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.

AI/ML Overview

This document is a 510(k) Summary for the XSTAT 30 device, a hemostatic device. The purpose of a 510(k) is to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This submission does not contain acceptance criteria or a study proving the device meets acceptance criteria in the way this request is typically interpreted for AI/ML devices, or even for many traditional medical devices.

Instead, the document details a comparison of the new XSTAT 30 (K180051) to its predicate devices (XSTAT 30 and XSTAT 12, K170334). The "acceptance criteria" here are essentially that the new device performs similarly to or better than the predicate device across various performance and safety metrics, and that any differences do not raise new questions of safety or effectiveness.

Here's a breakdown based on your request, as best as the provided text allows:

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" is the demonstration that the new device meets or exceeds those. The document states:
"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."

The table provided directly compares the characteristics of the "New: XSTAT 30" and "Predicate: XSTAT 30 and XSTAT 12 (K170334)". In all categories, the specifications for the new device are either identical or shown to be an acceptable variation (e.g., slightly different dimensions/weight for a one-pack vs. a three-pack configuration, with similar underlying technology).

Therefore, the acceptance criteria are implicitly that the new XSTAT 30 performs equivalently in these areas, and the reported device performance is that it does.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (New XSTAT 30)
Intended Use	Control of bleeding from wounds in the groin or axilla not amenable to tourniquet application and narrow entrance extremity wounds in the arms or legs in adults and adolescents.	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. (Identical)
Indications for Use	Hemostatic device for the control of severe, life-threatening bleeding from junctional wounds in the groin or axilla not amenable to tourniquet application or narrow entrance extremity wounds in the arms or legs in adults and adolescents; temporary device for use up to 4 hours; only for high-risk patients with hemodynamically significant, non-compressible wounds when definitive care cannot be achieved within minutes. Exclusions: thorax, pleural cavity, mediastinum, retroperitoneal space, sacral space, above inguinal ligament, above clavicle.	(Identical to Predicate) 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 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 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. (Identical)
Technological Characteristics	Minisponges, Applicator, Casualty Card, Packaging.	Minisponges, Applicator, Casualty Card, Packaging. (Identical)
Dimensions (l x w x h)	3-Pack: 254mm x 165mm x 38mm; 1-Pack: 254mm x 165mm x 38mm	1-Pack: 295mm x 180mm x 35mm (Slight dimensional difference for a 1-pack, not raising new safety/effectiveness)
Weight	3-Pack: 0.25kg; 1-Pack: 0.1kg	1-Pack: 0.11kg (Slight weight difference for a 1-pack, not raising new safety/effectiveness)
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. (Identical)
Biocompatibility	Cytotoxicity (ISO 10993-5); Sensitization (ISO 10993-10); Irritation (ISO 10993-10); Acute systemic toxicity (ISO 10993-11); 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); Hemocompatibility (ISO 10993-4); Materials-Mediated Pyrogenicity. (Identical)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes a substantial equivalence submission, not a new clinical study with a defined test set for a new device. The performance data provided is primarily:

Bench Testing: Mechanical testing on the XSTAT 30 applicator (Deployment Force, Plunger Axial Force, Tip Tensile Strength, Fluid Immersion). No specific sample sizes are mentioned, but these are typically done on multiple units.
Minisponges: The minisponges are stated to be "identical to the predicate devices." Therefore, prior testing for the predicate (K170334), including radiopacity, immunogenicity, absorption capacity, extent of swelling, expansion force/pressure, and viral inactivation, is referenced.
Biocompatibility Testing: Similar to minisponges, this testing was performed on the predicate devices (K170334) and referenced, as the minisponges are identical.
Animal Study: The animal performance testing was also conducted on the predicate devices (K170334) and referenced.

