Intended Use:
The XSTAT-12 is intended for the control of bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.

Indications for Use:
XSTAT-12 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents.

XSTAT-12 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT-12 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inquinal ligament; or tissues above the clavicle.

Device Description

The XSTAT-12 dressing is composed of a standard, regenerated cellulose medical sponge that is compressed and formed into a group of approximately 38 minisponges. Each minisponge has a height of 4-5 mm and a circular surface diameter of 9.8 mm. The minisponges absorb blood upon contact, and within approximately 20 seconds expand to their pre-compressed height of 40-50 mm. The minisponges expand only in length, not radially. Each minisponge absorbs approximately 3 mL of blood. Each minisponge contains a radiopaque marker for easy detection via X-ray. The XSTAT-12 dressing includes an applicator and plunger that facilitate delivery of the minisponges to external bleeding wounds. Individual applicators are filled with the STAT-12 minisponges and are packaged in a vacuum-sealed foil pouch with one (1) plunger, terminally sterilized by gamma radiation to a sterility assurance level of 10°. The inner pouches are then packaged inside a larger outer pouch, along with one (1) casualty card and one (1) package insert. The Instructions for Use (IFU) are affixed to the outer pouch.

For the treatment of severe. life-threatening bleeding from pelvis or shoulder wounds not amenable to tourniquet application, the XSTAT-12 sponges are applied to the applicator. Once applied to the wound, the XSTAT-12 sponges absorb blood and expand, thereby packing the wound. All minisponges must be removed from wounds before surgical repair and closure of the wounds. Following removal of the minisponges and definitive surgical repair of the wound, a radiograph is required prior to wound closure to confirm that every minisponge has been removed.

AI/ML Overview

The acceptance criteria and study proving the device meets them are summarized below.

1. Table of Acceptance Criteria & Reported Device Performance:

Category	Acceptance Criteria (from predicate K152624 & DEN130016/K130218, 21 CFR 878.4452)	XSTAT-12 Reported Performance (via reference to predicate)
Mechanical Testing	Specific mechanical criteria for deployment force, plunger axial force, tip tensile strength, fluid immersion, and wound volume for the applicator (not explicitly detailed in provided text, but implied as standards met by predicate).	Applicator: Demonstrated safety and efficacy through Deployment Force Testing, Plunger Axial Force Testing, Tip Tensile Strength Testing, Fluid Immersion Testing, and Wound Volume Testing. Minisponges: Demonstrated through predicate (K152624) for radiopacity, immunogenicity, absorption capacity, extent of swelling, expansion force/pressure, and viral inactivation.
Biocompatibility	Biocompatibility in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1 for external communicating, limited duration (≤ 24 hour) devices with potential for tissue/bone contact and indirect blood contact (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Hemocompatibility).	Applicator: Demonstrated biocompatibility per ISO 10993 for external communicating, limited duration (≤ 24 hour), blood-contacting devices through Cytotoxicity, Sensitization, Irritation, System Toxicity, and Hemocompatibility tests. Minisponges: Demonstrated through predicate (K152624) via ISO 10993 tests (Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, Hemocompatibility).
Animal Study	Performance in animal studies for hemostatic efficacy (exact criteria not detailed, but demonstrated by predicate).	Demonstrated through predicate (K152624) for hemostatic efficacy.
Sterilization	Gamma radiation to a sterility assurance level of 10⁻⁶.	Gamma radiation to a sterility assurance level of 10⁻⁶.
Safety Features	Radiopaque marker for easy detection via X-ray.	Each minisponge contains a radiopaque marker for easy detection via X-ray.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes for the "test set" for the XSTAT-12 device. Instead, it relies heavily on equivalence to a previously cleared predicate device (XSTAT 30, K152624, and reference device DEN130016/K130218).

Mechanical Testing: Performed on the XSTAT-12 applicator in expected use scenarios and extreme temperature conditions. No specific sample counts for each test are provided.
Biocompatibility Testing: The battery of tests for the XSTAT-12 applicator included Cytotoxicity, Sensitization, Irritation, System Toxicity, and Hemocompatibility. Specific sample sizes for these tests are not provided.
Minisponges & Animal Study: The XSTAT-12 minisponges are stated to be identical to the predicate device. Therefore, the testing and data provenance for these aspects are implicitly derived from the predicate's clearance. The original provenance for the predicate data is not detailed in this document.

