(66 days)
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.
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.
The provided 510(k) summary (K022670) for Carrington Laboratories CarraKlenz and UltraKlenz Wound Cleansers does not contain any information regarding clinical studies, acceptance criteria, or performance data for the device.
This submission is a premarket notification (510(k)), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data or performance metrics against defined acceptance criteria. The core of this 510(k) is to assert that the CarraKlenz and UltraKlenz wound cleansers are "substantially equivalent" to existing, cleared predicate devices (Aliclenz Wound Cleanser K965120 and Derma Sciences Dermagran Wound Cleanser with Zinc K954743 and K945802).
Therefore, based solely on the provided document, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present. The submission focuses on substantial equivalence in terms of intended use, technological characteristics, and mechanism of action, not on specific performance metrics or acceptance criteria derived from a study.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method for the test set: No test set is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a wound cleanser, not an AI-assisted diagnostic device, and no MRMC study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical wound cleanser.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is described.
- The sample size for the training set: No training set is described.
- How the ground truth for the training set was established: No training set or ground truth is described.
In summary, the 510(k) provided focuses on substantial equivalence claims rather than presenting primary clinical or performance study data against specific acceptance criteria. Such detailed performance data and study methodologies are typically required for different types of regulatory submissions or for devices with higher risk classifications or novel technology.
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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: 972-714-5032
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
Page C-1
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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 (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 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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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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N/A