QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.

Device Description

QuikClot Control+™ Hemostatic Device consists of a white to yellow, sterile, X-Ray detectable hemostatic dressing and is packaged for aseptic removal.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the primary endpoint of the study, which was "successful control of bleeding." The reported performance directly addresses this.

Acceptance Criteria (Implied)	Reported Device Performance
Successful control of bleeding in internal use cases	98.7%
Successful control of bleeding in external use cases	97%
Acceptable rates of device-specific adverse events (e.g., hematoma, thrombus formation, thromboembolism)	Hematoma: 0.5% (internal), 1% (external). No thrombus formation or thromboembolism reported.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 603 patient cases.
- Internal uses: 404
- External uses: 199
Data Provenance: Retrospective observational study of real-world data (RWD) from medical records. The data was collected from healthcare professionals at 74 individual sites across 27 states in the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for the test set. It mentions "healthcare professionals from 74 individual sites...who performed the clinical procedures in which the device was used." This implies that the ground truth (successful control of bleeding, adverse events) was established by the treating healthcare professionals at the point of care, rather than a separate panel of experts reviewing the cases.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). Given it's a retrospective observational study where healthcare professionals recorded outcomes at the time of treatment, formal adjudication by a separate group of experts is unlikely to have occurred. The "ground truth" appears to be based on the clinical assessment and documentation by the treating clinicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This section is not applicable. The device is a hemostatic dressing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to readers improving with AI assistance would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a physical medical device (hemostatic dressing), not an algorithm or software. Its performance is inherent in its physical action and chemical properties, not in a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth used was clinical outcomes data (successful control of bleeding, rates of hematoma, thrombus formation, and thromboembolism) as recorded in the medical records by treating healthcare professionals.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of this study. The device is a physical product, and the study described is for clinical performance evaluation, not for training a machine learning model.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" or a machine learning model, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 18, 2025

Teleflex Medical Jane Doll Regulatory Affairs Team Lead 3015 Carrington Mill Blyd Morrisville, North Carolina 27560

Re: K243553

Trade/Device Name: QuikClot Control+ Hemostatic Device Regulation Number: 21 CFR 878.4454 Regulation Name: Non-Absorbable, Hemostatic Gauze For Temporary Internal Use Regulatory Class: Class II Product Code: POD. OSY Dated: February 14, 2025 Received: February 14, 2025

Dear Jane Doll:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

TEK N. LAMICHHANE -S

Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive 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) K243553

Device Name QuikClot Control+ Hemostatic Device

Indications for Use (Describe)

QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY (K243553)

I. Submitter Information

Name:	Teleflex Medical
Address:	3015 Carrington Mill BlvdMorrisville, NC 27560

Contact Person:	Jane Doll
Telephone Number:	(919) 361-3973
Email:	jane.doll@teleflex.com

Date Prepared: February 21, 2025

II. Device Name

Name of Device:	QuikClot Control+TM Hemostatic Device
Common Name:	Temporary, Internal Use Hemostatic Wound Dressing
Classification Name:	Temporary, Internal Use Hemostatic (21 CFR 878.4454)
Regulatory Class:	II
Product Code:	POD

III. Predicate Device

Primary Predicate: QuikClot Control+TM Hemostatic Dressing (K220971) Secondary Predicate: D2 Hemostatic Dressing (K140757)

IV. Device Description and Mechanism of Action

Device Description

QuikClot Control+™ Hemostatic Device consists of a white to yellow, sterile, X-Ray detectable hemostatic dressing and is packaged for aseptic removal.

Mechanism of Action

The QuikClot Control+ Hemostatic Devices are packed into or on the wound and pressure is applied. Pressure is maintained until the bleeding is controlled and may be left in place up to 48 hours. More than one QuikClot Control+ hemostatic device can be used. Hemostasis is achieved through the activity of the hemostatic agent kaolin bound to the gauze in conjunction with compression.

V. Indications for Use

QuikClot Control+ is indicated for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.

VI. Technological Characteristics and Substantial Equivalence

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formulation, mode of operation/mechanism of action, and scientific technological characteristics.

The change to the device is a modification to the indications for use. Table 1 below provides a comparison of the Proposed Device and Primary Predicate Device.

