Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a hemostatic dressing and its performance in controlling bleeding, with no mention of AI or ML technologies. The performance studies are based on real-world data collection and statistical analysis of device effectiveness, not on the training or testing of an AI/ML algorithm.

Therapeutic

Yes

The device is indicated for "temporary control of external and identifiable sites of internal mild, moderate, severe, and life-threatening bleeding," which describes a therapeutic action to manage a medical condition.

Diagnostic

No

The device description and intended use clearly state that it is a hemostatic dressing designed to control bleeding, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "sterile, X-Ray detectable hemostatic dressing," which is a physical hardware component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the temporary control of external and identifiable sites of internal bleeding. This is a therapeutic intervention performed directly on the patient's body to stop bleeding.
Device Description: The device is a hemostatic dressing, which is a physical material applied to a wound.
Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.

The information provided clearly describes a device used for direct patient treatment to control bleeding, which falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

POD

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

identifiable sites of internal, external, bone surfaces, suture line, epicardial

Indicated Patient Age Range

All patient populations

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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 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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
Sample Size: 603 patient cases in total (404 internal use cases, 199 external use cases).
Key Results:
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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Successful control of bleeding: 98.7% (internal use cases), 97% (external use cases).
Rates of hematoma: 0.5% (internal use cases), 1% (external use cases).

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K220971, K140757

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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.

1

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

2

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

3

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)

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

4

510(k) SUMMARY (K243553)

I. Submitter Information

Name:	Teleflex Medical
Address:	3015 Carrington Mill Blvd
Morrisville, 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

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

5

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+TM
Hemostatic Device | Primary Predicate
Device – K220971
QuikClot Control+TM
Hemostatic Dressing | Comparison |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | QuikClot Control+ is
indicated for temporary
control of external and
identifiable sites of
internal mild, moderate,
severe, and life-
threatening bleeding. | QuikClot Control+
Hemostatic Dressing is
indicated for temporary
control of internal organ
space bleeding for
patients displaying class
III or class IV
bleeding. It may also be
used for control of
severely bleeding
wounds such as surgical
wounds and traumatic
injuries.

Cardiac surgical
procedures: for
temporary control of
mild and moderate
bleeding in cardiac
surgical procedures, as
well as in patients
displaying Class III or
class IV bleeding.

Bone surfaces following
sternotomy: to control
bleeding from bone
surfaces following a
sternotomy. | Modification to the
indications for use
wording to align
with the wording of
the VIBe scale for
mild, moderate,
severe, and life-
threatening, covering
the full range of
identifiable sites of
internal bleeding. |
| Intended Use | To control internal and
external bleeding.

To control bone surface
bleeding. | To control internal and
external bleeding.

To control bone surface
bleeding at the
sternotomy access site | Minor edits for
clarity.

