MODIFICATION TO TIELLE HYDROPOLMER DRESSING

K983394 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · MGP · Nov 3, 1998 · SU

Device Facts

• Record ID: K983394
• Device Name: MODIFICATION TO TIELLE HYDROPOLMER DRESSING
• Applicant: Johnson & Johnson Medical, Div. of Ethicon, Inc.
• Product Code: MGP · SU
• Decision Date: Nov 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

TIELLE* Hydropolymer Dressing is an exudate handling system intended for low to moderately exuding wounds. The island dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under optimum conditions. During use the absorbent island gently expands as it takes up exudate. TIELLE* Hydropolymer Dressing is indicated for the management of chronic and acute, low to moderately exuding, partial and full thickness wounds including: - Superficial wounds 1. Minor abrasions 2. Skin Tears 3. Second Degree Burns. TIELLE* Hydropolymer Dressing should be used under health care professional direction for the following indications: - Pressure ulcers - Lower extremity ulcers 1. Venous 2. Arterial 3. Mixed etiology - Diabetic ulcers - Donor sites. TIELLE* Hydropolymer Dressing is suitable for use under compression bandaging.

Device Story

TIELLE Hydropolymer Dressing is an island-style wound dressing for low to moderately exuding wounds; functions as an exudate handling system. Consists of an adhesive-coated, water-resistant, permeable polyurethane backing, a non-woven wicking layer, and an absorbent polyurethane central island. During use, the absorbent island expands as it absorbs exudate; maintains a moist wound environment to support autolytic debridement and granulation. Applied by healthcare professionals or patients (as indicated by OTC/Prescription status); suitable for use under compression bandaging. Benefits include moisture management and support of natural healing processes. Does not treat or cure wounds; not for use on third-degree burns.

Clinical Evidence

Bench testing only. Biocompatibility testing conducted per ISO 10993 Part 1, including skin irritation, sensitization, cytotoxicity, hemolysis, acute oral toxicity, intramuscular injection, systemic injection, and mutagenesis assays (Ames, L5178Y). Results indicate the materials are non-irritant, non-sensitizing, non-cytotoxic, non-hemolytic, and non-mutagenic.

Technological Characteristics

Island dressing construction: adhesive-coated water-resistant permeable polyurethane backing, non-woven wicking layer, and absorbent polyurethane central island. Biocompatibility tested per ISO 10993. Suitable for compression bandaging. No electronic or software components.

Indications for Use

Indicated for management of chronic and acute, low to moderately exuding, partial and full thickness wounds including superficial wounds, minor abrasions, skin tears, second degree burns, pressure ulcers, lower extremity ulcers (venous, arterial, mixed etiology), diabetic ulcers, and donor sites. Contraindicated for third degree burns and lesions with active vasculitis.

Predicate Devices

• DuoDERM CGF Control Gel Formula Border Dressing (K973688)

Submission Summary (Full Text)

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K983394

3 1998 NOV

# APPENDIX H

# 510(k) SUMMARY

#### 1. DATE PREPARED

October 13, 1998

#### 2. SUBMITTER

Johnson & Johnson Medical Division of Ethicon Inc. 2500 Arbrook Blvd. P.O. Box 90130 Arlington, TX 76004-3130

#### 3. CONTACT PERSON

Terry James Dagnon Regulatory Affairs Project Manager Phone: [phone] Fax: [phone] or 817-784-5292

#### NAME OF THE MEDICAL DEVICE 4.

Classification Name: Common/Usual Name: Proprietary Name:

Dressing, Wound Topical wound dressing TIELLE* Hydropolymer Dressing

#### DEVICE CLASSIFICATION 5.

Product Code/Classification Number: Regulatory Class:

Unclassified Unclassified

#### STATEMENT OF SUBSTANTIAL EQUIVALENCE 6.

TIELLE* Hydropolymer Dressing is substantially equivalent and identical in function to DuoDERM* CGF Control Gel Formula Border Dressing (K973688) manufactured by ConvaTec - A Division of E.R. Squibb & Sons, Inc.

#### 7. INDICATIONS FOR USE

TIELLE* Dressing is indicated for the management of chronic and acute, low to moderately exuding, partial and full thickness wounds including:

- . Superficial wounds
- 1. Minor abrasions
- 2. Skin tears
- Second degree burns 3.

TIELLE* Hydropolymer Dressing should be used under health care professional direction for the following indications:

- Pressure ulcers 트
- Lower extremity ulcers II
- 1. Venous
- Arterial 2.
- 3. Mixed etiology
- Diabetic ulcers 트

Trademark *

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- I Donor sites
TIELLE Dressing is suitable for use under compression bandaging.

# PRECAUTIONS

TIELLE Dressing is not indicated for use on the following:

- · Third degree burns
- · Lesions with active vasculitis TIELLE Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause.

#### 8. PHYSICAL DESCRIPTION

TIELLE* Hydropolymer Dressing is an exudate handling system for low to moderately exuding wounds. The island dressing maintains a moist environment that supports the wound healing process and allows granulation to proceed under optimum conditions. During use the absorbent island gently expands as it takes up exudate. It allows the wound to remain moist which causes autolytic debridement to occur. This may initially increase lesion size, which is normal and to be expected prior to wound granulation.