Parameter	Proposed Device(K243553)QuikClot Control+TMHemostatic Device	Primary PredicateDevice – K220971QuikClot Control+TMHemostatic Dressing	Comparison
Indications forUse	QuikClot Control+ isindicated for temporarycontrol of external andidentifiable sites ofinternal mild, moderate,severe, and life-threatening bleeding.	QuikClot Control+Hemostatic Dressing isindicated for temporarycontrol of internal organspace bleeding forpatients displaying classIII or class IVbleeding. It may also beused for control ofseverely bleedingwounds such as surgicalwounds and traumaticinjuries.Cardiac surgicalprocedures: fortemporary control ofmild and moderatebleeding in cardiacsurgical procedures, aswell as in patientsdisplaying Class III orclass IV bleeding.Bone surfaces followingsternotomy: to controlbleeding from bonesurfaces following asternotomy.	Modification to theindications for usewording to alignwith the wording ofthe VIBe scale formild, moderate,severe, and life-threatening, coveringthe full range ofidentifiable sites ofinternal bleeding.
Intended Use	To control internal andexternal bleeding.To control bone surfacebleeding.	To control internal andexternal bleeding.To control bone surfacebleeding at thesternotomy access site	Minor edits forclarity.Removal of “at thesternotomy accesssite” to support the
Parameter	Proposed Device(K243553)QuikClot Control+TMHemostatic Device	Primary PredicateDevice - K220971QuikClot Control+TMHemostatic Dressing	Comparison
	To control suture linebleeding followingcardiac surgicalprocedures, such as butnot limited to, heartvalve repairs orreplacements, coronaryartery bypass graftsurgery (CABG), oraortic aneurysm repairs.	To control suture linebleeding followingcardiac surgicalprocedures, such as butnot limited to, heartvalve repairs orreplacements, coronaryartery bypass graftsurgery (CABG), oraortic aneurysm repairs.	proposedindications for use.
	To control bleeding dueto tears, lacerations, andabrasions to includeepicardial repairs withor without sutures.	To control bleeding dueto tears, lacerations, andabrasions to includeepicardial repairs withor without sutures.
	May be used with orwithout the use ofcardiopulmonary bypasssystems. The dressingcan be applied to controlbleeding while thepatient is 'on or offpump'.	To be used with orwithout the use ofcardiopulmonary bypasssystems. The dressingcan be applied to controlbleeding while thepatient is 'on or offpump'.
	May be used with orwithout autotransfusion(blood salvage)equipment.	To be used with orwithout autotransfusion(blood salvage)equipment.
	May be used on patientson anticoagulation /antiplatelet medication.	To be used on patientson anticoagulation /antiplatelet medication.
TargetPopulation	All patient populationsneeding control ofbleeding.	All patient populationsneeding control ofbleeding.	Same
Contraindication	Do not leave QuikClotControl+ in place formore than 48 hours.	Do not leave QuikClotControl+ in place formore than 48 hours.	Same
Parameter	Proposed Device(K243553)QuikClot Control+TMHemostatic Device	Primary PredicateDevice – K220971QuikClot Control+TMHemostatic Dressing	Comparison
	QuikClot Control+ isnot indicated forintraluminal vascularuse.	QuikClot Control+ isnot indicated forintraluminal vascularuse.
Warnings	QuikClot Control+TM is not to beblindly inserted intoa non-compressibleinternal wound. Adhesion formationassociated withQuikClot Control+Dressing use wasnoted in preclinicalstudies; adhesionswere also observedwith controlmaterials. It is notknown whetheradhesions elicited byQuikClot Control+Dressing areequivalent to thosecaused by controlmaterials. QuikClot Control+Dressing is notabsorbable and mustbe removed from thewound prior towound closure. Read all packageinsert warnings,precautions, andinstructions prior touse. Failure to doso may result insevere patient injuryor death.	Adhesion formationassociated withQuikClot Control+Dressing use wasnoted in preclinicalstudies; adhesionswere also observedwith controlmaterials. It is notknown whetheradhesions elicited byQuikClot Control+Dressing areequivalent to thosecaused by controlmaterials. QuikClot Control+Dressing is notabsorbable and mustbe removed from thewound prior towound closure. Warning: Read allpackage insertwarnings,precautions, andinstructions prior touse. Failure to doso may result insevere patient injuryor death. Warning: Single use:Do not reuse,reprocess or re-sterilize. Reuse ofdevice creates a	Addition of"QuikClot Control+TM is not to beblindly inserted intoa non-compressibleinternal wound."
Parameter	Proposed Device(K243553)QuikClot Control+TMHemostatic Device	Primary PredicateDevice – K220971QuikClot Control+TMHemostatic Dressing	Comparison
	Single use: Do not reuse, reprocess or re-sterilize. Reuse of device creates a potential risk of serious injury and/or infection which may lead to death.Reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality.	potential risk of serious injury and/or infection which may lead to death.Reprocessing of medical devices intended for single use only may result in degraded performance or a loss of functionality.
Materials ofConstruction	Gauze Substrate, Kaolin (hemostatic agent), and Calcium Alginate (binder)	Gauze Substrate, Kaolin (hemostatic agent), and Calcium Alginate (binder)	Same
Sizes	Various sizes including but not limited to1" x 1", 3 ply;4" x 2", 6 ply or 10 ply;4" x 6", 6 ply or 10 ply;4" x 8", 6 -10 plies;4" x 12", 9 ply5" x 5", 4 ply8" x 8", 2 ply12" x 12", 3 ply3" x 4 yards, 1 ply3" x 2 yards, 1 ply	Various sizes including but not limited to1" x 1", 3 ply;4" x 2", 6 ply or 10 ply;4" x 6", 6 ply or 10 ply;4" x 8", 6 -10 plies;4" x 12", 9 ply5" x 5", 4 ply8" x 8", 2 ply12" x 12", 3 ply3" x 4 yards, 1 ply3" x 2 yards, 1 ply	Same
Prescription Useor Over-the-Counter (OTC)	Prescription Use	Prescription Use	Same
Patient ContactTime	Up to 48 hours	Up to 48 hours	Same
How Supplied	Sterile	Sterile	Same
SterilizationMethod	Gamma	Gamma	Same
Parameter	Proposed Device(K243553)QuikClot Control+TMHemostatic Device	Primary PredicateDevice – K220971QuikClot Control+TMHemostatic Dressing	Comparison
Single Use /Reusable	Single use	Single use	Same
Packaging	Peelable foil pouch	Peelable foil pouch	Same
Biocompatibility	Biocompatible materialsused (per ISO 10993-1prolonged contactduration).	Biocompatible materialsused (per ISO 10993-1prolonged contactduration).	Same

