Axiostat Patch

K202830 · Advamedica, Inc. · QSY · Apr 15, 2021 · SU

Device Facts

• Record ID: K202830
• Device Name: Axiostat Patch
• Applicant: Advamedica, Inc.
• Product Code: QSY · SU
• Decision Date: Apr 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, surgical debridement sites, skin surface puncture sites, vascular sites and sites involving percutaneous catheters, tubes and pins.

Device Story

Axiostat Patch is a sterile, single-use, non-absorbable hemostatic dressing composed of chitosan; a natural polysaccharide derived from shellfish. Used in clinical settings by healthcare providers to manage bleeding wounds. Applied directly to the wound with firm pressure; the chitosan material facilitates hemostasis and acts as a physical barrier against bacterial penetration. The dressing is removed after clotting occurs, with a maximum application time of 24 hours. It is not intended for implantation. By controlling bleeding and providing a bacterial barrier, the device aids in wound management and reduces infection risk. The device is terminally sterilized via gamma irradiation and packaged in moisture-proof pouches.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing and animal studies. Bench testing confirmed barrier properties against six bacterial species (Gram-positive and Gram-negative) compared to gauze. Animal study (swine vascular injury model) demonstrated hemostasis in <5 minutes with no rebleeding or thrombi observed during a 2-hour observation period. Biocompatibility testing (ISO 10993) confirmed non-cytotoxic, non-toxic, and non-pyrogenic status.

Technological Characteristics

Primary material: Chitosan. Form factor: Sterile, non-absorbable dressing in various sizes. Sterilization: Gamma irradiation (ISO 11137-2) to SAL 10^-6. Packaging: Moisture-proof pouches. Biocompatibility: ISO 10993-1 compliant. Shelf life: 5 years validated via ASTM F88 (seal strength) and ASTM F1929-15 (dye penetration).

Indications for Use

Indicated for patients requiring local management of bleeding wounds and rapid control of moderate to severe bleeding. Applicable to lacerations, surgical debridement sites, skin surface puncture sites, vascular procedure sites, and sites involving percutaneous catheters, tubes, and pins.

Regulatory Classification

Identification

To temporarily control bleeding and cover external wounds.

Predicate Devices

• HemCon® Bandage PRO, HemCon® Patch PRO, HemCon® Strip PRO, HemCon® ChitoFlex PRO (K150916)
• Coreleader Hemo-Pad (K102944)

Reference Devices

• Axiostat Chitosan Hemostatic Dressing (K172324)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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

Advamedica Inc. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, California 92108

Re: K202830 Trade/Device Name: Axiostat Patch Regulatory Class: Unclassified Product Code: QSY

Dear Alan Donald:

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 15, 2021. 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

{1}------------------------------------------------

April 15, 2021

Image /page/1/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Advamedica Inc. % Alan Donald President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, California 92108

Re: K202830

Trade/Device Name: Axiostat Patch Regulatory Class: Unclassified Product Code: FRO Dated: September 7, 2020 Received: September 25, 2020

Dear Alan Donald:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for

{2}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Lixin Liu -S

Lixin Liu. Ph.D. Acting 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

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known) K202830

Device Name Axiostat Patch

Indications for Use (Describe)

Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, surgical debridement sites, skin surface puncture sites, vascular sites and sites involving percutaneous catheters, tubes and pins.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div style="display:flex; align-items:center;"> <div style="margin-right:5px;"> <span style="font-size: 20px;">☒</span> </div> <span>Prescription Use (Part 81 CFR 201, Subpart D)</span> </div> | |
| <div style="display:flex; align-items:center;"> <div style="margin-right:5px;"> <span style="font-size: 20px;">☐</span> </div> <span>Over-The-Counter Use (21 CFR 201, Subpart G)</span> </div> | |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

## 510(k) SUMMARY - K202830 AXIOSTAT PATCH

## 1. ADMINISTRATIVE INFORMATION

- Date of preparation: 10 March 2021 a.

| b. | Submitter: | Advamedica Inc.<br>Harvard Square, 1 Mifflin Place,<br>Suite 400, Cambridge,<br>Massachusetts 02138, USA<br>Phone: [phone]<br>Fax: [phone] |
|----|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| c. | Contact Person: | Mr. Leo Mavely,<br>President, Advamedica Inc.<br>Email: [e-mail]<br>Web: www.advamedica.com |
| d. | Prepared By: | Mr. Leo Mavely, President<br>Advamedica. Inc. |

