The FortaDerm™ Antimicrobial PHMB Wound Dressing is intended for the management of wounds and as an effective barrier to resist microbial colonization within the dressing and reduce microbes penetrating through the dressing. FortaDerm™ Antimicrobial PHMB Wound Dressing may be used for the management of: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.

The device is intended for one-time use.

Device Description

FortaDerm™ Antimicrobial PHMB Wound Dressing consists of two layers, crosslinked sheet of fenestrated sheet of porcine intestinal collagen coated with 0.1 % Polyhexamethylene Biguanide hydrochloride (PHMB). FortaDerm Wound Dressing is supplied dry in sheet form in sizes ranging from 4 x 4 cm to 12 x 36 cm. The device is packaged in sterile, sealed single pouches.

AI/ML Overview

This 510(k) summary (K051647) describes the FortaDerm™ Antimicrobial PHMB Wound Dressing. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than independent performance claims against specific acceptance criteria. Therefore, much of the requested information regarding a formal study with detailed acceptance criteria, sample sizes, expert involvement, and statistical analysis is not provided in this document.

However, based on the available text, here's what can be extracted:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Passed the requirements
Performance	Passed the requirements
Specific quantitative criteria (e.g., microbial reduction percentage, barrier effectiveness)	Not specified in this document.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified, but likely from in-vitro and/or in-vivo laboratory tests given the nature of the device and testing categories (biocompatibility, performance). It is not stated if this was retrospective or prospective data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. The testing described (biocompatibility, performance) implies laboratory assessments against predetermined standards or methods rather than expert consensus on a 'ground truth' in a clinical diagnostic sense.
- Qualifications of Experts: Not applicable/not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This type of adjudication is typically used in clinical studies involving interpretation of data by multiple readers, which is not described here.
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. This device is a wound dressing, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical wound dressing, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For "biocompatibility" and "performance" tests, the "ground truth" would be the predefined pass/fail criteria or standards for those specific tests (e.g., ISO standards for biocompatibility, or specific laboratory protocols for antimicrobial efficacy or barrier properties). The document does not detail these specific standards.
The sample size for the training set:
- Sample Size: Not applicable. This is not a machine learning device that requires a training set. The "testing" likely refers to validation against established physical and biological performance characteristics.
How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable, as there is no training set for this device.

Summary based on the provided text:

The 510(k) submission for the FortaDerm™ Antimicrobial PHMB Wound Dressing primarily relies on demonstrating substantial equivalence to existing predicate devices (FortaDerm™ Wound Dressing K011026 and Xcell Antimicrobial Cellulose Wound Dressing K024054) in terms of intended use, technological characteristics, materials, and physical construction.

The only "performance data" mentioned is that the device underwent "a number of tests to assess biocompatibility and performance" and "passed the requirements of all tests." However, specific acceptance criteria for these tests, the methodology, sample sizes, or detailed results are not provided in this summary. This is typical for a 510(k) where detailed study reports are usually referenced but not fully included in the public-facing summary. The evaluation focuses on meeting general safety and performance standards for wound dressings, rather than specific quantitative metrics against a defined "ground truth" involving expert interpretation (as would be the case for a diagnostic AI).

Summary

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K051647 page

NOV - 8 2005

510(K) SUMMARY

Submitted by:

Organogenesis Inc. 150 Dan Road Canton, Massachusetts 02021

Contact

Patrick R. Bilbo Telephone: (781) 401-1155 Facsimile: --------------------------------------------------------------------------------------------(781) 575-1570

October 21, 2005 Date:

Device:

Trade Name:	FortaDerm™ Antimicrobial PHMB WoundDressing coated with 0.1% PolyhexamethyleneBiguanide Hydrochloride (PHMB)
Common/Usual Name:	Topical Wound Dressing, Wound ManagementBiomaterial
Classification Name:	Dressing, Wound (KMF)
Classification:	Unclassified

Predicate Devices:

The relevant predicate devices are FortaDerm™ (PuraPly™) Wound Dressing (K011026) manufactured by Organogenesis, Inc. and Xcell Antimicrobial Cellulose Wound Dressing (K024054) manufactured by Xylos Corporation.

Statement of Substantial Equivalence:

The FortaDerm™ Antimicrobial PHMB Wound Dressing is similar with respect to intended use, technological characteristics, materials and physical construction to the predicate devices in terms of section 510(k) equivalency.

Intended Use:

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K051647 page 2/2

dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.

The device is intended for one-time use.

Device Description:

Performance Data:

FortaDerm™ Antimicrobial PHMB Wound Dressing was subjected to a number of tests to assess biocompatibility and performance. The device passed the requirements of all tests.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2005

Patrick R. Bilbo, Vice President Regulatory and Clinical Affairs Organogenesis, Inc. 150 Dan Road Canton, Massachusetts 02021

Re: K051647

Trade/Device Name: FortaDerm™ Antimicrobial PHMB Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: October 21, 2005 Received: October 25, 2005

Dear Mr. Bilbo:

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.

If 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 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.

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Page 2- Patrick R. Bilbo, Vice President

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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Barbara boehup
for

Mark N. Melkerson Acting 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): KOSIC47

Device Name: FortaDerm™ Antimicrobial PHMB Wound Dressing

Indications for Use:

The FortaDerm™ Antimicrobial PHMB Wound Dressing is intended for the management of wounds and as an effective barrier to resist microbial colonization within FortaDerm™ the dressing and reduce microbes penetrating through the dressing. Antimicrobial PHMB Wound Dressing may be used for the management of: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.

The device is intended for one-time use.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

bare buem Pageof

(Division St Division of General, Restorative, and Neurological Devices

510(k) Number K051647

(Posted November 13, 2003)

Regulation Number and Section

N/A