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 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

The XSTAT 30 Pouch is comprised of the following components:

Minisponge Pouches (3 pouches per device)
Applicator/Plunger
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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the XSTAT 30 Pouch. This document outlines the device's substantial equivalence to a predicate device, not the acceptance criteria and performance of a new AI/ML-driven medical device, which is typically what the requested questions target.

Therefore, many of the requested details about acceptance criteria, study types, sample sizes for training/test sets, ground truth establishment, and expert involvement are not applicable to this document. The document describes a medical device (hemostatic wound dressing) and its comparison to a previously cleared predicate device, focusing on bench testing, biocompatibility, sterility, shelf-life, and an animal study. It does not mention any AI/ML components.

However, I can extract the information that is present and indicate where the requested information is not applicable.

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

The document does not explicitly state "acceptance criteria" in the traditional sense for an AI/ML device. Instead, it describes performance characteristics and testing conducted to demonstrate substantial equivalence to a predicate device. The performance is reported in terms of successful completion of tests or equivalence.

Acceptance Criteria (Inferred)	Reported Device Performance
Minisponge and Sponge Pouch Expansion Rate meets specifications	Testing was performed for the subject device's Minisponge Pouches. (Results not detailed in the summary, assumed to meet internal specifications given clearance)
Minisponge Absorption Capacity meets specifications	Testing was performed for the subject device's Minisponge Pouches. (Results not detailed in the summary, assumed to meet internal specifications given clearance)
Sponge Pouch Durability meets specifications	Testing was performed for the subject device's Minisponge Pouches. (Results not detailed in the summary, assumed to meet internal specifications given clearance)
Sponge Pouch Expansion Force/Pressure in Gel Wound Model meets specifications	Testing was performed for the subject device's Minisponge Pouches. (Results not detailed in the summary, assumed to meet internal specifications given clearance)
Sponge Pouch Radiopacity meets specifications	Testing was performed for the subject device's Minisponge Pouches. (Results not detailed in the summary, assumed to meet internal specifications given clearance)
Applicator Deployment Force meets specifications	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. (Assumed to meet specifications)
Sterility Assurance Level (SAL) of 10⁻⁶	Sterility Validation was performed per ISO 11137:2006 by the VDmax method with a VDmax of 25 kGy, demonstrating a SAL of 10⁻⁶.
Shelf-life stability meets standards	Evaluated for shelf life per accelerated and real-time stability testing in accordance with ASTM F1980-16. (Assumed to meet standards given clearance)
Biocompatibility in accordance with ISO 10993	Biocompatibility testing for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, and Materials-Mediated Pyrogenicity were performed. (Assumed to meet standards given clearance)
Performance in femoral animal injury model is comparable to predicate device	A GLP animal study using a femoral animal injury model demonstrated that the XSTAT 30 Pouch is as safe and effective as the predicate device (XSTAT 30).
Human Factors and Usability	Usability and human factors have been demonstrated by the premarket clearance of the Predicate XSTAT 30 Gen2 device (K180051) as the applicator/plunger form factor and principles of operation are identical. User observations and feedback regarding ease of application/removal were gathered during the GLP Animal Study.
Overall safety and effectiveness compared to predicate	The XSTAT 30 Pouch is as safe and effective as the predicate devices, with differences not presenting new issues of safety or effectiveness.

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

Test Set Sample Size: Not applicable in the context of an AI/ML test set.
- For the animal study, the document states "The company has conducted a GLP animal study." The specific number of animals is not provided.
- For bench testing, biocompatibility, and sterility validation, sample sizes for individual tests are not detailed in this summary document but would be part of the full study reports.
Data Provenance:
- The animal study was a GLP (Good Laboratory Practice) study, which implies a controlled, prospective experimental design. The country of origin for the animal study or other testing is not specified.

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 device is not an AI/ML diagnostic tool requiring expert-established ground truth for a test set. The efficacy and safety were evaluated through bench, animal, and biocompatibility testing. The "ground truth" for these tests would be objective measurements and observations according to established protocols.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring an adjudication method for a test set.

