HEMCON HEMOSTATIC GEL

K112215 · Hemcon Medical Technologies Europe, Ltd. · QSY · Apr 12, 2012 · SU

Device Facts

• Record ID: K112215
• Device Name: HEMCON HEMOSTATIC GEL
• Applicant: Hemcon Medical Technologies Europe, Ltd.
• Product Code: QSY · SU
• Decision Date: Apr 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

HemCon GuardaGel™ is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from skin surface wounds. HemCon GuardaGel™ First Aid is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from minor topical cuts and lacerations.

Device Story

HemCon GuardaGel™ is a sterile, viscous, aqueous gel for topical wound management and minor bleeding control. Composed of pectin, m.doc™ (proprietary oxidized cellulose), potassium sorbate, glycerol, and ethanol. Supplied in a pre-filled syringe for external application by clinicians or patients (OTC). The gel acts as a hemostatic agent by activating the intrinsic pathway of the blood coagulation cascade (contact activation of Factor XII and kallikrein). Applied directly to skin surface wounds to accelerate cessation of bleeding. Benefits include rapid hemostasis compared to untreated wounds, facilitating wound management in clinical or first-aid settings.

Clinical Evidence

No human clinical data. Bench testing included in vitro spectrophotometric assays measuring activation of intrinsic pathway contact enzymes (Factor XII, kallikrein). In vivo testing in a rabbit model (n=not specified) showed mean cessation of bleeding of 23.1s ± 5.8s for treated wounds vs. 106.8s ± 18.6s for untreated controls. Biocompatibility testing per ISO 10993 (cytotoxicity, irritation, sensitization) confirmed safety for surface-contacting use on breached/compromised skin for up to 30 days.

Technological Characteristics

Homogenous aqueous viscous gel. Materials: pectin, m.doc™ (oxidized cellulose), potassium sorbate, glycerol, 5% w/w ethanol. Form factor: pre-filled sterile syringe. Sterilization: ISO 11137:2006 (VDmax25 method, 10^-6 SAL). Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for management of wounds and temporary control of minor bleeding from skin surface wounds, cuts, and lacerations in patients requiring topical hemostasis. Not indicated for traumatic or severe bleeding.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• BloodSTOP™ (K072681)
• Seal-On™ Hemostatic Powder Spray (K010933)

Submission Summary (Full Text)

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HemCon Medical Technologies Europe, Ltd. % HemCon Medical Technologies Inc. Kendra Rathkey 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363

July 28, 2023

Re: K112215 Trade/Device Name: HemCon GuardaGel™ Regulatory Class: Unclassified Product Code: QSY

Dear Kendra Rathkey:

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 April 12, 2012. 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, [e-mail].

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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

APR 1 2 2012

HemCon Medical Technologies Europe Ltd % HemCon Medical Technologies, Inc. Ms. Kendra Rathkey 10575 SW Cascade Avenue, Suite 130 Portland, Oregon 97223-4363

Re: K112215

Trade/Device Name: HemCon GuardaGel™ Regulatory Class: Unclassified Product Code: FRO Dated: February 10, 2012 Received: February 13, 2012

# Dear Ms. Rathkey:

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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Page 2 - Ms. Kendra Rathkey

forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours, .

For Mello

Van Lin M.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health -

Enclosure

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K112215
Page 1 of 1

HemCon | EUROPE

6 Courtyard Business Centre, Orchard Lane, Blackrock, Dublin, Ireland

Applicant: HemCon Medical Technologies Europe Limited 510(k) Number: K112215 Device Name: HemCon GuardaGe/™

# Indications for Use - Rx Only:

HemCon GuardaGel™ is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from skin surface wounds.

# Indications for Use - OTC:

HemCon GuardaGel™ First Aid is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from minor topical cuts and lacerations.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(Please Do Not Write Below This Line - Continue On Another Page If Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kime for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112215

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6 Courtyard Business Centre, Orchard Lane, Blackrock, Dublin, Ireland

Image /page/4/Picture/2 description: The image shows the text "K112215 Page 1 of 3" written in black ink. Below the text is the HemCon logo, with the word "HemCon" in a sans-serif font. To the right of "HemCon" is a vertical line, followed by the word "EUROPE" in a smaller font.

APR 1 2 2012

# 510(k) Summary

Trade Name: Classification Name: Regulation No: Product Code: Predicate Device(s):

く

Company Name:

Company Address:

Contact Person (Europe):

Contact Phone:

Contact Person (US):

Contact Phone: Contact Fax:

Date of Preparation:

HemCon GuardaGel™ Dressing, Wound, Drug Unclassified FRO BloodSTOP™ (K072681) Seal-On™ Hemostatic Powder Spray (K010933)

HemCon Medical Technologies Europe Ltd.

