The Ax-Surgi is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds and traumatic injuries.

Device Description

The Ax-Surgi Surgical Hemostat Surgical Hemostat is a sterile, single-use, surgical hemostatic patch. It is composed of a soft, lyophilized chitosan pad attached to a standard viscose-polyester gauze with a radiopaque element.

AI/ML Overview

The document provided is a 510(k) Summary for the Ax-Surgi Surgical Hemostat and outlines the device's characteristics, intended use, and performance testing to demonstrate substantial equivalence to a predicate device. However, it does not detail acceptance criteria in the form of specific quantitative metrics for comparison with the device performance. Instead, it lists studies and their general positive outcomes ("Pass," "Non-cytotoxic," "successful safety and performance assessment").

Therefore, I cannot generate a table of acceptance criteria and reported device performance with specific quantitative metrics. The document describes a series of tests performed and provides a qualitative outcome for each.

Here's an analysis of the provided information related to the other requested points:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, the document does not present quantitative acceptance criteria. Instead, it lists various tests and their qualitative outcomes.

Testing	Reported Device Performance
Cytotoxicity	Non-cytotoxic
Sensitization	Non-sensitizing
Genotoxicity	Non-mutagenic
Acute Systemic Toxicity	Non-toxic
Implantation	Non-toxic
Pyrogenicity	Non-pyrogenic
Subacute Toxicity	Non-toxic
Intracutaneous Reactivity	Non-irritating
Hemolysis Test	Non-hemolytic
Animal Studies (Pilot & Pivotal)	Achieved successful safety and performance assessment, successful hemostasis in swine liver resection model displaying class III or class IV bleeding. Demonstrated safety and hemostatic performance comparable to standard of care. No evidence of vascular obstruction or embolization. Inflammation and adhesions were as expected and substantially equivalent to standard of care. Radiographically detectable.
Moisture Content	Pass
Tensile Strength	Pass
Integrity	Pass
Radiopacity	Pass
In vitro Clot Assessment	Pass
Particulate Release	Pass
Absorbency	Pass
pH	Pass

2. Sample size used for the test set and the data provenance:

Animal Studies (Test Set): Two animal studies were conducted:
- Pilot Study: "To evaluate the safety and performance of chitosan hemostatic dressing in non- heparinized porcine hepatic resection model (48hr and 28 days non-GLP)" - Sample size is not explicitly stated, but it's a "pilot study."
- Pivotal Study: "Evaluation of Safety and Hemostatic Performance of the Ax-Surgi Chitosan Surgical Hemostat in a Liver Resection Model in Swine, 48 Hours and 28 Day." - Sample size is not explicitly stated.
Data Provenance: The animal studies were conducted in a porcine (swine) model. Information on the country of origin or whether the data was retrospective/prospective is not provided, although preclinical animal studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The studies are described as animal studies assessing physiological outcomes (hemostasis, inflammation, toxicity, adhesion), which would typically be assessed by veterinarians, pathologists, and researchers involved in the study, but the specific number and qualifications are not listed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document. The adjudication method for the preclinical animal studies is not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study involving human readers or AI assistance was not mentioned. The device is a surgical hemostat, not an imaging or diagnostic AI device. The comparison was to a "standard of care" in animal models.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This question is not applicable as the device is a physical hemostat, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the animal studies, the ground truth was established through direct observation of physiological outcomes (e.g., successful hemostasis, inflammation, adhesion formation, systemic/local toxicity) and histopathological examination of tissues over observation periods (48 hours and 28 days). This would align with pathology and direct outcomes data from the animal model.

8. The sample size for the training set:

This information is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set. The "training set" concept does not apply to the development and testing of this type of hemostat.

9. How the ground truth for the training set was established:

This information is not applicable, as explained in point 8.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG ADMINISTRATION' are written in blue.

