K Number

Device Name

Hemogrip Patch

Manufacturer

REMEDIUM TECHNOLOGIES, INC.

Date Cleared

2015-06-08

(186 days)

Product Code

QSY FRO

Regulation Number

N/A

Intended Use

Hemogrip™ Patch is indicated for use, under the direction of a healthcare professional, in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes.

Device Description

The Hemogrip™ Patch Hemostasis Pad is a non-invasive topical bandage intended to promote hemostasis when in contact with a bleeding wound. Hemogrip™ Patch is composed of a soft, sterile, palmitoyl-N-acetylglucomasine substrate/backing coated with a freeze-dried layer of poly N-acetylglucosamine (chitosan). The environment of use for the Hemogrip™ Patch is at a healthcare facility/hospital under the direction of a healthcare professional. The Hemogrip™ Patch Hemostasis Pad promotes the control of bleeding wounds in patients. This is achieved by applying proximal pressure to the puncture site and placing a Hemogrip™ Patch over the puncture site using a sterile folded gauze. Firm compression is applied over the puncture site until hemostasis is achieved. Proximal pressure can be released after 2 to 3 minutes. Once hemostasis is achieved, pressure is released and a dry gauze is placed over the Hemogrip" Patch. The site is then covered with an appropriate dressing. Within 24 hours, Hemogrip™ Patch should be soaked with water and gently removed. The Hemogrip™ Patch is sterilized via y-irradiation and is for single use only.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K984177

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and physical mechanism of action for hemostasis, with no mention of AI or ML.

Therapeutic

Yes
The device is intended to promote hemostasis and manage bleeding wounds, which is a therapeutic function.

Diagnostic

No
Explanation: The device, Hemogrip™ Patch, is a hemostatic pad intended to stop bleeding by promoting hemostasis. Its function is therapeutic (management of bleeding wounds), not diagnostic (identifying or characterizing a medical condition).

SaMD (Software as a Medical Device)

The device description clearly states it is a "non-invasive topical bandage" composed of physical materials (palmitoyl-N-acetylglucomasine substrate/backing coated with poly N-acetylglucosamine). It is a physical hemostatic device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Hemogrip™ Patch is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the "management of bleeding wounds," specifically to "promote hemostasis." This is a therapeutic or wound management function, not a diagnostic one.
Device Description: The description details a topical bandage that physically interacts with a bleeding wound to control bleeding. It does not involve analyzing samples (like blood, urine, or tissue) outside of the body to provide diagnostic information.
Performance Studies: The performance studies focus on the device's ability to control bleeding in an animal model and its biocompatibility, not on its ability to diagnose a condition or provide diagnostic data.
Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any information about a patient's health status beyond the immediate control of bleeding.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Hemogrip™ Patch does not fit this definition. It is a medical device used for wound management and hemostasis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Hemogrip™ Patch is indicated for use, under the direction of a healthcare professional, in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes.

Product codes (comma separated list FDA assigned to the subject device)

QSY, FRO

Device Description

The Hemogrip™ Patch Hemostasis Pad promotes the control of bleeding wounds in patients. This is achieved by applying proximal pressure to the puncture site and placing a Hemogrip™ Patch over the puncture site using a sterile folded gauze. Firm compression is applied over the puncture site until hemostasis is achieved. Proximal pressure can be released after 2 to 3 minutes. Once hemostasis is achieved, pressure is released and a dry gauze is placed over the Hemogrip" Patch. The site is then covered with an appropriate dressing. Within 24 hours, Hemogrip™ Patch should be soaked with water and gently removed.

The Hemogrip™ Patch is sterilized via y-irradiation and is for single use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vascular access sites and percutaneous catheters or tubes.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professional / healthcare facility/hospital

Description of the training set, sample size, data source, and annotation protocol

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)

An animal study was conducted in a controlled acute swine model of splenic hemorrhage to evaluate the chitosan materials of both the Syvek Patch and the Hemogrip Patch. The swine model was selected based on published comparisons evaluating the effectiveness of hemostatic agents. Analysis of the results indicated no statistically reliable difference in the performance of the Syvek Patch and Hemogrip™ Patch in their ability to promote hemostasis. In all instances, the Hemogrip TM Patch functioned as intended and the control of bleeding observed was as expected.

Extensive biological testing to verify the biocompatibility of Hemogrip™ Patch was conducted. The biological tests required to establish biocompatibility are identified in FDA Blue Book Memorandum G95-1, "Use of International Stanard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." Hemogrip™ Patch is a topical chitosan-based pad that remains in contact with a breached or compromised external surface on human skin for less than 24 hours. Hence, the device was tested via ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation), ISO 10993-10 (Sensitization) and ISO 10993-11 (Acute Systemic Toxicity). Hemogrip™ Patch met the requirements of biocompatibility for each of these tests.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Marine Polymer Technologies Syvek Patch® (K984177)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 21, 2023

Remedium Technologies, Inc. John Gustin, Ph.D. Regulatory Affairs Coordinator 387 Technology Dr., Suite 3110B College Park, Maryland 20742

Re: K143466 Trade/Device Name: Hemogrip™ Patch Regulatory Class: Unclassified Product Code: QSY

Dear John Gustin, 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 June 8, 2015. 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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized human figure with three faces, representing the department's focus on health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 8, 2015

