K Number
K140573
Device Name
WOUNDCLOT HEMOSTATIC GAUZE
Date Cleared
2014-11-24

(263 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
WoundClot Hemostatic Gauze is intended to be used as a topical dressing for local management of bleeding wounds, such as cuts, lacerations and abrasions, and for use as a temporary treatment of severely bleeding wounds, such as surgical wounds (operative, postoperative, donor sites, dermatological) and traumatic injuries.
Device Description
Core Scientific Creations WoundClot Hemostatic Gauze device is made from regenerated cellulose, chemically treated to become water-soluble. When the regenerated cellulose contacts blood and exudates, it expands and forms into gel, adheres and creates pressure to seal wound.
More Information

None

No
The description focuses on the material properties and physical mechanism of action of the hemostatic gauze. There is no mention of AI or ML in the intended use, device description, or performance studies.

Yes
This device is intended for local management of bleeding wounds and temporary treatment of severely bleeding wounds, which describes a therapeutic purpose.

No

The device is a hemostatic gauze intended to manage bleeding wounds and does not perform any diagnostic functions.

No

The device description clearly states it is a physical gauze made from regenerated cellulose, which is a hardware component.

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 "local management of bleeding wounds" and "temporary treatment of severely bleeding wounds." This describes a device that is applied directly to the body to control bleeding.
  • Device Description: The description explains how the device works by contacting blood and exudates on the wound and forming a gel to seal the wound. This is a physical interaction with external bodily fluids at the site of injury.
  • IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body (in vitro means "in glass").

The WoundClot Hemostatic Gauze is a topical medical device used for wound care and hemostasis, not for diagnostic testing of bodily fluids in a laboratory setting.

N/A

Intended Use / Indications for Use

WoundClot Hemostatic Gauze is intended to be used as a topical dressing for local management of bleeding wounds, such as cuts, lacerations and abrasions, and for use as a temporary treatment of severely bleeding wounds, such as surgical wounds (operative, postoperative, donor sites, dermatological) and traumatic injuries.

Product codes

QSY, FRO

Device Description

Core Scientific Creations WoundClot Hemostatic Gauze device is made from regenerated cellulose, chemically treated to become water-soluble. When the regenerated cellulose contacts blood and exudates, it expands and forms into gel, adheres and creates pressure to seal wound.

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

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

Biocompatibility Testing:

  • Cytotoxicity (per ISO 10993-5:2009)
  • Irritation/ ISO Intracutaneous (per ISO 10993-10:2010)
  • Sensitization (per ISO 10993-10:2010)
  • Acute Systemic Toxicity (per ISO 10993-11:2006)

Non-Clinical (Bench) Testing: The similarity of the chemical and physical properties and modifications was shown by comparative performance bench tests between WoundClot Hemostatic Gauze and the predicate device including physical appearance, weight and density, conductivity, pH, solubility, dissolution profile, FTIR analysis and Degree of Substitution test.

Animal Study:

  • Study type: femoral arteriotomy in swine.
  • Sample size: 10, 35-38 Kg Large white Landrace cross-bred (male) swine. 5 animals were tested with the WoundClot device and 5 animals were tested with the BenaCel device.
  • Key results: The primary end points of the study were mean arterial pressure (MAP), survival time, percentage survival, bleeding/hemostasis time (time period necessary for bleeding to stop) and post-treatment blood loss. The secondary end points were measurements of hemoglobin, hematocrit, platelet counts, pH, base deficit and coagulation values (PT, aPTT, fibrinogen, and TEG parameters). In addition, histology analysis was conducted and showed similarities in the pathological findings between the WoundClot and the predicate device. This study has demonstrated that WoundClot is equivalent to Benacel Hemostatic Gauze in achieving hemostasis in a severe bleeding animal model.

Key Metrics

Not Found

Predicate Device(s)

K080532

Reference Device(s)

No reference devices were used in this submission.

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

N/A

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April 21, 2023

Core Scientific Ltd. Dr. Sigalit Ariely-Portnoy Gsap, Ltd. POB 3 Shave-Zion, 22806 Israel

Re: K140573 Trade/Device Name: WoundClot Hemostatic Gauze Regulatory Class: Unclassified Product Code: QSY

Dear Dr. Sigalit Ariely-Portnoy:

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 November 24, 2014. 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

November 24, 2014

Core Scientific LTD. Dr. Sigalit Ariely-Portnoy Gsap LTD. POB 3 22806. Shave-Zion Israel

Re: K140573

Trade/Device Name: WoundClot Hemostatic Gauze Regulatory Class: Unclassified Product Code: FRO Dated: October 13, 2014 Received: October 21, 2014

