(475 days)
Not Found
Not Found
No
The summary describes a wound dressing and contains no mention of AI, ML, or related concepts like image processing or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the local management of surgical wounds and dermal ulcers, which are conditions requiring therapeutic intervention for healing.
No
The provided text describes a wound dressing intended for the local management of wounds and ulcers. It does not mention any function related to diagnosing medical conditions.
No
The device description clearly states "SilverLeaf Contact Wound Dressing," which is a physical dressing, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "non-adherent antibacterial barrier dressing intended for local management of surgical wounds... and dermal ulcers." This describes a device that is applied externally to the body to treat wounds.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
The description of the SilverLeaf Contact Wound Dressing does not involve any testing of samples taken from the body. It is a topical wound dressing.
N/A
Intended Use / 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).
Product codes
FRO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or progress.
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
2
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: 613-830-9513, email: tanderson@primus.ca or silverleaf@globalserve.net
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