(151 days)
No
The device description and performance studies focus on the material properties and physical characteristics of the dressing, with no mention of AI or ML.
Yes
The device is described as a topical dressing for minor skin surface bleeding wounds, forming a gel that expands and adheres to the wound for bleeding control, which are all characteristics of a therapeutic device.
No
The device is described as a topical dressing for minor skin surface bleeding wounds and is used for bleeding control. Its purpose is to physically interact with the wound, not to diagnose a medical condition.
No
The device description clearly states it is a "water soluble, based on cellulosic structure" and forms an "adhesive gel," indicating it is a physical dressing, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a topical dressing for minor skin surface bleeding wounds". This describes a device that is applied directly to the body to treat a physical condition (bleeding).
- Device Description: The description details a physical material that interacts with liquids and forms a gel to control bleeding. This is a physical mechanism of action, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. WoundClot does not perform any such function. It is a topical hemostatic dressing.
N/A
Intended Use / 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.
Product codes
QSY, FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin surface
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)
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.
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
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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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a sense of community and care.
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)
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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 Israel | |
| Tel: +972-9-7881919 | |
| Fax: +972-9-7790263 |
| Contact Person: | Dr. Sigalit Ariely-Portnoy |
|---|---|
| Company Name: | Gsap Ltd. |
| Address: | POB 3, Shave-Zion 22806, Israel |
| Tel: +972-4-9520995 | |
| Fax: +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.