Who is the manufacturer of SIMPLICARE THIN FILM WOUND DRESSINGS?

Hollister, Inc. filed the 510(k) submission for SIMPLICARE THIN FILM WOUND DRESSINGS (K980209).

What is the FDA product code for SIMPLICARE THIN FILM WOUND DRESSINGS?

MGP. as a Class U device in the SU panel.

What is the regulatory pathway for SIMPLICARE THIN FILM WOUND DRESSINGS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SIMPLICARE THIN FILM WOUND DRESSINGS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SIMPLICARE THIN FILM WOUND DRESSINGS

Q: What are the predicate devices for SIMPLICARE THIN FILM WOUND DRESSINGS?

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

K980209 · Hollister, Inc. · MGP · Feb 20, 1998 · SU

Device Facts

Record ID	K980209
Device Name	SIMPLICARE THIN FILM WOUND DRESSINGS
Applicant	Hollister, Inc.
Product Code	MGP · SU
Decision Date	Feb 20, 1998
Decision	SESK
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

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.

Device Story

Transparent polyurethane film dressing with pressure-sensitive acrylic adhesive; includes closed-cell polyethylene/ethylene vinyl acetate copolymer foam application grid for handling. Provides moisture vapor transmission and oxygen permeability while acting as a bacterial barrier. Used in clinical settings by healthcare professionals or for OTC minor wound care. Applied to wound sites to maintain a moist healing environment; protects against external contaminants like feces/urine. Functions as primary dressing for non-exuding/minimally exuding wounds or secondary fixation for other wound care products (alginates, gels, foams). Benefits patient by facilitating normal healing process and protecting wound site.

Clinical Evidence

Bench testing only. Biocompatibility assessed via biomaterial history and in vitro/in vivo laboratory evaluations per EN 30993, FDA G95-1, and USP guidelines. No clinical trial data presented.

Technological Characteristics

Transparent polyurethane film with pressure-sensitive acrylic adhesive. Includes closed-cell polyethylene/ethylene vinyl acetate copolymer foam application grid. Permeable to moisture vapor and oxygen. MVTR ranges <2500 g/m²/24h or 3000-6000 g/m²/24h. Sterilized via gamma irradiation. Biocompatible per EN 30993, USP, and FDA G95-1 standards.

Indications for Use

Indicated for OTC use on minor burns, superficial cuts, lacerations, abrasions, and minor skin irritations. Under professional care, indicated for 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, and as a secondary fixation device. Contraindicated for third degree burns.

Predicate Devices

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

Related Devices

K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING · Hollister, Inc. · Oct 14, 1999
K982939 — BTF THIN FILM WOUND DRESSING · Bioderm, Inc. · Oct 13, 1998
K981753 — INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING · Innovative Technologies , Ltd. · Jun 30, 1998
K990875 — DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING · Dermaphylyx, Inc. · May 27, 1999
K982892 — 3M TEGASORB THIN HYDROCOLLOID DRESSING · 3M Company · Oct 26, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ **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 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. #### 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 {1}------------------------------------------------ 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 - 2. 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 | <2500 | 3000-6000 | <2500 | 3000-15000 | | Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | | method | | | | | {2}------------------------------------------------ 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?: # {3}------------------------------------------------ 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. {4}------------------------------------------------ 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. - 3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin. ------------------------------------------------------------------------------------------------------------------------------------------- - 4. 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ ## 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: b. 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. - 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 - 2. 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) 5