MODIFICATION TO TIELLE HYDROPOLMER DRESSING

• K Number: K983394
• Device Name: MODIFICATION TO TIELLE HYDROPOLMER DRESSING
• Manufacturer: JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC.
• Date Cleared: 1998-11-03 ( 39 days)
• Product Code: MGP
• Regulation Number: N/A

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 - 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.

Device 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.

Predicate Devices

K973688

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 a wound dressing intended to support the healing process of various types of wounds, which is a therapeutic function.

Diagnostic

No

This device is a dressing for wound management, focusing on exudate handling and maintaining a moist wound environment to support healing. It does not perform any diagnostic functions.

SaMD (Software as a Medical Device)

No

The device is a physical dressing (hydropolymer dressing) intended for wound care, not a software application. The description focuses on the material properties and function of the dressing itself.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is for managing wounds by handling exudate and maintaining a moist environment to support healing. This is a direct therapeutic application to the body.
• Device Description: The description focuses on the physical properties of the dressing and its interaction with the wound and exudate.
• Lack of Diagnostic Language: There is no mention of analyzing samples from the body (like blood, urine, tissue) to diagnose a condition, monitor a disease, or screen for health issues.
• Biocompatibility Testing: The performance studies focus on the safety of the material in contact with the body, which is typical for devices that interact directly with the patient.

IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is applied in vivo (on the body) for wound management.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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

MGP

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care professional direction

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)

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
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 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 place of steam
Effect of Injection of hot water derived residue on the cat blood pressure: No increased risk if sterilized via radiation in place of steam
Rabbit Intra-cutaneous Irritation Test: No increased risk if sterilized via radiation in place of steam
Rabbit Optic Mucosa Irritation Test: No increased risk if sterilized via radiation in place of steam

Non-Woven Wicking Layer
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

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.

K973688

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

0

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 *

1

• 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
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
place of steam
Effect of Injection of hot water derived
residue on the cat blood pressure	No increased risk if sterilized via radiation in
place of steam
Rabbit Intra-cutaneous Irritation Test	No increased risk if sterilized via radiation in
place of steam
Rabbit Optic Mucosa Irritation Test	No increased risk if sterilized via radiation in
place of steam

Non-Woven Wicking Layer

2

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:

3

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/3/Picture/3 description: The image shows a black and white graphic. The graphic appears to be a stylized representation of three faces or heads, stacked vertically. The faces are abstract, with flowing lines suggesting hair or features. The image is cropped, with only a portion of the word "DEPART" visible on the left side.

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

4

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

5

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
(Per 21 CFR 801.109)	✓ Or Over-The-Counter Use	✓
(Division Sign-Off)	* Trademark
Division of General Restorative Devices
510(k) Number	K983394	000 00001