TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING by INNOVATIVE TECHNOLOGIES LTD.

Innovative Technologies' Transparent Film & Intelligent Film Dressings are conformable, sterile wound dressings intended to provide a moist healing environment for partial thickness wounds, eg. pressure sores, abrasions, lacerations, donor sites and superficial burns. The dressings may also be used for IV sites or as secondary fixation devices for products such as alginates, gels and foams used for venous stasis and diabetic ulcers. Dressings are supplied sterile in single use blister packs.

AI/ML Overview

This submission, K973312, is for Transparent Film and Intelligent Film Dressings. The submission does not contain information about acceptance criteria or a study to prove the device meets these criteria. Instead, it describes a substantial equivalence comparison to a predicate device (Hydroderm, K935796).

Here's a breakdown of the provided information, noting the absence of the requested points:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the submission. The document lists comparative features between the applicant's devices and the predicate device, but these are characteristics, not pre-defined acceptance criteria with performance targets.

Characteristics	IT Transparent Film (Reported Performance)	IT Intelligent Film (Reported Performance)	Predicate: Hydroderm™ (Comparative Feature)	Acceptance Criteria (Not Provided)
Composition	Polyurethane film and pressure sensitive acrylic adhesive	Polyurethane film and pressure sensitive acrylic adhesive	Polyurethane film and pressure sensitive acrylic adhesive	N/A
Adhesive Coverage	100%	Pattern coated 50 + 30%	Pattern Coated 40%	N/A
MVTR g/m²/24hrs	< 2500	3000-15000	8,000	N/A
Transparent	Yes	Yes	Yes	N/A
Indications For Use	Partial thickness wounds, eg. pressure sores, abrasions, superficial burns, lacerations, donor sites, IV sites, fixation device	Partial thickness wounds. eg. pressure sores, abrasions, superficial burns, lacerations, donor sites, IV sites, fixation device	Partial thickness wounds, eg. pressure sores, abrasions, superficial burns, lacerations, donor sites, IV sites, fixation device	N/A
Packaging	Printed Pouch	Printed Pouch	Printed Pouch	N/A
Sterilisation Method	Gamma Irradiation	Gamma Irradiation	ETO	N/A
Biocompatibility	Successfully completed per ISO/Tripartite guidelines	Successfully completed per ISO/Tripartite guidelines	N/A (Assumed similar/equivalent due to 510k process)	N/A
Sterility Assurance	SAL of 10-6	SAL of 10-6	N/A (Assumed similar/equivalent due to 510k process)	N/A

Regarding the study proving the device meets acceptance criteria:

The submission highlights several aspects related to safety and effectiveness, but it uses an equivalence approach rather than presenting a standalone study with pre-defined acceptance criteria.

Sterilization: The devices are gamma irradiated according to ANSI/AAMI/ISO11137-1995 and AAMI TIR8-1991, achieving a sterility assurance level (SAL) of 10^-6. This ensures the product is sterile.
Biocompatibility: Biocompatibility testing, including cytotoxicity, acute systemic toxicity, skin irritation, and sensitization, was successfully completed per ISO/Tripartite guidelines. This addresses the biological safety of the materials.
Performance Comparison: The submission primarily relies on a comparison of features and intended use with a legally marketed predicate device (Hydroderm K935796) to establish substantial equivalence.

The 510(k) summary explicitly states: "The Innovative Technologies' Film & Intelligent Film Dressings are similar in design, composition and function to Hydroderm Breathable Simmar in actigh, Complex #K935796." This indicates that the predicate device serves as the benchmark against which the new devices are deemed "substantially equivalent."

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

This information is not provided. The submission details manufacturing, sterilization, and biocompatibility testing, but it does not describe a clinical "test set" with a specified sample size or data provenance in the context of device performance against specific criteria. The comparison is based on device characteristics, not clinical study data for a "test set."

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):

This information is not provided. As there's no mention of a clinical "test set" requiring ground truth establishment by experts, this detail is absent.

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

This information is not provided. Without a clinical "test set" requiring adjudication, there is no mention of such a method.

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:

This is not applicable to this submission. The device is a wound dressing, not an AI-powered diagnostic tool that would involve human readers or AI assistance.

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

This is not applicable to this submission. The device is a wound dressing, not an algorithm.

