SIMPLICARE THIN FILM WOUND DRESSINGS by HOLLISTER, INC.

The Hollister Thin Film Wound Dressings are intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Thin Film Wound Dressings provide a barrier to bacteria and external contaminates such as urine and feces. The Hollister Thin Film Wound Dressings are also intended to be used on IV sites or as secondary fixation devices for products such as alginates, gels and foam dressings used for venous stasis and diabetic ulcers.

Indications for Use:
OTC:

minor burns
superficial cuts, lacerations and abrasions
minor irritations of the skin

Under the care of a health care professional:

non-exuding to minimally exuding wounds
pressure sores
lacerations/abrasions
partial and full thickness wounds
post-operative surgical wounds
second degree burns
donor sites
IV sites
secondary fixation device

Device Description

The Hollister Incorporated Thin Film Wound Dressings are transparent polyurethane films that are backed with a pressure sensitive acrylic adhesive. An unique closed cell foam application grid allows for easy handling of the film dressing during application to the wound sites. The Hollister Thin Film Wound Dressings are designed to have a ligh moisture vapor transmission rate and are intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Thin Film Wound Dressings provide a barrier to bacteria and external contaminates such as feces and urine.

The dressings are also intended to be used on IV sites or as secondary fixation devices for products such as alginates, gels, and foams used for venous stasis and diabetic ulcers.

The Hollister Thin Film Wound Dressings are presented sterile and are available in a variety of sizes to accommodate various sizes of wounds.

The Hollister Transparent Film Dressings are comprised of two parts: A transparent film dressing with removable backing paper and a foam application grid. The Transparent Film Dressings are permeable to moisture vapor and oxygen. The films transmit water, but retain other exudate components creating the ideal environment for wound healing.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device performance:

This document is a 510(k) premarket notification for the Hollister Thin Film Wound Dressings, seeking substantial equivalence to predicate devices. It does not contain a study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial with performance metrics. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and intended use, which is a different regulatory pathway.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable to the information provided in this 510(k) submission.

Here's what can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't define "acceptance criteria" in terms of specific performance metrics that need to be met by the Hollister device in a study. Instead, it compares the technological characteristics and indications for use of the proposed device against predicate devices to establish substantial equivalence.

Characteristic	Hollister Proposed 1	Hollister Proposed 2	I.T. Transparent Film (Predicate)	I.T. Intelligent Film (Predicate)
Intended Use	Moist wound healing environment to facilitate normal wound healing process	Same	Same	Same
Indications for Use (OTC)	Minor burns, superficial cuts, lacerations and abrasions, minor irritations of the skin	Same	Partial thickness wounds, pressure sores, abrasions, superficial burns, lacerations, donor sites, IV sites, fixation device, post-operative surgical wounds	Partial thickness wounds, pressure sores, abrasions, superficial burns, lacerations, donor sites, IV sites, fixation device, post-operative surgical wounds
Indications for Use (Healthcare Professional)	Non-exuding to minimally exuding wounds, pressure sores, lacerations/abrasions, partial and full thickness wounds, surgical incisions, second degree burns, donor sites, IV sites, secondary fixation device	Same	(Implicitly covered by OTC indications for predicate)	(Implicitly covered by OTC indications for predicate)
Contraindications	Third degree burns	Third degree burns	Third degree burns	Third degree burns
Transparent Film	Yes	Yes	Yes	Yes
Composition	Polyurethane film/pressure sensitive acrylic adhesive laminate	Polyurethane film/pressure sensitive acrylic adhesive laminate	Polyurethane film/pressure sensitive acrylic adhesive laminate	Polyurethane film/pressure sensitive acrylic adhesive laminate
Application Grid	Closed cell Polyethylene/Ethylene Vinyl Acetate Copolymer Foam/Acrylic Adhesive Laminate	Closed cell Polyethylene/Ethylene Vinyl Acetate Copolymer Foam/Acrylic Adhesive Laminate	NA	NA
MVTR (g/m²/24 h)	<2500	3000-6000	<2500	3000-15000
Sterilization Method	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation

Note: The "acceptance criteria" here are essentially the characteristics and performance of the legally marketed predicate devices, which the new device aims to be substantially equivalent to.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a 510(k) submission based on comparison to predicate devices, not a clinical study involving a "test set" of patient data for performance evaluation in the way a diagnostic AI would use it. The regulatory pathway of substantial equivalence relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a 510(k) submission for a wound dressing, not a diagnostic device requiring expert interpretation of a test set for ground truth.

