INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING by INNOVATIVE TECHNOLOGIES LTD.

Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on wounds including: . Minor scalds and burns Superficial Wounds such as Abrasions, Laccrations, and cuts t This wound dressing may be also used under the care of a health care professional for such wound as, Pressure sores, post operative surgical wounds, donor sites, trauma wounds and dermal Icsions. And for such uses as a IV site and us a secondary fixation device for other wound care products such as alginates, gels and foams used for diabctic ulccrs.

Device Description

Innovative Technologies Transparent & Intelligent Film Wound Dressings, are conformable, sterile wound dressings intended to provide a moist environment ideally suited for wound management. In particular for partial thickness wounds. Innovative Technologies Transparent Film dressings act as a semi occlusive barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing. The Innovative Technologies Intelligent wound dressings utilize an intelligent film to enhance product performance. The semi occlusive dressing acts as a barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing.

AI/ML Overview

The provided document is a 510(k) summary for the "Innovative Technologies Transparent and Intelligent Film Wound Dressings." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It is important to note that 510(k) summaries, especially those from 1998, typically focus on demonstrating substantial equivalence through a comparison to a predicate device, rather than presenting de novo clinical study data that would include detailed acceptance criteria and performance studies of the novel device itself. The provided text does not contain a detailed study report with acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in the prompt.

Therefore, the following information is based on the available text, and where specific details are missing (as they are not part of a 510(k) summary of this nature), it will be explicitly stated.

Acceptance Criteria and Device Performance

As this is a 510(k) submission from 1998 for wound dressings, the "device performance" and "acceptance criteria" are implied by the claim of substantial equivalence to a predicate device and the general functional description of the dressings. There are no explicit quantitative performance metrics or acceptance criteria stated in the document as would be found in a modern clinical study report for an AI/advanced medical device.

The "performance" is described in terms of its functional properties and intended use:

Acceptance Criteria (Implied from Device Description)	Reported Device Performance (from "Description" and "Intended Use" sections)
Barrier Function: Semipermeable to moisture vapor and oxygen, barrrier to exogenous moisture and bacteria.	The film acts as a semi occlusive barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen.
Moist Wound Environment: Creates an ideal environment for wound healing.	The film transmits water, but retains other exudate components creating the ideal environment for wound healing.
Extended Dressing Life: Extends the life of the dressing.	Retains other exudate components extending the life of the dressing.
Conformability: Conformable dressing.	"conformable, sterile wound dressings"
Sterility: Must be sterile.	"conformable, sterile wound dressings"
Applicability to Wound Types: Effective for partial thickness wounds.	Used for "partial thickness wounds," "pressure sores," "superficial wounds such as minor cuts, lacerations and abrasions, minor scalds and burns (1st & 2nd degree), donor sites, dermal lesions, trauma wounds and post operative surgical wounds."

Specific Study Details (Based on Available Text)

1. A table of acceptance criteria and the reported device performance:
Provided above based on the functional description and intended use, as explicit quantitative criteria are not present in this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable / Not provided. This document is a 510(k) premarket notification. It does not describe a new clinical study with a test set in the way a modern AI/diagnostic device submission would. The basis for substantial equivalence typically relies on existing data or performance of the predicate device, or non-clinical (e.g., benchtop) testing for the new device.
The manufacturer is based in the United Kingdom.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable / Not provided. No specific clinical test set for ground truth establishment is described for this device in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Not provided. No clinical test set is described.

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 / Not provided. This device is a wound dressing, not an AI or diagnostic tool. Therefore, an MRMC study is not relevant to this product.

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

Not applicable / Not provided. This device is a physical wound dressing and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / Not provided. No specific ground truth for a clinical study is detailed for this 510(k) submission. The "truth" for such devices is typically established through a combination of manufacturing standards, biocompatibility testing, material science, and prior clinical use experience of similar predicate devices, demonstrating the physical and biological properties meet safety and performance expectations.

8. The sample size for the training set:

Not applicable / Not provided. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable / Not provided. As above, no training set is relevant.

Summary

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Attachment 2

K981753

JUN 3 0 1998

Summary of Safety and Efficacy Summary of Innovative Technologies Transparent and Intelligent Film Wound Dressings

Manufacturer:

Regulatory Affairs Contact:

Telephone:

Date Summary Prepared:

Device Trade Name:

Common or Usual Name:

Classification:

Description:G

Intended Use:

Innovative Technologies, Limited Road Three, Winsford Industrial Estate Cheshire CW7 3PD, United Kingdom

Christopher Oakes, Manager

44 1606 863 500

May 13, 1998

Transparent Film & Intelligent Film Wound Dressing.

Film Wound Dressings

Wound Dressings, currently unclassified by FDA.

Innovative Technologies Transparent Film dressings act as a semi occlusive barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing.

The Innovative Technologies Intelligent wound dressings utilize an intelligent film to enhance product performance. The semi occlusive dressing acts as a barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing.

Innovative Technologies Transparent Films & Intelligent Films can be used for partial thickness wounds. They can be used for pressure sores. superficial wounds such as minor cuts. Iacerations and abrasions, minor scalds and burns (18 & 2" degree), donor sites, dermal lesions, trauma wounds and post operative surgical wounds.

Discontinue use if any infection of the wound is suspected and seek guidance from a health care professional.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, graphic style, with bold lines and a sense of movement. The text is in a sans-serif font and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 1998

Mr. Christopher Oakes Innovative Technologies, Limited Road Three Winsford Industrial Estate Winsford, Cheshire United Kingdom CW7 3PD

Re: K981753 Trade Name: Innovative Technologies' Transparent and Intelligent Film Wound Dressing Regulatory Class: Unclassified Dated: May 13, 1998 Received: May 18, 1998

Dear Mr. Oakes:

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:

1. This device may not be labeled for use on third degree burns.
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.
1. This device may not be labeled as a treatment or a cure for any type of 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 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.

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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,

Celia 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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Page lof I

K981753. 510(k) Number (if known): _

Device name: Innovative Technologies: Transparent Film & Intelligent Film Dressings

Indications For Use:

Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on wounds including:

. Minor scalds and burns
Superficial Wounds such as Abrasions, Laccrations, and cuts t

This wound dressing may be also used under the care of a health care professional for such wound as, Pressure sores, post operative surgical wounds, donor sites, trauma wounds and dermal Icsions. And for such uses as a IV site and us a secondary fixation device for other wound care products such as alginates, gels and foams used for diabctic ulccrs.

(PLUASE DO NOT WRITE RELOW THIS LINE. CONTINUE ON ANDTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

	OR Over The Counter Use ✓
	(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K981753

P - 02

Regulation Number and Section

N/A