The Sentrex BioSponge Wound Dressing is a sterile, porous, soft chitosan sponge dressing that provides a moist healing environment to support wound healing. The Sentrex Wound Dressing is provided dry, in 10 cm x 10 cm and 5 cm x 5 cm squares. The dressing is made of chitosan, a naturally occurring, biocompatible polysaccharide derived from shellfish. The shells are processed and chemically treated. Once in bandage form, they are sterilized by gamma irradiation and packed in a heat-sealed foil laminate pouch. The Sentrex Wound Dressing may be moistened with saline in accordance with physician recommendation.

AI/ML Overview

The provided text describes the Sentrex BioSponge Wound Dressing and its 510(k) premarket application. However, it does not include detailed information regarding specific acceptance criteria, a scientific study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods in the manner typically found in a clinical study report for an AI/device performance evaluation.

The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, technical/material characteristics, and performance. The performance information provided is primarily related to non-clinical testing.

Therefore, many of the requested details cannot be extracted from the given document as they are not present.

Here's an analysis of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance in the context of a clinical study or a table showcasing performance against such criteria. The "performance" mentioned is primarily in relation to biocompatibility, local tissue response, and bacterial inhibition, which are non-clinical evaluations for safety and basic function, not efficacy in wound healing against specific quantitative targets.

The statement: "Numerous studies including, biocompatibility testing, local tissue response testing, and bacterial inhibition (AATCC Test Method 100, Microbial Strike-Through Test, and Kirby-Bauer Antimicrobial Susceptibility Test performed with the naïve Sentrex BioSponge and the Sentrex BioSponge with antibiotics) testing demonstrate the performance of the Sentrex BioSponge Wound Dressing" refers to passing specific non-clinical tests.

Acceptance Criteria Category	Reported Device Performance (as described)
Biocompatibility	Studies performed demonstrate performance. (Implies meeting established standards for biocompatibility)
Local Tissue Response	Studies performed demonstrate performance. (Implies acceptable tissue interaction)
Bacterial Inhibition	Studies performed using AATCC Test Method 100, Microbial Strike-Through Test, and Kirby-Bauer Antimicrobial Susceptibility Test demonstrate performance with both naive and antibiotic-treated BioSponge. (Implies effective bacterial inhibition)
Moisture Retention	Retains more moisture than standard gauze, providing a moist environment to support wound healing. (Comparative claim to standard gauze)

2. Sample size used for the test set and the data provenance

Not specified for any clinical performance evaluation. The "numerous studies" mentioned are non-clinical, so "test set" in the context of patient data (which would imply provenance) is not applicable or provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. The document does not describe a clinical study involving human assessment of device performance against a ground truth.

4. Adjudication method for the test set

Not applicable/Not specified.

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 device is a wound dressing, not an AI-powered diagnostic or assistive tool for human readers/clinicians, so an MRMC study comparing human performance with and without AI assistance is irrelevant to this submission.

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

Not applicable. This is a physical wound dressing, not an algorithm.

7. The type of ground truth used

The ground truth for the non-clinical performance tests would be defined by the specific test methods used (e.g., AATCC 100 for bacterial inhibition, ISO standards for biocompatibility). For example, "ground truth" for bacterial inhibition would be the quantitative reduction in bacterial count as measured by laboratory methods. There is no mention of clinical ground truth (e.g., pathology, outcomes data) in the context of device efficacy demonstration for this 510(k).

8. The sample size for the training set

Not applicable/Not specified. No algorithms or AI are described.

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

Not applicable/Not specified. No algorithms or AI are described.

Summary of what the document does indicate about how the device meets requirements:

The Sentrex BioSponge Wound Dressing secured 510(k) clearance by demonstrating substantial equivalence to previously cleared predicate devices (K071552, K080010, K092552). This means the FDA determined it is as safe and effective as the predicates, not that it met novel, pre-defined quantitative performance criteria in a clinical trial.

The "performance" demonstration relies on:

Non-clinical testing: Biocompatibility, local tissue response, and bacterial inhibition (using AATCC 100, Microbial Strike-Through, and Kirby-Bauer methods) studies were conducted. These studies "demonstrate the performance" of the device, implying they met the relevant standards for these specific tests.
Material characteristics: The dressing is made from chitosan, a well-established biocompatible and biodegradable biopolymer with extensive safety data in biomedical applications.
Functional comparison: It's noted that chitosan "retains more moisture than standard gauze," supporting a moist wound healing environment.
Intended Use consistency: The indications for use match those of the predicate devices.