Table 1. Substantial Equivalence Comparison to Primary Predicate

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The Proposed Device is substantially equivalent to the Secondary Predicate Device in that both devices are indicated for temporary control of severe bleeding and both are intended to control external bleeding. Moreover, the Proposed Device and the Secondary Predicate Device contain identical materials of construction (including hemostatic agent and binder). Accordingly, the Proposed Device and Secondary Predicate Device have identical mechanisms of action. The Proposed Device is also identical to the Secondary Predicate in terms of prescription use, how supplied, sterilization method, single use, packaging and biocompatibility. For differences in sizes, patient contact time, and shelf life, the Proposed Device is supported by testing and data from the Primary Predicate for the differences in size, and the longer patient contact time and shelf-life.

Table 2 below provides a comparison of the proposed device and secondary predicate device.

Parameter	Proposed Device(K243553)QuikClot Control+TMHemostatic Device	Secondary PredicateDevice - K140757D2 Hemostatic Dressing	Comparison
Indications forUse	QuikClot Control+ isindicated for temporarycontrol of external andidentifiable sites ofinternal mild, moderate,severe, and life-threatening bleeding.	D2 Hemostatic Dressingis intended for use as ahemostatic dressing forthe temporary control ofseverely bleedingwounds such as surgicalwounds and traumaticinjuries.	Both are indicatedfor temporary,external control ofsevere bleeding.
Intended Use	To control internal andexternal bleeding.To control bone surfacebleeding.	To control externalbleeding.	Both are intended tocontrol externalbleeding.
Parameter	Proposed Device(K243553) QuikClot Control+TM Hemostatic Device	Secondary Predicate Device - K140757 D2 Hemostatic Dressing	Comparison
	To control suture line bleeding following cardiac surgical procedures, such as but not limited to, heart valve repairs or replacements, coronary artery bypass graft surgery (CABG), or aortic aneurysm repairs.To control bleeding due to tears, lacerations, and abrasions to include epicardial repairs with or without sutures.May be used with or without the use of cardiopulmonary bypass systems. The dressing can be applied to control bleeding while the patient is 'on or off pump'.May be used with or without autotransfusion (blood salvage) equipment.May be used on patients on anticoagulation / antiplatelet medication.
Target Population	All patient populations needing control of bleeding.	Battleground / Pre-Hospital / Hospital / Medical Office	The Target Population is broader and defined in line with the Primary Predicate.
Contraindication	Do not leave QuikClot Control+ in place for more than 48 hours.	[No Contraindications stated.]	The warnings are in line with the Primary Predicate device.
Parameter	Proposed Device(K243553)QuikClot Control+TMHemostatic Device	Secondary PredicateDevice – K140757D2 Hemostatic Dressing	Comparison
	QuikClot Control+ isnot indicated forintraluminal vascularuse.		Vascular useappears as aContraindication inthe ProposedDevice but appearsas a Warning in theSecondaryPredicate Device(see Warnings, 5thbullet point).