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 device is not an AI/ML diagnostic tool and no "human readers" or AI assistance are part of its intended use or evaluation.

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

Not applicable. There is no algorithm or AI component mentioned for this device.

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

The "ground truth" for this device's evaluation was primarily based on:

Objective measurements from bench testing (e.g., expansion rate, absorption capacity, durability, radiopacity, deployment force).
Results from biocompatibility testing against ISO 10993 standards.
Demonstration of sterility to a specified SAL (10⁻⁶).
Physiological and clinical outcomes from a GLP animal study, comparing the new device's performance (e.g., hemostasis) to the predicate device in a femoral injury model.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

Not applicable. This device does not involve an AI/ML "training set" or its ground truth establishment.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 narrow entrance extremity wounds in the arms or legs in adults and adolescents.

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)

☑ 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: 503-270-7828 (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 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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DEVICE DESCRIPTION:

XSTAT 30 Pouch:

The XSTAT 30 Pouch is comprised of the following components:

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

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 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.

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 ahemostatic wound dressing.	XSTAT 30 is intended to be a hemostaticwound dressing.
Indications forUse	XSTAT 30 Pouch is a hemostatic devicefor the control of severe, life-threateningbleeding from junctional wounds in thegroin or axilla not amenable to tourniquetapplication in adults and adolescents.	XSTAT is a hemostatic device for thecontrol of severe, life-threatening bleedingfrom junctional wounds in the groin oraxilla not amenable to tourniquetapplication in adults and adolescents.
	XSTAT 30 Pouch is a hemostatic devicefor the control of severe, life-threateningbleeding from extremity wounds in thearms or legs in adults and adolescents.	XSTAT is a hemostatic device for thecontrol of severe, life-threatening bleedingfrom extremity wounds in the arms or legsin adults and adolescents.
	XSTAT 30 Pouch is a temporary devicefor use up to six (6) hours until surgicalcare is acquired. It should only be usedfor patients at high risk for immediate life-threatening bleeding from,hemodynamically significant (AdvancedTrauma Life Support class 3 or 4hemorrhagic shock), non-compressiblejunctional wounds or narrow entrance	XSTAT is a temporary device for use upto four (4) hours until surgical care isacquired. It should only be used forpatients at high risk for immediate life-threatening bleeding from,hemodynamically significant (AdvancedTrauma Life Support class 3 or 4hemorrhagic shock), non-compressiblejunctional 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 cannotbe achieved within minutes.	care at an emergency care facility cannotbe achieved within minutes.
	XSTAT 30 Pouch is NOT indicated for usein: the thorax; the pleural cavity; themediastinum; the abdomen; theretroperitoneal space, the sacral space;tissues above the inguinal ligament; ortissues above the clavicle.	XSTAT is NOT indicated for use in: thethorax; the pleural cavity; themediastinum; the abdomen; theretroperitoneal space, the sacral space;tissues above the inguinal ligament; ortissues above the clavicle.
User Population	Civilian and battlefield patientsAdults and Adolescents	Civilian and Battlefield patientsAdults and Adolescents
TechnologicalCharacteristics	1. Minisponge Pouches (3/applicator)2. Applicator3. Packaging and Labeling	1. Minisponges2. Applicator3. Casualty Card4. Packaging
SpongeComponent	Three (3) porous, expanding pouchesloaded into the applicator with hexagonalcompressed cellulose minisponges.~36 minisponges/pouch ~108 minisponges/applicator	Compressed cellulose minispongesloaded into the XSTAT 30 Gen2Applicator ~108 minisponges/applicator
Safety Features	Radiopaque marker attached to eachpouch within the applicator	Radiopaque marker laminated to spongewith medical grade low-densitypolyethylene film
Dimensions (I x wx 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);Sensitization (ISO 10993-10);Irritation (ISO 10993-10);Acute systemic toxicity (ISO 10993-11);andMaterials-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
Sterilization	Gamma radiation sterilization	Gamma radiation sterilization

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.