RETRO-TECH DRESSING by RETRO-TECH, LLC

Retro-Tech Dressing is indicated for moderately to heavily exuding, partial to full thickness wounds, including: Pressure ulcers, Leg ulcers, Diabetic foot ulcers, Graft wounds and donor sites, Skin tears, First and second degree burns, Surgical wounds, Lacerations and abrasions.

Device Description

The Retro-Tech Dressing is a dry medium, wound dressing. Retro-Tech Dressing is an absorbent foam. It is ideal for highly exudating wounds. It provides both antibacterial and antifungal protection. It is extremely hydrophilic.

AI/ML Overview

This 510(k) summary describes a wound dressing product, the Retro-Tech Dressing. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study. As such, information regarding acceptance criteria, device performance tables, sample sizes, expert involvement, and ground truth methodologies are not explicitly provided in the document.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided. The document states that the Retro-Tech Dressing and predicate devices were compared in various areas and "found to have similar technological characteristics and to be equivalent," implying that the device meets the characteristics of the predicate, but no specific performance metrics or acceptance criteria are listed.

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

Not applicable. There is no mention of a clinical or analytical test set with associated sample sizes or data provenance for proving performance against set criteria. The submission relies on technological characteristic comparison.

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

Not applicable. As no specific test set requiring expert ground truth is described, this information is not present.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. There is no mention of an MRMC study or any assessment of human reader improvement with or without AI assistance. This device is a wound dressing, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

No. This is a physical wound dressing, not an algorithm.

7. Type of Ground Truth Used:

Not applicable in the context of typical device performance studies involving diagnostic or prognostic outputs. The "ground truth" for this submission is effectively the established characteristics and equivalency of the predicate devices.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model that requires a training set.

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

Not applicable.

Summary of Device Equivalence and Performance Information Available:

The submission focuses on establishing substantial equivalence to predicate devices (K013462, K022416, K032742) based on the following technological characteristics:

Indications For Use: Retro-Tech Dressing is indicated for moderately to heavily exuding, partial to full thickness wounds, including: pressure ulcers, leg ulcers, diabetic foot ulcers, graft wounds and donor sites, skin tears, first and second degree burns, surgical wounds, lacerations and abrasions. These are the same as the predicate devices.
Design: Similar to predicate devices.
Materials: Similar to predicate devices. The device is described as a "dry medium, wound dressing," an "absorbent foam," "antibacterial and antifungal," and "extremely hydrophilic."
Performance: Stated as similar to predicate devices. No specific quantitative performance data is provided beyond this general statement of equivalence. "In-Vitro Antibacterial Activity" is listed as a 'Testing Done' characteristic, implying it was evaluated, but no results or specific acceptance criteria for this are given in the summary.
Sterility: Similar to predicate devices.
Testing Done: Includes "In-Vitro Antibacterial Activity."
Where Used: Similar to predicate devices.
Anatomical Sites: Similar to predicate devices.

The FDA's decision to grant 510(k) clearance (K060832) is based on this assertion of substantial equivalence, meaning the device is deemed as safe and effective as the legally marketed predicate devices without requiring new clinical efficacy data.

Summary

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

K060832 5. 510(k) Summary Retro-Tec Retro-Tech, LLC Submitter's name: 7120 Nicki Ct. Address: Dallas, TX 75252-6125 Phone: 214-673-5465 972-220-0054 Fax number: Name of contact person: Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821 Date the summary was prepared: March 21, 2006

Name of the device: Retro-Tech Dressing

Trade or proprietary name: RTD Common or usual name: Wound Dressing Classification name: Wound Dressing

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

K#	Applicant	Device Name
K013462	Hydrofera, LLC	Hydrofera Blue
K022416	Coloplast Corp.	Contreet Foam Adhesive/Non-adhesive
Advanced MedicalSolutions, Inc.	Silver Foam Wound Dressing	K032742

MAR 1 3 2007

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

Description of the device:

Indications:

Retro-Tech Dressing is indicated for moderately to heavily exuding, partial to full thickness wounds, including: pressure ulcers, leg ulcers, diabetic foot ulcers, graft wounds and donor sites, skin tears, first and second degree burns, surgical wounds, lacerations and abrasions.

Summary of the technological characteristics of our device compared to the predicate device:

The predicates as listed above and RTD were compared in the following areas and found to have similar technological characteristics and to be equivalent.

Indications For Use -
Design -
Materials -
Performance -
Sterility -
Testing Done -
In-Vitro Antibacterial Activity -
Where Used -
Anatomical Sites -

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

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Retro-Tech, LLC % Regulatory Specialists, Inc. Ms. Grace Holland 7120 Nicki Court Dallas, Texas 75262-6125

MAR 1 3 2007

Re: K060832

Trade/Device Name: Retro-Tech Dressing Regulatory Class: Unclassified Product Code: FRO Dated: Decembetr 11, 2006 Received: December 13, 2006

Dear Ms. Holland:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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

Page 2 - Ms. Grace Holland

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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

4. Indications for Use Statement Indications for Use

510(k) Number (if known): _K06083 2

Device Name: _________________________________________________________________________________________________________________________________________________________________

Retro-Tech Dressing is indicated for moderately to heavily exuding, partial to full thickness wounds, including:

Pressure ulcers .
Leg ulcers .
Diabetic foot ulcers .
Graft wounds and donor sites .
Skin tears .
First and second degree burns .
Surgical wounds .
Lacerations and abrasions ●

Prescription Use	X	AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	14060832
---------------	----------

Page 1 of 1
-------------

REGULATORY SPECIALISTS, INC.

Regulation Number and Section

N/A