TENDERWET ACTIVE

K040517 · Medline Industries, Inc. · MGQ · Mar 25, 2004 · SU

Device Facts

• Record ID: K040517
• Device Name: TENDERWET ACTIVE
• Applicant: Medline Industries, Inc.
• Product Code: MGQ · SU
• Decision Date: Mar 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

TenderWet® active and TenderWet® active Cavity are for the wet management of dry, light and moderately exudating partial and full thickness wounds such as minor burns, superficial injuries, laccrations, cuts, abrasions, incisions/surgical wounds, and skin tears. TenderWet active may also be used under the direction of a health care professional for chronic wounds such as pressure uleers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology.

Device Story

TenderWet® active is a wound dressing designed for wet management of various wound types. It functions by maintaining a moist wound environment to facilitate healing. Used in clinical or home settings; applied by healthcare professionals or patients/caregivers. The dressing manages exudate levels in dry to moderately exudating wounds, aiding in the treatment of acute and chronic wounds. It serves as a physical barrier and moisture-regulating interface for wound beds.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Wound dressing for moisture management. Materials and specific construction details not provided in the document.

Indications for Use

Indicated for wet management of dry, light, and moderately exudating partial and full-thickness wounds, including minor burns, lacerations, abrasions, surgical incisions, and skin tears. Also indicated for chronic wounds (pressure, venous, arterial, diabetic, and mixed etiology ulcers) under professional supervision.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2004

Ms. Andrea Haferkamp Corporate Director of Regulatory Affairs Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060

Re: K040517

Trade/Device Name: TenderWet® Active Regulatory Class: Unclassified Product Code: MGQ Dated: February 26, 2004 Received: February 27, 2004

Dear Ms. Haferkamp:

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 markcted predicate devices markcted 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 (Spccial 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 detcrmination 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.

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Page 2 - Mr. Jay M. Patel

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 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/dsma/dsmamain.html

Sincerely vours.

sincerely yours,

Mark N Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K040517

## Indications for Use

510(k) Number (if known): K040517

Device Name: TenderWet® active

Indications For Use:

TenderWet® active and TenderWet® active Cavity are for the wet management of dry, light and moderately exudating partial and full thickness wounds such as minor burns, superficial injuries, laccrations, cuts, abrasions, incisions/surgical wounds, and skin tears. TenderWet active may also be used under the direction of a health care professional for chronic wounds such as pressure uleers, lower extremity ulcers, venous ulcers, arterial ulcers, diabetic ulcers, and ulcers of mixed etiology.

Prescription Use X ============================================================================================================================================================================ AND/OR Over-Thie-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

/ Mark A. Mikkelson
Division Sign-Off

Division of General, Restorative,
and Neurological Devices

510(k) Number K040517

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