XSTAT 30, 1-Pack

• K Number: K180051
• Device Name: XSTAT 30, 1-Pack
• Manufacturer: RevMedx, Inc.
• Date Cleared: 2018-05-18 ( 130 days)
• Product Code: PGZ NAB
• Regulation Number: 878.4452

Intended Use

XSTAT 30 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 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents. XSTAT 30 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 or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes. XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the retroperitoneal space; the sacral space; tissues above the inguinal ligament; or tissues above the clavicle.

Device Description

The XSTAT 30 device consists of an applicator and plunger that facilitates delivery of minisponges to external bleeding wounds. Upon contact with blood, the minisponges absorb blood and, if unencumbered, can expand to a pre-compressed height of 40-50 mm within approximately 20 seconds. The applicator is a cylindrical body comprised of injection molded, medical grade polypropylene with an attached medical grade, phthalate-free PVC tip and an attached low density polyethylene (LDPE) end cap. The plunger is comprised of injection molded, 20% glass-filled polycarbonate and is used to deplov the minisponges from the applicator. One (1) applicator filled with ~ 108 minisponges and packaged with one (1) plunger in a vacuum-sealed nylon/poly pouch and terminally sterilized by gamma radiation to a sterility assurance level of 106. The XSTAT 30 device consists of vacuumsealed, gamma radiated, inner pouch, packaged inside a larger outer pouch as a one (1) pack configuration. Each outer pouch also contains one (1) casualty card and one (1) package insert. The Indications for Use, Instructions for Use (IFU) and UDI labels are affixed to the outer pouch, along with a UDI label on the inner pouch.

Predicate Devices

K170334

Reference Devices

Reference Device(s)

XSTAT 30 (DEN13006/K130218/K152624), XSTAT 12 (K161020)

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical components and physical properties of the device and its minisponges. There is no mention of AI, ML, image processing, or data-driven decision making.

Therapeutic

Yes
The device is described as a "hemostatic device for the control of severe, life-threatening bleeding," which directly addresses a medical condition, making it a therapeutic device.

Diagnostic

No

The XSTAT 30 is described as a hemostatic device used to control severe, life-threatening bleeding. Its function is to absorb blood and expand to apply pressure, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (applicator, plunger, minisponges) and mentions mechanical testing, indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
• XSTAT 30 Function: The XSTAT 30 is a hemostatic device designed to be inserted into a wound to control bleeding. It works by absorbing blood and expanding within the wound. This is an in vivo application, meaning it is used within the living body.
• Lack of Diagnostic Testing: The description of the XSTAT 30 does not mention any diagnostic testing of bodily fluids or tissues. Its purpose is purely therapeutic (controlling bleeding).

Therefore, based on the provided information, the XSTAT 30 is not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Extract the following key information from the FDA summary:

• Intended Use / Indications for Use
• Product codes (comma separated list FDA assigned to the subject device)
• Device Description
• Mentions image processing
• Mentions AI, DNN, or ML
• Input Imaging Modality
• Anatomical Site
• Indicated Patient Age Range
• Intended User / Care Setting
• Description of the training set, sample size, data source, and annotation protocol
• Description of the test set, sample size, data source, and annotation protocol
• Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
• Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
• 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.
• 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.
• 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).

Instructions:

• Quote the text exactly as it appears in the document unless you are converting to human readable text.
• If the exact text is not available, summarize and infer based on the provided content without adding external commentary.
• Do not include any additional analysis, opinions, or explanations.
• If the document does not contain the information, respond with 'Not Found'. Do not make up information.
• Output the response in markdown format. Do not include any other commentary or backticks.
• Convert math markup like mathrm to human readable text.

Example output:

Intended Use / Indications for Use

...

Device Description

...

Predetermined Change Control Plan (PCCP) - All Relevant Information

...

Input:
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 features an abstract design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in bold blue letters, with "ADMINISTRATION" written in smaller letters below.

May 18, 2018

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

Re: K180051

Trade/Device Name: XSTAT 30, 1-Pack Regulation Number: 21 CFR 878.4452 Regulation Name: Non-absorbable, Expandable, Hemostatic Sponge for Temporary Internal Use Regulatory Class: Class II Product Code: PGZ, NAB Dated: February 27, 2018 Received: March 1, 2018

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

2

VI. INDICATIONS FOR USE STATEMENT

The company's Indications for Use Statement for each XSTAT Device is provided below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.