6 Courtyard Business Centre, Orchard Lane, Blackrock, Co. Dublin, Ireland

Máire Ní Beilliú R&D Manager and Quality Representative HemCon Medical Technologies Europe Ltd. [phone]

Kendra Rathkey Regulatory Manager HemCon Medical Technologies Inc. [phone] x139 [phone]

30 March 2012

HemCon Medical Technologies Europe Ltd. Premarket Notification - 510(k) K112215 Additional Information Ronuactad.

GuardaGel TM Page 18 of 32

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6 Courtyard Business Centre, Orchard Lane, Blackrock, Dublin, Ireland

### Description of the Device:

HemCon GuardaGel™ is intended for the management of wounds and for emergency external use in the temporary control of minor bleeding from the skin and other surface wounds where temporary control of bleeding is required. It is a homogenous aqueous, viscous opaque gel comprised of pectin, m.doc™ (HemCon's proprietary hemostatic oxidized cellulose formulation), potassium sorbate, glycerol and 5 %w/w ethanol. The gel comes in a sterile pre-filled svringe.

HemCon GuardaGel™ has not been evaluated for the control of traumatic or severe bleeding.

#### Intended Use:

Prescription: HemCon GuardaGel™ is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from skin surface wounds.

OTC: HemCon GuardaGel™ First Aid is intended for management of wounds and for emergency external use for the temporary control of minor bleeding from minor topical cuts and lacerations.

# Basis for Substantial Equivalence:

HemCon is claiming substantial equivalence of the proposed device to two predicate devices, Seal-On™ Hemostatic Spray (K010933) and BloodSTOP™ (K072681). Like HemCon GuardaGel™, both BloodSTOP™ and Seal-On™ contain plant sourced cellulose as a hemostatic agent. In the case of the Hemostatic Gel and Seal-On™ the plant sourced cellulose is HemCon's proprietary hemostatic agent microdispersed oxidized cellulose (m.doc™). The hemostatic agent in BloodSTOP™ is regenerated cotton cellulose.

HemCon GuardaGel™, BloodSTOP™ (K072681) and Seal-On™ Hemostatic Spray (K010933) have the same intended use, namely to provide temporary control of bleeding from the skin and other surface wounds. Both HemCon GuardaGel™ and BloodSTOP™ are intended for emergency and therapeutic use.

HemCon believes that the proposed device is substantially equivalent to the predicate devices and that the predicate devices adequately demonstrate the safety and efficacy of hemostats comprising a form of cellulose as the hemostatic agent

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Image /page/6/Picture/1 description: The image shows the logo for HemCon Europe. Above the logo, there is handwritten text that reads "K 112215 page 3 of 3". The logo consists of two overlapping circles with a line separating the words "HemCon" and "Europe".

6 Courtyard Business Centre, Orchard Lane, Blackrock, Dublin, Ireland

# Summary of Performance Testing:

Based on the performance testing of eleven individual lots of gel HemCon has demonstrated the ability to repeatedly product that the meets existing acceptance criteria.

#### Hemostatic Efficacy

The hemostatic efficacy of HemCon GuardaGe!™ has been determined using an in vitro assay which evaluates the activation of the intrinsic pathway of the blood coagulation cascade. The assay is a spectrophotometric assay which measures the activity of the contact activation proteins. Factor XII and kallikrein. The HemCon Hemostatic Gel formulation has been shown to activate the contact phase enzymes of the intrinsic pathway of the blood coaqulation cascade.

The hemostatic efficacy of the HemCon GuardaGel™ has also been demonstrated in vivo in rabbits. The average time for cessation of bleeding of wounds treated with HemCon GuardaGel™ was 23.1 s ± 5.8 s compared to 106.8 s ± 18.6 s for untreated wounds.

## Biocompatibility

Biocompatibility has been demonstrated for the device according to ISO 10993. Categorization of the device by nature of body contact deduces HemCon GuardaGel™ is a surface-contacting device that contacts breached or compromised surfaces. The duration of contact may be prolonged at more than 24 hours, but no more than 30 days. Cytotoxicity, irritation and sensitization testing was performed.

#### Sterility

Sterility validations were completed following ISO 11137:2006 requirements to demonstrate a 10t SAL using the VDma25 method.

#### Conclusion:

The conclusion drawn from the substantial equivalence argument and non-clinical performance data is that the proposed device is as safe and effective as the predicate devices

HemCon Medical Technologies Europe Ltd. Premarket Notification - 510(k) K112215 Additional Information Dar

GuardaGel™ Page 20 of 32