## 2. DEVICE NAME AND CLASSIFICATION

| a. Trade/ Proprietary Name | : Axiostat Patch |
|----------------------------|-------------------------------|
| b. Common Name | : Hemostatic dressing |
| c. Classification Name | : Dressing, Wound, Drug |
| d. Regulatory Class | : Unclassified |
| e. Product code | : FRO |
| f. Classification Panel | : General and Plastic Surgery |

## 3. IDENTIFICATION OF PREDICATE DEVICE

| PREDICATES | PREDICATE 1 | PREDICATE 2 |
|-------------------|----------------------|---------------------|
| 510(k) Number | K150916 | K102944 |
| Trade/Proprietary | HemCon® Bandage PRO, | Coreleader Hemo-Pad |

{5}------------------------------------------------

| Name | HemCon® Patch PRO,<br>HemCon® Strip PRO,<br>HemCon® ChitoFlex PRO | |
|---------------------|-------------------------------------------------------------------|-----------------------------|
| Manufacturer | HemCon Medical<br>Technologies, Inc. | Coreleader Biotech Co. Ltd. |
| Classification Name | Dressing, Wound, Drug | Dressing, Wound, Drug |
| Regulatory Class | Unclassified | Unclassified |
| Product Code | FRO | FRO |
| Panel | General & Plastic Surgery | General & Plastic Surgery |

## 4. DEVICE DESCRIPTION

The Axiostat Patch is a sterile, single use, non-absorbable hemostatic dressing. It is composed of chitosan a well-known natural polysaccharide generally derived from shellfish which has widely recognized hemostatic properties.

When applied directly to a wound with firm pressure, the dressing controls bleeding and provides a barrier against bacterial penetration. The hemostatic dressing can be removed after the clotting has occurred but should not remain on for more than 24 hours. The hemostatic dressing is not intended to be implanted.

The Axiostat Patch is equivalent in material, design, composition, manufacturing, intended use, sterilization, and biocompatibility to the legally marketed Axiostat Chitosan Hemostatic Dressing (K172324, cleared on 23th Feb 2018). The only differences are the Indication for Use and the variations in size for this use.

The Axiostat Patch is individually packaged in moisture proof packs and terminally sterilized using gamma irradiation. The product may be cut to any size, and the company anticipates introducing the following sizes:

- 4 in x 4 in (10 cm x 10 cm)
- 3 in x 3 in (8 cm x 8 cm) .
- 3 in x 2 in (8 cm x 5 cm) .
- 2 in x 2 in (5 cm x 5 cm) .
- 2 in x 1 in (5 cm x 2.5 cm) ●
- 1.4 in x 1.4 in (3.5 cm x 3.5 cm)
- 1 in x 1 in (2.5 cm x 2.5 cm) .
- 0.8 in x 0.8 in (2 cm x 2 cm) .
- . 0.4 in x 3 in (1 cm x 8 cm)
- 0.4 in x 1.5 in (1 cm x 4 cm) .

#### Advamedica Inc.

{6}------------------------------------------------

## 5. INDICATIONS FOR USE (Prescription use)

The Axiostat Patch is intended for local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing for patients and for the rapid control of moderate to severe bleeding. The dressing is indicated for the following wounds: lacerations, abrasions, surgical debridement sites, skin surface puncture sites. vascular procedure sites and sites involving percutaneous catheters, tubes and pins.

## 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF SUBJECT AND PREDICATE DEVICES

The Axiostat Patch is technologically similar to the HemCon Patch Pro and the Coreleader Hemo-Pad. The Subject Device has the following similarities to one or both proposed predicate devices:

- Intended use .
- Indications for use .
- Mechanism of action .
- Primary material .
- . Patient contacting material (chitosan)
- Biocompatibility .
- Bacterial Barrier .
- Sterilization method .

