(197 days)
Prescription Use: SilverStream Gel 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.
OTC Use: SilverStream Gel is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas.
SilverStream Gel is a clear hypertonic, non-pyrogenic liquid gel, designed for the 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, minor skin irritations, minor cuts, minor burns, abrasions and irritated areas. The action of SilverStream Gel is achieved by moisturizing wounds and maintaining wound moisture between dressing changes. A maintaining of the moist environment in the wound has been shown to be conducive to wound healing. Silver, serves as a preservative which, based on in vitro testing, inhibits the growth of microorganisms within the product during the shelf storage. The SilverStream Gel is supplied in 60mL polyethylene terephthalate (PETG) bottles. A pump head for dispensing is also supplied.
Here's an analysis of the provided text regarding the acceptance criteria and study proving a device meets these criteria:
Based on the provided K200767 document for SilverStream Gel, direct information on specific acceptance criteria for a device performance study and the detailed results of such a study are not explicitly presented in the format of a typical clinical trial or performance study report. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SilverStream®) through various tests and comparisons.
The document highlights the following:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a direct table linking specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) for a clinical performance study and the device's reported performance against those criteria.
However, the "Performance Data" section describes categories of tests performed and the general outcome:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | |
| Antimicrobial Preservative Effectiveness | Met specifications |
| Microbial Limits | Met specifications |
| Silver Concentration | Met specifications |
| Biocompatibility Testing | |
| Cytotoxicity | Passed (in accordance with FDA guidance and ISO 10993-1) |
| Irritation | Passed (in accordance with FDA guidance and ISO 10993-1) |
| Sensitization | Passed (in accordance with FDA guidance and ISO 10993-1) |
| Systemic Toxicity | Passed (in accordance with FDA guidance and ISO 10993-1) |
| Material Mediated Pyrogenicity | Passed (in accordance with FDA guidance and ISO 10993-1) |
| Porcine Wound Healing Study | Demonstrated safety and efficacy (details not provided) |
| Repeated Subcutaneous Toxicity Rat Study | Demonstrated safety and efficacy (details not provided) |
| Shelf Life Testing | |
| Visual Inspection | Met specifications |
| Viscosity | Met specifications |
| pH | Met specifications |
| Menthol Concentration | Met specifications |
| Silver Concentration | Met specifications |
| Microbial Count | Met specifications |
| Bacterial Endotoxin Testing (LAL) | Met specifications |
Key takeaway: The "acceptance criteria" here are largely implied by meeting "specifications" for various physical, chemical, and biological properties, as well as demonstrating safety and efficacy in general terms for biocompatibility. There are no quantitative performance metrics for a specific clinical outcome provided against pre-defined thresholds.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify sample sizes for individual tests. For example, it mentions "representative samples" for bench testing and does not quantify the number of animals used in the porcine wound healing study or the rat study. It also doesn't refer to any human test set in the context of an AI/algorithm.
- Data Provenance: Not specified beyond the types of tests (bench, biocompatibility, shelf life). There's no mention of country of origin of data or whether it was retrospective or prospective, as these are typically relevant for clinical studies, not the types of tests described here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document does not describe a study involving human interpretation of data where "ground truth" would be established by experts. The studies mentioned are laboratory-based and animal studies, where the "ground truth" is determined by the experimental setup and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as there is no human-involved "test set" and thus no need for an adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device (SilverStream Gel) is a wound dressing, not an AI/imaging device that would be subject to MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. SilverStream Gel is a material-based medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the studies mentioned:
- Bench Testing: Ground truth is established by chemical analysis, microbiological assays, and physical property measurements against pre-defined specifications.
- Biocompatibility Testing: Ground truth is established by histological examination, clinical observation (in animal models), and various cellular/molecular assays conducted by toxicologists and pathologists according to standardized protocols (ISO 10993-1).
- Shelf Life Testing: Ground truth is established by physical inspection, chemical analysis, and microbiological testing against pre-defined stability specifications.
8. The sample size for the training set:
This is not applicable. There is no "training set" as SilverStream Gel is not an AI/machine learning device.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
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October 8, 2020
EnzySurge Ltd. % Daniel Albahari Regulatory Consultant BioReg Services 6 Beit HaShoeva St. Jerusalem, 9751723 Israel
Re: K200767
Trade/Device Name: SilverStream Gel Regulatory Class: Unclassified Product Code: FRO Dated: August 27, 2020 Received: September 2, 2020
Dear Daniel Albahari:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Anjana Jain, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200767
Device Name SilverStream Gel
Indications for Use (Describe)
Prescription Use
SilverStream Gel 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, post-surgical wounds, first and seconddegree burns, cuts abrasions and minor skin irritations.
