TIELLE HYDROPOLYMER FOAM DRESSING

K964016 · Johnson & Johnson Medical, Inc. · KMF · Dec 31, 1996 · General Hospital

Device Facts

• Record ID: K964016
• Device Name: TIELLE HYDROPOLYMER FOAM DRESSING
• Applicant: Johnson & Johnson Medical, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Dec 31, 1996
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

TIELLE Dressing is indicated for the management of both chronic and superficial, moderate to heavily exudating wounds, including the following: - Pressure sores (all stages) - Venous ulcers - Skin tears - Second degree burns - Donor and graft sites - Acute wounds healing by secondary or primary intention - Surgically debrided wounds

Device Story

TIELLE Hydropolymer Foam Dressing; hydrophilic polyurethane polymer wound dressing; manages moderate to heavily exudating chronic and superficial wounds; applied topically to wound site; absorbs exudate; maintains moist wound environment; used in clinical or home settings; applied by healthcare professionals or patients; facilitates healing of pressure sores, venous ulcers, burns, and surgical wounds.

Clinical Evidence

Bench testing only. Biocompatibility testing confirms device is non-sensitizing and non-irritating.

Technological Characteristics

Hydrophilic polyurethane polymer foam dressing. Material properties support exudate absorption and moisture management. No electronic, software, or energy-based components.

Indications for Use

Indicated for management of chronic and superficial, moderate to heavily exudating wounds in patients with pressure sores, venous ulcers, skin tears, second degree burns, donor/graft sites, acute wounds healing by primary/secondary intention, and surgically debrided wounds.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• Allevyn Hydrophilic Polyurethane Dressing (Smith & Nephew)

Submission Summary (Full Text)

{0}

DEC 24. 1996 10:00AM

K964016

# 510(k) SUMMARY

## TIELLE* Hydropolymer Foam Dressing

DEC 31 1996

1. **DATE PREPARED**

December 24, 1996

2. **SUBMITTER**

Johnson & Johnson Medical, Inc.
2500 Arbrook Boulevard, P.O. Box 90130
Arlington, Texas 76004-3130

3. **CONTACT**

Ralph H. Larsen, [phone]
Sr. Project Manager, Regulatory Affairs

4. **NAME OF THE MEDICAL DEVICE**

Classification name: Dressing, wound
Common/usual name: Topical wound dressing
Proprietary name: TIELLE* Hydropolymer Foam Dressing

5. **DEVICE CLASSIFICATION**

Classification for topical wound dressings has not yet been finalized by the Division of Surgical and Rehabilitation Devices. These devices are classified into Class I (General Controls).

6. **STATEMENT OF SUBSTANTIAL EQUIVALENCE**

TIELLE* Hydropolymer Foam Dressing is substantially equivalent and identical in function to Allevyn Hydrophilic Polyurethane Dressing marketed by Smith & Nephew.

7. **INDICATIONS FOR USE**

TIELLE Dressing is indicated for the management of both chronic and superficial, moderate to heavily exudating wounds, including the following:

- Pressure sores (all stages)
- Venous ulcers
- Skin tears
- Second degree burns
- Donor and graft sites
- Acute wounds healing by secondary or primary intention
- Surgically debrided wounds

8. **PHYSICAL DESCRIPTION**

TIELLE* Hydropolymer Foam Dressing is made from a hydrophilic polyurethane polymer.

9. **BIOCOMPATIBILITY**

{1}

DEC. 24. 1990 10.03AM

K464016

Safety tests demonstrate that TIELLE* Hydropolymer Foam Dressing is non-sensitizing, and non-irritating and suitable for its intended use.