#### 9. BIOCOMPATIBILITY

The following safety testing was conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices to support the Biocompatibility of this product.

# Adhesive Coated Water Resistant Permeable Polyurethane Backing

| | PRECLINICAL Testing Results |
|-----------------------------------------|-----------------------------|
| Five Day Repeated Skin Irritation | Non-irritant |
| Skin Sensitization Guinea-Pig (Buehler) | Non-sensitizer |
| Cytotoxicity | Non-cytotoxic |

| PRECLINICAL Testing Results Appendix D | |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Cotton pellet granuloma test of Meir, Schuler<br>and Desaulles (1950. | Non-Hazardous |
| Mammalian blood pressure | Non-Hazardous |
| Rabbit Intracutaneous Irritation Test | Non-irritant |
| Rabbit Optic Mucosa Irriatation Test | Mild effects of Hot extract only |
| Guinea pig dermal sensitisation test | Non-sensitizer |
| Steam vs. Irradiated Sterilization Toxicology Wicking Layer | |
| Subcutaneous pellet implantation in the rat | No increased risk if sterilized via radiation in<br>place of steam |
| Effect of Injection of hot water derived<br>residue on the cat blood pressure | No increased risk if sterilized via radiation in<br>place of steam |
| Rabbit Intra-cutaneous Irritation Test | No increased risk if sterilized via radiation in<br>place of steam |
| Rabbit Optic Mucosa Irritation Test | No increased risk if sterilized via radiation in<br>place of steam |

# Non-Woven Wicking Layer

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| Safety / Toxicity Testing | |
|-----------------------------------|------------------------------------------|
| Hemolysis (Rabbit RBCs) | Non-hemolytic |
| Primary Skin Irritation (Rabbits) | Non-irritant |
| Acute Oral Toxicity | Non-cytotoxic |
| Intramuscular Injection Test | Non-cytotoxic |
| Kligman Maximization Test | Non-sensitizer |
| Systemic Injection (Mice) | Non-cytotoxicity |
| MEM Elution Test | Non-cytotoxic |
| Agar Diffusion Test | Non-Cytotoxic |
| Ames Assay | Non-mutagenic |
| L5178Y TK+/- Mouse Lymphoma | Non-mutagenic |
| Mutagenesis Assay | Non-mutagenic |
| Rat Oral LD50 | LD50 > than 40g/kg |
| Rabbit Dermal LD50 | LD50 for B-15J found to be > 5/g/kg |
| Rabbit Dermal Irritancy (Draize) | Non-irritating |
| Rabbit Eye Irritation | Non-irritating |
| Human Repeat Insult Patch Test | Non-irritating & Non-sensitising |
| Cytotoxicity Test (Agar Overlay) | Non-cytotoxic using L929 mammalian cells |

# Absorbent Polyurethane Wound Contact Layer (Central Island)

: 上一篇:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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3 1998 NOV

Mr. Terry James Dagnon Regulatory Affairs Project Manager Johnson & Johnson Medical Division of Ethicon Inc. 2500 Arbrook Boulevard Arlington, Texas 76004-3130

Re: K983394

> Trade Name: TIELLE* Hydropolymer Dressing Regulatory Class: Unclassified Product Code: MGP Dated: September 21, 1998 Received: September 25, 1998

Dear Mr. Dagnon:

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:

- This device may not be labeled for use on third degree burns. 1.
- 2. This device may not be labeled as having any accelerating effect on the rate of 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

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Page 2 - Mr. Terry James Dagnon

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 (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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] 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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## 510(k) Number : K983394

# Applicant: Johnson & Johnson Medical Division of Ethicon Inc. 2500 Arbrook Blvd. Arlington, TX 76004-3130

## Device Name: TIELLE* Hydropolymer Dressing Indications for Use:

TIELLE* Hydropolymer Dressing is an exudate handling system intended for low to moderately exuding wounds. The island dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under optimum conditions. During use the absorbent island gently expands as it takes up exudate.

TIELLE* Hydropolymer Dressing is indicated for the management of chronic and acute, low to moderately exuding, partial and full thickness wounds including:

- Superficial wounds .
- 1. Minor abrasions
- 2. Skin Tears
- Second Degree Burns 3.

TIELLE* Hydropolymer Dressing should be used under health care professional direction for the following indications:

- . Pressure ulcers
- . Lower extremity ulcers
- 1. Venous
- 2. Arterial
- 3. Mixed etiology
- . Diabetic ulcers
- . Donor sites

TIELLE* Hydropolymer Dressing is suitable for use under compression bandaging.

## PRECAUTIONS

TIELLE Dressing is not indicated for use on the following:

- · Third dearee burns
- · Lesions with active vasculitis as this type of ulcer needs more frequent observation by a healthcare professional.

TIELLE Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause.

## (Please Do Not Write Below This Line-Continue on Another Page if Needed)

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | <div style="display:inline-block;">✓</div> Or <div style="display:inline-block;">Over-The-Counter Use</div> | <div style="display:inline-block;">✓</div> |
| (Division Sign-Off) | * Trademark | |
| Division of General Restorative Devices<br>510(k) Number | K983394 | 000 00001 |