510(k) Number (if known)	K180051
Device Name	XSTAT 30
Indications for Use (Describe)

XSTAT 30 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 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT 30 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 or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the retroperitoneal space; the sacral space; tissues above the inguinal ligament; or tissues above the clavicle.

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)

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 [e-mail]

"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."

PSC Publishing Services [phone] EF

3

510(k) SUMMARY RevMedx, Inc. XSTAT 30 (K180051)

Manufacturer Information:

RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville. OR 97070 Phone: [phone] Facsimile: 503-218-2274 Contact Person: Amy K. Pointer, Director of RA/QA Date Prepared: 12-15-2017

Trade/Proprietary Name:

XSTAT 30

Classification Name:

Non-Absorbable. Expandable. Hemostatic Sponge for Temporary Internal Use Non-absorbable, qauze/sponge for external use

Product Classification & Code:

Class II 21 CFR 878.4452, PGZ and 21 CFR 828.4014, NAB

Predicate Devices:

XSTAT 30 and XSTAT 12 (K170334)

Reference Clearances: XSTAT 30 (DEN13006/K130218/K152624) and XSTAT 12 (K161020)

Intended Use / Indications for Use:

Intended Use:

XSTAT 30 is intended for the control of bleeding from wounds in the groin or axilla that are not amenable to tourniquet application or narrow entrance extremity wounds in the arms or legs in adults and adolescents.

Indications for Use:

XSTAT 30 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 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT 30 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 or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space; tissues above the inguinal ligament; or tissues above the clavicle.

4

Device Description:

Description XSTAT 30:

The XSTAT 30 device consists of an applicator and plunger that facilitates delivery of minisponges to external bleeding wounds. Upon contact with blood, the minisponges absorb blood and, if unencumbered, can expand to a pre-compressed height of 40-50 mm within approximately 20 seconds.

The applicator is a cylindrical body comprised of injection molded, medical grade polypropylene with an attached medical grade, phthalate-free PVC tip and an attached low density polyethylene (LDPE) end cap. The plunger is comprised of injection molded, 20% glass-filled polycarbonate and is used to deplov the minisponges from the applicator. One (1) applicator filled with ~ 108 minisponges and packaged with one (1) plunger in a vacuum-sealed nylon/poly pouch and terminally sterilized by gamma radiation to a sterility assurance level of 106. The XSTAT 30 device consists of vacuumsealed, gamma radiated, inner pouch, packaged inside a larger outer pouch as a one (1) pack configuration. Each outer pouch also contains one (1) casualty card and one (1) package insert. The Indications for Use, Instructions for Use (IFU) and UDI labels are affixed to the outer pouch, along with a UDI label on the inner pouch.

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Bench Testing

Applicator

Mechanical testing was completed on the XSTAT 30 applicator to verify the performance of the XSTAT 30 applicator design.

The following mechanical tests were performed and demonstrated the performance of the XSTAT 30 applicator and device:

• Deployment Force Testing o
• Plunger Axial Force Testing o
• Tip Tensile Strength Testing O
• Fluid Immersion Testing o

Minisponges

The XSTAT 30 minisponges are identical to the predicate devices. 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 devices (K170334). The testing provided in the cleared XSTAT 30 and XSTAT 12 notification (K170334) is incorporated herein by reference.

Biocompatibility Testing

The biocompatibility of the XSTAT 30 device was demonstrated per ISO 10993.

• Cytotoxicity (ISO 10993-5) o
• Sensitization (ISO 10993-10) o
• Irritation (ISO 10993-10) O
• Acute System Toxicity (ISO 10993-11) o
• o Hemocompatibility (ISO 10993-4)
• Materials-Mediated Pyrogenicity O

5

The XSTAT 30 minisponges are identical to the predicate devices. Thus, the biocompatibility testing per 21 CFR 878.4452 of the XSTAT 30 minisponges has been demonstrated per ISO 10993 by the premarket clearance of the Predicate XSTAT 30 and XSTAT 12 devices (K170334). The testing provided in the cleared XSTAT 30 and XSTAT 12 notification (K170334) is incorporated herein by reference.

