K152624 · Revmedx, Inc. · PGZ · Dec 7, 2015 · General, Plastic Surgery
Device Facts
Record ID
K152624
Device Name
XSTAT 30, 3-PACK, XSTAT 30, 1-PACK
Applicant
Revmedx, Inc.
Product Code
PGZ · General, Plastic Surgery
Decision Date
Dec 7, 2015
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4452
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents. XSTAT 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, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes. XSTAT 30 is NOT indicated for use in the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space, the sacral space above the inguinal ligament; or tissues above the clavicle.
Device Story
Hemostatic device for severe, non-compressible junctional wounds (groin/axilla); used when tourniquets ineffective and surgical care delayed. Consists of applicator delivering ~92 compressed, chitosan-coated regenerated cellulose mini-sponges. Upon blood contact, sponges expand (40-50 mm) to pack wound; provide temporary hemorrhage control (up to 4 hours). Includes radiopaque marker for post-removal verification via X-ray. Used by clinicians/first responders in civilian or battlefield settings. Output is physical wound packing; aids clinical decision-making by stabilizing patient during transport to definitive surgical care. Benefits patient by minimizing blood loss in life-threatening trauma.
Clinical Evidence
Bench testing only. Performance data incorporated by reference from predicate device (K130218). Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility).
Technological Characteristics
Regenerated cellulose mini-sponges coated with chitosan; radiopaque marker embedded. Dimensions: 4-5 mm height, 9.8 mm diameter (compressed); expands to 40-50 mm. Applicator-based delivery. Sterilized via gamma radiation (SAL 10^-6). Biocompatibility per ISO 10993-4, 5, 10, 11.
Indications for Use
Indicated for adults and adolescents with severe, life-threatening, hemodynamically significant (ATLS class 3 or 4 hemorrhagic shock) non-compressible junctional wounds in the groin or axilla not amenable to tourniquet application. Contraindicated for use in thorax, pleural cavity, mediastinum, abdomen, retroperitoneal space, sacral space 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.
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 7, 2015
RevMedx Incorporated John J. Smith, M.D., J.D. Hogan Lovells US LLP 555 Thirteenth Street, Northwest Washington, DC 20004
Re: K152624
Trade/Device Name: XSTAT 30 Regulation Number: 21 CFR 878.4452 Regulation Name: Nonabsorbable expandable hemostatic sponge for temporary internal use Regulatory Class: Class II Product Code: PGZ Dated: September 14, 2015 Received: September 14, 2015
Dear Dr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
# Binita S. Ashar -S
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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510(k) Number (if known)
Device Name
XSTAT 30
Indications for Use (Describe)
XSTAT 30 is a hemostatic device for the control of severe, life-threatening bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.
XSTAT 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, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non-compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.
XSTAT 30 is NOT indicated for use in the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space, the sacral space above the inguinal ligament; or tissues above the clavicle.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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#### 510(k) SUMMARY RevMedx, Inc. XSTAT 30
#### Manufacturer Information:
RevMedx, Inc. 25999 SW Canvon Creek Road. Suite C Wilsonville, OR 97070 Phone: 503-218-2172 Facsimile: 503-218-2274
Contact Person: Amy K. Pointer, RA/QA Manager
Date Prepared: September 14, 2015
#### Trade/Proprietary Name:
XSTAT 30
#### Classification Name:
Non-Absorbable, Expandable, Hemostatic Sponge for Temporary Internal Use
## Product Classification & Code:
21 CFR 878.4452; PGZ
#### Predicate Devices:
XSTAT (DEN130016; K130218)
#### Intended Use / Indications for Use:
Intended Use:
The XSTAT 30 is intended for the control of bleeding from wounds in the groin or axilla that are not amenable to tourniquet application in adults and adolescents.
Indications for Use:
XSTAT 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 temporary device for use up to four (4) hours until surgical care is acquired. It should only be used for patients at high risk for immediate life-threatening bleeding from, hemodynamically significant (Advanced Trauma Life Support class 3 or 4 hemorrhagic shock), non- compressible junctional wounds, and when definitive care at an emergency care facility cannot be achieved within minutes.
XSTAT 30 is NOT indicated for use in: the thorax; the pleural cavity; the mediastinum; the abdomen; the retroperitoneal space; the sacral space above the inguinal ligament; or tissues above the clavicle.
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# Technological Characteristics
The XSTAT 30 dressing is composed of a standard, regenerated cellulose medical sponge that is compressed and formed into a group of approximately 92 mini-sponges. Each minisponge has a height of 4-5 mm and a circular surface diameter of 9.8 mm. The compressed regenerated cellulose sponge is coated with chitosan. Upon contact with blood, the mini-sponges absorb blood and, if unencumbered, are capable of expanding to a pre-compressed height of 40-50 mm within approximately 20 seconds. A radiopaque marker is embedded into a circular surface of the mini-sponges to render each sponge detectable via X-ray. The XSTAT 30 dressing includes an applicator that facilitates delivery of the mini-sponges to external bleeding wounds. Three applicators filled with the XSTAT 30 dressing (i.e., mini-sponges) are packaged in a sealed foil pouch and terminally sterilized by gamma radiation to a sterility assurance level of 10°.
