HEALADEX®-P Wound Dressing provides a moist environment that is supportive of wound healing. HEALADEX-P is indicated for dry, light and moderately exudating partial and full thickness wounds such as:

First and second degree burns
Severe sunburns
Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical wounds, and skin tears

HEALADEX-P dressing should be used under health care professional direction for the following indications:

Pressure ulcers, Stage I-IV
Lower extremity ulcers
Venous ulcers
Arterial ulcers
Ulcers of mixed etiology
Diabetic ulcers
Donor sites and skin grafts
Burns caused by radiation oncology procedures

Device Description

HEALADEX-P is a sterile wound-dressing comprised of carboxymethylcellulose and lyophilized formulated porcine plasma, which is island mounted on moisture vapor permeable adhesive film dressing sheet coated with acrylic adhesive and a polyurethane protective film. This dressing aids the healing process by maintaining a moist environment at the wound site.

HEALADEX-P dressing is individually packaged in a foil moisture barrier chevron peel pouch appropriately labeled with lot number and expiration date. Five units are packaged into a cardboard box with Instructions for Use (IFU).

AI/ML Overview

The provided text is a 510(k) summary for a medical device called HEALADEX®-P Occlusive Dressing. It focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description and intended use.

Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The text clearly states: "Safety testing was conducted in accordance with ISO 10993 Part1 in support of the claim of biocompatibility for this product." This indicates the nature of the testing performed, but it's not a performance study of the wound healing properties or a comparative effectiveness study as typically found in submissions for AI/ML-driven devices or those requiring clinical efficacy data for their primary function beyond safety.

Therefore, I cannot populate the table or answer most of the questions you've asked because the information is not present in the provided document.

To directly address your request given the provided input:

Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: Not specified in the provided text. The document focuses on demonstrating biocompatibility and substantial equivalence to legally marketed predicate devices, not on proving a specific performance metric against a defined acceptance criterion.
Sample size used for the test set and the data provenance: Not applicable. No test set for performance evaluation is described. The document mentions "Safety testing" in accordance with ISO 10993 Part 1, which typically involves in-vitro and in-vivo tests on animal models or cell cultures for biocompatibility, not human patient data for device performance as you might expect for an AI/ML device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert ground truth is described.
Adjudication method: Not applicable. No test set requiring adjudication is described.
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: No. An MRMC study was not done. This device is a physical wound dressing, not an AI/ML-driven diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This device is a physical wound dressing, not an algorithm.
The type of ground truth used: Not applicable for performance evaluation in the context of your questions. For biocompatibility testing, the "ground truth" would be established by the results of the ISO 10993 tests against accepted biological safety limits.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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KD 63517

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FEB 1 6 2007

HEALADEX®-P 510(k) SUMMARY

(510(K) Summary, Required Under 21 CFR 807.87(h))

COMPANY (APPLICANT) NAME AND ADDRESS

HEALAGENICS 800 West Cummings Park Suite 2900 Woburn, MA. 01801

CONTACT PERSON

Contact Name: Paul Strati, CEO Ph: 781-376-4114 / Fax 781-376-4115 Cell: 781-775-1050

MEDICAL DEVICE INFORMATION

Proprietary Name	HEALADEX®-P Occlusive Dressing
Common Names	Wound Dressing
Classification Name	Dressing, Wound and Burn, Hydrogel, with drug or biologic

DEVICE CLASSIFICATION INFORMATION

Regulatory Class:

Unclassified

Product code:

FRO, KGN

STATEMENT OF SUBSTANTIAL EQUIVALENCE

HEALADEX®-P Dressing is substantially equivalent to the following approved products in indications, and to Gelita-spon Absorbable Gelatin sponge for porcine biomaterial source.

Nu-Gel Wound Dressing (K983362) manufactured by Johnson & Johnson Medical イ Inc.,
HEALAGENICS®, Inc.

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Premarket Notification Submission HEALADEX®-P

K063177

Collatek Hydrogel (K022995) manufactured by Biocore Medical Technologies, Inc.) رق イ
Woun'Dres Collagen Hydrogel Wound Dressing (K991202) manufactured by > Coloplast Corporation

Indications for Use

First and second degree burns >
Severe sunburns
Superficial injuries, superficial lacerations, cuts, abrasions, > incisions/surgical wounds, and skin tears

HEALADEX-P dressing should be used under health care professional direction for the following indications:

Pressure ulcers, Stage I-IV V
Lower extremity ulcers イ
Venous ulcers イ
Arterial ulcers イ
Ulcers of mixed etiology V
Diabetic ulcers イ
Donor sites and skin grafts ✔
Burns caused by radiation oncology procedures V

Device Description and Principles of Operation

BIOCOMPATIBILITY

HEALAGENICS®, Inc.

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K06317

3/5

Safety testing was conducted in accordance with ISO 10993 Part1 in support of the claim of biocompatibility for this product.

. . .

HEALAGENICS®, Inc.

. ,

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its head facing left and its wings forming three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

HEALAGENICS, Inc. % Mr. Paul Strati CEO 800 West Cummings Park Suite 2900 Woburn, Massachusetts 01801

FEB -16 2007

Re: K063517

Trade/Device Name: HEALADEX®-P Wound Dressing Regulatory Class: Unclassified Product Code: FRO, KGN Dated: November 1, 2006 Received: November 21, 2006

Dear Mr. Strati:

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.

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

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Page 2 - Mr. Paul Strati

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

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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K063517

Indications for Use

510(k) Number (if known): K063517

Device Name: HEALADEX®-P Wound Dressing

Indications For Use:

First and second degree burns
Severe sunburns
Superficial injuries, superficial lacerations, cuts, abrasions, incisions/surgical wounds, > and skin tears

HEALADEX-P dressing should be used under health care professional direction for the following indications:

Pressure ulcers, Stage I-IV
Lower extremity ulcers >
V Venous ulcers
Arterial ulcers
Ulcers of mixed etiology
Diabetic ulcers
Donor sites and skin grafts
Burns caused by radiation oncology procedures

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

estorative

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

Concurrence of CDRH, Office of Device Evaluation (Ob

Regulation Number and Section

N/A