Animal Study

The XSTAT 30 minisponges are identical to the predicate devices. Thus, the animal performance testing of the XSTAT 30 device (as per 21 CFR 878.4452) has been demonstrated by the premarket clearance of the predicate devices (K170334). The testing provided in the cleared XSTAT 30 and XSTAT 12 notification (K170334) is incorporated herein by reference.

Substantial Equivalence

XSTAT 30 has the same intended use and indications for use, same principles of operation and similar technological characteristics. The differences between the subject device and the predicate devices do not present any new issues of safety or effectiveness because bench testing, biocompatibility testing and pre-clinical animal studies have shown that the XSTAT 30 is substantially equivalent to the predicate devices.

Conclusions

The XSTAT 30 device is substantially equivalent to the predicate devices. The XSTAT 30 has the same intended use and indications for use, same principles of operation and similar technological characteristics. The Substantial Equivalence Summary tables below details and compares the XSTAT 30 to the predicate XSTAT devices.

6

Substantial Equivalence Summary Table – XSTAT 30

| | Characteristic | New: XSTAT 30 | Predicate: XSTAT 30 and XSTAT 12
(K170334) |
|--|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended Use | XSTAT 30 is intended for the control of
bleeding from wounds in the groin or axilla
that are not amenable to tourniquet
application and narrow entrance extremity
wounds in the arms or legs in adults and
adolescents. | XSTAT is intended for the control of
bleeding from wounds in the groin or axilla
that are not amenable to tourniquet
application and narrow entrance extremityadolescents. |
| | Indications for Use | XSTAT 30 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 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 30 is a hemostatic device for the
control of severe, life-threatening bleeding
from extremity wounds in the arms or legs in
adults and adolescents. | XSTAT is a hemostatic device for the control
of severe, life-threatening bleeding from
extremity wounds in the arms or legs in
adults and adolescents. |
| | | XSTAT 30 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 or narrow entrance
extremity wounds, and when definitive care
at an emergency care facility cannot be
achieved within minutes. | XSTAT 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 or narrow entrance
extremity wounds, and when definitive care
at an emergency care facility cannot be
achieved within minutes. |
| | | XSTAT 30 is NOT indicated for use in: the
thorax; the pleural cavity; the mediastinum;
the abdomen; the retroperitoneal space, the
sacral space; tissues above the inguinal
ligament; or tissues above the clavicle. | XSTAT is NOT indicated for use in: the
thorax; the pleural cavity; the mediastinum;
the abdomen; the retroperitoneal space, the
sacral space; tissues above the inguinal
ligament; or tissues above the clavicle. |
| | User Population | Civilian and battlefield patients
Adults and Adolescents | Civilian and Battlefield patients
Adults and Adolescents |
| | Technological
Characteristics | 1. Minisponges
2. Applicator
3. Casualty Card
4. Packaging | 1. Minisponges
2. Applicator
3. Casualty Card
4. Packaging |
| | Dimensions (I x w
x h) | 1-Pack: 295mm x 180mm x 35mm | 3-Pack: 254mm x 165mm x 38mm
1-Pack: 254mm x 165mm x 38mm |
| | Weight | 1-Pack: 0.11kg | 3- Pack: 0.25kg
1-Pack: 0.1kg |
| | Safety Features | Radiopaque marker laminated to sponge
with medical grade low-density polyethylene
film | Radiopaque marker laminated to sponge
with medical grade low-density polyethylene
film |
| | Biocompatibility | Cytotoxicity (ISO 10993-5);
Sensitization (ISO 10993-10);
Irritation (ISO 10993-10);
Acute systemic toxicity (ISO 10993-11); and
Hemocompatibility (ISO 10993-4)
Materials-Mediated Pyrogenicity | Cytotoxicity (ISO 10993-5);
Sensitization (ISO 10993-10);
Irritation (ISO 10993-10);
Acute systemic toxicity (ISO 10993-11); and
Hemocompatibility (ISO 10993-4)
Materials-Mediated Pyrogenicity |

Intended Use / Indications for Use

Intended Use:
XSTAT 30 is intended for the control of bleeding from wounds in the groin or axilla that are not amenable to tourniquet application or narrow entrance extremity wounds in the arms or legs in adults and adolescents.

