K Number

Device Name

SIMPLICARE THIN FILM WOUND DRESSINGS

Manufacturer

HOLLISTER, INC.

Date Cleared

1998-02-20

(31 days)

Product Code

MGP

Regulation Number

N/A

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

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

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use focus on the physical properties and function of a wound dressing, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as a wound dressing intended to facilitate the normal wound healing process and is indicated for various types of wounds, including partial and full thickness wounds, burns, and ulcers, which are conditions requiring therapeutic intervention.

Diagnostic

The device description and intended use clearly state that it is a wound dressing intended to provide a moist healing environment and a barrier to contaminants, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical product made of transparent polyurethane films with adhesive and a foam application grid. It is a tangible wound dressing, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Function: The description clearly states that the Hollister Thin Film Wound Dressings are applied externally to wounds and IV sites. Their function is to provide a protective barrier, maintain a moist healing environment, and act as a secondary fixation device.
No Mention of Sample Analysis: There is no indication that this device analyzes any biological samples or provides diagnostic information based on such analysis.

The device is a wound dressing, which is a type of medical device used for wound management, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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
Contraindications for Use
- Third degree burns

Product codes (comma separated list FDA assigned to the subject device)

MGP

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Wound sites, IV sites

Indicated Patient Age Range

Not Found

Intended User / Care Setting

OTC (Over-the-Counter) and Under the care of a health care professional

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

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

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 a
moist wound healing
environment to
facilitate the normal
wound healing
process	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 and
abrasions	• superficial cuts,
lacerations and
abrasions	• Pressure sores	• Pressure sores
	• minor irritations of
the skin
Under the care of a
health care
professional:
• non-exuding to
minimally exuding
wounds	• minor irritations of
the skin
Under the care of a
health care
professional:
• non-exuding to
minimally exuding
wounds	• Abrasions	• Abrasions
	• pressure sores
• lacerations/
abrasions
• partial and full
thickness wounds
• surgical incisions
• second degree burns
• donor sites
• IV sites
• secondary fixation
device	• pressure sores
• lacerations/
abrasions
• partial and full
thickness wounds
• surgical incisions
• second degree burns
• donor sites
• IV sites
• secondary fixation
device	• Superficial
burns
• Lacerations
• Donor sites
• IV sites
• Fixation device
• Post-operative
surgical wounds	• Superficial
burns
• Lacerations
• Donor sites
• IV sites
• Fixation device
• Post-operative
surgical 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 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
Composition
Application	Closed cell
Polyethylene/Ethylene
Vinyl Acetate
Copolymer Foam/
Acrylic Adhesive
Laminate	Closed cell
Polyethylene/Ethylene
Vinyl Acetate
Copolymer Foam/
Acrylic Adhesive
Laminate	NA	NA
Grid
MVTR g/m²/24 h	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.

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

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)