4. Adjudication Method for the Test Set

Not applicable. As above, there's no "test set" in the context of a performance study as described in your prompt.

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 document pertains to a physical wound dressing, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This document pertains to a physical wound dressing, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the safety and effectiveness of the predicate devices, as established through their prior regulatory clearance (or grandfathered status). The Hollister device demonstrates substantial equivalence to these established predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for this type of device submission.

In summary, the provided document describes a 510(k) premarket notification for a wound dressing. The "study" proving the device meets acceptance criteria (in the context of regulatory approval) is the submission itself, which demonstrates substantial equivalence to predicate devices based on a comparison of fundamental technological characteristics, intended use, and biocompatibility. It does not involve performance studies with test sets, experts, or AI algorithms as implied by many of your prompt's questions.

Summary

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FEB 20 1992

Image /page/0/Picture/1 description: The image shows the word "Hollister" in a serif font, next to a geometric logo. The logo is a stylized, symmetrical shape resembling a snowflake or a complex cross. The word "Hollister" is in a bold, black font, and the logo is also black. The overall impression is clean and professional.

Hollister Incorporated 2000 Hollister Drive Libertvville, Illinois 60048-3781

980a209

Hollister Incorporated Thin Film Wound Dressings

Safety and Effectiveness Summary

1. Submitter's name, Address and Contact Person

Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048

Contact Person Joseph S. Tokarz Manager, Regulatory Affairs Phone (847)680-2849 (847)918-3860 Fax

Date Summary Prepared - January 5, 1998

2. Name of Device:

SimpliCare Thir. Illin Woland Dreasing i

3. Name of Predicate Device(s)

Innovative Technologies Transparent Thin Film Wound Dressing Innovative Technologies Intelligent Thin Film Wound Dressing

4. Description of Device

The dressings are also intended to be used on IV sites or as secondary fixation devices for products such as alginates, gels, and foams used for venous stasis and diabetic ulcers.

The Hollister Thin Film Wound Dressings are presented sterile and are available in a variety of sizes to accommodate various sizes of wounds.

5. Statement of Intended Use

The Hollister Thin Film Wound Dressings are intended to provide a moist wound healing environment to facilitate the normal wound healing process. The Hollister Thin Film

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Image /page/1/Picture/0 description: The image shows a black and white symbol that resembles a stylized cross or asterisk. It is composed of thick, intersecting lines that create a symmetrical pattern. The central area of the symbol forms a small, cross-shaped void, and the overall design has a bold, geometric appearance. The symbol is isolated against a white background.

新

Hollister.

Hollister Incorporated Thin Film Wound Dressings

Wound Dressings provide a barrier to bacteria and external contaminates such as urine and Would Dressings provins Film Wound Dressings are also intended to be used on IV sites Icocs. The Hombres for products such as alginates, gels and foam dressings used for venous stasis and diabetic ulcers.

1. Indications for Use
- minor burns OTC:
  - · superficial cuts, lacerations and abrasions
  - · minor irritations of the skin

Under the care of a health care professional:

· non-exuding to minimally exuding wounds
pressure sores
· iacerations/abrasions
· partial and full thickness wounds
· surgical incisions
· second degree burns
donor sites
· IV sites
· secondary fixation device
1. Contraindications for Use
- · Third degree burns

6. Statement of Technological Characteristics of the Device

A. The Hollister Transparent Film Dressings are comprised of two parts: A transparent film dressing with removable backing paper and a foam application grid. The Transparent Film Dressings are permeable to moisture vapor and oxygen. The films transmit water, but retain other exudate components creating the ideal environment for wound healing.