Warnings	QuikClot Control+TM is not to beblindly inserted intoa non-compressibleinternal wound. Adhesion formationassociated withQuikClot Control+Dressing use wasnoted in preclinicalstudies; adhesionswere also observedwith controlmaterials. It is notknown whetheradhesions elicited byQuikClot Control+Dressing areequivalent to thosecaused by controlmaterials. QuikClot Control+Dressing is notabsorbable and mustbe removed from thewound prior towound closure. Read all packageinsert warnings,precautions, and	Product is notabsorbable and mustbe removed from thewound prior towound closure. The D2 HemostaticDressing is notintended as asubstitute formeticulous surgicaltechnique, the use ofsterile procedures,and the properapplication ofligatures or otherconventionalprocedures tocontrol bleeding. The D2 HemostaticDressing must notremain in the woundfor longer than 24hours. Avoid contact witheyes. The safety andeffectiveness of theD2 HemostaticDressing for use in	The Warnings are inline with thePrimary Predicate.Addition of"QuikClot Control+TM is not to beblindly inserted intoa non-compressibleinternal wound."
Parameter	Proposed Device(K243553)QuikClot Control+TMHemostatic Device	Secondary PredicateDevice - K140757D2 Hemostatic Dressing	Comparison
	instructions prior touse. Failure to do somay result in severepatient injury ordeath.Single use: Do notreuse, reprocess orre-sterilize. Reuseof device creates apotential risk ofserious injury and/orinfection which maylead to death.Reprocessing ofmedical devicesintended for singleuse only may resultin degradedperformance or aloss offunctionality.	neurological,ophthalmic, spinal,GI, orthopedic (bonerepair), allanastomoses(including vascular)and femoral arterypuncture sites havenot been established.
Materials ofConstruction	Gauze Substrate, Kaolin(hemostatic agent), andCalcium Alginate(binder)	Gauze Substrate, Kaolin(hemostatic agent), andCalcium Alginate(binder)	Same
Sizes	Various sizes includingbut not limited to1" x 1", 3 ply;4" x 2", 6 ply or 10 ply;4" x 6", 6 ply or 10 ply;4" x 8", 6 -10 plies;4" x 12", 9 ply5" x 5", 4 ply8" x 8", 2 ply12" x 12", 3 ply3" x 4 yards, 1 ply3" x 2 yards, 1 ply	Various sizes rangingfrom 1" x 1" x 1 ply to4" x 12ft x 2 ply	The ProposedDevice includesadditional sizes ascleared in thePrimary Predicate,K220971.
Prescription Useor Over-the-Counter (OTC)	Prescription Use	Prescription Use	Same
Patient ContactTime	Up to 48 hours	Up to 24 hours	The ProposedDevice can be used
Parameter	Proposed Device(K243553)QuikClot Control+TMHemostatic Device	Secondary PredicateDevice – K140757D2 Hemostatic Dressing	Comparison
			for 24 hours, up to48 hours. This is inline with thePrimary Predicate.
How Supplied	Sterile	Sterile	Same
SterilizationMethod	Gamma	Gamma	Same
Shelf-life	39 months	27 months	The ProposedDevice aligns withthe longer shelf-lifeof the PrimaryPredicate.
Single Use /Reusable	Single-use	Single-use	Same
Packaging	Peelable foil pouch	Peelable foil pouch	Same
Biocompatibility	Biocompatible materialsused (per ISO 10993-1prolonged contactduration).	Biocompatible materialsused (per ISO 10993-1prolonged contactduration).	Same

Table 2. Substantial Equivalence Comparison to Secondary Predicate

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VII. Performance Data

The Proposed Device is identical to the Primary Predicate Device in reprocessing, sterility (including sterilization method, pyrogenicity, and packaging), and shelf-life. The Proposed Device will continue to be sterilized using the existing validated parameters and commercialized utilizing the same packaging system as the Primary Predicate. All previously executed performance testing (animal, biocompatibility, bench, stability) remain applicable. No new testing was necessary.

