XSTAT 30, 1-Pack

K180051 · Revmedx, Inc. · PGZ · May 18, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180051
• Device Name: XSTAT 30, 1-Pack
• Applicant: Revmedx, Inc.
• Product Code: PGZ · General, Plastic Surgery
• Decision Date: May 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4452
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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.

Device Story

XSTAT 30 is a hemostatic device for emergency trauma care; used in pre-hospital or battlefield settings to control severe, life-threatening hemorrhage. Device consists of a handheld applicator containing ~108 compressed minisponges. Upon deployment into a wound, minisponges absorb blood and expand (40-50 mm) within ~20 seconds to provide mechanical pressure and hemostasis. Operated by trained personnel; provides temporary stabilization for up to 4 hours until surgical care is acquired. Benefits include rapid control of non-compressible junctional or extremity bleeding where tourniquets are ineffective, potentially reducing mortality in high-risk hemorrhagic shock patients.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing (deployment force, axial force, tensile strength, fluid immersion) and biocompatibility testing (ISO 10993-4, 5, 10, 11). Animal performance data and minisponges characteristics are identical to predicate devices and incorporated by reference from K170334.

Technological Characteristics

Applicator: injection-molded medical-grade polypropylene, phthalate-free PVC tip, LDPE end cap. Plunger: 20% glass-filled polycarbonate. Minisponges: compressed, expandable, radiopaque-marked. Sterilization: gamma radiation (SAL 10^-6). Packaging: vacuum-sealed nylon/poly pouch. Connectivity: none.

Indications for Use

Indicated for adults and adolescents with severe, life-threatening bleeding from junctional wounds (groin/axilla) not amenable to tourniquet or narrow entrance extremity wounds. Temporary use (up to 4 hours) for patients at high risk for immediate life-threatening bleeding from hemodynamically significant (ATLS class 3 or 4) non-compressible wounds when definitive care is not immediately available. Contraindicated for use in thorax, pleural cavity, mediastinum, abdomen, retroperitoneal space, sacral space, or tissues above the inguinal ligament or clavicle.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the Food, Drug & Cosmetic Act, the Non-absorbable, expandable, hemostatic sponge for temporary internal use is subject to the following special controls:

*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.

Predicate Devices

• XSTAT 30 and XSTAT 12 (K170334)

Reference Devices

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

Submission Summary (Full Text)

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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);

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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

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#### 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)

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#### 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.

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#### 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

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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.

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## Substantial Equivalence Summary Table – XSTAT 30

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