Remedium Technologies Incorporated John Gustin, Ph. D. Regulatory Affairs Coordinator 387 Technology Drive, Suite 3110B College Park, Maryland 20742

Re: K143466

Trade/Device Name: Hemogrip Patch Regulatory Class: Unclassified Product Code: FRO Dated: May 6, 2015 Received: May 6, 2015

Dear Dr. Gustin:

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

Page 2 - John Gustin, 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 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

Indications for Use

510(k) Number (if known) K143466

Device Name Hemogrip Patch

Indications for Use (Describe)

Hemogrip Patch is indicated for use, under the direction of a healthcare professional, in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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HEMOGRIP™ PATCH 510(k) Summary

Traditional 510(k) Summary

| A. Name and Address of Applicant : | Remedium Technologies, Inc.
387 Technology Dr., Suite 3110B
College Park, MD 20742 | |
|------------------------------------|------------------------------------------------------------------------------------------------------|--|
| B. Contact Person: | John Gustin, Ph.D.
Regulatory Affairs Coordinator
Phone: (301) 405-3585
Fax: (301) 314-9592 | |
| C. Date Prepared: | June 4, 2015 | |
| D. Device Trade Name: | Hemogrip™ Patch | |
| E. Device Common Name: | Topical Hemostasis Pad | |
| F. Device Classification: | Unclassified Device | |
| G. Classification Name: | Dressing, Wound, Drug | |
| H. Product Code: | FRO | |
| I. Predicate Device: | Marine Polymer Technologies Syvek Patch®
(K984177) | |

J. Indications for Use:
Hemogrip™ Patch is indicated for use, under the direction of a healthcare professional, in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes.
K. Device Description:
The Hemogrip™ Patch Hemostasis Pad is a non-invasive topical bandage intended to promote hemostasis when in contact with a bleeding wound. Hemogrip™ Patch is composed of a soft, sterile, palmitoyl-N-acetylglucomasine substrate/backing coated with a freeze-dried layer of poly N-acetylglucosamine (chitosan). The environment of use for the Hemogrip™ Patch is at a healthcare facility/hospital under the direction of a healthcare professional.

compression is applied over the puncture site until hemostasis is achieved. Proximal pressure can be released after 2 to 3 minutes. Once hemostasis is achieved, pressure is released and a dry gauze is placed over the Hemogrip" Patch. The site is then covered with an appropriate dressing. Within 24 hours, Hemogrip™ Patch should be soaked with water and gently removed.

The Hemogrip™ Patch is sterilized via y-irradiation and is for single use only.

L. Performance Data

M. Summary of Substantial Equivalence:
Remedium Technologies has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that the Hemogrip 100 Patch is substantially equivalent to the currently marketed predicate device. See Table 1 (below) for a tabulated summary of substantial equivalence.

Hemogrip 110 Patch has essentially the same intended use as the predicate device. Results of scientific testing have ensured that all materials are biocompatible, no new adverse effects were introduced and physical properties are appropriate for the intended use. Non-clinical testing was conducted. Animal testing was performed to simulate clinical conditions with no adverse events noted.

In conclusion, Hemogrip™ Patch has been shown to be substantially equivalent to the Class II predicate on which the device is based.

	Marine Polymer Technologies		Remedium Technologies
	Syvek Patch® (K984177)		Hemogrip™ Patch
Indications for Use	SyvekPatch is indicated for use under		Hemogrip™ Patch is indicated for
	the direction of a healthcare		use, under the direction of a healthcare
	professional. SyvekPatch promotes		professional, in the management of
	the rapid control of bleeding in		bleeding wounds such as vascular
	patients on hemodialysis and in		access sites and percutaneous catheters
	patients on anticoagulation therapy.		or tubes.
	SyvekPatch is indicated for use in the
	management of bleeding wounds
	such as vascular access sites and
	percutaneous catheters or tubes.
Target Population/	Diagnostic or interventional		Diagnostic or interventional
Anatomical Sites	catheterization procedures.		catheterization procedures.
Where Used	Bleeding wounds under the care of a		Bleeding wounds under the care of a
	physician or licensed practitioner.		physician or licensed practitioner.
Material	SyvekPatch is a soft, white, sterile		Hemogrip™ Patch is a soft, sterile,
	non-woven pad of cellulosic polymer,		non-woven palmitoyl-N-
	poly-N-acetylglucosamine (chitosan).		acetylglucosamine coated with N-
			acetylglucosamine (chitosan), a
			cellulosic polymer.
Sizes	2 cm x 2 cm	3 cm x 3 cm	2.5 cm x 2.5 cm	4 cm x 4 cm
Weight	0.01 g	0.03 g	0.5 g	0.8 g
Biocompatibility	Biocompatibility has been established		Biocompatibility has been established
	via ISO 10993.		via ISO 10993
Sterility	Sterilized with gamma radiation, for		Sterilized with gamma radiation, for
	single use only.		single use only.
Function/performance	Similar performance to other topical		Similar performance to other topical
	bandages intended to promote		bandages intended to promote
	hemostasis in an acute splenic		hemostasis in an acute splenic
	hemorrhage model in swine.		hemorrhage model in swine.

Table 1. Tabulated Summary of Substantial Equivalence