CARRAKLENZ AND ULTRAKLENZ

K022670 · Carrington Laboratories, Inc. · FRO · Oct 17, 2002 · SU

Device Facts

• Record ID: K022670
• Device Name: CARRAKLENZ AND ULTRAKLENZ
• Applicant: Carrington Laboratories, Inc.
• Product Code: FRO · SU
• Decision Date: Oct 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Carrington Wound Cleansers are surfactant wound cleansers intended for the removal of foreign material such as dirt and debris from dermal wounds. CarraKlenz is a wound cleanser that is indicated for high, medium, and low exudating wounds. UltraKlenz is a gentle wound cleanser which is used on intact skin.

Device Story

CarraKlenz and UltraKlenz are surfactant-based liquid wound cleansers. Device functions via mechanical action; liquid pressure during irrigation removes debris and foreign material from dermal wounds or skin. Used in clinical or home settings; applied by clinicians or patients. Output is a cleaned wound surface; facilitates wound healing by removing contaminants. No complex electronics or software involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Surfactant-based liquid wound cleanser. Mechanical irrigation principle. No energy source. Standalone liquid product. No software or electronic components.

Indications for Use

Indicated for removal of foreign material (dirt, debris) from dermal wounds. CarraKlenz indicated for high, medium, and low exudating wounds. UltraKlenz indicated for use on intact skin.

Predicate Devices

• Aliclenz Wound Cleanser (K965120)
• Derma Sciences Dermagran Wound Cleanser with Zinc (K954743)
• Derma Sciences Dermagran Wound Cleanser with Zinc (K945802)

Submission Summary (Full Text)

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K022670

# 510(k) Summary for Carrington Laboratories CarraKlenz and UltraKlenz Wound Cleansers

OCT 1 7 2002

#### 1. SPONSOR

Carrington Laboratories, Inc. 2001 Walnut Hill Lane Irving, TX 75038

Contact Person: Fran Shull Telephone: [phone]

Date Prepared: October 9, 2002

#### 2. Device Name

Proprietary Name: CarraKlenz and UltraKlenz Common/Usual Name: Wound Cleansers Classification Name: Liquid Bandage

#### 3. PREDICATE DEVICES

Aliclenz Wound Cleanser K965120 Derma Sciences Dermagran Wound Cleanser with Zinc K954743 and K945802

#### DEVICE DESCRIPTION 4.

The Carrington CarraKlenz Wound Cleansers are wound cleaning solutions that are intended for the cleansing and irrigation of dermal wounds. The Carrington Wound Cleansers work by mechanical action on the dermal wounds. The pressure of the liquid flowing onto the wound aids in the removal of the debris from the wound. The Carrington Wound Cleansers are offered in various bottle sizes.

#### INTENDED USE న.

The Carrington Wound Cleansers are surfactant wound cleansers intended for the removal of foreign material such as dirt and debris from dermal wounds. CarraKlenz is a wound cleanser that is indicated for high, medium, and low exudating wounds.

and and all all the comments from the

Carrington Laboratories 510(k) October 9, 2002 CarraKlenz and UltraKlenz Wound Cleansers

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K022670

UltraKlenz is a gentle wound cleanser which is used on intact skin.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Carrington Laboratories Wound Cleansers are substantially equivalent to the Allclenz Wound Cleanser cleared for marketing under K965120 and the Derma Sciences Dermagran Wound Cleanser with Zinc cleared under K954743 and K945802. All of the wound cleansers are intended for use on dermal wounds and abrasions and function by mechanical action on the wound to remove unwanted debris.

Carrington Laboratories 510(k) October 9, 2002 CarraKlenz and UltraKlenz Wound Cleansers

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of a human figure with three heads, which is meant to represent the department's focus on health and human services. The figure is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

Carrington Laboratories, Inc. Carringtonamara-Cullinane, RAC c/o Medical Devices Consultants, Inc. 49 Plain Street 49 Fram Street
North Attleboro, Massachusetts 02760

Re: K022670

K022670
Trade/Device Name: Carraklenz and Ultraklenz Regulatory Class: Unclassified Product Code: FRO Dated: August 8, 2002 Received: August 12, 2002

Dear Ms. McNamara-Cullinane:

This letter corrects our substantially equivalent letter of October 17, 2002.

We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 510(k) premarket nothically equivalent (for the indications
referenced above and have detectived the device is substantially equivalent (for the referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally marketed predical Device Americans, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device American Frood, commerce prior to May 28, 1976, the enactment and of the Pederal Food. Drug, 1978, 1978, 1998, 1998, 1998, 1998, 1994, 1994, 1994, 1994, 1994, 1994, 1994, 1 devices that have been reclassified in accordance with the provisions of PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval on the Act. The and Cosmetic Act (Act) that do not require approval of a previsions of the Act. The Act. The Act. The Act. The
You may, therefore, market the Access, subject to the gener You may, therefore, market the Aet include requirements for ammal registration, listing of
general controls provisions of the Aet include requirements for and general controls provisions of the Act include requirements for almad regions mistranding and adulteration.

ation of the is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into either class in (special comastig vior device can
may be subject to such additional controls. Existing major regulations affect 11 Journey of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
may be subject to such additional controls, Title 21, Parts 800 to 898. In addition, FDA be found in the Code of Federal Regulations, This DT, Frid Collections
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 Please be advised that FDA's issuance of a substantial equirements of the Act
that FDA has made a determination that your device complies with other requirements of the Act 1 that FDA has made a determination that your devices will beather.
That FDA has made a determinations administered by other Federal agencies. You must
or and regulations a this Federal statutes and regulations administered by online of the registration and listing (21
comply with all the Act s requirements, including, but not limited to: regult or any -CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice to electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the el forth in the quality systems (QS) regulation (21 CFR Part 620), and 2-1)
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Ms. Mary McNamara-Cullinane

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 premained from seem to 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 if you don't operio darroliance 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 Milliken

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

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K022670

510(k) Number (if known): K022670

Carrington Laboratories CarraKlenz and UltraKlenz Wound Cleansers Device Name:

Indications for Use:

The Carrington Wound Cleansers are surfactunt wound cleansers intended for the removal of foreign material such as dirt and debris from dermal wounds.

CarraKlenz is a wound cleanser that is indicated for high, medium, and low exudating wounds.

UltraKlenz is a gentle wound cleanser which is used on intact skin.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division of General, Restorative and Neurological Devices

510(k) Number K022676

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Carrington Laboratories Additional Information for K022670

October 3, 2002

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