For the treatment of severe bleeding from pelvis or shoulder wounds not amenable to tourniquet application, the XSTAT 30 sponges are applied to the wound using the applicator. Once applied to the wound, the XSTAT 30 sponges absorb blood and expand, thereby packing the wound. All mini-sponges must be removed from wounds before surgical repair and closure of the wounds. Following removal of the mini-sponges and definitive surgical repair of the wound, a radiograph is required prior to wound closure to confirm that every mini-sponge has been removed.
# Performance Data
The technological characteristics for XSTAT 30 are identical to the predicate device. Thus, the performance testing of the XSTAT 30 has been demonstrated by the clearance of the XSTAT predicate device. The testing provided in the cleared XSTAT notification (K130218) is incorporated herein by reference.
## Substantial Equivalence
XSTAT 30 and XSTAT have the same intended use, same technological characteristics, same principles of operation and similar indications. The difference between the devices is a change to the indications for use. The X-Stat devices have a specific indication for use to control hemorrhage from non-compressible junctional wounds. This type of wound is equally life threatening when sustained in either a combat environment or a civilian environment. where there may be a delay to expeditious surgical intervention. When available at the point of injury. X Stat 30 can help minimize blood loss and provide a bridge to surgery. Therefore, XSTAT 30 is substantially equivalent to XSTAT.
# Conclusions
The XSTAT 30 is as safe and effective as the predicate XSTAT device. The intended use is the same for both XSTAT 30 and XSTAT, as are the technological characteristics and principles of operation. The Substantial Equivalence Summary table below details and compares the XSTAT 30 to the XSTAT.
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| of<br>3<br>3 | |
|--------------|--|
|--------------|--|
| | XSTAT 30 | XSTAT (K130218) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same | Same |
| Indications for Use | XSTAT 30 is a hemostatic device<br>for the control of severe, life-<br>threatening bleeding from<br>junctional wounds in the groin or<br>axilla not amenable to tourniquet<br>application in adults and<br>adolescents. | XSTAT is a hemostatic device for<br>the control of bleeding from<br>junctional wounds in the groin or<br>axilla not amenable to tourniquet<br>application in adults and<br>adolescents. |
| | XSTAT 30 is a temporary device<br>for use up to four (4) hours until<br>surgical care is acquired. It should<br>only be used for patients at high<br>risk for immediate life-threatening<br>bleeding from, hemodynamically<br>significant (Advanced Trauma Life<br>Support class 3 or 4 hemorrhagic<br>shock), non-compressible<br>junctional wounds, and when<br>definitive care at an emergency<br>care facility cannot be achieved<br>within<br>minutes.<br>XSTAT 30 is NOT indicated for<br>use in the thorax; the pleural<br>cavity; the mediastinum; the<br>abdomen; the retroperitoneal<br>space, the sacral space above the | XSTAT is a temporary device for<br>use up to four (4) hours until<br>surgical care is acquired. XSTAT<br>is intended for use in the<br>battlefield.<br>XSTAT is NOT indicated for use<br>in: the thorax; the pleural cavity;<br>the mediastinum; the abdomen;<br>the retroperitoneal space; the<br>sacral space above the inguinal<br>ligament; or tissues above the |
| | inguinal ligament; or tissues above<br>the clavicle. | clavicle. |
| User Population | Civilian and battlefield patients | Battlefield patients |
| Technological<br>Characteristics | 1. Mini-sponges<br>2. Applicator<br>3. Casualty Card<br>4. Packaging | 1. Mini-sponges<br>2. Applicator<br>3. Casualty Card<br>4. Packaging |
| Dimensions | 3-Pack: 254mm x 165mm x 38mm | 3-Pack: 254mm x 165mm x 38mm |
| (l x w x h) | 1-Pack: 254mm x 165mm x 38mm | 1-Pack: 254mm x 165mm x 38mm |
| Weight | 3- Pack: 0.25kg<br>1-Pack: 0.1kg | 3- Pack: 0.25kg<br>1-Pack: 0.1kg |
| Safety Features | Radiopaque marker | Radiopaque marker |
| Biocompatibility | Cytotoxicity (ISO 10993-5);<br>Sensitization (ISO 10993-10);<br>Irritation (ISO 10993-10);<br>Acute systemic toxicity (ISO<br>10993-11); and | Cytotoxicity (ISO 10993-5);<br>Sensitization (ISO 10993-10);<br>Irritation (ISO 10993-10);<br>Acute systemic toxicity (ISO<br>10993-11); and |
| | Hemocompatibility (ISO 10993-4). | Hemocompatibility (ISO 10993-4). |
| Sterilization | Gamma radiation sterilization | Gamma radiation sterilization |
# Substantial Equivalence Summary Table
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