Characteristic	Hollister Proposed 1	Hollister Proposed 2	I.T. Transparent Film	I. T. Intelligent Filr
Intended Use	intended to provide amoist wound healingenvironment tofacilitate the normalwound healingprocess	same	same	same
Characteristic	Hollister Proposed 1	Hollister Proposed 2	I.T. Transparent Film	I. T. Intelligent Film
			!
Indications for	OTC:• minor burns	OTC:• minor burns	• Partial thickness wounds	• Partial thickness wounds
Use	• superficial cuts,lacerations andabrasions	• superficial cuts,lacerations andabrasions	• Pressure sores	• Pressure sores
	• minor irritations ofthe skinUnder the care of ahealth careprofessional:• non-exuding tominimally exudingwounds	• minor irritations ofthe skinUnder the care of ahealth careprofessional:• non-exuding tominimally exudingwounds	• Abrasions	• Abrasions
	• pressure sores• lacerations/abrasions• partial and fullthickness wounds• surgical incisions• second degree burns• donor sites• IV sites• secondary fixationdevice	• pressure sores• lacerations/abrasions• partial and fullthickness wounds• surgical incisions• second degree burns• donor sites• IV sites• secondary fixationdevice	• Superficialburns• Lacerations• Donor sites• IV sites• Fixation device• Post-operativesurgical wounds	• Superficialburns• Lacerations• Donor sites• IV sites• Fixation device• Post-operativesurgical wounds
Contraindications	Third degree burns	Third degree burns	Third degree burns	Third degree burns
for Use
Transparent	Yes	Yes	Yes	Yes
Film	Polyurethane film/pressure sensitiveacrylic adhesivelaminate	Polyurethane film/pressure sensitiveacrylic adhesivelaminate	Polyurethanefilm/ pressuresensitive acrylicadhesivelaminate	Polyurethanefilm/ pressuresensitive acrylicadhesivelaminate
Composition
Application	Closed cellPolyethylene/EthyleneVinyl AcetateCopolymer Foam/Acrylic AdhesiveLaminate	Closed cellPolyethylene/EthyleneVinyl AcetateCopolymer Foam/Acrylic AdhesiveLaminate	NA	NA
Grid
MVTR g/m²/24 h	<2500	3000-6000	<2500	3000-15000
Sterilization	Gamma Irradiation	Gamma Irradiation	GammaIrradiation	GammaIrradiation
method

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Image /page/2/Picture/0 description: The image shows the word "Hollister" in a serif font, with a stylized logo to the left. The logo is a geometric shape resembling a cross or asterisk, composed of intersecting bars. The word "Hollister" is in a simple, clean typeface, and the overall design is minimalist and modern.

!你?:

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Image /page/3/Picture/0 description: The image shows the word "Hollister" in a serif font, next to a geometric symbol. The symbol is a stylized cross or asterisk shape, composed of several intersecting lines. The word "Hollister" is written in a classic, elegant typeface, with a slight curve to the letters. Both the symbol and the word are in black, contrasting with the white background.

Hollister Incorporated Thin Film Wound Dressings

B. Material Biocompatibility: The biocompatibility of the Hollister Thin Film Wound Dressings was assessed based on principles and guidelines established by various governmental and standard setting organizations, such as: EN 30993, European Commission (EC) Standard; General Program Memorandum #G95-1, U.S. FDA Office of Device Evaluation; United Stated Pharmacopeia (USP). Material biocompatibility issues have been addressed based upon biomaterial history or in separate in vitro or in sivo laboratory evaluations using licensed commercial reference laboratories. These evaluations have been contracted either by Hollister or the suppliers of the materials. Based upon the results of this assessment, the materials used to fabricate the Hollister Thin Film Wound Dressings are considered biocompatible and appropriate for their intended use.

C. Based upon information presented above, the Hollister Thin Film Wound Dressings are substantially equivalent to the predicate devices.

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Image /page/4/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 three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 1998

Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781

Re: K980209

Trade Name: SimpliCare Thin Film Wound Dressing Regulatory Class: Unclassified Product Code: MGP Dated: January 19, 1998 Received: January 21, 1998

Dear Mr. Tokarz:

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.
This device may not be labeled as having any accelerating effect on the rate of 2. 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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Page 2 - Mr. Joseph S. Tokarz

If vour 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 vour 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,

fo Oelfo

Celia M. Witten, Ph.D., M.D.
Director

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Hollister Incorporated Thin Film Wound Dressings

Statement of Indications for Use

K980209 510(k) Number (if Known): Hollister Thin Film Wound Dressings Device Name:

Indications For Use:

l . Indications for Use
- OTC: · minor burns
  - · superficial cuts, lacerations and abrasions
  - · minor irritations of the skin

Under the care of a health care professional:

· non-exuding to minimally exuding wounds
· pressure sores
· lacerations/abrasions
· partial and full thickness wounds
· post-operative surgical wounds ...
· second degree burns
· donor sites
· IV sites
· secondary fixation device
1. Contraindications for Use
- · Third degree burns

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)ું જ

AND

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter-Use

(Optional Format 1-2-96)

Regulation Number and Section

N/A