(203 days)
Not Found
No
The 510(k) summary describes a topical wound cream with antimicrobial properties. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the chemical composition and function of the cream.
Yes
The device description and intended use clearly state that the cream aids in healing various types of wounds, which is a therapeutic function.
No.
The device is a wound cream intended for topical application to aid in wound healing and provide an antimicrobial barrier. It does not perform any diagnostic function.
No
The device is described as a "semi-viscous emulsion intended for topical application," which is a physical substance (cream) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "external management of partial and full-thickness wounds". This describes a topical treatment applied directly to the wound on the body.
- Device Description: The device is described as a "semi-viscous emulsion intended for topical application for external wound management". This further reinforces its use on the body's surface.
- Lack of IVD Characteristics: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve the analysis of such specimens.
Therefore, Silcryst® Silver Antimicrobial Wound Cream is a topical wound care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Silcryst® Silver Antimicrobial Wound Cream is intended for external management of partial and full-thickness wounds including decubitus ulcers, venous)stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, cuts, donor sites and surgical wounds.
Product codes
FRO
Device Description
Silcryst® Silver Antimicrobial Wound Cream is a non-sterile, semi-viscous emulsion intended for topical application for external wound management. It aids the body by providing a moist wound environment optimal for healing. The cream also serves as a broad spectrum anti-microbial barrier. It is presented as a prescription product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Functional and performance testing has been conducted to assess the safety and efficacy of Silver Antimicrobial Wound Cream and results are satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JUL 1 3 2007
SECTION 5 - 510(K) SUMMARY
K063805
Page 1 of 1
Nucryst
pharmaceuticals
NUCRYST Pharmaceutica Silcryst™ Silver Antimicrobial Wound Cream Traditional 510(k) Premarket Notification
| 1. Submitter of the Application: | NUCRYST Pharmaceuticals, Inc.
50B Audubon Rd.
Wakefield, MA 01880 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Steven J. Chartier
NUCRYST Pharmaceuticals, Inc.
50B Audubon Rd.
Wakefield, MA 01880
781-992-6044 (tel)
781-246-6032 (fax) |
| 2. Proprietary Name: | Silcryst® Silver Antimicrobial Wound Cream |
| Common/Usual Name: | Dressing, Wound & Burn,
Hydrogel w/Drug or Biologic |
| Classification Name: | Dressing, Wound & Burn,
Hyrdrogel w/Drug or Biologic |
3. Substantially Equivalent Devices:
NUCRYST Pharmaceuticals, Inc. believes that Silcryst® Silver Antimicrobial Wound Cream is substantially equivalent to the currently marketed devices, Bioderm Sciences Wound Cream cleared under K042352, Acryderm Silver Antimicrobial Wound Gel cleared under K011994, and Acticoat™ Antimicrobial Barrier Dressing cleared under K955453.
4. Device Description:
Silcryst® Silver Antimicrobial Wound Cream is a non-sterile, semi-viscous emulsion intended for topical application for external wound management. It aids the body by providing a moist wound environment optimal for healing. The cream also serves as a broad spectrum anti-microbial barrier. It is presented as a prescription product.
ડ. Intended Use of the Device:
Silcryst@ Silver Antimicrobial Wound Cream is intended for external management of partial and full-thickness wounds including decubitus ulcers, venous stasis ulcers, first and second degree burns, abrasions, lacerations, cuts, donor sites and surgical wounds. It can be used in conjunction with a conventional dressing that absorbs fluids.
Summary of the Technological Characteristics of the Device Compared to the Predicate Device(s): 6.
All products referenced are wound care products that are applied topically to externally manage the treatment of various wounds.
7. Tests and Conclusions:
Functional and performance testing has been conducted to assess the safety and efficacy of Silver Antimicrobial Wound Cream and results are satisfactory.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
JUL 1 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NUCRYST Pharmaceuticals, Inc. % Mr. Steven J. Chartier Sr. Director, Preclinical Development & Regulatory Affairs 50B Audubon Road Wakefield, Massachusetts 01880
Re: K063805
Trade/Device Name: Silcryst™ Silver Antimicrobial Wound Cream Regulatory Class: Unclassified Product Code: FRO Dated: June 28, 2007 Received: July 2, 2007
Dear Mr. Chartier:
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 may 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 (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.
2
Page 2 - Mr. Steven J. Chartier
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, permitte 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 (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/indystry/support/index.html.
Sincerely yours,
for
Mark N. Melkerson
Director
Division of General, Restorative
LUM DEP DIR
and Monologi D
23/07
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
NUCRYST Pharmaceuticals, Inc. Silcryst™ Silver Antimicrobial Wound Cream Traditional 510(k) Premarket Notification
SECTION 4 - INDICATIONS FOR USE STATEMENT
Silcryst™ Silver Antimicrobial Wound Cream
510(k) Number:
Device Name: Silcryst™ Silver Antimicrobial Wound Cream
Indications for Use:
JUCRYST
Silcryst® Silver Antimicrobial Wound Cream is intended for external management of partial and full-thickness wounds including decubitus ulcers, venous)stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, cuts, donor sites and surgical wounds.
or
V Prescription (Per 21 CFR 801.109)
Over the Counter Use (Optional Format 1-2-96)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 1063808