XSTAT 30 Pouch

K210676 · Revmedx, Inc. · PGZ · Aug 27, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210676
• Device Name: XSTAT 30 Pouch
• Applicant: Revmedx, Inc.
• Product Code: PGZ · General, Plastic Surgery
• Decision Date: Aug 27, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4452
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

XSTAT 30 Pouch is intended to be a hemostatic wound dressing.

Device Story

Hemostatic device for severe, life-threatening junctional or extremity wounds; used in emergency/trauma settings. Device consists of applicator, plunger, and three porous pouches containing hexagonal compressed cellulose minisponges. Upon deployment into wound, minisponges absorb blood and expand (40-50 mm length) to pack wound and provide hemostasis. Pouches facilitate removal from wound; radiopaque markers in each pouch allow visualization. Used by trained personnel until surgical care acquired. Benefits include rapid hemorrhage control in non-compressible wounds where tourniquets fail.

Clinical Evidence

No human clinical data. Evidence includes bench testing (expansion rate, absorption capacity, pouch durability, radiopacity) and a GLP femoral animal injury model comparing subject device to predicate. Animal study confirmed safety and effectiveness equivalent to predicate and provided usability feedback.

Technological Characteristics

Components: compressed cellulose minisponges in UHMWE fiber pouches, polypropylene applicator, glass-filled polycarbonate plunger. Sensing/Actuation: passive mechanical expansion upon blood contact. Dimensions: 5mm height/9mm diameter (compressed). Connectivity: none. Sterilization: gamma radiation (ISO 11137, SAL 10^-6). Biocompatibility: ISO 10993 (limited duration, tissue/bone contact).

Indications for Use

Indicated for control of severe, life-threatening bleeding from junctional wounds in groin or axilla not amenable to tourniquet, and narrow entrance extremity wounds in arms or legs in adults and adolescents. Temporary use up to 6 hours until surgical care. Indicated 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 available within minutes. Contraindicated for use in thorax, pleural cavity, mediastinum, abdomen, retroperitoneal space, sacral space, tissues above inguinal ligament, or tissues above 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 Gen2 (K180051)

Reference Devices

• XSTAT 30 (DEN13006/K130218/K152624/K170334)
• XSTAT 12 (K161020/K170334)

Submission Summary (Full Text)

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August 27, 2021

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

Re: K210676

Trade/Device Name: XSTAT 30 Pouch Regulation Number: 21 CFR 878.4452 Regulation Name: Nonabsorbable Expandable Hemostatic Sponge For Temporary Internal Use Regulatory Class: Class II Product Code: PGZ Dated: July 26, 2021 Received: July 29, 2021

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely,

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

Enclosure

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# Indications for Use

510(k) Number (if known) K210676

Device Name XSTAT 30 Pouch

#### Indications for Use (Describe)

XSTAT 30 Pouch 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 Pouch 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 Pouch is a temporary device for use up to six (6) 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 Pouch is NOT indicated for use in: the pleural cavity; the mediastinum; the abdomen; 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)

| <span style="font-family: Arial, sans-serif;">☑</span> 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 Pouch

### Manufacturer Information:

RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville, OR 97070 Phone: [phone] (Mobile) Facsimile: 503-218-2274 Contact Person: Amy K. Pointer, Director of RA/QA Date Prepared: 03-02-2021 (Revised 08-26-2021)

# Trade/Proprietary Name:

XSTAT 30 Pouch

# Classification Name:

Non-Absorbable, Expandable, Hemostatic Sponge for Temporary Internal Use Non-absorbable, Gauze/Sponge for external use

# Product Classification & Code:

Class II 21 CFR 878.4452, PGZ NAB

# Predicate Devices:

XSTAT 30 Gen2 (K180051)

Reference Clearances: XSTAT 30 (DEN13006/K130218/K152624/K170334) and XSTAT 12 (K161020/K170334)

# Intended Use / Indications for Use:

# Intended Use:

XSTAT 30 Pouch is intended to be a hemostatic wound dressing.

# Indications for Use:

XSTAT 30 Pouch 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 Pouch 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 Pouch is a temporary device for use up to six (6) 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), noncompressible junctional wounds or narrow entrance extremity wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.

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

# DEVICE DESCRIPTION:

# XSTAT 30 Pouch:

The XSTAT 30 Pouch is comprised of the following components:

- 1. Minisponge Pouches (3 pouches per device)
- 2. Applicator/Plunger
- 3. Packaging and Labeling

The XSTAT 30 Pouch is a modified version of the company's legally marketed XSTAT 30 Gen2 device (K180051, "XSTAT 30 Gen2' or "predicate device"). The technological differences between the XSTAT 30 Pouch and the predicate device are:

- The enclosure of the minisponges in three (3) porous pouches to facilitate their removal from . wounds;
- Changing the shape of the minisponges from round to hexagonal; and
- Including a radiopaque marker in each pouch in lieu of marking each individual minisponge. .

