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 Description

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

AI/ML Overview

I am sorry, but a detailed description of acceptance criteria and a study proving a device meets them, as requested, is not possible to extract from the provided text. The document is a 510(k) summary for a medical device (TIELLE* Hydropolymer Foam Dressing).

Here's why the information cannot be extracted:

Nature of 510(k) Summary: A 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, rather than presenting a detailed clinical study with acceptance criteria and performance data in the format you've requested. It typically includes indications for use, device description, and a general statement about safety/biocompatibility, but not the specifics of a study proving performance against defined acceptance criteria.
Missing Information:
- The document states "Safety tests demonstrate that TIELLE* Hydropolymer Foam Dressing is non-sensitizing, and nonirritating and suitable for its intended use." However, it does not provide:
  - A table of acceptance criteria and reported device performance.
  - Details about the sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for any performance study.
  - Information about training sets or how ground truth for training sets was established.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence based on safety and intended use, not a clinical study report detailing performance against specific, quantitative acceptance criteria.

Summary

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K964016

510(k) SUMMARY

DEC 31 1996

TIELLE* Hydropolymer Foam Dressing

DATE PREPARED 1.

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., (817)784-4993 Sr. Project Manager, Regulatory Affairs

4 NAME OF THE MEDICAL DEVICE

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

DEVICE CLASSINGATION ર્ડ

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).

STATEMENT OF SUBSTANTIAL EQUIVALENCE ર.

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

7. INDICATIONS FOR USE

PHYSICAL DESCRIPTION 8.

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

9. BIOCOMPATIBILITY

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K464016

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

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
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.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.