishing ground truth for biocompatibility or barrier effectiveness tests in the same way they would be for an AI diagnostic.

4. Adjudication Method: Not applicable.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant for a medical dressing.

6. Standalone Performance Study: Not applicable in the context of an "algorithm only" performance. The device itself (the dressing) was tested for its properties (biocompatibility, barrier effectiveness).

7. Type of Ground Truth Used: For biocompatibility, the ground truth is established by standardized biological assays. For barrier effectiveness, the ground truth is established by physical testing against viral and blood contaminants according to ASTM standards.

8. Sample Size for Training Set: Not applicable. There is no training set for a medical dressing.

9. How Ground Truth for Training Set was Established: Not applicable.

In conclusion, the provided document details the safety and effectiveness testing of a transparent film dressing, demonstrating its substantial equivalence to existing products through standardized biological and physical tests, rather than through AI/ML performance evaluation.

Summary

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Image /page/0/Picture/0 description: The image is a logo for Tri-State Hospital Supply Corporation. The logo features an image of a person on the left, followed by the company name in bold, black letters. Below the company name, it says "Manufacturers of Centurion Healthcare Products".

510(k) Summary

P.O. Box 170 · Howell, MI 48844 [phone] • [phone] • Fax [phone] www.tshsc.com • e-mail: [e-mail]

APR 2 3 2008

K080524
Page 1 of 2

Manufacturer:	Tri-State Hospital Supply Corporation301 Catrell Drive
	Howell, MI 48843
Contact:	Mr. Matthew K. PriceDirector of Quality Assurance & Regulatory AffairsTri-State Hospital Supply Corporation301 Catrell DriveHowell, MI 48843Phone: [phone]
	Facsimile: [phone]
Date Summary Prepared:	February 22, 2008
Proprietary Name:	Centurion® Sorba View® OTC
Common Name of Device:	Dressing
Classification Name:	Dressing, Wound and Burn, Occlusive
Device Classification:	Unclassified
Regulation:	Pre-Amendment
Product Code:	MGP
Panel:	General and Plastic Surgery

Predicate SE Device(s):

This product is similar in design, composition, function, and method of use to the following products:

• . Centurion® SiteGuard® Transparent Dressing (K945977)
• 3M Tegaderm™ + Pad (K811291) .

Description:

Sorba View® dressings are highly permeable, self-adhesive, transparent film dressings that are of multi-layer construction. The multi-layer construction consists of:

• Polyurethane film, .
• . Solvent-spun cellulose,
• . Medical grade adhesive,
• ◆ Non-woven fabric, and
• Kraft liner with silicone release coating. .

Intended Use:

Centurion® SorbaView® OTC dressings are intended for medical purposes to cover and protect wounds, hold together the skin edges of a wound, support an injured part of the body, or to secure objects to the skin.

This device is intended for lay or prescription use by pediatric or adult patients.

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K080524
Page 2 of 2

Image /page/1/Picture/1 description: The image is a logo for Tri-State Hospital Supply Corporation. The logo features the text "Tri-State" in a bold, sans-serif font, with "HOSPITAL SUPPLY CORPORATION" in a smaller font below it. Below that is the text "MANUFACTURERS OF CENTURION" in a bold, sans-serif font, with the registered trademark symbol next to "CENTURION". Finally, the text "HEALTH CARE PRODUCTS" is at the bottom.

P.O. Box 170 · Howell, MI 48844 [phone] ● [phone] ● Fax [phone] www.tshsc.com • e-mail: [e-mail]

Summary of Technological Characteristics between Subject and Predicate Device:

The predicate device (K945977 and K811291) provides the same functions, characteristics described herein for the device. Although there are some material and dimensional differences between the predicate and Centurion® SorbaView® OTC, the differences are minor and raise no new questions of safety or effectiveness.

Summary of Testing:

Biocompatibility testing was performed on SorbaView@ dressings in accordance with AAMI Standards and Recommended Practices, "Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices " Results of testing validate SorbaView® is non-cytotoxic, non-sensitizing, and a negligible irritant.

Sorba View @ dressings were also tested for viral and blood barrier effectiveness in accordance with ASTM F 1671-97b and 107098; respectively, and found to be effective against penetration of both viral and blood contaminants.

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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 consists of a stylized symbol resembling an eagle or bird-like figure with three curved lines forming its body and wings. The symbol is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2008

Tri-State Hospital Supply Corporation % Mr. Matthew K. Price Director, Quality Assurance and Regulatory Affairs 301 Catrell Drive Howell, Michigan 48843

Re: K080524

Trade/Device Name: Centurion® Sorba View® OTC Regulation Code: 21 CFR 880.5240 Regulation Name: Medical adhesive tape and adhesive bandage Regulatory Class: I Product Code: KGX Dated: March 27, 2008 Received: March 31, 2008

Dear Mr. Price:

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.

1f 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

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Page 2 - Mr. Matthew K. Price

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millerson

Mark N. Melkerson 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):

Indications for Use
K080524

Device Name: Centurion® SorbaView® ORG

Indications for Use:

Centurion® SorbaView® OTC dressings are intended for medical purposes to cover and protect wounds, hold together the skin edges of a wound, support an injured part of the body, or to secure objects to the skin.

This device is intended for lay or prescription use by pediatric or adult patients.

Contraindications:

Centurion® Sorba View® OTC dressings are not intended for application on third degree burns or infected or heavily draining wounds.

Caution:

Centurion® Sorba View® OTC dressings are not to be used on dirty, contaminated, bleeding, infected or punctured wounds. Consult your health care provider if you experience any itching, burning, rash, or signs of infection: fever, pain, redness, or swelling,

Dressing should not be used in place of stitches.

Do not use medications, ointments, lotions, or salves under dressing unless directed by your health care provider; they will prevent the dressing from sticking properly and may cause skin irritation.

Warnings:

Frequent observation of the site is warranted as with all protective dressing products.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Rpd for nx

(Division Division of General, Restorative, and Neurological Devices

510(k) Number K080524

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Centurion® SorbaView® OTC 510(k) Submission

Indications for Use

Regulation Number and Section

N/A