The minisponge pouches are comprised of a tubular knit woven textile constructed with an ultra-high molecular weight polyethylene (UHMWE) fiber. The pouch has a tensile strength of > 200 lbs and is resistant to tearing with surgical tools such as forceps and standard shears. The XSTAT 30 Pouch contains three (3) separate minisponge pouches within each applicator. A medical-grade radiopaque filament (barium sulfate-infused polypropylene) is attached on the interior of each of the three pouches.

The minisponges are comprised of a compressed cellulose sponge. When compressed, each minisponge has a height of approximately 5 mm and a surface diameter of 9 mm. Upon contact with blood, the minisponges absorb blood and, if unencumbered, are capable of expanding to a precompressed height of 40-50 mm within approximately 20 seconds. The sponge expands only in length (not width).

The applicator and plunger facilitates delivery of minisponge pouches to external bleeding wounds. Upon contact with blood, the minisponges absorb blood and expand to fill and pack the wound.

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 deploy the minisponge pouches from the applicator.

One (1) applicator is filled with three (3) minisponge pouches and packaged with one (1) plunger in a vacuum-sealed nylon/poly package and terminally sterilized by gamma radiation to a sterility assurance level of 10°. The Instructions for Use (IFU) will be printed on or adhesively affixed to the package.

# PERFORMANCE DATA

The company has conducted testing to characterize the performance of the XSTAT 30 Pouch. Protocols and results of the studies are summarized below.

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K210676 p. 3 of 5

### Bench Testing

### XSTAT 30 Minisponge Pouches

The following bench tests were performed for the subject device's Minisponge Pouches:

- o Minisponge and Sponge Pouch Expansion Rate
- Minisponge Absorption Capacity o
- Sponge Pouch Durability o
- Sponge Pouch Expansion Force/Pressure in Gel Wound Model o
- Sponge Pouch Radiopacity O

### XSTAT 30 Applicator

The subject device's applicator is identical to the applicator used in the XSTAT 30 Gen2 (predicate device). Thus, performance testing of the applicator has been demonstrated by the clearance of the XSTAT 30 Gen2 predicate device.

Deployment force testing (with and without fluid ingress, at both room temperature and low temperature conditions) was completed on the subject device's applicator to verify the safety and efficacy of the applicator design when used with the minisponge pouch(s).

### XSTAT 30 Pouch Sterility Validation

The XSTAT 30 Pouch is sterilized by gamma radiation and are provided sterile for single patient use. Sterility Validation was performed per ISO 11137:2006 by the VDmax method. A VDmax of 25 kGy was used to demonstrate a sterility assurance level (SAL) of 10°, with a dose range of 25 – 40 kGv.

RevMedx performed tests on the XSTAT 30 Pouch to demonstrate that a sterility assurance level (SAL) of 10- is achieved with a minimum radiation dose of 25 kGy.

### XSTAT 30 Pouch Shelf Life

The subject device's minisponges pouches were evaluated for shelf life per accelerated and realtime stability testing in accordance with ASTM F1980-16.

The subject device's applicator and barrier packaging is identical to the predicate device. Thus the shelf-life of these components have been demonstrated by premarket clearance of the predicate device (K180051).

#### Biocompatibility Testing

The subject device's minisponge pouches were evaluated for biocompatibility per ISO 10993 as a "Limited Duration (<24 Hours), implant device with tissue/bone contact".

The following biocompatibility tests were performed for the XSTAT 30 Sponge Pouch:

- o Cytotoxicity
- Sensitization o
- Irritation o
- O Acute Systemic Toxicity
- Materials-Mediated Pyrogenicity O

The subject device's applicator is identical to the predicate device. Thus, the biocompatibility of the applicator has been demonstrated by the premarket clearance of the Predicate XSTAT 30 Gen2 device (K180051).

### Animal Study

The company has conducted a GLP animal study to demonstrate the performance testing of the XSTAT 30 Pouch. The XSTAT 30 Pouch was compared to the predicate device, XSTAT 30, using a femoral animal injury model.

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The GLP Femoral Animal Study demonstrates that the XSTAT 30 Pouch is as safe and effective as the predicate device.

# Human Factors and Usability Testing

The subject device's applicator/plunger form factor and principles of operation are identical to the predicate device. Therefore, usability and human factors have been demonstrated by the premarket clearance of the Predicate XSTAT 30 Gen2 device (K180051).

In addition, the GLP Animal Study provided user observations and feedback regarding the ease and simplicity of minisponges pouch application and removal.