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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/Resourcesfor You/Industry/default.htm. 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/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

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K140573

Device Name WoundClot Hemostatic Gauze

Indications for Use (Describe)

WoundClot Hemostatic Gauze is intended to be used as a topical dressing for local management of bleeding wounds, such as cuts, lacerations and abrasions, and for use as a temporary treatment of severely bleeding wounds, such as surgical wounds (operative, postoperative, donor sites, dermatological) and traumatic injuries.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. SUBMITTER

Core Scientific Creations Ltd. Yohanan Hasandlar 4 St. Kfar Saba 44425, Israel Address for letters: Emek Horon 9b Kfar Saba 4467320 Israel

Phone: +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: November 19, 2014.

II. DEVICE

Name of Device: WoundClot Hemostatic Gauze Common or Usual Name: Hemostatic Gauze Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Medical Device Product Code: FRO

III. PREDICATE DEVICE

BenaCel Hemostatic Gauze, K080532 This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

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IV. DEVICE DESCRIPTION

Core Scientific Creations WoundClot Hemostatic Gauze device is made from regenerated cellulose, chemically treated to become water-soluble. When the regenerated cellulose contacts blood and exudates, it expands and forms into gel, adheres and creates pressure to seal wound.

V. INDICATIONS FOR USE

Prescription Use: WoundClot Hemostatic Gauze is intended to be used as a topical dressing for local management of bleeding wounds, such as cuts, lacerations and abrasions, and for use as a temporary treatment of severely bleeding wounds, such as surgical wounds (operative, postoperative, donor sites, dermatological) and traumatic injuries.

There are no differences between WoundClot Hemostatic Gauze and the predicate device's intended use.

The Indication for Use statement for WoundClot Hemostatic Gauze is identical to the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

WoundClot Hemostatic Gauze is substantially equivalent to the legally marketed BenaCel Hemostatic Gauze (K080532) in composition, design and processing.

The indications for use and technological characteristics of the WoundClot Hemostatic Gauze device are substantially equivalent to the indications for use and technological characteristics of the predicate BenaCel.

The chemical composition (regenerated cotton cellulose) of the WoundClot Hemostatic Gauze device is similar to the chemical composition of the predicate BenaCel device. The principle of operation of the WoundClot Hemostatic Gauze is substantially equivalent to that of the BenaCel device; both transform into a gel, covering and protecting the wound while hemostasis is being achieved.

The physical performance specifications of the WoundClot Hemostatic Gauze device are substantially equivalent to those in the BenaCel device. Patient contact materials are also similar.

Any minor differences in the technological characteristics do not raise new safety or effectiveness concerns.

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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 Hemostatic Gauze puts it within the biocompatibility category of limited contact duration, and an external communicating device.

Biocompatibility testing for the WoundClot gauze device were performed in compliance with the following international standards:

  • Cytotoxicity (per ISO 10993-5:2009) ●
  • Irritation/ ISO Intracutaneous (per ISO 10993-10:2010) ●
  • Sensitization (per ISO 10993-10:2010) ●
  • Acute Systemic Toxicity (per ISO 10993-11:2006)

Non-Clinical (Bench) Testing:

The similarity of the chemical and physical properties and modifications was shown by comparative performance bench tests between WoundClot Hemostatic Gauze and the predicate device including physical appearance, weight and density, conductivity, pH, solubility, dissolution profile, FTIR analysis and Degree of Substitution test.

Animal Study:

The animal model for the clinical study was a femoral arteriotomy in swine. In this study, 10, 35-38 Kg Large white Landrace cross-bred (male) swine, with normal coagulation functions were tested on the right femoral artery. 5 animals were tested with the WoundClot device and 5 animals were tested with the BenaCel device.

The primary end points of the study were mean arterial pressure (MAP), survival time, percentage survival, bleeding/hemostasis time (time period necessary for bleeding to stop) and post-treatment blood loss. The secondary end points were measurements of hemoglobin, hematocrit, platelet counts, pH, base deficit and coagulation values (PT, aPTT, fibrinogen, and TEG parameters). In addition, histology analysis was conducted and showed similarities in the pathological findings between the WoundClot and the predicate device.

This study has demonstrated that WoundClot is equivalent to Benacel Hemostatic Gauze in achieving hemostasis in a severe bleeding animal model.

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VIII. CONCLUSIONS

Taken together, the technological characteristics, the indications for use and the performance data including bench testing and pre-clinical animal testing, demonstrate that WoundClot Hemostatic Gauze is as safe and as effective as the predicate device, hence both devices are substantially equivalent.