Advamedica Inc. % Ainoa Forteza Vice Director Regulatory Consultant Alira Health Avinguda Josep Tarradellas, 123 (7th Floor), Barcelona, 08029 ESP

Re: K213198

Trade/Device Name: Ax-Surgi Surgical Hemostat Regulation Number: 21 CFR 878.4454 Regulation Name: Non-Absorbable, Hemostatic Gauze For Temporary Internal Use Regulatory Class: Class II Product Code: POD Dated: September 28, 2021 Received: September 29, 2021

Dear Ainoa Forteza:

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

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

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 and Part 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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 (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image shows the name "Deborah A. Fellhauer" in a clear, sans-serif font. Below the name, there is a "-S". The text is positioned against a background that includes a faded, light blue watermark of the letters "FDA".

Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

4. INDICATIONS FOR USE STATEMENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name Ax-Surgi Surgical Hemostat

Indications for Use (Describe)

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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

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."

FORM FDA 3881 (6/20)

Page 1 of 1

PSC Publishing Services (201)-443-6740

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

510(k) Summary K213198 Ax-Surgi Surgical Hemostat (per 21CFR 807.92)

Date: January 5, 2023

1. 510K APPLICANT / SUBMITTER

Advamedica Inc., Harvard Square, 1 Mifflin Place, Suite 400 Cambridge, MA 02138, USA Email: office(@advamedica.com Telephone: +1 973-718-7575

2. SUBMISSION CONTACT PERSON

Ainoa Forteza Alira Health Avinguda Josep Tarradellas, 123 (7th Floor) 08029 Barcelona, Spain Email: ainoa.forteza@alirahealth.com

3. DEVICE NAME

Proprietary Name: Ax-Surgi Surgical Hemostat Common/Usual Name: Temporary, internal use hemostat Classification Name: Non-absorbable hemostatic gauze for temporary internal use Device Classification: II Regulation Number: 21 CFR 878.4454 Product Code: POD

4. PREDICATE DEVICES

Primary Predicate- QuikClot Control+ Hemostatic Dressing - K200167 Reference Predicate - Axiostat Patch K202830

ട. DEVICE DESCRIPTION

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

The lyophilized chitosan pad component of Ax-Surgi Surgical Hemostat is identical in material, composition, manufacturing, and biocompatibility to the legally marketed Axiostat Patch K202830, except that it is attached to a viscose-polyester gauze with a radiopaque element. The viscose-polyester gauze backing provides greater wet strength to the chitosan pad and the radiopaque element allows for detection via X-ray.

INTENDED USE 6.

The Ax-Surgi Surgical Hemostat is indicated for temporary control of internal organ space bleeding for patients displaying class III or class IV bleeding. It may also be used for control of severely bleeding wounds such as surgical wounds and traumatic injuries.

7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Ax-Surgi Surgical Hemostat is substantially equivalent to the predicate device, QuikClot Control+ Hemostatic Dressing, with respect to device characteristics and intended use. Table 5-1 on the next page provides a comparison of the technological and design characteristics of the subject device to the predicate.

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

Table 5-1:Comparison with Predicate Devices

	Subject Device	Predicate Device	ReferenceDevice	Comparison
510(k) Number	K213198	K200167	K202830
Trade Name	Ax-Surgi Surgical Hemostat	QuikClot Control+Hemostatic Dressing	Axiostat Patch
Manufacturer	Advamedica Inc.	Z-Medica LLC	Advamedica, Inc.
Indicationsfor Use	The Ax-Surgi Surgical Hemostatis indicated for temporarycontrol of internal organ spacebleeding for patients displayingclass III or class IV bleeding. Itmay also be used for control ofseverely bleeding wounds suchas surgical wounds andas traumatic injuries.	QuikClot Control+ is indicatedfor temporary control ofinternal organ space bleedingfor patients displaying class IIIor class IV bleeding. It mayalso be used for control ofseverely bleeding wounds suchas surgical wounds andas traumatic injuries	The Axiostat Patch is intended for localmanagement of bleeding wounds and toprovide a barrier to bacterialpenetration of the dressing for patientsand for the rapid control of moderate tosevere bleeding. The dressing isindicated for the following wounds:lacerations, abrasions, surgicaldebridement sites, skin surfacepuncture sites, vascular procedure sitesand sites involving percutaneouscatheters, tubes and pins.	Same
ActiveMaterial	Chitosan	Kaolin	Chitosan	SimilarThe hemostatic agent in Ax-SurgiSurgical Hemostat uses chitosanwhile the hemostatic agent in thepredicate QuikClot Control+ deviceis kaolin.See Note 1.