# Substantial Equivalence

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

# CONCLUSIONS

The XSTAT 30 Pouch is a modified version of the company's legally marketed XSTAT 30 Gen2 device (K180051, "XSTAT 30 Gen2' or "predicate device"). The XSTAT 30 Pouch is as safe and effective as the predicate device. The XSTAT 30 Pouch has the same intended use and similar indications for use. The XSTAT 30 Pouch has the same principles of operation and similar technological characteristics as the predicate device. The Substantial Equivalence Summary Table below details and compares the XSTAT 30 Pouch to the predicate XSTAT device.

| Characteristic | New: XSTAT 30 Pouch | Predicate: XSTAT 30 Gen2 (K180051) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | XSTAT 30 Pouch is intended to be a<br>hemostatic wound dressing. | XSTAT 30 is intended to be a hemostatic<br>wound dressing. |
| Indications for<br>Use | XSTAT 30 Pouch is a hemostatic device<br>for the control of severe, life-threatening<br>bleeding from junctional wounds in the<br>groin or axilla not amenable to tourniquet<br>application in adults and adolescents. | XSTAT is a hemostatic device for the<br>control of severe, life-threatening bleeding<br>from junctional wounds in the groin or<br>axilla not amenable to tourniquet<br>application in adults and adolescents. |
| | XSTAT 30 Pouch is a hemostatic device<br>for the control of severe, life-threatening<br>bleeding from extremity wounds in the<br>arms or legs in adults and adolescents. | XSTAT is a hemostatic device for the<br>control of severe, life-threatening bleeding<br>from extremity wounds in the arms or legs<br>in adults and adolescents. |
| | XSTAT 30 Pouch is a temporary device<br>for use up to six (6) hours until surgical<br>care is acquired. It should only be used<br>for patients at high risk for immediate life-<br>threatening bleeding from,<br>hemodynamically significant (Advanced<br>Trauma Life Support class 3 or 4<br>hemorrhagic shock), non-compressible<br>junctional wounds or narrow entrance | XSTAT is a temporary device for use up<br>to four (4) hours until surgical care is<br>acquired. It should only be used for<br>patients at high risk for immediate life-<br>threatening bleeding from,<br>hemodynamically significant (Advanced<br>Trauma Life Support class 3 or 4<br>hemorrhagic shock), non-compressible<br>junctional wounds or narrow entrance |
| | extremity wounds, and when definitive | extremity wounds, and when definitive |

### Substantial Equivalence Summary Table - XSTAT 30 Pouch

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| Characteristic | New: XSTAT 30 Pouch | Predicate: XSTAT 30 Gen2 (K180051) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | care at an emergency care facility cannot<br>be achieved within minutes. | care at an emergency care facility cannot<br>be achieved within minutes. |
| | XSTAT 30 Pouch is NOT indicated for use<br>in: the thorax; the pleural cavity; the<br>mediastinum; the abdomen; the<br>retroperitoneal space, the sacral space;<br>tissues above the inguinal ligament; or<br>tissues above the clavicle. | XSTAT is NOT indicated for use in: the<br>thorax; the pleural cavity; the<br>mediastinum; the abdomen; the<br>retroperitoneal space, the sacral space;<br>tissues above the inguinal ligament; or<br>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. Minisponge Pouches (3/applicator)<br>2. Applicator<br>3. Packaging and Labeling | 1. Minisponges<br>2. Applicator<br>3. Casualty Card<br>4. Packaging |
| Sponge<br>Component | Three (3) porous, expanding pouches<br>loaded into the applicator with hexagonal<br>compressed cellulose minisponges.<br>~36 minisponges/pouch ~108 minisponges/applicator | Compressed cellulose minisponges<br>loaded into the XSTAT 30 Gen2<br>Applicator ~108 minisponges/applicator |
| Safety Features | Radiopaque marker attached to each<br>pouch within the applicator | Radiopaque marker laminated to sponge<br>with medical grade low-density<br>polyethylene film |
| Dimensions (I x w<br>x h) | 1-Pack: 250mm (L) x 90mm (W) x 35mm (H) | 1-Pack: 295mm x 180mm x 35mm |
| Weight | 1-Pack: 0.07kg | 1-Pack: 0.11kg |
| Biocompatibility | Cytotoxicity (ISO 10993-5);<br>Sensitization (ISO 10993-10);<br>Irritation (ISO 10993-10);<br>Acute systemic toxicity (ISO 10993-11);<br>and<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);<br>and<br>Hemocompatibility (ISO 10993-4)<br>Materials-Mediated Pyrogenicity |
| Sterilization | Gamma radiation sterilization | Gamma radiation sterilization |