(57 days)
Not Found
No
The summary describes a wound care solution with antimicrobial properties and does not mention any AI or ML components.
Yes
The device is described as "intended for use under the supervision of a healthcare professional for management and moisturizing of wounds" and "intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas," which are therapeutic actions.
No
The device is described as a solution for the management and moisturizing of wounds, not for diagnosing any condition. Its intended use focuses on care and preservation rather than detection or identification of diseases.
No
The device description clearly states that the device is a "clear, hypertonic aqueous solution," indicating it is a liquid product, 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 "management and moisturizing of wounds" and "minor cuts, minor burns, abrasions and irritated areas." This describes a topical application for treating external conditions.
- Device Description: The device is a "clear, hypertonic aqueous solution" applied to the "application site." It contains a preservative and a surfactant. This aligns with a wound care product, not a diagnostic test performed on samples taken from the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It is intended for treatment and management of existing wounds and skin irritations.
- No Mention of Samples: IVD devices typically involve testing samples like blood, urine, tissue, etc. This device is applied directly to the wound.
Therefore, the description clearly indicates a wound care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Prescription Use: SilverStream is intended for use under the supervision of a healthcare professional for management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, cuts abrasions and minor skin irritations
Over-The-Counter Use: DermaSept is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The SilverStream (prescription), and DermaSept (OTC) Solutions, are clear, hypertonic aqueous solutions designed for the management and moisturizing of the application site by the action of the fluid moving across the wound bed. The product is hypertonic and contains a surfactant. The SilverStream, and DermaSept, Solution contains an antimicrobial ionic silver, as a preservative, which has been shown, by in vitro testing, to inhibit the growth of microorganisms such as Eschericha coli, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae Pseudomonas aeruginosa, Candida albicans and Aspergillus niger.
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
Prescription Use: under the supervision of a healthcare professional.
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)
A set of in vitro and in vivo biocompatibility tests were performed in order to demonstrate the safety and performance of the SilverStream and DermaSept. The available performance data demonstrate substantial equivalence of the SilverStream, and DermaSept, to predicates and that there are no new issues of safety and effectiveness.
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.
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
page 1 of 3
DEC 1 0 2009
510(K) SUMMARY
510(K) Number K_K09 322 7
5.1 Applicant's Name: EnzySurge Ltd. 26 Shabazi Street Rosh Ha'Ayin 48021 Israel
ול
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5.2 Contact Person: Keren Shtiegman, Ph.D. BioMedical Strategy (2004) Ltd. 7 Jabotinsky Street. Ramat Gan 52520, Israel Tel: +972-3- 6123281 Fax: +972-3-6123282 Email: keren@ebms.co.il And/Or Miriam C. Provost, Ph.D. Biologics Consulting Group, Inc. 1317 King Street Alexandria, VA 22314 Tel: (703) 242-0459 Fax: (703) 548-7457 Email: mprovost@bcg-usa.com
| 5.3 Date Prepared: | December 2009 |
|---|---|
| Trade Name: | SilverStream (for Prescription Use) |
| DermaSept (for Over the Counter Use) |
5.4 Classification Name: Dressing, Wound, Drug
5.5 Product Codes: FRO
5.6 Device Class: Class II
5.7 Regulation Number: unclassified
5.8 Panel: General & Plastic Surgery
1
5.9 Predicate Devices:
-
- Anasept™ Antimicrobial Skin and Wound Technologies Inc.); cleared under K073547
-
- Silvaklenz Antibacterial Silver Skin & Wound Cleanser (Medical Molecular Therapuetics LLC); cleared under K063069
5.15 Intended Use / Indication for Use:
Prescription Use: SilverStream is intended for use under the supervision of a healthcare professional for management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, cuts abrasions and minor skin irritations
Over-The-Counter Use: DermaSept is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas
5.16 Device Description:
The SilverStream (prescription), and DermaSept (OTC) Solutions, are clear, hypertonic aqueous solutions designed for the management and moisturizing of the application site by the action of the fluid moving across the wound bed. The product is hypertonic and contains a surfactant. The SilverStream, and DermaSept, Solution contains an antimicrobial ionic silver, as a preservative, which has been shown, by in vitro testing, to inhibit the growth of microorganisms such as Eschericha coli, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae Pseudomonas aeruginosa, Candida albicans and Aspergillus niger.
5.17 Substantial Equivalence:
Intended Use and Indications for Use
The SilverStream labeled for prescription use, has a similar intended use and the same indications for use as the predicates, i.e., all devices are used in the management of wounds. The DermaSept, labeled for OTC use, also has a similar intended use and indications for use as its predicates. Therefore the SilverStream and the DermaSept can be considered substantially equivalent to the predicate devices with regard to the intended use.
Technological Characteristics
The SilverStream, and DermaSept, has substantially similar technological characteristics, including principles and mode of operation, to the predicate devices. Primarily, in similarity to the predicate devices, the SilverStream and DermaSept, is a solution that moves across the wound surface (flushing).
2
In addition, the SilverStream, DermaSept, and the predicate devices all contain an antimicrobial agent that inhibits the growth of microorganisms.
Performance Testing
A set of in vitro and in vivo biocompatibility tests were performed in order to demonstrate the safety and performance of the SilverStream and DermaSept. The available performance data demonstrate substantial equivalence of the SilverStream, and DermaSept, to predicates and that there are no new issues of safety and effectiveness.
Summary
The SilverStream, and DermaSept have similar intended uses and indications, technological characteristics and principles of operation as the predicate devices. Based on the performance testing results and the analysis of the similarities and differences, EnzySurge Ltd believes SilverStream and DermaSept are substantially equivalent to the predicates and do not raise any new issues of safety or effectiveness.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
EnzySurge Ltd. % BioMedical Strategy (2004) Ltd. Ms. Keren Shtiegman, Ph.D. Regulatory Consultant Moshe Aviv Tower, 34th Floor 7 Jabotinksy Street Ramat-Gan 52520. Israel
DEC 1 0 2009
Re: K093227
Trade/Device Name: SilverStream (prescription); DermaSept (OTC) Regulatory Class: Unclassified Product Code: FRO Dated: October 12, 2009 Received: October 14, 2009
Dear Dr. Shtiegman:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Keren Shtiegman, Ph.D.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K093227
Device Name: SilverStream (for Prescription Use)
Indications for Use:
Prescription Use
SilverStream is intended for use under the supervision of a healthcare professional for management and moisturizing of wounds such as stage I-IV pressure ulcers, stasis ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, cuts abrasions and minor skin irritations.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Kine for MXM Page 1 of 1
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number. K093227
6
INDICATIONS FOR USE
510(k) Number (if known): K093227
Device Name: DermaSept (for Over the Counter Use)
Indications for Use:
Over-The-Counter Use:
DermaSept is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use. V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kroneber WKM
(Division Sign-Off)
Page 1 of 1
510(k) Number K093227
Division of Surgical. Orthopedic,
and Restorative Devices