Indications for Use:
XSTAT 30 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 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT 30 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 or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space; tissues above the inguinal ligament; or tissues above the clavicle.

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

PGZ, NAB

Device Description

The XSTAT 30 device consists of an applicator and plunger that facilitates delivery of minisponges to external bleeding wounds. Upon contact with blood, the minisponges absorb blood and, if unencumbered, can expand to a pre-compressed height of 40-50 mm within approximately 20 seconds.

The applicator is a cylindrical body comprised of injection molded, medical grade polypropylene with an attached medical grade, phthalate-free PVC tip and an attached low density polyethylene (LDPE) end cap. The plunger is comprised of injection molded, 20% glass-filled polycarbonate and is used to deplov the minisponges from the applicator. One (1) applicator filled with ~ 108 minisponges and packaged with one (1) plunger in a vacuum-sealed nylon/poly pouch and terminally sterilized by gamma radiation to a sterility assurance level of 106. The XSTAT 30 device consists of vacuumsealed, gamma radiated, inner pouch, packaged inside a larger outer pouch as a one (1) pack configuration. Each outer pouch also contains one (1) casualty card and one (1) package insert. The Indications for Use, Instructions for Use (IFU) and UDI labels are affixed to the outer pouch, along with a UDI label on the inner pouch.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

junctional wounds in the groin or axilla, narrow entrance extremity wounds in the arms or legs

Indicated Patient Age Range

adults and adolescents

Intended User / Care Setting

Not Found

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

Not Found

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)

Bench Testing
Mechanical testing was completed on the XSTAT 30 applicator to verify the performance of the XSTAT 30 applicator design.
The following mechanical tests were performed and demonstrated the performance of the XSTAT 30 applicator and device:

• Deployment Force Testing o
• Plunger Axial Force Testing o
• Tip Tensile Strength Testing O
• Fluid Immersion Testing o

The XSTAT 30 minisponges are identical to the predicate devices. 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 devices (K170334). The testing provided in the cleared XSTAT 30 and XSTAT 12 notification (K170334) is incorporated herein by reference.

Biocompatibility Testing
The biocompatibility of the XSTAT 30 device was demonstrated per ISO 10993.

• Cytotoxicity (ISO 10993-5) o
• Sensitization (ISO 10993-10) o
• Irritation (ISO 10993-10) O
• Acute System Toxicity (ISO 10993-11) o
• o Hemocompatibility (ISO 10993-4)
• Materials-Mediated Pyrogenicity O

The XSTAT 30 minisponges are identical to the predicate devices. Thus, the biocompatibility testing per 21 CFR 878.4452 of the XSTAT 30 minisponges has been demonstrated per ISO 10993 by the premarket clearance of the Predicate XSTAT 30 and XSTAT 12 devices (K170334). The testing provided in the cleared XSTAT 30 and XSTAT 12 notification (K170334) is incorporated herein by reference.

Animal Study
The XSTAT 30 minisponges are identical to the predicate devices. Thus, the animal performance testing of the XSTAT 30 device (as per 21 CFR 878.4452) has been demonstrated by the premarket clearance of the predicate devices (K170334). The testing provided in the cleared XSTAT 30 and XSTAT 12 notification (K170334) is incorporated herein by reference.

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.

XSTAT 30 and XSTAT 12 (K170334)

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.

XSTAT 30 (DEN13006/K130218/K152624), XSTAT 12 (K161020)

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

§ 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.

Summary

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 features an abstract design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in bold blue letters, with "ADMINISTRATION" written in smaller letters below.

May 18, 2018

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

Re: K180051

Trade/Device Name: XSTAT 30, 1-Pack Regulation Number: 21 CFR 878.4452 Regulation Name: Non-absorbable, Expandable, Hemostatic Sponge for Temporary Internal Use Regulatory Class: Class II Product Code: PGZ, NAB Dated: February 27, 2018 Received: March 1, 2018

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

2

VI. INDICATIONS FOR USE STATEMENT

The company's Indications for Use Statement for each XSTAT Device is provided below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.

