Innovative Technologies' Hydrocolloid with Zinc Wound Dressings is a combination of two products with existing 510(k)s: 510(k) #K951499, Dermagran-B™ Hydrophilic Wound Dressing manufactured by Derma Sciences, and 510(k) #K971126, Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressing. Innovative Technologies' Hydrocolloid with Zinc Wound Dressings are highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds. The low profile of the dressing allows for ease in the use of pressure garments and normal clothing. The hydrocolloid dressing may be left in place until the exuding phase is complete. The wound may then be covered with a breathable polyurethane film such as Innovative Technologies' Film Wound Dressing 510(k) #K9204008 which protects the new tissue from mechanical trauma and maceration. Dressings are supplied sterile in single use blisters / pouches. Product is gamma irradiated in accordance with EN 552, JEN556, and ANSI / AAMI / ISO11137-1994, Sterilisation Of Health Care Products - Requirements For Validation and Routine Control - Radiation Sterilisation, 3rd Edition, Method 1 for dosimetric release with a sterility assurance level of 10^-6.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, specifically Innovative Technologies' Hydrocolloid with Zinc Wound Dressing. This document is a regulatory submission for market clearance and does not describe a study that establishes acceptance criteria and proves the device meets them in the way a clinical or performance study would for an AI/ML diagnostic device.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for this type of medical device. The "acceptance criteria" here are essentially the characteristics and performance of the predicate devices. The "study" is the comparison made between the new device and the predicate devices.

Let's break down why this information is not present in the format requested, and then extract what is available:

Why the requested information (for AI/ML diagnostic devices) is not directly applicable:

Acceptance Criteria & Device Performance Table (for AI/ML): This typically involves performance metrics like sensitivity, specificity, AUC, etc., measured against a gold standard for a diagnostic task. For a wound dressing, performance is assessed differently (e.g., biocompatibility, absorbency, sterility, wound healing environment).
Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone (for AI/ML): These are concepts specifically related to the evaluation of diagnostic algorithms. They do not apply to the evaluation of a physical wound dressing in the same manner.
Training Set (for AI/ML): This is irrelevant as there's no algorithm being trained.

Information Extracted from the provided document, reframed as closely as possible to the request's intent for a non-AI/ML device:

1. Table of Acceptance Criteria (Predicate Characteristics) and Reported Device Performance (New Device Characteristics):

The document uses a comparative table to show that the new device's characteristics are similar to the predicate devices. The "acceptance criteria" are implied to be the characteristics of the predicate devices, and the "reported device performance" are the characteristics of the Innovative Technologies Hydrocolloid with Zinc.

Characteristics	Predicate 1: Derma Sciences Dermagran-B Hydrophilic Wound Dressing (Implied Acceptance Criteria)	Predicate 2: IT Intelligent Hydrocolloid (Implied Acceptance Criteria)	Innovative Technologies' Hydrocolloid with Zinc (Reported Device Performance)
Composition	Modified USP petrolatum based ointment	Hydrocolloid & polyurethane film	Hydrocolloid & polyurethane film
Non-Therapeutic Additives	Zinc / B-6 / Vitamin A	N/A	Zinc / B-6 / Vitamin A
Surface	N/A (implied not extruded and laminated or not a key feature of this type of dressing)	Extruded and laminated	Extruded and laminated
Indications For Use	Management of venous stasis ulcers, surgical incisions, pressure sores, minor thermal burns, superficial lacerations, cuts and abrasions, other superficial injuries	Dermal ulcers, superficial wounds, burns (1st & 2nd degree), donor sites, post operative wounds, protective dressings	Dermal ulcers, superficial wounds, burns (1st & 2nd degree), donor sites, post operative wounds, protective dressings (Also explicitly lists: partial full thickness wounds, arterial, venous, diabetic ulcers, post-operative surgical wounds, trauma wounds, dermal lesions, protective dressing)
Self-adhesive	No	Yes	Yes
Packaging	Poly Tube	Blister Pack / Pouch	Blister Pack / Pouch
Sterilisation Method	Preservatives	Gamma Irradiation	Gamma Irradiation

2. Sample size used for the test set and the data provenance:
This type of information is not applicable to a 510(k) submission for a wound dressing, which relies on demonstrating substantial equivalence to predicate devices rather than a performance study on a specific test set of cases. The "data provenance" for the predicate devices would be their own regulatory submissions and market history.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as understood in AI/ML is not a concept for wound dressings in this context. Substantial equivalence relies on comparing product design, materials, and intended use as assessed by regulatory bodies.

4. Adjudication method used for the test set:
Not applicable.

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 is not an AI device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.

7. The type of ground truth used:
For the purpose of substantial equivalence, the "ground truth" is effectively the established safety and effectiveness of the legally marketed predicate devices. The document states:

"Previous biocompatibility testing and use in the market place have shown safety and effectiveness of the two products [predicate devices]."
The device is found "substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..."

