DUKAL NON ADHERENT DRESSING

• K Number: K970455
• Device Name: DUKAL NON ADHERENT DRESSING
• Manufacturer: DUKAL CORP.
• Date Cleared: 1997-05-08 ( 91 days)
• Product Code: EFQ
• Regulation Number: N/A

Intended Use

Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency.

Device Description

Absorbent non adherent dressing

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a simple wound dressing and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.

Therapeutic

Yes
The device is used to cover a wound or operative site, which is a therapeutic function.

Diagnostic

No
The device is described as an "Absorbent non adherent dressing" used to "cover a wound or operative site while providing absorbency." This functionality is for protection and absorption, not for identifying a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "Absorbent non adherent dressing," which is a physical medical device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
• Device Description and Intended Use: The description clearly states the device is an "Absorbent non adherent dressing" used "as a topical dressing to cover a wound or operative site while providing absorbency." This is a physical barrier and absorbent material applied externally to the body.
• Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.

Therefore, based on the provided information, this device falls under the category of a topical wound dressing, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency.

Product codes

Not Found

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

Kendell Non Adherent Dressing

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

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K970455

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510(K) SUMMARY (as required by 807.92(c))

MAY - 8 1997

Regulatory & Marketing Services, Inc. (RMS) Submitter of 510(k): 40178 U.S. 19 North Tarpon Springs, FL 34689

813-942-3908 Phone: [phone] Fax:

Contact Person:

Ed Ransom

February 3, 1997 Date of Summary:

Dukal Non Adherent Pad Trade Name:

Classification Name: Dressing

Kendell Non Adherent Dressing Predicate Device:

Device Description/

Comparison:
Material	Dukal	Kendall
Thickness	47 mil	same
Delnet Fracture	5lb/in	same
T-Peel	700 lb/in	same
Absorptive Capacity	38 oz/yd²	same
MD Tensile	6lb/in	same
Basis weight	5.0 oz/yd²	same
Intended Use	Absorbent non adherent dressing is
used as a topical dressing to cover a
wound or operative site while providing
absorbency.	same

Absorbent non adherent dressing is used as a topical dressing to Intended Use: cover a wound or operative site while providing absorbency.