510(k) Number (if known)	K180051
Device Name	XSTAT 30
Indications for Use (Describe)

XSTAT 30 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 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT 30 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 or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the retroperitoneal space; the sacral space; tissues above the inguinal ligament; or tissues above the clavicle.

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)

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 [e-mail]

"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."

PSC Publishing Services [phone] EF

3

510(k) SUMMARY RevMedx, Inc. XSTAT 30 (K180051)

Manufacturer Information:

RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville. OR 97070 Phone: [phone] Facsimile: 503-218-2274 Contact Person: Amy K. Pointer, Director of RA/QA Date Prepared: 12-15-2017

Trade/Proprietary Name:

XSTAT 30

Classification Name:

Non-Absorbable. Expandable. Hemostatic Sponge for Temporary Internal Use Non-absorbable, qauze/sponge for external use

Product Classification & Code:

Class II 21 CFR 878.4452, PGZ and 21 CFR 828.4014, NAB

Predicate Devices:

XSTAT 30 and XSTAT 12 (K170334)

Reference Clearances: XSTAT 30 (DEN13006/K130218/K152624) and XSTAT 12 (K161020)

Intended Use / Indications for Use:

Intended Use:

XSTAT 30 is intended for the control of bleeding from wounds in the groin or axilla that are not amenable to tourniquet application or narrow entrance extremity wounds in the arms or legs in adults and adolescents.

Indications for Use:

XSTAT 30 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 30 is a hemostatic device for the control of severe, life-threatening bleeding from narrow entrance extremity wounds in the arms or legs in adults and adolescents.

XSTAT 30 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 or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space; tissues above the inguinal ligament; or tissues above the clavicle.

4

Device Description:

Description XSTAT 30:

The XSTAT 30 device consists of an applicator and plunger that facilitates delivery of minisponges to external bleeding wounds. Upon contact with blood, the minisponges absorb blood and, if unencumbered, can expand to a pre-compressed height of 40-50 mm within approximately 20 seconds.

The applicator is a cylindrical body comprised of injection molded, medical grade polypropylene with an attached medical grade, phthalate-free PVC tip and an attached low density polyethylene (LDPE) end cap. The plunger is comprised of injection molded, 20% glass-filled polycarbonate and is used to deplov the minisponges from the applicator. One (1) applicator filled with ~ 108 minisponges and packaged with one (1) plunger in a vacuum-sealed nylon/poly pouch and terminally sterilized by gamma radiation to a sterility assurance level of 106. The XSTAT 30 device consists of vacuumsealed, gamma radiated, inner pouch, packaged inside a larger outer pouch as a one (1) pack configuration. Each outer pouch also contains one (1) casualty card and one (1) package insert. The Indications for Use, Instructions for Use (IFU) and UDI labels are affixed to the outer pouch, along with a UDI label on the inner pouch.

Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Bench Testing

Applicator

Mechanical testing was completed on the XSTAT 30 applicator to verify the performance of the XSTAT 30 applicator design.

The following mechanical tests were performed and demonstrated the performance of the XSTAT 30 applicator and device:

• Deployment Force Testing o
• Plunger Axial Force Testing o
• Tip Tensile Strength Testing O
• Fluid Immersion Testing o

Minisponges

The XSTAT 30 minisponges are identical to the predicate devices. 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 devices (K170334). The testing provided in the cleared XSTAT 30 and XSTAT 12 notification (K170334) is incorporated herein by reference.

Biocompatibility Testing

The biocompatibility of the XSTAT 30 device was demonstrated per ISO 10993.

• Cytotoxicity (ISO 10993-5) o
• Sensitization (ISO 10993-10) o
• Irritation (ISO 10993-10) O
• Acute System Toxicity (ISO 10993-11) o
• o Hemocompatibility (ISO 10993-4)
• Materials-Mediated Pyrogenicity O

5

The XSTAT 30 minisponges are identical to the predicate devices. Thus, the biocompatibility testing per 21 CFR 878.4452 of the XSTAT 30 minisponges has been demonstrated per ISO 10993 by the premarket clearance of the Predicate XSTAT 30 and XSTAT 12 devices (K170334). The testing provided in the cleared XSTAT 30 and XSTAT 12 notification (K170334) is incorporated herein by reference.

