The Sentrex BioSponge MPD is indicated for wounds with moderate to high amounts of exudate, and may be used in conjunction with negative pressure wound therapy (NPWT).

Device Description

The Sentrex BioSponge MPD is a sterile, porous, soft chitosan sponge dressing that provides a moist healing environment to support wound healing. The dressing is made of chitosan, a naturally occurring, biodegradable, 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 BioSponge MPD may be moistened with saline in accordance with physician recommendation.

When moistened, the Sentrex BioSponge MPD is a highly conformable dressing that maintains contact with the wound surface. The Sentrex BioSponge MPD provides a moist wound environment, which may help minimize wound trauma at dressing changes. In vivo data has shown that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT).

The Sentrex BioSponge MPD is provided in the following sizes (I x w x h):

2.5cm x 10cm x 0.6cm 2.5cm x 20cm x 0.6cm 5cm x 5cm x 0.6cm 5cm x 10cm x 0.6cm 5cm x 15cm x 0.6cm 10cm x 10cm x 0.6cm 10cm x 15cm x 0.6cm 10cm x 20cm x 0.6cm

2.5cm x 10cm x 1cm 2.5cm x 20cm x 1cm 5cm x 5cm x 1cm 5cm x 10cm x 1cm 5cm x 15cm x 1cm 10cm x 10cm x 1cm 10cm x 15cm x 1cm 10cm x 20cm x 1cm

AI/ML Overview

The provided document describes a 510(k) premarket application for the Sentrex BioSponge MPD, a wound dressing. The focus of the application is on establishing substantial equivalence to previously cleared predicate devices and introducing a new claim for use in conjunction with Negative Pressure Wound Therapy (NPWT).

However, the document does not contain the level of detail typically found in studies for AI/ML-driven medical device performance, especially regarding specific acceptance criteria metrics (like sensitivity, specificity, accuracy, etc.), test set details, expert qualifications, or MRMC studies.

Instead, the document focuses on:

Technological Characteristics: Stating that the Sentrex BioSponge MPD has the same technological characteristics as a previously cleared predicate device (K112191).
Nonclinical Testing: Highlighting "New in vivo testing" performed to demonstrate compatibility with NPWT.
Substantial Equivalence: Asserting equivalence based on intended use, device description, product technical/material characteristics, and performance characteristics compared to predicate devices.

Given this, I can only extract information relevant to the study mentioned, which is "New in vivo testing" for NPWT compatibility, and the general basis for regulatory acceptance.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format you requested (e.g., sensitivity, specificity, or specific numerical targets). The acceptance is based on demonstrating substantial equivalence to predicate devices and showing compatibility with NPWT.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices	Sentrex BioSponge MPD is considered "as safe and as effective, with substantially equivalent performance to the predicate devices" based on intended use, device description, product technical/material characteristics, and performance characteristics.
Compatibility with Negative Pressure Wound Therapy (NPWT)	"New in vivo testing has been performed ... to demonstrate that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT)." "In vivo data has shown that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT)."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "New in vivo testing" but does not specify the sample size for this testing or the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth and Qualifications

Not applicable. This type of information is generally relevant for AI/ML device studies where ground truth is established by human experts interpreting data. The testing mentioned in this document is "in vivo," implying biological or animal studies, not expert interpretation of image or other clinical data.

4. Adjudication Method for the Test Set

Not applicable for this type of in vivo testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI assistance on human readers, which is not the focus of this device approval. The device is a wound dressing, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. The Sentrex BioSponge MPD is a physical wound dressing, not an algorithm.

7. Type of Ground Truth Used

For the "new in vivo testing" demonstrating compatibility with NPWT, the "ground truth" would be biological outcomes observed in the in vivo model (likely animal studies, though not explicitly stated) related to wound healing characteristics and successful use with NPWT.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve AI/ML models that require training sets.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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K123466
p 1/3
510k Premarket Application

Section 5: 510(k) Summary

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

Applicant: Bionova Medical, Inc. 3011 Centre Oak Way, Suite 102 Germantown. TN 38138 Ph: (901) 748-2581 Fax: (901) 748-2583

Official Correspondent: Alex Greene Director Clinical and Regulatory Bionova Medical, Inc. Phone: (901) 748-2581 Email: alex@bionovamedical.com

18 December 2012 Date of Submission:

Proprietary Name: Sentrex BioSponge MPD

Common Name: Dressing, Wound, Drug

Regulatory Class: Unclassified

FRO Product Codes:

Predicate Device(s):

K112191, Sentrex BioSponge Wound Dressing .
K071552, Puracol Plus AG Collagen Microscaffold BioSponge ◆
. K984371, Mepitel Non-Adherent Silicone Dressing
. K083113, ACTICOAT Flex 7 Dressing
. K033869, Contreet Foam Cavity Dressing with Silver
K081635, INTEGRA Meshed Bilayer Wound Matrix ●

Device Description:

APR 5 2013

ﺗﺎ ﮨ

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The Sentrex BioSponge MPD is provided in the following sizes (I x w x h):

2.5cm x 10cm x 0.6cm 2.5cm x 20cm x 0.6cm 5cm x 5cm x 0.6cm 5cm x 10cm x 0.6cm 5cm x 15cm x 0.6cm 10cm x 10cm x 0.6cm 10cm x 15cm x 0.6cm 10cm x 20cm x 0.6cm

2.5cm x 10cm x 1cm 2.5cm x 20cm x 1cm 5cm x 5cm x 1cm 5cm x 10cm x 1cm 5cm x 15cm x 1cm 10cm x 10cm x 1cm 10cm x 15cm x 1cm 10cm x 20cm x 1cm

Intended Use:

The Sentrex BioSponge MPD 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 �
� Grafts

The Sentrex BioSponge MPD may be cut to size.

The Sentrex BioSponge MPD is indicated for wounds with moderate to high amounts of exudate, and may be used in conjunction with negative pressure wound therapy (NPWT).

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Summary of Technological Characteristics

The Sentrex BioSponge MPD requested for clearance in this submission has the same technological characteristics as the previously cleared Sentrex BioSponge Wound Dressing (K112191). It 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

New in vivo testing has been performed since K112191 was cleared to demonstrate that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT).

Determination of Substantial Equivalence

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: April 5, 2013

Bionova Medical, Inc. % Mr. Alex Greene Director, Clinical and Regulatory 3011 Centre Oak Way, Suite 102 Germantown, Tennessee 38138

Re: K123961

Trade/Device Name: Sentrex BioSponge MPD Regulatory Class: Unclassified Product Code: FRO Dated: March 05, 2013 Received: March 07, 2013

Dear Mr. Greene:

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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Alex Greene

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark Nimelkerson -S

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

Enclosure

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Section 4: Indications for Use Statement

510(k) Number: To be assigned

Device Name:

Sentrex BioSponge MPD

Indications for Use:

The Sentrex BioSponge MPD 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
t Grafts

The Sentrex BioSponge MPD may be cut to size.

The Sentrex BioSponge MPD is indicated for wounds with moderate to high amounts of exudate, and may be used in conjunction with negative pressure wound therapy (NPWT).

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

Over-The-Counter Use (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)

David Kraūse

Page 1 of _ 1

(Division Sign-Off) . Division of Surgical Devices 510(k) Number: K123961

Bionova Medical, Inc. 5 March 2013

Regulation Number and Section

N/A