SILVERLEAF CONTACT WOUND DRESSING

• K Number: K013936
• Device Name: SILVERLEAF CONTACT WOUND DRESSING
• Manufacturer: SILVERLEAF TECHNOLOGIES INC
• Date Cleared: 2003-03-18 ( 475 days)
• Product Code: FRO
• Regulation Number: N/A
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

SilverLeaf Contact Wound Dressings are non-adherent antibacterial barrier dressings intended for local management of surgical wounds (donor and graft sites, incisions) and dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

Device Description

SilverLeaf Contact Wound Dressing

AI/ML Overview

I am sorry, but the provided text does not contain the information requested. The document is a 510(k) clearance letter for the SilverLeaf Contact Wound Dressing and the Indications for Use form. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as described in your request. This type of information would typically be found in the 510(k) summary or a detailed study report, neither of which is present in the provided text.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

MAR 1 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SilverLeaf Technologies, Inc. Theresa Anderson VP Operations 3 Woodburn Drive Ottawa, Ontario K1B3A6 Canada

Re: K013936

Trade/Device Name: SilverLeaf Contact Wound Dressing Regulation Name: Wound dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 20, 2003 Received: January 28, 2003

Dear Ms. Anderson:

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 mav 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

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Page 2 - Ms. Theresa Anderson

(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 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). Other general information on your responsibilities under the Act may be obtained 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.

Miriam C. Provost

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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KO13936

Form B Indications for Use Form

510(k) Number: K013936

Device Name: SilverLeaf Contact Wound Dressing

Indications for Use:

SilverLeaf Contact Wound Dressings are non-adherent antibacterial barrier dressings intended for local management of surgical wounds (donor and graft sites, incisions) and dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

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

Muriam C. Provost

sion Sign-Off Division of General Destorative and Neurologi ... De vous

510(k) Number: K013936

SilverLeaf Technologies Inc., 3 Woodburn Dr, Ottawa, Ontario, KIB3A6, telephone/fax: [phone], email: [e-mail] or [e-mail]

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Regulation Number and Section

N/A