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

DeviceDesign/Composition	Chitosan pad attached to arayon-polyester gauzebacking containing aradiopaque thread	Non-absorbable devicecontaining kaolin bound togauze. The dressing is x-raydetectable.	Chitosan pad	Similar, the difference is notexpected to raise any concerns interms of safety and effectiveness.See Note 2.
Non-absorbable	Yes	Yes	Yes	Same
X-raydetectable	Yes	Yes	No	Same
Mechanismof Action	Absorption of plasma by thechitosan pad, which results inphysical aggregation of bloodcells and clotting factors at thesite of application. In addition,when applied with pressure,Ax-Surgi Surgical Hemostatcreates a mechanical barrieragainst bleeding	Hemostasis is achievedthrough the activity of thehemostatic agent kaolinbound to the gauze inconjunction withcompression	Absorption of plasma by the chitosanpad, which results in physicalaggregation of blood cells and clottingfactors at the site of application. Inaddition, when applied with pressure,Axiostat Patch creates a mechanicalbarrier against bleeding	the difference is notSimilar,expected to raise any concerns interms of safety and effectiveness.See Note 3.
Sterilizationmethod	Gamma radiation	Gamma radiation	Gamma radiation	Same

Note 1:

Both chirosan and kaolin are non-abordable hemostals, the difference in the hemostate agent between the subject and procents no additional issues of safety or effectiveness.

Note 2:

Both the proposed and primary predicate devices are composed of material to be biocompatible and hemostatic. The use of chitosan in the proposed Ax-Surgical Hemostat device compared to kaolin-impregated gauze does not present any new issues of safety or effectiveness as evident from the extensive preclinical, bocompatibility, animal testing and proposed Ax-Surgi Surgical Hemostat and the reference device, Axiostal in design in that both pads are composed of 10% chiosan. The proposed Hemotat differs in that it is attached to a visoose-polyester gauze backing ontaining a radiopaque thread to support the revised indications for use. These are nocompatibility testing has been conducted the backing is safe for its intended use and that there are no new issues of safety.

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

Note 3:

Both Ax-Surgical Hemostat and the predicate Quilt Control+ Hemostato Dressing hemostasis by physical means through the activity of a hemostatic agent in compression. Both the proposed Ax-Surgi Surgical Hemostat and the predicate QuikClot Control + devices are to be used to apply pressure to an internal wound until bled. The hemostatic agent in Ax-Surgi Surgical Hemostations while the hemoratio agent in the predicate Quick Control+ device is kaoin. Both the proposed Ax-Surgical Hemosta and the Axiostal in that hey operate by absorpion of plasma by the chitosan pad, which results in physical aggregation of blood cells at the site of application. In addition, when applied with pressure, both devices create a mechanical barrier against bleeding.

Nor-clinical testing has been conducted the safety and performance of Ax-Surgi Surgical Hemostat. The results from all the testing conducted confirms that Ax-Surgical Hemostat is as safe and as effective as the predicate in its intended use and that it is substantially equivalent to the predicate and reference devices.

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

8. PERFORMANCE TESTING

Table 5-2 lists all of the testing that has been performed on Ax-Surgi Surgical Hemostat.