Summary

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K112191

Sentrex BioSponge Wound Dressing

510k Premarket Application

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JUN - 5 200

Section 5: 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Applicant: Bionova Medical, Inc. 8275 Tournament Drive Suite 160 Memphis, TN 38125 Ph: (901) 748-2581 Fax: (901) 748-2583

Official Correspondent: M Squared Associates, Inc Deborah Lavoie Grayeski 901 King Street. Suite 200 Alexandria, VA 22314 Phone: 703-562-9800 ext. 250 Fax: 703-562-9797 Email: dgrayeski@msquaredassociates.com

Date of Submission: July 27, 2011

Proprietary Name: Sentrex BioSponge Wound Dressing

Common Name: Dressing, Wound, Drug

Requlatory Class: Unclassified

Product Codes: FRO

Predicate Device(s):

. K071552, Puracol Plus AG Collagen Microscaffold BioSponge
. K080010, NOCC Hydrophilic BioSponge
. K092552, Scion Cardiovascular Clo-SurPLUS P.A.D.

Device Description:

Bionova Medical, Inc. June 4, 2012

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K112191

510k Premarket Application

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Sentrex BioSponge Wound Dressing

Intended Use:

The Sentrex BioSponge Wound Dressing is indicated in the dressing and management of:

. Full thickness and partial thickness wounds
. Pressure ulcers
. Venous ulcers
. Ulcers caused by mixed vascular etiologies
. Diabetic ulcers
. First and second degree burns
. Donor sites and other bleeding surface wounds
Abrasions .
. Trauma wounds healing by secondary intention
. Dehisced wounds
. Surgical wounds
Dehisced surgical wounds

Summary of Technological Characteristics

The Sentrex BioSponge Wound Dressing is a sterile, porous, soft sponge dressing manufactured by a proprietary process from chitosan, a non-toxic, biodegradable, biocompatible, natural-based biopolymer. Chitosan has extensive safety data associated with its use in biomedical applications. Like collagen, chitosan induces a minimal foreign body reaction and retains more moisture than standard gauze, providing a moist environment to support wound healing.

Summary of Nonclinical Testing

Numerous studies including, biocompatibility testing, local tissue response testing, and bacterial inhibition (AATCC Test Method 100, Microbial Strike-Through Test, and Kirby-Bauer Antimicrobial Susceptibility Test performed with the naïve Sentrex BioSponge and the Sentrex BioSponge with antibiotics) testing demonstrate the performance of the Sentrex BioSponge Wound Dressing.

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KH2191
3/5
510k Premarket Application

Determination of Substantial Equivalence

The claim of substantial equivalence of the Sentrex Wound Dressing to the predicate devices is based on the comparison of the intended use, product technical/material characteristics, and performance characteristics. Bionova Medical, Inc. considers the Sentrex BioSponge Wound Dressing to be as safe and as effective, with substantially equivalent performance to the predicate devices.

Bionova Medical, Inc. June 4, 2012

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with stylized lines representing its wings and body.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN - 5 2012

Bionova Medical Inc. % M Squared Associates, Inc Ms. Deborah Lavoie Grayeski 901 King Street Suite 200 Alexandria, Virginia 22314

Re: K112191

Trade/Device Name: Sentrex Biosponge Wound Dressing Regulation Class: Unclassified Product Code: FRO Dated: May 29, 2012 Received: May 30, 2012

Dear Ms. Deborah Grayeski:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical

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Page 2 - Ms. Grayeski

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eunice Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K113191

510k Premarket Application

Section 4: Indications for Use Statement

K112191

510(k) Number: Device Name:

Sentrex BioSponge Wound Dressing

Indications for Use:

The Sentrex BioSponge Wound Dressing is indicated in the dressing and

management of:

Full thickness and partial thickness wounds
Pressure ulcers
Venous ulcers
Ulcers caused by mixed vascular etiologies
Diabetic ulcers
First and second degree burns
Donor sites and other bleeding surface wounds
Abrasions
Trauma wounds healing by secondary intention
Dehisced wounds
Surgical wounds
Dehisced surgical wounds

Prescription Use_ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MM
(Division Sign-Off)

Page 1 of 1

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112191

Bionova Medical, Inc. June 4, 2012

Regulation Number and Section

N/A