8. The sample size for the training set:
Not applicable. There is no AI algorithm or training set.

9. How the ground truth for the training set was established:
Not applicable.

In summary: The provided document is a regulatory submission for a physical medical device (wound dressing) seeking market clearance through substantial equivalence. It is not an AI/ML device, and thus the requested specific details regarding AI/ML study design and evaluation metrics are not present or applicable. The "study" for this device is the comparison of its characteristics and indications for use against established predicate devices.

Summary

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Innovative Technologies Ltd

Safety & Effectiveness Summary: Classification Name Common / Usual Name Contact: Prepared:

K973855

Innovative Technologies' Hydrocolloid with Zinc Wound Dressing

79 MGP Wound & Burn, Occlusive DEC - I Hydrocolloid Wound Dressing Priscilla Whitehead Cox, Director of QA/RA Monday, October 6, 1997 Monday, Ookobor of Hydrocolloid with Zinc Wound Dressings is a combination of two products with existing 510(k)s: 510(k) #K951499, Dermagran-B™ Hydrophilic Wound Dressing manufactured by Derma Sciences, and 510(k) #K971126, Innovative Technologies' Hydrocolloid & Intelligent Hydrocolloid Wound Dressing.

Innovative Technologies' Hydrocolloid with Zinc Wound Dressings are highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds. The low profile of the of the of the dressing allows for ease in the use of pressure garments and normal clothing. The hydrocolloid dressing may be left in place until the exuding phase is complete. The wound may then be covered with a breathable polyurethane film such as Innovative Technologies' Film Wound Dressing 510(k) #K9204008 which protects the new tissue from mechanical trauma and maceration.

Dressings are supplied sterile in single use blisters / pouches. Product is gamma irradiated in accordance with EN 552, JEN556, and ANSI / AAMI / ISO11137-1994, Sterilisation Of Health Care Products - Requirements For Validation and Routine Control - Radiation Sterilisation, 3rd Edition, Method 1 for dosimetric release with a sterility assurance level of 10°

Previous biocompatibility testing and use in the market place have shown safety and effectiveness of the two products.

The Innovative Technologies' Hydrocolloid with Zinc Wound Dressings are similar in design, composition and function to Dermagran-B™ Hydrophilic Wound Dressing manufactured by Derma Sciences, 510(k) #K951499 and Innovative Technologies' Intelligent Hydrocolloid Dressing, 510(k) #K971126.

Characteristics	IT Hydrocolloid with Zinc	Derma Sciences Dermagran-B Hydrophilic Wound Dressing	IT Intelligent Hydrocolloid
Composition	Hydrocolloid & polyurethane film /	Modified USP petrolatum based ointment	Hydrocolloid & polyurethane film /
Non-Theraputic Additives	Zinc / B-6 / Vitamin A	Zinc / B-6 / Vitamin A	N/A
Surface	Extruded and laminated	N/A	Extruded and laminated
Indications For Use	Dermal ulcers, superficial wounds, burns (1st & 2nd degree), donor sites, post operative wounds, protective dressings	Management of venous stasis ulcers, surgical incisions, pressure sores, minor thermal burns, superficial lacerations, cuts and abrasions, other superficial injuries	Dermal ulcers, superficial wounds, burns (1st & 2nd degree), donor sites, post operative wounds, protective dressings
Self adhesive	Yes	No	Yes
Packaging	Blister Pack / Pouch	Poly Tube	Blister Pack / Pouch
Sterilisation Method	Gamma Irradiation	Preservatives	Gamma Irradiation

COMPARATIVE FEATURE

Head Office

Road Three, Winsford Industrial Estate, Winsford, Cheshire CW7 3PD U.K. Tel: 44 (0) 1606 86 3500 Fax: 44 (0) 1606 86 3600 Registered in England 2666957

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Tarvin Sands Complex Tarvin, Cheshire, CH3 8JF U.K. Tel: 44 (0) 1829 741515 Fax: 44 (0) 1829 740456

180 9001 EN 46001

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - I 1997

Ms. Priscilla Whitehead Cox Director, Quality Assurance/Regulatory Affairs Innovative Technologies, Ltd. Road Three, Winsford Industrial Estate Winsford. Cheshire England CW7 3PD

Re: K973855

Innovative Technologies Hydrocolloid with Zinc Wound Dressings Regulatory Class: Unclassified Product Code: MGP Dated: October 7, 1997 Received: October 9, 1997

Dear Ms. Cox:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:

This device may not be labeled for use on third degree burns. 1 .
1. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
1. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
This device may not be labeled as a treatment or a cure for any type of 4. wound.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR

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Page 2 - Ms. Priscilla Whitehead Cox

807.81).The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celta M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K973855 510(k) Number (if known):

Device Name: Innovative Technologies Hydrocolloid with Zinc Wound Dressings

Indications For Use:

Innovative Technologies' Hydrocolloid with Zinc Wound Dressings may be used for the management of wounds including:

Partial full thickness wounds, ie. arterial, venous, diabetic ulcers ●
Post-operative surgical wounds .
Superficial burns (1st & 2nd degree) .
. Donor Sites
Trauma Wounds ●
Dermal Lesions .
. Protective dressing

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR Over The Counter Use

(Division Sign-Off) Division of General Restorative Device 510(k) Number

Regulation Number and Section

N/A