(151 days)
WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
Core Scientific Creations WoundClot device is water soluble, based on cellulosic structure. In contact with liquids it forms an adhesive gel which expands and adheres to the wound for bleeding control.
The provided text is a 510(k) summary for the medical device WoundClot. It describes the device, its intended use, and comparison to predicate devices, but it does not contain acceptance criteria or study results in the format requested. The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is a different regulatory hurdle than proving the device meets specific performance acceptance criteria through a dedicated study.
Here's a breakdown of why I cannot fulfill your request for a table of acceptance criteria and reported device performance based on the provided text, and what information is available:
Missing Information and Why:
- Acceptance Criteria Table: The document does not specify quantitative acceptance criteria (e.g., "device must stop bleeding within X seconds" or "achieve Y% reduction in blood loss").
- Reported Device Performance against Acceptance Criteria: Since no specific acceptance criteria are stated, there are no reported performance values to compare against them.
- Study That Proves Device Meets Acceptance Criteria: The document mentions "Performance Data" but this refers to biocompatibility testing and non-clinical (bench) testing, not a clinical study designed to prove efficacy against specific performance criteria.
Information Derived from the Text (where applicable):
Since the document does not present efficacy data in the way you've requested, I will address points 2-9 by detailing what information is provided regarding testing and ground truth, and explicitly state where the requested information is absent.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| Not specified | Not specified |
| Not specified | Not specified |
| Not specified | Not specified |
Explanation: The 510(k) summary does not include specific quantitative acceptance criteria for the device's hemostatic performance (e.g., time to hemostasis, blood loss reduction). It focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety (biocompatibility). Therefore, there are no reported device performance figures that directly correspond to such criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for efficacy studies. The document refers to "Biocompatibility Testing" and "Non-Clinical (Bench) Testing" which would involve various samples (e.g., rabbits, guinea pigs, mice for in vivo biocompatibility, and physical samples for bench tests).
- Data Provenance (country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not specified. The document does not describe a clinical study involving human readers or assessment of outcomes that would require 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
- MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. This device (WoundClot, a hemostatic dressing) is not an AI-assisted diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not applicable. The WoundClot is a physical medical device (hemostatic dressing), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the "Biocompatibility Testing," the "ground truth" would be established by observation of biological responses (e.g., cytotoxicity, irritation, sensitization, systemic toxicity) against predefined toxicological endpoints and thresholds as per ISO 10993 standards.
- For "Non-Clinical (Bench) Testing," the "ground truth" for physical properties (color, odor, uniformity, softness, weight, pH, solubility, dissolution) would be established by objective measurements and comparisons.
- There is no indication of clinical outcomes data in this summary.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document describes a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. This document describes a physical medical device, not an AI algorithm that requires a training set.
Summary of available "Performance Data" from the document:
The "Performance Data" referenced in Section VII of the 510(k) summary includes:
- Biocompatibility Testing: Conducted in compliance with ISO 10993 standards (1, 5, 10, 11). This included tests for cytotoxicity, skin irritation (in rabbits), guinea pig maximization sensitization, and systemic toxicity (in mice). The implication is that the device passed these tests given the substantial equivalence determination.
- Non-Clinical (Bench) Testing: Comparison of physical characteristics (color, odor, uniformity, softness, weight, pH, solubility, dissolution behavior) between WoundClot and its predicate, BloodSTOP and BloodSTOP iX Hemostatic Gauze. The document states "found to have substantial equivalent physical properties." It also notes that solubility results demonstrated WoundClot is "completely soluble in water and can be easily rinsed and removed from the wound."
This information supports the safety profile and physical equivalence, but not a specific set of efficacy-related acceptance criteria being met.
