← Product Code MGP · K983234
# TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING (K983234)
_Johnson & Johnson Medical, Div. of Ethicon, Inc. · MGP · Nov 25, 1998 · SU · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K983234
## Device Facts
- **Applicant:** Johnson & Johnson Medical, Div. of Ethicon, Inc.
- **Product Code:** MGP
- **Decision Date:** Nov 25, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
## Intended Use
TIELLE® PLUS Hydropolymer Dressing is an exudate handling system intended for moderate to heavily 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* PLUS Hydropolymer Dressing is indicated for the management of chronic and acute, moderate to heavily exuding, partial and full thickness wounds including: Superficial wounds 1. Minor abrasions 2. Skin Tears 3. Second Degree Burns TIELLE* PLUS 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 4. Diabetic ulcers 5. Donor sites TIELLE® PLUS Hydropolymer Dressing is suitable for use under compression bandaging.
## Device Story
TIELLE PLUS is an adhesive wound dressing designed for moderate to heavily exuding chronic and acute wounds. The device consists of an absorbent polyurethane central island, a non-woven wicking layer, and an adhesive-coated, water-resistant, permeable polyurethane backing. It functions as an exudate handling system; the absorbent island expands upon contact with wound fluid to maintain a moist environment, which facilitates autolytic debridement and granulation. The dressing is applied topically to the wound site by a healthcare professional or patient (as indicated by the dressing type) and is compatible with compression bandaging. It does not treat or cure wounds but supports the natural healing process. The device is intended for use in clinical or home settings under professional guidance.
## Clinical Evidence
Bench testing only. Biocompatibility testing performed in accordance with ISO 10993, including cytotoxicity (Agar Overlay, MEM Elution), sensitization (Kligman Maximization), irritation (primary skin, eye, dermal), hemolysis, and mutagenicity (Ames, Mouse Lymphoma). All results confirmed the device is non-toxic, non-irritating, and non-sensitizing.
## Technological Characteristics
Materials: Polyurethane backing, non-woven wicking layer, absorbent polyurethane central island. Principle: Exudate absorption and moisture vapor transmission. Form factor: Adhesive island dressing. Sterilization: Not specified. Connectivity: None. Software: None.
## Predicate Devices
- DuoDERM CGF Control Gel Formula Border Dressing ([K973688](/device/K973688.md))
## Submission Summary (Full Text)
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510 (k) TIELLE® PLUS Hydropolymer Adhesive Dressing
# APPENDIX I
NOV 25 1998
# 510(k) SUMMARY
Image /page/0/Picture/7 description: The image shows a series of bold, black numbers and a letter, seemingly handwritten. The sequence reads 'K983234'. The characters are large and take up most of the frame, with the letter 'K' appearing first, followed by the numbers in succession.
### DATE PREPARED 1.
November 14, 1998
#### 2. SUBMITTER
Johnson & Johnson Medical Division of Ethicon Inc. 2500 Arbrook Blvd. P.O. Box 90130 Arlington, TX 76004-3130
### CONTACT PERSON 3.
Terry James Dagnon Regulatory Affairs Project Manager Phone: 817-262-4953 817-262-5369 or 817-262-5292 Fax:
#### NAME OF THE MEDICAL DEVICE 4.
Classification Name: Common/Usual Name: Proprietary Name:
Dressing, Wound Topical wound dressing TIELLE* PLUS Hydropolymer Adhesive Dressing
### DEVICE CLASSIFICATION 5.
Regulatory Class: Product Code:
Unclassified Unknown
### STATEMENT OF SUBSTANTIAL EQUIVALENCE હે.
TIELLE* PLUS Hydropolymer Adhesive 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.
#### INDICATIONS FOR USE 7.
### Indications for Use:
TIELLE PLUS Hydropolymer Dressing is indicated for the management of chronic and acute, moderate to heavily exuding, partial and full thickness wounds including:
- . Superficial wounds
- 1. Minor abrasions
- 2. Skin Tears
- Second Degree Burns 3.