Animal Study

The XSTAT 30 minisponges are identical to the predicate devices. Thus, the animal performance testing of the XSTAT 30 device (as per 21 CFR 878.4452) has been demonstrated by the premarket clearance of the predicate devices (K170334). The testing provided in the cleared XSTAT 30 and XSTAT 12 notification (K170334) is incorporated herein by reference.

Substantial Equivalence

XSTAT 30 has the same intended use and indications for use, same principles of operation and similar technological characteristics. The differences between the subject device and the predicate devices do not present any new issues of safety or effectiveness because bench testing, biocompatibility testing and pre-clinical animal studies have shown that the XSTAT 30 is substantially equivalent to the predicate devices.

Conclusions

The XSTAT 30 device is substantially equivalent to the predicate devices. The XSTAT 30 has the same intended use and indications for use, same principles of operation and similar technological characteristics. The Substantial Equivalence Summary tables below details and compares the XSTAT 30 to the predicate XSTAT devices.

6

Substantial Equivalence Summary Table – XSTAT 30

| | Characteristic | New: XSTAT 30 | Predicate: XSTAT 30 and XSTAT 12
(K170334) |
|--|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended Use | XSTAT 30 is intended for the control of
bleeding from wounds in the groin or axilla
that are not amenable to tourniquet
application and narrow entrance extremity
wounds in the arms or legs in adults and
adolescents. | XSTAT is intended for the control of
bleeding from wounds in the groin or axilla
that are not amenable to tourniquet
application and narrow entrance extremityadolescents. |
| | Indications for Use | XSTAT 30 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 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 30 is a hemostatic device for the
control of severe, life-threatening bleeding
from extremity wounds in the arms or legs in
adults and adolescents. | XSTAT is a hemostatic device for the control
of severe, life-threatening bleeding from
extremity wounds in the arms or legs in
adults and adolescents. |
| | | XSTAT 30 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 or narrow entrance
extremity wounds, and when definitive care
at an emergency care facility cannot be
achieved within minutes. | XSTAT 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 or narrow entrance
extremity wounds, and when definitive care
at an emergency care facility cannot be
achieved within minutes. |
| | | XSTAT 30 is NOT indicated for use in: the
thorax; the pleural cavity; the mediastinum;
the abdomen; the retroperitoneal space, the
sacral space; tissues above the inguinal
ligament; or tissues above the clavicle. | XSTAT is NOT indicated for use in: the
thorax; the pleural cavity; the mediastinum;
the abdomen; the retroperitoneal space, the
sacral space; tissues above the inguinal
ligament; or tissues above the clavicle. |
| | User Population | Civilian and battlefield patients
Adults and Adolescents | Civilian and Battlefield patients
Adults and Adolescents |
| | Technological
Characteristics | 1. Minisponges
2. Applicator
3. Casualty Card
4. Packaging | 1. Minisponges
2. Applicator
3. Casualty Card
4. Packaging |
| | Dimensions (I x w
x h) | 1-Pack: 295mm x 180mm x 35mm | 3-Pack: 254mm x 165mm x 38mm
1-Pack: 254mm x 165mm x 38mm |
| | Weight | 1-Pack: 0.11kg | 3- Pack: 0.25kg
1-Pack: 0.1kg |
| | Safety Features | Radiopaque marker laminated to sponge
with medical grade low-density polyethylene
film | Radiopaque marker laminated to sponge
with medical grade low-density polyethylene
film |
| | Biocompatibility | Cytotoxicity (ISO 10993-5);
Sensitization (ISO 10993-10);
Irritation (ISO 10993-10);
Acute systemic toxicity (ISO 10993-11); and
Hemocompatibility (ISO 10993-4)
Materials-Mediated Pyrogenicity | Cytotoxicity (ISO 10993-5);
Sensitization (ISO 10993-10);
Irritation (ISO 10993-10);
Acute systemic toxicity (ISO 10993-11); and
Hemocompatibility (ISO 10993-4)
Materials-Mediated Pyrogenicity |