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April 21, 2023
Core Scientific Creation Ltd. % Sigalit Ariely-Portnoy, Ph.D. CEO & Founder Gsap Ltd. POB 3. Shave-Zion 22806 Israel
Re: K160679 Trade/Device Name: WoundClot Regulatory Class: Unclassified Product Code: QSY
Dear Sigalit Ariely-Portnoy, Ph.D .:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 8, 2016. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2016
Core Scientific Creation Ltd. % Sigalit Ariely-Portnoy, Ph.D. GSAP Ltd. POB 3, Shave-Zion 22806 Israel
Re: K160679 Trade/Device Name: Woundclot Regulatory Class: Unclassified Product Code: FRO Dated: July 19, 2016
Received: July 29, 2016
Dear Dr. Ariely-Portnoy:
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. 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160679
Device Name WoundClot
Indications for Use (Describe)
'WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
. .
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpairt C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
I. SUBMITTER
| Company Name: | Core Scientific Creations Ltd. |
|---|---|
| Address: | Yohanan Hasandlar 4 St.Kfar Saba POB 2270 .4464102 IsraelTel: +972-9-7881919Fax: +972-9-7790263 |
| Contact Person: | Dr. Sigalit Ariely-Portnoy |
|---|---|
| Company Name: | Gsap Ltd. |
| Address: | POB 3, Shave-Zion 22806, IsraelTel: +972-4-9520995Fax: +972-4-6359852 |
Date Prepared: August 2nd, 2016.
II. DEVICE
Name of Device: WoundClot Common or Usual Name: Hemostatic wound dressing Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Medical Device Product Code: FRO
III. PREDICATE DEVICE
-
- Primary Predicate: LifeScience PLUS, Inc, BloodSTOP and BloodSTOP iX Hemostatic Gauze K071578.
- Core Scientific Creations Ltd., WoundClot Hemostatic Gauze, K140573.
The predicates have not been subject to a design-related recall.
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IV. DEVICE DESCRIPTION
Core Scientific Creations WoundClot device is water soluble, based on cellulosic structure. In contact with liquids it forms an adhesive gel which expands and adheres to the wound for bleeding control.
V. INDICATIONS FOR USE
WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
WoundClot has the same intended use as the predicate devices, BloodSTOP and BloodSTOP iX Hemostatic Gauze and WoundClot Hemostatic Gauze. All devices are intended for hemostatic wound dressing.
The indications for use of the WoundClot device are similar to the indications for use listed for the primary predicate BloodSTOP and BloodSTOP iX Hemostatic Gauze, which is OTC use as topical dressing for local management of skin surface bleeding wounds.
The chemical composition (modified cellulose) of the WoundClot device is similar to the chemical composition of its predicate devices. Additionally, the mechanism of action of the WoundClot device is substantially equivalent to that of the BloodSTOP and BloodSTOP iX Hemostatic Gauze and the WoundClot Hemostatic Gauze device; all devices transform into gel, covering and protecting the wound while hemostasis is being achieved.
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The Intended Use of the WoundClot puts it within the biocompatibility category of limited contact duration, and an external communicating device.
Biocompatibility testing for the WoundClot device were performed in compliance with the following international standards:
- Biological evaluation of medical devices Part 1: Evaluation and testing within a risk . management process (per ISO 10993-1:2009)
- . Cytotoxicity Study Using the ISO Elution Method (per ISO 10993-5:2009)
- ISO Skin Irritation Study in Rabbits (per ISO 10993-10:2010) .
- ISO Guinea Pig Maximization Sensitization Test (per ISO 10993-10:2010) .
- Systemic Toxicity Study in Mice (per ISO 10993-11:2006) .
Non-Clinical (Bench) Testing:
The physical characteristics of WoundClot and its predicate, BloodSTOP and BloodSTOP iX Hemostatic Gauze were compared and found to have substantial equivalent physical properties such as color, odor, uniformity softness, weight, pH, solubility and dissolution behavior.
The solubility results described in the test report demonstrates that WoundClot device is completely soluble in water and can be easily rinsed and removed from the wound.
VIII. CONCLUSIONS
Taken together, the intended use, the technological characteristics and the performance data, demonstrate that WoundClot device is as safe and as effective as the predicate devices, hence the devices are substantially equivalent.
N/A