(71 days)
Not Found
No
The device description and performance studies focus on the material properties and biological compatibility of a wound dressing, with no mention of AI or ML.
No
Therapeutic devices are for treating a disease or health problem. This device is a dressing for managing wound exudate and maintaining a moist wound environment, which supports the healing process but does not directly treat a disease.
No
The device is a wound dressing designed for managing exudate and supporting wound healing, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical dressing ("Hydropolymer Dressing") and the performance studies focus on biocompatibility testing, which is relevant to physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The TIELLE® PLUS Hydropolymer Dressing is a wound dressing applied externally to the body to manage exudate and promote wound healing. It does not involve testing samples taken from the body.
- Intended Use: The intended use is for the management of various types of wounds, which is a therapeutic application, not a diagnostic one.
The information provided clearly describes a topical wound care product, not a diagnostic test.
N/A
Intended Use / 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
- Minor abrasions
- Skin Tears
- Second Degree Burns
TIELLE* PLUS Hydropolymer Dressing should be used under health care professional direction for the following indications:
- Pressure ulcers
- Lower extremity ulcers
- Venous
- Arterial
- Mixed etiology
- Diabetic ulcers
- Donor sites
TIELLE® PLUS Hydropolymer Dressing is suitable for use under compression bandaging.
Product codes (comma separated list FDA assigned to the subject device)
Unknown, MGP
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. During use the lesion size may initially increase. This 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
Wounds (Superficial, Pressure ulcers, Lower extremity ulcers, Diabetic ulcers, Donor sites)
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 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.
PRECLINICAL Testing Results - Adhesive Coated Water Resistant Permeable Polyurethane Backing:
- AMES bacterial mutagenicity: Non-mutagenic
- Acute eye irritation: Non-irritant
- Acute dermal irritation: Non-irritant
- Skin sensitization: Non-sensitizer
- Cytotoxicity (Agar Overlay): Non-toxic
Safety / Toxicity Testing - Absorbent Polyurethane Wound Contact Layer (Central Island):
- 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
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.
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
N/A
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: 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
-
- Minor abrasions
-
- 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
-
- Venous
-
- 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 and
11 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 1
1871 11 16
| STATE 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 OF
ABURACIALAR, ILL L.
|
AND CLAIM
CONTRACTOR COLLEGION OF CONSULERS OF | |
| ----------------------------------------------------------------------
AND AND CONSULER OF LEBELLERS OF
A
LANDA FREE LAR BIR STAT
MAN CAR CHICALLAR
AND A Children Children County of
AND CONSUL CONSULTION COLLEGION | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
NO OF OF CHINAS AND ORDER OF COLLECTION OF CLAIM
I consumer on and come come con-
And Albert A & L L -----------------------------------------------------------------------------------------------------------------------------------------------------------
Annual proper and Property and Party of Concession of Children
Collection 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 commend
1 | |
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 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 |
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.
- 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 (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
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 .
-
- Minor abrasions
- ﻨﺎ Skin Tears
-
- Second Degree Burns
-
TIELLE* PLUS Hydropolymer Dressing should be used under health care professional direction for the following indications:
-
Pressure ulcers
Lower extremity ulcers -
- Venous
-
- 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