K Number

Device Name

Manufacturer

ENZYSURGE, LTD.

Date Cleared

2009-12-10

(57 days)

Product Code

FRO

Regulation Number

N/A

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K073547,K063069

Predicate For

N/A

Intended 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

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for SilverStream and DermaSept:

Summary of Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific numerical acceptance criteria for a novel performance claim. The key acceptance criteria revolve around:

Similar intended use and indications for use.
Substantially similar technological characteristics, including principles and mode of operation.
Safety and performance demonstrated through in vitro and in vivo biocompatibility tests.
Inhibition of microorganism growth (as a preservative).

The reported device performance confirms these criteria, stating that:

The SilverStream/DermaSept has a similar intended use and indications for use as the predicate devices.
It has substantially similar technological characteristics, including being a solution that moves across the wound surface (flushing).
It contains an antimicrobial ionic silver as a preservative, shown by in vitro testing to inhibit the growth of several common microorganisms (Escherichia coli, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger).
In vitro and in vivo biocompatibility tests were performed to demonstrate safety and performance, and the available data suggested "no new issues of safety and effectiveness."

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Stated Goal for Equivalence)	Reported Device Performance
Intended Use / Indications for Use: Similar to predicate devices.	Met: "The SilverStream labeled for prescription use, has a similar intended use and the same indications for use as the predicates... The DermaSept, labeled for OTC use, also has a similar intended use and indications for use as its predicates."
Technological Characteristics: Substantially similar to predicate devices (principles, mode of operation).	Met: "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)."
Antimicrobial Activity: Contains an antimicrobial agent that inhibits growth of microorganisms (as a preservative).	Met: "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."
Safety and Performance: Demonstrated through in vitro and in vivo biocompatibility tests, with no new safety/effectiveness issues.	Met: "A set of in vitro and in vivo biocompatibility tests were performed... The available performance data demonstrate substantial equivalence... and that there are no new issues of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "A set of in vitro and in vivo biocompatibility tests were performed." However, it does not provide details on the sample size used for these tests, nor the country of origin or whether the data was retrospective or prospective. The information is very high-level.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not mention the use of experts or radiologists to establish ground truth for any test set. The evaluation focuses on laboratory (in vitro), animal (in vivo biocompatibility), and comparative analysis against predicate device claims.

4. Adjudication Method for the Test Set:

Given that there's no mention of experts or a human-led evaluation of image data or similar, there is no adjudication method provided or implied in this documentation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. The document describes a 510(k) submission for a wound dressing, not an AI or imaging device that would typically undergo an MRMC study. It does not involve human readers interpreting data with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable in the context of an AI algorithm. The antimicrobial activity was assessed in vitro, which could be considered an "algorithm only" type of test for the active ingredient's function, but it's not an AI algorithm.

7. The Type of Ground Truth Used:

For antimicrobial efficacy: In vitro laboratory testing against specified microorganisms served as the basis for the claim of growth inhibition. This "ground truth" would be established by standard microbiological assays.
For biocompatibility: In vitro and in vivo (animal) biocompatibility tests serve as the ground truth for safety and biological response. These tests typically follow standardized protocols (e.g., ISO 10993).
For overall substantial equivalence: The "ground truth" is a comparison to the established characteristics and performance of the identified predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a passive wound dressing, not an AI/machine learning algorithm that requires a training set. The "testing" referred to is for product characteristics and biological safety.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no AI algorithm or training set, this question does not apply.

Summary

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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

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

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5.9 Predicate Devices:

1. Anasept™ Antimicrobial Skin and Wound Technologies Inc.); cleared under K073547
1. Silvaklenz Antibacterial Silver Skin & Wound Cleanser (Medical Molecular Therapuetics LLC); cleared under K063069

5.15 Intended Use / Indication for Use:

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:

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).

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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.

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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

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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

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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

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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

Regulation Number and Section

N/A