RETRO-TECH DRESSING

K060832 · Retro-Tech, LLC · FRO · Mar 13, 2007 · SU

Device Facts

• Record ID: K060832
• Device Name: RETRO-TECH DRESSING
• Applicant: Retro-Tech, LLC
• Product Code: FRO · SU
• Decision Date: Mar 13, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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 .

Device Story

Retro-Tech Dressing (RTD) is an absorbent, hydrophilic foam wound dressing. It functions as a dry medium to manage wound exudate while providing antibacterial and antifungal protection. Used in clinical or home settings for wound care management; applied topically by clinicians or patients to the wound bed. The dressing absorbs excess fluid from highly exudating wounds, maintaining a moist environment conducive to healing while protecting the wound site. Benefits include exudate management and infection prevention.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through comparative bench testing of technological characteristics, performance, and in-vitro antibacterial activity against predicate devices.

Technological Characteristics

Absorbent, hydrophilic foam wound dressing. Provides antibacterial and antifungal protection. Designed for topical application to partial to full thickness wounds. Sterility is maintained via standard medical device processing.

Indications for Use

Indicated for patients with moderately to heavily exuding, partial to full thickness wounds, including pressure ulcers, leg ulcers, diabetic foot ulcers, graft wounds, donor sites, skin tears, first and second degree burns, surgical wounds, lacerations, and abrasions.

Predicate Devices

• Hydrofera Blue (K013462)
• Contreet Foam Adhesive/Non-adhesive (K022416)
• Silver Foam Wound Dressing (K032742)

Submission Summary (Full Text)

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## K060832 5. 510(k) Summary Retro-Tec Retro-Tech, LLC Submitter's name: 7120 Nicki Ct. Address: Dallas, TX 75252-6125 Phone: [phone] Fax number: Name of contact person: Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] fax: [phone] 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-<br>adhesive |
| Advanced Medical<br>Solutions, Inc. | Silver Foam Wound Dressing | K032742 |

12

MAR 1 3 2007

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Description of the device:

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.

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 -

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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

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## 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 [phone]. 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 [phone] or [phone] 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

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## 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 |
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REGULATORY SPECIALISTS, INC.