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
- 1. 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
- 1. Arterial
- 1. 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.

AI/ML Overview

The document provided is a 510(k) summary for a medical device called TIELLE* Hydropolymer Dressing. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in a Premarket Approval (PMA) application or a de novo submission for novel devices.

Therefore, the document does not contain information about:

A table of acceptance criteria and reported device performance related to a clinical study.
Sample sizes used for a test set or its data provenance.
Number of experts, their qualifications, or adjudication methods for ground truth.
A multi-reader multi-case (MRMC) comparative effectiveness study.
A standalone (algorithm-only) performance study.
Specific details about the ground truth used (beyond general "biocompatibility" or "safety").
Sample size for a training set.
How ground truth for a training set was established.

Instead, the document focuses on biocompatibility testing to demonstrate the safety of the materials used in the device. The "acceptance criteria" here are implied by the "preclinical testing results" showing that the materials are "non-irritant," "non-sensitizer," "non-cytotoxic," and "non-hazardous."

Here's the information that can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't define explicit numerical acceptance criteria for performance in the context of a clinical study measuring efficacy on wound healing, but rather for safety (biocompatibility) of the materials. The "performance" column indicates the successful outcome of these safety tests.

Test Category	Test Method / Type	Acceptance Criteria (Implied)	Reported Device Performance
Material: Adhesive Coated Water Resistant Permeable Polyurethane Backing
Biocompatibility	Five Day Repeated Skin Irritation	Non-irritant	Non-irritant
Biocompatibility	Skin Sensitization Guinea-Pig (Buehler)	Non-sensitizer	Non-sensitizer
Biocompatibility	Cytotoxicity	Non-cytotoxic	Non-cytotoxic
Biocompatibility (Appendix D)	Cotton pellet granuloma test of Meir, Schuler and Desaulles (1950)	Non-Hazardous	Non-Hazardous
Biocompatibility (Appendix D)	Mammalian blood pressure	Non-Hazardous	Non-Hazardous
Biocompatibility (Appendix D)	Rabbit Intracutaneous Irritation Test	Non-irritant	Non-irritant
Biocompatibility (Appendix D)	Rabbit Optic Mucosa Irritation Test	Mild effects acceptable	Mild effects of Hot extract only
Biocompatibility (Appendix D)	Guinea pig dermal sensitisation test	Non-sensitizer	Non-sensitizer
Biocompatibility (Appendix D)	Subcutaneous pellet implantation in the rat (Sterilization Toxicology)	No increased risk	No increased risk if sterilized via radiation in place of steam
Biocompatibility (Appendix D)	Effect of Injection of hot water derived residue on the cat blood pressure (Sterilization Toxicology)	No increased risk	No increased risk if sterilized via radiation in place of steam
Biocompatibility (Appendix D)	Rabbit Intra-cutaneous Irritation Test (Sterilization Toxicology)	No increased risk	No increased risk if sterilized via radiation in place of steam
Biocompatibility (Appendix D)	Rabbit Optic Mucosa Irritation Test (Sterilization Toxicology)	No increased risk	No increased risk if sterilized via radiation in place of steam
Material: Non-Woven Wicking Layer
Biocompatibility	Hemolysis (Rabbit RBCs)	Non-hemolytic	Non-hemolytic
Biocompatibility	Primary Skin Irritation (Rabbits)	Non-irritant	Non-irritant
Biocompatibility	Acute Oral Toxicity	Non-cytotoxic	Non-cytotoxic
Biocompatibility	Intramuscular Injection Test	Non-cytotoxic	Non-cytotoxic
Biocompatibility	Kligman Maximization Test	Non-sensitizer	Non-sensitizer
Biocompatibility	Systemic Injection (Mice)	Non-cytotoxicity	Non-cytotoxicity
Biocompatibility	MEM Elution Test	Non-cytotoxic	Non-cytotoxic
Biocompatibility	Agar Diffusion Test	Non-Cytotoxic	Non-Cytotoxic
Biocompatibility	Ames Assay	Non-mutagenic	Non-mutagenic
Biocompatibility	L5178Y TK+/- Mouse Lymphoma Mutagenesis Assay	Non-mutagenic	Non-mutagenic
Biocompatibility	Rat Oral LD50	LD50 > 40g/kg	LD50 > than 40g/kg
Biocompatibility	Rabbit Dermal LD50	LD50 > 5g/kg	LD50 for B-15J found to be > 5/g/kg
Biocompatibility	Rabbit Dermal Irritancy (Draize)	Non-irritating	Non-irritating
Biocompatibility	Rabbit Eye Irritation	Non-irritating	Non-irritating
Biocompatibility	Human Repeat Insult Patch Test	Non-irritating & Non-sensitising	Non-irritating & Non-sensitising
Biocompatibility	Cytotoxicity Test (Agar Overlay)	Non-cytotoxic	Non-cytotoxic using L929 mammalian cells

2. Sample sizes used for the test set and the data provenance:

Sample Sizes: Not explicitly stated numerically for each test, but standard animal models (Guinea-Pig, Rabbit, Rat, Mice, Cat) and in vitro tests (L929 mammalian cells, L5178Y TK+/- Mouse Lymphoma, Rabbit RBCs) were used. For the Human Repeat Insult Patch Test, the number of human subjects is not specified.
Data Provenance: Preclinical (laboratory/animal) testing, including in vitro and in vivo studies. No country of origin is mentioned for the data itself, but the submission is to the FDA in the USA for a device manufactured by a division of an American company (Johnson & Johnson Medical, a Division of Ethicon Inc.). The studies are retrospective from the perspective of the 510(k) submission, meaning they were conducted prior to the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. Biocompatibility testing results are typically derived from standardized protocols and measurements, rather than expert consensus on a "ground truth" in the clinical sense.

4. Adjudication method for the test set:

Not applicable as this is not a study requiring adjudication of clinical outcomes or interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a medical device for wound dressing, not an AI/imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This applies to AI/software devices.

7. The type of ground truth used:

For biocompatibility tests, the "ground truth" is defined by the objective outcomes of the standardized tests (e.g., presence/absence of irritation, cytotoxicity, hemolysis, mutagenicity, and toxicity levels). These are typically quantitative or categorical assessments based on established biological responses.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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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: 817-784-4953 Fax: 817-784-4992 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
- 1. 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.
- 1. 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

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, Schulerand 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 inplace of steam
Effect of Injection of hot water derivedresidue on the cat blood pressure	No increased risk if sterilized via radiation inplace of steam
Rabbit Intra-cutaneous Irritation Test	No increased risk if sterilized via radiation inplace of steam
Rabbit Optic Mucosa Irritation Test	No increased risk if sterilized via radiation inplace 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.
1. This device may not be labeled as having any accelerating effect on the rate of 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

{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 (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,

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

Superficial wounds .
- 1. Minor abrasions
- 1. 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
- 1. Arterial
- 1. 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)

��

	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 Devices510(k) Number	K983394	000 00001

Regulation Number and Section

N/A