Testing	Results
Cytotoxicity	Non-cytotoxic
Sensitization	Non-sensitizing
Genotoxicity	Non-mutagenic
Acute Systemic Toxicity	Non-toxic
Implantation	Non-toxic
Pyrogenicity	Non-pyrogenic
Subacute Toxicity	Non-toxic
Intracutaneous Reactivity	Non-irritating
Hemolysis Test	Non-hemolytic
Animal Studies Pilot study on “To evaluate the safety and performance of chitosan hemostatic dressing in non- heparinized porcine hepatic resection model (48hr and 28 days non-GLP)” Pivotal study on "Evaluation of Safety and Hemostatic Performance of the Ax-Surgi Chitosan Surgical Hemostat in a Liver Resection Model in Swine, 48 Hours and 28 Day."	Ax-Surgi Surgical Hemostat achieved successful safety and performance assessment in a pilot non-GLP and a pivotal study conducted in porcine hepatic resection model. Both the pilot and pivotal animal studies demonstrated that the Ax-Surgi Surgical Hemostat was safe to be used as a hemostatic dressing for temporary internal use. During the pivotal study, Ax-Surgi Surgical Hemostat achieved successful hemostasis in a swine liver resection model displaying class III or class IV bleeding. The hemostatic performance and safety of Ax-Surgi Surgical Hemostat was compared with the standard of care as control group. This study evaluated inflammation, adhesion formation, systemic and local toxicity according to ISO 10993-06 and ISO 10993-11 and the local effect after implantation as compared to the predicate device. The preclinical studies demonstrated that the subject device is; Able to achieve hemostasis Can be radiographically detected Inflammation and adhesions associated with the device were as expected for this type of surgery (laparotomy and liver resection) and were substantially equivalent to the standard of care. No evidence of vascular obstruction or embolization The results of the study were satisfactory and met necessary safety end points as per special controls mentioned in Regulation no. 21 CFR 878.4454 and the study results support the substantial equivalence of the device

Table 5-2: Ax-Surgi Surgical Hemostat Testing

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

Moisture Content	Pass
Tensile Strength	Pass
Integrity	Pass
Radiopacity	Pass
In vitro Clot Assessment	Pass
Particulate Release	Pass
Absorbency	Pass
pH	Pass

9. STERILIZATION AND PACKAGING

Ax-Surgi Surgical Hemostat is provided sterile in a moisture proof packs. The product is terminally sterilized gamma sterilization to a sterility assurance level (SAL) of 10th. 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 18 months. The stability and effectiveness of packaging of the sterilized product during the shelf life was confirmed by real time study.

After a real time, aging period of 18 months, testing conducted demonstrates that Ax-Surgi Surgical Hemostat retains sterility, functionality, and its physical characteristics. The tests results demonstrate that Ax-Surgi Surgical Hemostat dressings stored for a period of 18 months are safe and effective for their intended use.

10. CONCLUSION

The subject device complies with special controls as identified in 21 CFR 878.4454 "Nonabsorbable, hemostatic gauze for temporary internal use". Based on the information provided in this 510(k) premarket notification, Advamedica Inc. concludes that Ax-Surgi Surgical Hemostat is substantially equivalent to the predicate device. QuikClot Control+ Hemostatic Dressing.

Regulation Number and Section

§ 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.

(a)
Identification. A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:
(i) Demonstrate that the device is able to achieve hemostasis;
(ii) Demonstrate that the device can be radiographically detected; and
(iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation.
(2) The device must be demonstrated to be biocompatible.
(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:
(i) In vitro clot assessment;
(ii) Particulate release testing;
(iii) Physical characterization, including swelling percent and particulate size;
(iv) Chemical characterization;
(v) Radiopacity testing; and
(vi) Mechanical integrity testing, including tensile strength and tear strength.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling must include the following:
(i) Instructions for use, including an instruction to remove all visible device components by irrigation;
(ii) The maximum amount of time the device may be left within the body;
(iii) A shelf life;
(iv) A contraindication for intravascular use of the device; and
(v) A warning regarding the potential for adhesion formation.