There is no specific test set sample size or data provenance mentioned for a new clinical study in this document. The "tests" are primarily bench and referenced pre-clinical data from the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study involving expert readers or ground truth establishment in the context of an AI/ML device or diagnostic test.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device or a diagnostic device where MRMC studies would typically be conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical hemostatic device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the chemical and mechanical properties, the "ground truth" is established through standardized laboratory testing (e.g., ISO standards for biocompatibility). For clinical effectiveness, it refers to the performance demonstrated in animal studies and potentially human experience with the predicate devices, against which the new device is deemed "substantially equivalent" because its active components and mechanism of action are identical.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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:

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"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 (301) 443-6740 EF

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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: 503-218-2172 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:

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(K170334)
Intended Use	XSTAT 30 is intended for the control ofbleeding from wounds in the groin or axillathat are not amenable to tourniquetapplication and narrow entrance extremitywounds in the arms or legs in adults andadolescents.	XSTAT is intended for the control ofbleeding from wounds in the groin or axillathat are not amenable to tourniquetapplication and narrow entrance extremityadolescents.
Indications for Use	XSTAT 30 is a hemostatic device for thecontrol of severe, life-threatening bleedingfrom junctional wounds in the groin or axillanot amenable to tourniquet application inadults and adolescents.	XSTAT is a hemostatic device for the controlof severe, life-threatening bleeding fromjunctional wounds in the groin or axilla notamenable to tourniquet application in adultsand adolescents.
	XSTAT 30 is a hemostatic device for thecontrol of severe, life-threatening bleedingfrom extremity wounds in the arms or legs inadults and adolescents.	XSTAT is a hemostatic device for the controlof severe, life-threatening bleeding fromextremity wounds in the arms or legs inadults and adolescents.
	XSTAT 30 is a temporary device for use upto four (4) hours until surgical care isacquired. It should only be used for patientsat high risk for immediate life-threateningbleeding from, hemodynamically significant(Advanced Trauma Life Support class 3 or 4hemorrhagic shock), non-compressiblejunctional wounds or narrow entranceextremity wounds, and when definitive careat an emergency care facility cannot beachieved within minutes.	XSTAT is a temporary device for use up tofour (4) hours until surgical care is acquired.It should only be used for patients at highrisk for immediate life-threatening bleedingfrom, hemodynamically significant(Advanced Trauma Life Support class 3 or 4hemorrhagic shock), non-compressiblejunctional wounds or narrow entranceextremity wounds, and when definitive careat an emergency care facility cannot beachieved within minutes.
	XSTAT 30 is NOT indicated for use in: thethorax; the pleural cavity; the mediastinum;the abdomen; the retroperitoneal space, thesacral space; tissues above the inguinalligament; or tissues above the clavicle.	XSTAT is NOT indicated for use in: thethorax; the pleural cavity; the mediastinum;the abdomen; the retroperitoneal space, thesacral space; tissues above the inguinalligament; or tissues above the clavicle.
User Population	Civilian and battlefield patientsAdults and Adolescents	Civilian and Battlefield patientsAdults and Adolescents
TechnologicalCharacteristics	1. Minisponges2. Applicator3. Casualty Card4. Packaging	1. Minisponges2. Applicator3. Casualty Card4. Packaging
Dimensions (I x wx h)	1-Pack: 295mm x 180mm x 35mm	3-Pack: 254mm x 165mm x 38mm1-Pack: 254mm x 165mm x 38mm
Weight	1-Pack: 0.11kg	3- Pack: 0.25kg1-Pack: 0.1kg
Safety Features	Radiopaque marker laminated to spongewith medical grade low-density polyethylenefilm	Radiopaque marker laminated to spongewith medical grade low-density polyethylenefilm
Biocompatibility	Cytotoxicity (ISO 10993-5);Sensitization (ISO 10993-10);Irritation (ISO 10993-10);Acute systemic toxicity (ISO 10993-11); andHemocompatibility (ISO 10993-4)Materials-Mediated Pyrogenicity	Cytotoxicity (ISO 10993-5);Sensitization (ISO 10993-10);Irritation (ISO 10993-10);Acute systemic toxicity (ISO 10993-11); andHemocompatibility (ISO 10993-4)Materials-Mediated Pyrogenicity

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.