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. The studies mentioned (mechanical, biocompatibility) appear to be conducted specifically for this device and its predicate.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

This information is not provided in the document. The studies primarily involve mechanical and biological testing, rather than human expert interpretation of medical images or conditions for establishing ground truth.

4. Adjudication Method:

This information is not provided. As the studies are primarily about device performance in mechanical and biological contexts, an adjudication method for human interpretation is not applicable here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through engineering, mechanical, and biological performance data. There is no mention of human readers, AI assistance, or comparative effectiveness with or without AI.

6. Standalone (Algorithm Only) Performance:

Not applicable. The XSTAT-12 is a physical medical device (hemostatic sponges and applicator), not an algorithm or AI. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

The "ground truth" for the device's performance is established through:

Mechanical performance standards: Demonstrating the applicator functions as intended under various conditions.
Biocompatibility standards: Proving the materials are safe for biological contact.
Material properties: Verifying the minisponges (identical to predicate) meet specifications for radiopacity, absorption, expansion, etc.
Animal study results: (from predicate) demonstrating hemostatic efficacy.

This is primarily empirical evidence against pre-defined physical and biological criteria, rather than expert consensus, pathology, or outcomes data in the typical sense of AI/imaging studies.

8. Sample Size for the Training Set:

Not applicable. This device is hardware (sponges and applicator), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As the device is not an AI algorithm, there is no training set or ground truth in that context.

Summary

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

July 28, 2016

RevMedx, Inc. Ms. Amy K. Pointer Director of RA/OA 25999 SW Canyon Creek Road Suite C Wilsonville, Oregon 97070

Re: K161020 Trade/Device Name: XSTAT-12, 3-pack, XSTAT-12, 1-pack Regulation Number: 21 CFR 878.4452 Regulation Name: Non-Absorbable, Exapandable, Hemostatic Sponge For Temporary Internal Use Regulatory Class: Class II Product Code: PGZ Dated: June 23, 2016 Received: June 27, 2016

Dear Ms. Pointer:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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/ResourcesforYou/Industry/default.htm. 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

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

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K161020

Device Name

XSTAT-12

Indications for Use (Describe)

XSTAT-12 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.

XSTAT-12 is a temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT-12 is NOT indicated for use in the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space, the sacral space above the inguinal ligament; or tissues above the clavicle.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY RevMedx, Inc. XSTAT-12

Manufacturer Information:

RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville. OR 97070 Phone: 503-218-2172 Facsimile: 503-218-2274 Contact Person: Amy K. Pointer, RA/QA Manager Date Prepared: 04/06/2016

Trade/Proprietary Name: XSTAT-12

Classification Name: Non-Absorbable, Expandable, Hemostatic Sponge for Temporary Internal Use

Product Classification & Code: 21 CFR 878.4452; PGZ, Class II

Predicate Devices:

XSTAT 30 (K152624)

Reference Device: XSTAT (DEN130016/K130218)

Intended Use / Indications for Use:

Intended Use:

The XSTAT-12 is intended for the control of bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.

Indications for Use:

XSTAT-12 is a hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application in adults and adolescents.

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Device Description

Performance Data

The following performance data were provided in support of the substantial equivalence determination and as required per 21 CFR 878.4452.

Mechanical Testing

Mechanical testing was completed on the XSTAT-12 applicator to verify the safety and efficacy of the XSTAT-12 applicator design when used in expected use scenarios, as well as in extreme temperature conditions.

The following mechanical tests were performed and demonstrated the safety and efficacy of the XSTAT-12 applicator and device:

Deployment Force Testing o
Plunger Axial Force Testing o
Tip Tensile Strenath Testing o
Fluid Immersion Testing O
Wound Volume Testing O

The STAT-12 minisponges are identical to the predicate device. Thus the testing defined in the Special Controls (as per 21 CFR 878.4452) related to minisponges (radiopacity, immunogenicity, absorption capacity, extent of swelling, expansion force/pressure and viral inactivation testing for animal-derived materials) has been demonstrated by the premarket clearance of the predicate device (K152624 and reference device DEN130016/K130218). The testing provided in the cleared XSTAT 30 notification (K152624) is incorporated herein by reference.