## Table 1: Comparison of technological characteristics of Subject and Predicate Devices

| PARAMETER | SUBJECT DEVICE | PREDICATE 1 | PREDICATE 2 | SE |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Manufacturer | Advamedica Inc. | HemCon, Inc. | Coreleader Biotech<br>Co. Ltd. | - |
| Model/Trade<br>Name | Axiostat Patch | HemCon Bandage<br>PRO, HemCon Patch<br>PRO, HemCon Strip<br>PRO, Hemcon<br>ChitoFlex PRO | Coreleader Hemo-<br>Pad | - |
| 510(k) Number | K202830 | K150916 | K102944 | - |
| Product Code | FRO | FRO | FRO | Same |
| Common name | Hemostatic dressing | Wound dressing | Topical<br>Hemostasis Pad | Same |
| Classification | Unclassified | Unclassified | Unclassified | Same |
| Primary<br>Material | Chitosan | Chitosan | Chitosan | Same |
| Intended Use | Wound<br>management | Wound management | Wound<br>management | Same |
| Indications for<br>Use | The Axiostat Patch is<br>intended for local<br>management of<br>bleeding wounds and<br>to provide a barrier to<br>bacterial penetration<br>of the dressing for<br>patients and for the<br>rapid control of<br>moderate to severe<br>bleeding. The<br>dressing is indicated<br>for the following<br>wounds: lacerations,<br>abrasions, surgical<br>debridement sites,<br>skin surface puncture<br>sites, vascular<br>procedure sites and<br>sites involving<br>percutaneous<br>catheters, tubes and<br>pins. | The HemCon®<br>prescription devices<br>are intended for local<br>management of<br>bleeding wounds and<br>to provide a barrier to<br>bacterial penetration of<br>the dressing in all<br>patients and for the<br>promotion of rapid<br>control (hemostasis) of<br>bleeding in patients<br>following<br>hemodialysis and for<br>those on<br>anticoagulation<br>therapy. The dressing<br>is indicated for the<br>following wounds:<br>lacerations, abrasions,<br>nose-bleeds, surgical<br>debridement sites, skin<br>surface puncture sites,<br>vascular procedure<br>sites and sites<br>involving<br>percutaneous<br>catheters, tubes and<br>pins. | The Coreleader<br>Hemo-Pad is a<br>dressing indicated<br>for topical wound<br>management and<br>for the external<br>topical temporary<br>control of<br>moderate to severe<br>bleeding. The<br>dressing is<br>indicated for the<br>following wounds:<br>abrasions,<br>lacerations, skin<br>surface puncture<br>sites for vascular<br>procedures<br>(arteries and veins) | See Note<br>1 |
| OTC/<br>Prescription | Prescription Only | OTC and Prescription | Prescription Only | Similar |
| Single Use | Yes | Yes | Yes | Same |
| Packaging | Moisture proof pouch | Foil Bags | Foil pouch | Similar.<br>See Note<br>2 |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Same |
| Shelf life | 5 years | 3 years | 3 years | Different.<br>See Note |
| | | | | 3 |
| Biocompatibility<br>Tests | Compliant to ISO<br>10993 | Compliant to ISO<br>10993 | Compliant to ISO<br>10993 | Same |
| Size | Various | Various | Various | Same |

{7}------------------------------------------------

## TRADITIONAL 510(k) Axiostat Patch

{8}------------------------------------------------

## Note 1:

Technologically, the Subject Device is similar to both the predicate devices. The Subject Device and the Predicate Device 1 have similar Indications for Use. Additionally, the Subject Device also includes indications for management of moderate to severely bleeding wounds. Hence, Predicate Device 2 is identified for this additional Indication for Use.

## Note 2:

Differences in the packaging material do not raise any different device safety and performance issues. Additionally, the shelf life and package integrity of the product has been validated through real time stability studies.

## Note 3:

The Subject Device has a shelf life of 5 years. This has been evaluated through real-time stability studies.

## 7. PERFORMANCE DATA

The Subject Device has been evaluated through a series of nonclinical studies to determine whether Axiostat meets the acceptance criteria for its intended applications. These tests are summarized below.

