TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING

• K Number: K983234
• Device Name: TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING
• Manufacturer: JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC.
• Date Cleared: 1998-11-25 ( 71 days)
• Product Code: MGP , UNC
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K973688
• Predicate For: N/A

Intended 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
  • 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.

Device 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.

AI/ML Overview

Here's an analysis of the provided text regarding the TIELLE® PLUS Hydropolymer Adhesive Dressing, focusing on acceptance criteria and supporting studies:

This document is a 510(k) summary for a medical device, which primarily demonstrates substantial equivalence to a predicate device rather than presenting a full clinical study with specific acceptance criteria directly tied to efficacy metrics. The "acceptance criteria" discussed here are mainly related to biocompatibility and safety, and the "study" referred to is a series of preclinical (safety/toxicity) tests.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (General)	Acceptable for use as a Topical Wound Dressing (ISO 10993 Part-1)	Demonstrated as acceptable (statement of compliance)
Non-Woven Wicking Layer
AMES bacterial mutagenicity	Non-mutagenic	Non-mutagenic
Acute eye irritation	Non-irritant	Non-irritant
Acute dermal irritation	Non-irritant	Non-irritant
Skin sensitization	Non-sensitizer	Non-sensitizer
Cytotoxicity (Agar Overlay)	Non-toxic	Non-toxic
Absorbent Polyurethane Wound Contact Layer
Hemolysis (Rabbit RBCs)	Non-hemolytic	Non-hemolytic
Primary Skin Irritation (Rabbits)	Non-irritant	Non-irritant
Acute Oral Toxicity	Non-cytotoxic (from context of other tests)	Non-cytotoxic
Intramuscular Injection Test	Non-cytotoxic (from context of other tests)	Non-cytotoxic
Kligman Maximization Test	Non-sensitizer	Non-sensitizer
Systemic Injection (Mice)	Non-cytotoxicity (from context of other tests)	Non-cytotoxicity
MEM Elution Test	Non-cytotoxic	Non-cytotoxic
Agar Diffusion Test	Non-Cytotoxic	Non-Cytotoxic
Ames Assay	Non-mutagenic	Non-mutagenic
L5178Y TK+/- Mouse Lymphoma Mutagenesis Assay	Non-mutagenic	Non-mutagenic
Rat Oral LD50	LD50 > than X g/kg (threshold for non-toxic)	LD50 > than 40g/kg
Rabbit Dermal LD50	LD50 for B-15J > than X g/kg (threshold for non-toxic)	LD50 for B-15J found to be > 5g/kg
Rabbit Dermal Irritancy (Draize)	Non-irritating	Non-irritating
Rabbit Eye Irritation	Non-irritating	Non-irritating
Human Repeat Insult Patch Test	Non-irritating & Non-sensitising	Non-irritating & Non-sensitising
Cytotoxicity Test (Agar Overlay)	Non-cytotoxic using L929 mammalian cells	Non-cytotoxic using L929 mammalian cells

Explanation of "Acceptance Criteria": For most of these preclinical tests, the "acceptance criteria" are implied by the nature of the test itself: a positive result (e.g., mutagenic, irritant, toxic, hemolytic, sensitizer) would indicate failure, while a negative or "non-" result indicates acceptance. For LD50 tests, the acceptance criterion is a sufficiently high LD50 value indicating low acute toxicity.

2. Sample Size Used for the Test Set and Data Provenance

The provided document details preclinical (safety/biocompatibility) testing, not a clinical test set on human subjects for performance evaluation in the traditional sense.