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

This information is not provided in the context of device performance or comparison. For biocompatibility, the "ground truth" is compliance with ISO/Tripartite guidelines. For sterility, it's achieving an SAL of 10^-6 through validated gamma irradiation processes. For the overall device, the "ground truth" for market clearance is its substantial equivalence to the predicate device K935796, as determined by the FDA.

8. The sample size for the training set:

This information is not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not provided. As there is no "training set," this detail is absent.

In summary, this 510(k) submission primarily demonstrates substantial equivalence to a predicate device (Hydroderm K935796) based on comparative features, intended use, manufacturing processes (sterilization), and biocompatibility testing against established standards, rather than a clinical study with specific acceptance criteria and detailed performance metrics as might be seen for novel diagnostic or therapeutic devices.

Summary

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K973312

Image /page/0/Picture/1 description: The image contains the letters "IT" on the left side of the image. To the right of the letters is a symbol that looks like a cross with a curved line above it. The cross has a horizontal line at the top, a vertical line in the middle, and a horizontal line at the bottom. The curved line above the cross is dotted.

Innovative Technologies Ltd

Safety & Effectiveness	Innovative Technologies' Transparent Film and Intelligent FilmDressings
Classification Name:	79 FRO, Dressing	OCT 22 1997
Common / Usual Name:	Film Wound Dressing
Contact:	Priscilla Whitehead Cox, Director of QA/RA
Prepared:	Monday, September 1, 1997
Innovative Technologies' Transparent Film & Intelligent FilmDressings are conformable, sterile wound dressings intended toprovide a moist healing environment for partial thickness wounds,eg. pressure sores, abrasions, lacerations, donor sites andsuperficial burns. The dressings may also be used for IV sites or assecondary fixation devices for products such as alginates, gels andfoams used for venous stasis and diabetic ulcers.
Dressings are supplied sterile in single use blister packs. Product isgamma irradiated in accordance with the Sterilisation OfHealth Care Products - Requirements For Validation and RoutineControl - Radiation Sterilisation, 3rd Edition (ANSI/AAMI/ISO11137-1995) and Microbiological Methods for GammaSterilisation (AAMI TIR8-1991) for qualification of Method 1 fordosimetric release with a sterility assurance level of 10-6.
Biocompatibility testing including cytotoxicity, acute systemictoxicity, skin irritation and sensitisation has been successfullycompleted per ISO/Tripartite guidelines.
The Innovative Technologies' Film & Intelligent Film Dressings aresimilar in design, composition and function to Hydroderm Breathable

Simmar in actigh, Complex #K935796. A table of comparative features may be found below.

Characteristics	IT Transparent Film	IT Intelligent Film	Hydroderm™
Composition	Polyurethane film andpressure sensitiveacrylic adhesive	Polyurethane film andpressure sensitive acrylicadhesive	Polyurethane film andpressure sensitiveacrylic adhesive
Adhesive Coverage	100%	Pattern coated 50 + 30%	Pattern Coated 40%
MVTR g/m²/24hrs	< 2500	3000-15000	8,000
Transparent	Yes	Yes	Yes
Indications For Use	Partial thicknesswounds, eg. pressuresores, abrasions,superficial burns,lacerations, donor sites,IV sites, fixation device	Partial thickness wounds.eg. pressure sores,abrasions, superficialburns, lacerations, donorsites, IV sites, fixationdevice	Partial thicknesswounds, eg. pressuresores, abrasions,superficial burns,lacerations, donor sites,IV sites, fixation device
Packaging	Printed Pouch	Printed Pouch	Printed Pouch
Sterilisation Method	Gamma Irradiation	Gamma Irradiation	ETO

COMPARATIVE FEATURES

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OCT 2 2 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

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

Re: K973312

Trade Name: Innovative Technologies Transparent Film & Intelligent Film Dressings Regulatory Class: Unclassified Product Code: MGP Dated: September 1, 1997 Received: September 3, 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 (Act). 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 (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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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

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Page 2 - Ms. Priscilla Whitehead Cox

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.

Aadeep

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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510(k) Number (if known): K973312

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 partial thickness wounds including:

Pressure sores
. Superficial burns ~===========================================================================================================================================================
Abrasions
. Lacerations
. Post-operative surgical wounds
. Donor Sites
. Trauma Wounds
Dermal Lesions
IV Sites .
Fixation device ●

biotela

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use - 2

OR over the Counter Use -

Regulation Number and Section

N/A