- a. Biocompatibility testing
Biocompatibility tests have been performed per the requirements of ISO 10993-1:2009, under the section "Surface devices used on Breached or compromised surface with limited contact duration (≤24 hrs)". The following tests have been performed as per these requirements.

| Biocompatibility test | Standard followed | Outcome |
|-----------------------|-------------------|---------------|
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Skin Sensitization | ISO 10993-10 | Non-toxic |

## Table 2: Biocompatibility test details

{9}------------------------------------------------

| Intracutaneous Reactivity | ISO 10993-10 | Non-toxic |
|-----------------------------------|--------------|---------------|
| Acute Systemic Toxicity | ISO 10993-11 | Non-toxic |
| Material-Mediated<br>Pyrogenicity | ISO 10993-11 | Non-pyrogenic |
| Bacterial Endotoxin Test | USP 85 | Complies |

## b. Heavy metal testing

The Subject Device was tested for heavy metal contamination in the finished, sterilized product, which met USP-232 limits [(232) ELEMENTAL IMPURITIES-LIMITS].

- c. Bench performance testing
The Subject Device was evaluated through following bench tests.

| | Test | Test Method |
|----|------------------------------|-------------------|
| 1. | Appearance | In house protocol |
| 2. | Moisture Content | In house protocol |
| 3. | Absorbency | In house protocol |
| 4. | pH | In house protocol |
| 5. | Integrity test | In house protocol |
| 6. | Tensile strength of product | In house protocol |
| 7. | In vitro blood clotting test | In house protocol |

Table 3: Bench performance testing

## d. Barrier to bacteria testing

This study was performed to evaluate the barrier to bacteria property of the Axiostat Patch. In this test, the Axiostat Patch (n=3) was used as a test sample and a similarly sized gauze (n=3) was used as the control sample. Samples were challenged with 106 cells of three gram-positive and three gram-negative bacterial species.

After challenging for the maximum use-life (i.e. 24 hrs.), the dressings were removed. Then, the plates without the dressing were incubated to observe for the presence/absence of bacterial growth. The following organisms were used:

- Pseudomonas aeruginosa (ATCC 9027)
- 9 Staphylococcus aureus (ATCC 6538)
- Escherichia coli (ATCC 14169)

{10}------------------------------------------------

- . Enterococcus faecalis (ATCC 29212)
- . Proteus mirabilis (ATCC 12453)
- . Staphylococcus epidermidis (ATCC 12228)

No bacterial growth was observed in the plates containing Axiostat Patch, whereas all plates containing cotton gauze showed bacterial growth. These results demonstrate the capacity of the Axiostat Patch to act as a barrier to bacterial penetration through the device.

## e. Animal studies

The Axiostat Patch was evaluated using the animal testing procedures described in "Safety Evaluation of New Hemostatic Agents, Smectite Granules, and Kaolin-Coated Gauze in a Vascular Injury Wound Model in Swine; Kheirabadi, et al., J Trauma. 2010 Feb:68(2):269-78." This study was performed at an outside independent laboratory.

The Subject Device successfully achieved hemostasis in under 5 minutes in all test animals, and no rebleeding was observed in any animals during the observation period of two hours. Further, there were no thrombi or blood clots in the lumens of blood vessels at the repair site in the Axiostat treated animals.

## 8. STERILIZATION AND PACKAGING

The Axiostat Patch is packaged in moisture proof packs. The product is terminally sterilized using gamma radiation to a sterility assurance level (SAL) of 10-6. The dose of gamma radiation has been optimized and validated per ISO 11137-2.

Following gamma sterilization, the package integrity was subjected to sterile barrier testing to validate a shelf life of 5 years. The stability and effectiveness of packaging of the sterilized product during the shelf life was confirmed by real time (to support 5-year shelf life) and accelerated stability studies.

The following tests were performed periodically in the validation of 5-year shelf life.

- Seal strength test as per ASTM F88. .
- . Dye penetration test as per ASTM F1929-15.
- Sterility test as per US Pharmacopeia <71>. .
- Bacterial endotoxin test per US Pharmacopeia <85>. .
- Bench performance tests to validate the shelf life of the product .
- i. Appearance
- ii. Absorbency
- iii. pH testing
- iv. Moisture content
- . Tensile strength for Patch

#### 9. CONCLUSION

The Axiostat Patch is substantially equivalent to the predicate devices with respect to intended use, Indications for Use, design, material, sterilization, and biocompatibility.

#### Advamedica Inc.

{11}------------------------------------------------

The non-clinical testing data provided support the safety and performance of the device for the claimed Indications for Use statement. Hence, the minor differences between the Subject Device and the predicates do not raise any different device safety or performance issues.