• Test Set Sample Size:
  • For many tests (e.g., Ames, Cytotoxicity, Irritation, Sensitization), the sample size refers to the number of replicates or animals used per test category, which is not explicitly stated in this summary. Standard protocols for these tests typically involve a small, defined number of animals (e.g., 3-6 rabbits for irritation, multiple mice for systemic injection, specific cell cultures for cytotoxicity).
  • For Rat Oral LD50, the sample size would be the number of rats used.
  • For Rabbit Dermal LD50, the sample size would be the number of rabbits used.
  • For Human Repeat Insult Patch Test, the sample size would be the number of human volunteers. These specific numbers are not provided in this summary.
• Data Provenance: The document does not specify the country of origin for these preclinical test results. Given the context of a US 510(k) submission, it's highly likely to be US-based testing or testing conducted by internationally recognized labs. All tests are by nature prospective preclinical studies (i.e., experiments designed and conducted to evaluate the device's safety characteristics).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the preclinical safety testing described. Establishing "ground truth" with experts, adjudication, and inter-reader variability is relevant for clinical studies, especially those involving image interpretation or diagnostic performance. For biocompatibility tests, the "truth" is determined by the objective scientific measurement outcomes of standardized tests.

4. Adjudication Method for the Test Set

This is not applicable to the preclinical safety testing described. Adjudication methods are used in clinical studies, particularly those involving human readers/interpreters, to resolve discrepancies in diagnoses or assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. This type of study evaluates the diagnostic performance or effectiveness of a device when used by multiple human readers, often comparing performance with and without an AI assistant. The presented document focuses purely on the safety and basic physical characteristics of a wound dressing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done because this device is a physical wound dressing, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the preclinical tests consisted of:

• Laboratory Assay Results: Objective measurements and observations from standardized biological and chemical tests (e.g., bacterial growth, cell viability, irritation scores in animals, presence/absence of hemolysis, lethal dose concentrations).
• Histopathology/Pathology: For certain animal tests (e.g., irritation), microscopic examination of tissues may contribute to the "truth."
• Expert Interpretation of Test Data: While not "expert consensus" in the clinical sense, the evaluation of laboratory results requires expertise in toxicology, microbiology, and biocompatibility testing. The "ground truth" is established by the accepted scientific protocols and interpretation of these tests by trained scientists.

8. The Sample Size for the Training Set

Not Applicable. This device is a physical wound dressing, not an AI or machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for this device, there is no ground truth to establish for it.

---

Summary Takeaway:
This 510(k) submission focuses on demonstrating the safety and biocompatibility of the TIELLE® PLUS Hydropolymer Adhesive Dressing through a series of standardized preclinical tests. It is not an AI/ML-driven device, and therefore, concepts like MRMC studies, standalone algorithm performance, training/test sets, expert adjudication, and ground truth in the context of diagnostic accuracy are not relevant to this document. The "acceptance criteria" are derived from the expected negative outcomes of these safety tests (e.g., "non-mutagenic," "non-irritant").

Summary

{0}------------------------------------------------

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: [phone] 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

Image /page/0/Picture/32 description: The image shows the number 10 in bold font. To the right of the number 10 is a dark, blurry shape. The number 10 is the main focus of the image.

{1}------------------------------------------------

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

Free in and11 11 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 11871 11 16STATE THE CART THE CHANGE OF THE CHANGE OF THE CHANGE OF THE CHANGE OF THE CHANGE OF THE CHANGE OF THE CHART AND THE CHART AND THE CHANGE AND A CHANGE AND A CHANGE AND A CHAR
A Children of Children of Children and Children and------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	CALL CONSUL COLLECTION COLLEGI
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------A CONSULER OF CLAIM OF CHEARTH FOR COLLECTION OFABURACIALAR, ILL L.------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------AND CLAIMCONTRACTOR COLLEGION OF CONSULERS OF
----------------------------------------------------------------------AND AND CONSULER OF LEBELLERS OFALANDA FREE LAR BIR STATMAN CAR CHICALLARAND A Children Children County of------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- - - - - - - - - - -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------AND CONSUL CONSULTION COLLEGION	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------NO OF OF CHINAS AND ORDER OF COLLECTION OF CLAIMI consumer on and come come con-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------And Albert A & L L -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Annual proper and Property and Party of Concession of ChildrenCollection of the consideration of the consideration of the consistences and consisted to the contraction of the commended to the controlled to the contraction of the commend1

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

{2}------------------------------------------------

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 MutagenesisAssay	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

{3}------------------------------------------------

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.

{4}------------------------------------------------

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 [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 tollfree 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

{5}------------------------------------------------

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

Regulation Number and Section

N/A