VIII. Clinical Study

Real-world data (RWD) was collected through a retrospective observational study of the medical records of patients treated with QuikClot Control+TM. This study was a retrospective, statistically powered, observational study of emergency, trauma, and surgical patients on whom QuikClot Control+ was used to control internal or external bleeding.

Participants of the retrospective observational study were healthcare professionals from 74 individual sites covering 27 states in the United States that were qualified to use the device and who performed the clinical procedures in which the device was used. The sample size was statistically calculated and powered on the primary endpoint 'successful control of bleeding'. The primary endpoint assessed performance of the device while safety was

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assessed as secondary endpoints based on device-specific adverse events experienced with QuikClot Control+ use.

RWD was collected on both internal and external use of the device to control all grades of bleeding (mild, moderate, severe, life-threatening) in multiple and varied anatomical sites in a total of 603 patient cases. A total of 404 internal uses and 199 external uses were captured. Based on the primary endpoint, QuikClot Control+ successfully controlled bleeding in 98.7% of internal use cases and in 97% of external use cases, achieving the primary endpoints. QuikClot Control+ achieved all safety objectives with rates of hematoma at 0.5% in internal use cases and at 1% in external use cases. There were no reports of thrombus formation or thromboembolisation with either internal use.

In conclusion, results show successful control of both internal and external bleeding in all grades of bleeding, including mild, moderate, severe, and life-threatening. As evidenced from the Real-World Data of 603 patients, QuikClot Control+ has been used successfully across many surgery types and specialties to treat patients with bleeding in all anatomical sites in a broad and generalizable patient population. The study provides sufficient clinical evidence of the effectiveness and safety of QuikClot Control+ to modify the indications for use as described in Table 1 above.

IX. Conclusions

The Proposed Device is identical to the Primary Predicate in terms of intended use, target population, materials of construction (including hemostatic agent and binder), sizes, prescription use, patient contact time, how supplied, sterilization method, shelf-life, single use, packaging and biocompatibility. Additionally, the Proposed Device is identical in formulation, mode of operation/mechanism of action, and scientific technological characteristics. The Proposed Device is substantially equivalent to the Secondary Predicate. Design modifications or manufacturing process changes were not required to support the modification to the indications for use. All previously executed performance testing (animal, biocompatibility, bench, stability) remain applicable. The clinical testing Real-World Data collection demonstrated that QuikClot Control+™ Hemostatic Device is safe and effective for temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding.

Regulation Number and Section

§ 878.4454 Non-absorbable, hemostatic gauze for temporary internal use.

(a)
Identification. A non-absorbable, hemostatic gauze for temporary internal use is a prescription device intended to be placed temporarily for control of severely bleeding wounds such as surgical wounds and traumatic injuries. The gauze is coated or impregnated with a hemostatic material which may enhance hemostasis by physical means. The device is intended to be removed once the patient is stabilized.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Animal performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Specifically testing must:
(i) Demonstrate that the device is able to achieve hemostasis;
(ii) Demonstrate that the device can be radiographically detected; and
(iii) Assess pertinent safety endpoints including vascular obstruction and adhesion formation.
(2) The device must be demonstrated to be biocompatible.
(3) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be performed:
(i) In vitro clot assessment;
(ii) Particulate release testing;
(iii) Physical characterization, including swelling percent and particulate size;
(iv) Chemical characterization;
(v) Radiopacity testing; and
(vi) Mechanical integrity testing, including tensile strength and tear strength.
(4) Performance data must demonstrate the sterility of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Labeling must include the following:
(i) Instructions for use, including an instruction to remove all visible device components by irrigation;
(ii) The maximum amount of time the device may be left within the body;
(iii) A shelf life;
(iv) A contraindication for intravascular use of the device; and
(v) A warning regarding the potential for adhesion formation.