(57 days)
Not Found
No
The document describes a standard wound dressing with no mention of AI or ML capabilities.
No
The device is a dressing intended to cover and protect wounds, not to provide therapeutic treatment to the body.
No.
The device is described as a dressing intended to cover, protect, and support wounds, or to secure objects to the skin. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (polyurethane film, cellulose, adhesive, fabric, liner) and the performance studies focus on biocompatibility and barrier effectiveness, indicating a physical dressing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for covering and protecting wounds, holding skin edges, supporting injured body parts, or securing objects to the skin. These are all external, physical applications.
- Device Description: The description details the physical components of a dressing (film, adhesive, fabric, etc.). There is no mention of reagents, samples (like blood, urine, or tissue), or any process involving testing or analyzing biological samples in vitro (outside the body).
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Measuring analytes.
- Using reagents.
- Performing tests in a laboratory setting.
The device is a medical dressing, which is a type of medical device used for wound care and securing other medical items. It does not perform any diagnostic function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MGP, KGX
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. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric or adult patients.
Intended User / Care Setting
lay or prescription use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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 (517) 546-5400 • (800) 248-4058 • Fax (517) 546-9388 www.tshsc.com • e-mail: info@tshsc.com
APR 2 3 2008
K080524
Page 1 of 2
| Manufacturer: | Tri-State Hospital Supply Corporation
301 Catrell Drive |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Howell, MI 48843 |
| Contact: | Mr. Matthew K. Price
Director of Quality Assurance & Regulatory Affairs
Tri-State Hospital Supply Corporation
301 Catrell Drive
Howell, MI 48843
Phone: (517) 546-1135 |
| | Facsimile: (517) 546-3356 |
| 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:
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.
1
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 (517) 546-5400 ● (800) 248-4058 ● Fax (517) 546-9388 www.tshsc.com • e-mail: info@tshsc.com
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.
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 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
3
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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/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
4
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
Page 1 of /
Centurion® SorbaView® OTC 510(k) Submission
Indications for Use