Biocompatibility Testing

The biocompatibility evaluation for the XSTAT-12 device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993. 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The XSTAT-12 is an external communicating, limited duration (≤ 24 hour) contact device with potential for contact with tissue and/or bone, and indirect contact with circulating blood.

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The battery of testing included the following tests:

Cytotoxicity O
o Sensitization
Irritation o
System Toxicity o
Hemocompatibilitv O

The biocompatibility of the XSTAT-12 applicator was demonstrated per ISO 10993 for external communicating, limited duration (≤ 24 hour), blood-contacting devices.

The XSTAT-12 minisponges are identical to the predicate device. Thus the biocompatibility testing (as per 21 CFR 878.4452) of the XSTAT-12 minisponges has been demonstrated per ISO 10993 by the premarket clearance of the predicate device (K152624. reference device DEN130016/K130218). The testing provided in the cleared XSTAT 30 notification (K152624) is incorporated herein by reference.

Animal Study

The XSTAT-12 minisponges are identical to the predicate device. Thus the animal performance testing of the XSTAT-12 (as per 21 CFR 878.4452) has been demonstrated by the premarket clearance of the predicate device (K152624, reference device DEN130016/K130218). The testing provided in the cleared XSTAT 30 notification (K152624) is incorporated herein by reference.

Substantial Equivalence

The XSTAT-12 is as safe and effective as the XSTAT-12 and XSTAT-12 and XSTAT 30 have the same intended use and indications for use, similar principles of operation and similar technological characteristics. There are no differences to the minisponges used in XSTAT-12 as compared to XSTAT 30, with the quantity of sponges per applicator being the only difference. The differences between the XSTAT-12 and XSTAT 30 predicate device do not present any new issues of safety or effectiveness because the use of a smaller applicator design with fewer minisponges raises the same questions of safety and effectiveness as the predicate device. The minor differences in the applicator are based upon a similar, svringe-like design to aid in the delivery of the XSTAT minisponges to the wound, but with a smaller diameter to allow XSTAT minisponges to be used in smaller diameter wounds. Thus, the XSTAT-12 is substantially equivalent to the XSTAT 30.

Conclusions

The XSTAT-12 is as safe and effective as the predicate XSTAT 30 device. The intended use and indications for use are the same for both XSTAT-12 and XSTAT 30, with similar principles of operation and similar technological characteristics. The Substantial Equivalence Summary table below details and compares the XSTAT-12 to the XSTAT 30.