TIELLE* PLUS Hydropolymer Dressing should be used under health care professional direction for the following indications:
Pressure ulcers
:
Trademark
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12983234
1 1 13
# 510 (k) TIELLE* PLUS Hydropolymer Adhesive Dressing
Lower extremity uicers
- 1. Venous
- 2. Arterial
- Mixed etiology 3. Diabetic ulcers Donor sites
TIELLE® PLUS Hydropolymer Dressing is suitable for use under compression bandaging,
### PRECAUTIONS
TIELLE PLUS Dressing is not indicated for use on the following:
- · Third degree burns
- · Lesions with active vasculitis as this type of ulcer needs more frequent observation by a healthcare professional.
TIELLE PLUS 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* PLUS Hydropolymer Dressing is an exudate handling system intended for moderate to heavily 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. During use the lesion size may initially increase. This is normal and to be expected prior to wound granulation.
#### 9. BIOCOMPATIBILITY
...
The safety tests conducted below are in accordance with ISO 10993 Part-1 "Biological Evaluation Of Medical Devices" and demonstrate the TIELLE* PLUS Hydropolymer Adhesive Dressing is acceptable for use as a Topical Wound Dressing.
# Adhesive Coated Water Resistant Permeable Polyurethane Backing
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# Non-Woven Wicking Layer (Supraabsorbent)
| PRECLINICAL Testing Results | |
|-----------------------------|----------------|
| AMES bacterial mutagenicity | Non-mutagenic |
| Acute eye irritation | Non-irritant |
| Acute dermal irritation | Non-irritant |
| Skin sensitization | Non-sensitizer |
| Cytotoxicity (Agar Overlay) | Non-toxic |
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8983234
# 510 (k) TIELLE* PLUS Hydropolymer Adhesive Dressing
# Absorbent Polyurethane Wound Contact Layer (Central Island)
| 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 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 |
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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the upper portion of the circle.
# NOV 25 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Terry J. Dagnon Johnson & Johnson Medical Division 2500 East Arbrook Blvd. Arlington, Texas 76014
Re: K983234 Trade Name: Tielle Plus Hydropolymer Adhesive Dressing Regulatory Class: Unclassifed Product Code: MGP Dated: September 14, 1998 Received: September 15, 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.
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.
This device may not be labeled as a treatment or a cure for any type of wound. 4.
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 - Terry J. Dagnon
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 (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 tollfree number (800) 638-2041 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
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### 510 (k) TIELLE* PLUS Hydropolymer Adhesive Dressing Diabetic Ulcer Submission
# 510(k) Number :
### Johnson & Johnson Medical Applicant: Division of Ethicon Inc. 2500 Arbrook Blvd. Arlinaton. TX 76004-3130
# Device Name: TIELLE* PLUS Hydropolymer Dressing
### Indications for Use:
TIELLE® PLUS Hydropolymer Dressing is an exudate handling system intended for moderate to heavily 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* PLUS Hydropolymer Dressing is indicated for the management of chronic and acute, moderate to heavily exuding, partial and full thickness wounds including:
- Superficial wounds .
- 1. Minor abrasions
- ﻨﺎ Skin Tears
- 3. Second Degree Burns
TIELLE* PLUS Hydropolymer Dressing should be used under health care professional direction for the following indications:
- Pressure ulcers
Lower extremity ulcers
- 1. Venous
- 2. Arterial
Mixed etlology 3. Diabetic ulcers Donor sites
TIELLE* PLUS Hydropolymer Dressing is suitable for use under compression bandaging.
### PRECAUTIONS
TIELLE PLUS Dressing is not indicated for use on the following:
- · Third degree burns
- · Lesions with active vasculitis as this type of ulcer needs more frequent observation by a healthcare professional.
TIELLE PLUS 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)
Or
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
Counter Use
Division Sign-Off
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K98325
* Trademark
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