OTC Use
SilverStream Gel is intended for the management and moisturizing of minor burns, abrasions and irritated areas.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY K200767
510(K) Number K200767
| Applicant's Name: | EnzySurge Ltd. |
|---|---|
| 26 Shabazi Street | |
| Rosh Ha'Ayin 4802126 | |
| Israel | |
| Contact Person: | Daniel Albahari, M.Sc., RAC |
| Regulatory consultant | |
| BioReg Services | |
| 6 Beit HaShoeva Street | |
| Jerusalem 9751723, Israel | |
| Tel: +972-54-6896868 | |
| Email: daniel.albahari@bioregservices.com | |
| Date Prepared: | October 8th, 2020 |
| Trade Name: | SilverStream Gel |
| Classification Name: | Dressing, Wound, Drug |
| Product Code: | FRO |
| Device Classification: | Unclassified |
| Panel: | General & Plastic Surgery |
| Predicate Device: | SilverStream® [K0932271] |
Intended Use / Indication for Use:
Prescription Use
SilverStream Gel 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.
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OTC Use
SilverStream Gel is intended for the management and moisturizing of minor cuts, minor burns, abrasions and irritated areas.
Device Description:
SilverStream Gel is a clear hypertonic, non-pyrogenic liquid gel, designed for the 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, minor skin irritations, minor cuts, minor burns, abrasions and irritated areas.
The action of SilverStream Gel is achieved by moisturizing wounds and maintaining wound moisture between dressing changes. A maintaining of the moist environment in the wound has been shown to be conducive to wound healing. Silver, serves as a preservative which, based on in vitro testing, inhibits the growth of microorganisms within the product during the shelf storage.
The SilverStream Gel is supplied in 60mL polyethylene terephthalate (PETG) bottles. A pump head for dispensing is also supplied.
Substantial Equivalence:
SilverStream Gel has the same indication for use (both Rx and OTC) as the predicate device. Both SilverStream® and SilverStream Gel are intended for the management and moisturizing of wounds. Primarily, in similarity to SilverStream®, SilverStream Gel helps to moisturize wounds and maintains a moist wound environment that is conducive to healing.
In addition, the SilverStream Gel has essentially similar technological characteristics, including principles and mode of operation, as its predicate device.
Both SilverStream Gel and SilverStream® solution use the same ingredients, and they differ in formulation by the presence of the inactive ingredient Carbopol, which has been added for the purpose of providing viscosity to the gel formulation.
The SilverStream Gel, the predicate device as well as the reference devices contain silver, which acts as a preservative which, based on in vitro testing, inhibits the growth of microorganisms within the product during the shelf storage.
In summary, the intended use and indications for use of the SilverStream Gel are the same as the intended use and indications for use of its predicate device, SilverStream®. Further, the technological characteristics and principles of operation of SilverStream Gel are substantially similar to those of the claimed predicate device and any minor differences in
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technology due to more viscous formulation as compared to solution do not raise new questions of safety or effectiveness.
Performance Data:
Representative samples of the device underwent testing including bench testing -Antimicrobial Preservative Effectiveness Testing; Microbial Limits; and silver concentration.
The safety and efficacy are also demonstrated by biocompatibility tests in accordance with the FDA biocompatibility guidance issued on June 16, 2016 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The gel is considered a breached/compromised surface device with prolonged contact and testing included cytotoxicity, irritation, sensitization, systemic toxicity, material mediated pyrogenicity, porcine wound healing study and repeated subcutaneous toxicity rat study.
Visual inspection, viscosity, pH, menthol and silver concentration, microbial count, and Bacterial Endotoxin testing (LAL) were all tested as part of shelf life testing.
SilverStream Gel meets its specification and has been shown to be substantially equivalent to the predicate device.
Conclusion:
EnzySurge has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that the SilverStream Gel is substantially equivalent. It was concluded that the intended use, indications for use and technological characteristics of the SilverStream Gel are substantially equivalent to SilverStream (K093227) and there were no new questions of safety or effectiveness. Therefore. SilverStream Gel is substantially equivalent to the predicate device.
N/A