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Characteristic	XSTAT-12 - New	XSTAT 30 - Predicate(K152624)
Intended Use	XSTAT-12 is intended for the controlof bleeding from wounds in the groinor axilla that are not amenable totourniquet application in adults andadolescents.	XSTAT 30 is intended for the controlof bleeding from wounds in the groinor axilla that are not amenable totourniquet application in adults andadolescents.
Indications for Use	XSTAT-12 is a hemostatic device forthe control of severe, life-threateningbleeding from junctional wounds inthe groin or axilla not amenable totourniquet application in adults andadolescents.XSTAT-12 is a temporary device foruse up to four (4) hours until surgicalcare is acquired. It should only beused for patients at high risk forimmediate life-threatening bleedingfrom, hemodynamically significant(Advanced Trauma Life Supportclass 3 or 4 hemorrhagic shock),non-compressible junctionalwounds, and when definitive care atan emergency care facility cannot beachieved within minutes.XSTAT-12 is NOT indicated for usein: the thorax; the pleural cavity; themediastinum; the abdomen; theretroperitoneal space, the sacralspace above the inguinal ligament;or tissues above the clavicle.	XSTAT 30 is a hemostatic device forthe control of severe, life-threateningbleeding from junctional wounds inthe groin or axilla not amenable totourniquet application in adults andadolescents.XSTAT 30 is a temporary device foruse up to four (4) hours until surgicalcare is acquired. It should only beused for patients at high risk forimmediate life-threatening bleedingfrom, hemodynamically significant(Advanced Trauma Life Supportclass 3 or 4 hemorrhagic shock),non-compressible junctional wounds,and when definitive care at anemergency care facility cannot beachieved within minutes.XSTAT 30 NOT indicated for use in:the thorax; the pleural cavity; themediastinum; the abdomen; theretroperitoneal space, the sacralspace above the inguinal ligament;or tissues above the clavicle.
User Population	Civilian and battlefield patients	Civilian and Battlefield patients
TechnologicalCharacteristics	1. Minisponges2. Applicator3. Insert/Casualty Card4. Packaging	1. Minisponges2. Applicator3. Insert/Casualty Card4. Packaging
Dimensions (l x w x h)	3-Pack: 292mm x 171mm x 19mm1-Pack: 292mm x 171mm x 19mm	3-Pack: 254mm x 165mm x 38mm1-Pack: 254mm x 165mm x 38mm
Weight	3- Pack: 0.123kg1-Pack: 0.055kg	3- Pack: 0.25kg1-Pack: 0.1kg
Safety Features	Radiopaque marker	Radiopaque marker
Biocompatibility	Cytotoxicity (ISO 10993-5);Sensitization (ISO 10993-10);Irritation (ISO 10993-10);Acute systemic toxicity (ISO 10993-11); andHemocompatibility (ISO 10993-4)	Cytotoxicity (ISO 10993-5);Sensitization (ISO 10993-10);Irritation (ISO 10993-10);Acute systemic toxicity (ISO 10993-11); andHemocompatibility (ISO 10993-4)
Sterilization	Gamma radiation sterilization	Gamma radiation sterilization

Substantial Equivalence Summary Table

Regulation Number and Section

§ 878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use.

(a)
Identification. A nonabsorbable expandable hemostatic sponge for temporary internal use is a prescription device intended to be placed temporarily into junctional, non-compressible wounds, which are not amenable to tourniquet use, to control bleeding until surgical care is acquired. The sponges expand upon contact with blood to fill the wound cavity and provide a physical barrier and pressure that facilitates formation of a clot. The device consists of sterile, nonabsorbable radiopaque compressed sponges and may include an applicator to facilitate delivery into a wound.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance data must demonstrate the biocompatibility of patient-contacting components.
(2) Performance data must demonstrate the sterility of patient-contacting components including endotoxin and pyrogenicity assessments.
(3) Performance data must support device stability by demonstrating continued sterility of the patient-contacting components of the device, package integrity, and device functionality over the requested shelf life.
(4) Assessment of material characteristics must be sufficient to support safety under anticipated conditions of use. Assessments must include the following:
(i) Material specifications.
(ii) Immunogenicity.
(iii) Viral inactivation for animal-derived materials.
(5) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Absorption capacity.
(ii) Extent of swelling.
(iii) Mechanical properties.
(iv) Expansion force/pressure.
(v) Radiopacity.
(vi) Deployment/applicator functionality.
(6) In vivo performance data must demonstrate safe and effective use by verifying that the device performs as intended under anticipated conditions of use. Appropriate analysis/testing must demonstrate that the product: Controls bleeding, does not promote adverse local or systemic effects, and can be completely removed from the wound. The following performance characteristics must be tested:
(i) Deployment.
(ii) Control of bleeding.
(iii) Radiopacity.
(iv) Retrieval.
(v) Assessment of local and systemic effects.
(7) Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by emergency responders deploying the device as well as surgeons retrieving the device from wounds.
(8) Labeling must include:
(i) Specific instructions for deployment by emergency responders and retrieval by surgeons.
(ii) Warnings, cautions, and limitations needed for safe use of the device.
(iii) Information on how the device operates and the typical course of treatment.
(iv) A detailed summary of the in vivo and human factors testing pertinent to use of the device.
(v) Appropriate imaging information to ensure complete retrieval of device.
(vi) An expiration date/shelf life.