Removal of “at the
sternotomy access
site” to support the |
| Parameter | Proposed Device
(K243553)
QuikClot Control+TM
Hemostatic Device | Primary Predicate
Device - K220971
QuikClot Control+TM
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 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. | proposed
indications for use. |
| | To control bleeding due
to tears, lacerations, and
abrasions to include
epicardial repairs with
or without sutures. | 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'. | To 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. | To be used with or
without autotransfusion
(blood salvage)
equipment. | |
| | May be used on patients
on anticoagulation /
antiplatelet medication. | To be used on patients
on anticoagulation /
antiplatelet medication. | |
| Target
Population | All patient populations
needing control of
bleeding. | All patient populations
needing control of
bleeding. | Same |
| Contraindication | Do not leave QuikClot
Control+ in place for
more than 48 hours. | Do not leave QuikClot
Control+ in place for
more than 48 hours. | Same |
| Parameter | Proposed Device
(K243553)
QuikClot Control+TM
Hemostatic Device | Primary Predicate
Device – K220971
QuikClot Control+TM
Hemostatic Dressing | Comparison |
| | QuikClot Control+ is
not indicated for
intraluminal vascular
use. | QuikClot Control+ is
not indicated for
intraluminal vascular
use. | |
| Warnings | QuikClot Control+TM is not to be
blindly inserted into
a non-compressible
internal wound. Adhesion formation
associated with
QuikClot Control+
Dressing use was
noted in preclinical
studies; adhesions
were also observed
with control
materials. It is not
known whether
adhesions elicited by
QuikClot Control+
Dressing are
equivalent to those
caused by control
materials. QuikClot Control+
Dressing is not
absorbable and must
be removed from the
wound prior to
wound closure. Read all package
insert warnings,
precautions, and
instructions prior to
use. Failure to do
so may result in
severe patient injury
or death. | Adhesion formation
associated with
QuikClot Control+
Dressing use was
noted in preclinical
studies; adhesions
were also observed
with control
materials. It is not
known whether
adhesions elicited by
QuikClot Control+
Dressing are
equivalent to those
caused by control
materials. QuikClot Control+
Dressing is not
absorbable and must
be removed from the
wound prior to
wound closure. Warning: Read all
package insert
warnings,
precautions, and
instructions prior to
use. Failure to do
so may result in
severe patient injury
or death. Warning: Single use:
Do not reuse,
reprocess or re-
sterilize. Reuse of
device creates a | Addition of
"QuikClot Control+TM is not to be
blindly inserted into
a non-compressible
internal wound." |
| Parameter | Proposed Device
(K243553)
QuikClot Control+TM
Hemostatic Device | Primary Predicate
Device – K220971
QuikClot Control+TM
Hemostatic 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 of
Construction | 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 to
1" 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 ply
5" x 5", 4 ply
8" x 8", 2 ply
12" x 12", 3 ply
3" x 4 yards, 1 ply
3" x 2 yards, 1 ply | Various sizes including but not limited to
1" 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 ply
5" x 5", 4 ply
8" x 8", 2 ply
12" x 12", 3 ply
3" x 4 yards, 1 ply
3" x 2 yards, 1 ply | Same |
| Prescription Use
or Over-the-
Counter (OTC) | Prescription Use | Prescription Use | Same |
| Patient Contact
Time | Up to 48 hours | Up to 48 hours | Same |
| How Supplied | Sterile | Sterile | Same |
| Sterilization
Method | Gamma | Gamma | Same |
| Parameter | Proposed Device
(K243553)
QuikClot Control+TM
Hemostatic Device | Primary Predicate
Device – K220971
QuikClot Control+TM
Hemostatic Dressing | Comparison |
| Single Use /
Reusable | Single use | Single use | Same |
| Packaging | Peelable foil pouch | Peelable foil pouch | Same |
| Biocompatibility | Biocompatible materials
used (per ISO 10993-1
prolonged contact
duration). | Biocompatible materials
used (per ISO 10993-1
prolonged contact
duration). | Same |

Table 1. Substantial Equivalence Comparison to Primary Predicate

6

7

8

9

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+TM
Hemostatic Device | Secondary Predicate
Device - K140757
D2 Hemostatic Dressing | Comparison |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | QuikClot Control+ is
indicated for temporary
control of external and
identifiable sites of
internal mild, moderate,
severe, and life-
threatening bleeding. | D2 Hemostatic Dressing
is intended for use as a
hemostatic dressing for
the temporary control of
severely bleeding
wounds such as surgical
wounds and traumatic
injuries. | Both are indicated
for temporary,
external control of
severe bleeding. |
| Intended Use | To control internal and
external bleeding.

To control bone surface
bleeding. | To control external
bleeding. | Both are intended to
control external
bleeding. |
| 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+TM
Hemostatic Device | Secondary Predicate
Device – K140757
D2 Hemostatic Dressing | Comparison |
| | QuikClot Control+ is
not indicated for
intraluminal vascular
use. | | Vascular use
appears as a
Contraindication in
the Proposed
Device but appears
as a Warning in the
Secondary
Predicate Device
(see Warnings, 5th
bullet point). |
| Warnings | QuikClot Control+TM is not to be
blindly inserted into
a non-compressible
internal wound. Adhesion formation
associated with
QuikClot Control+
Dressing use was
noted in preclinical
studies; adhesions
were also observed
with control
materials. It is not
known whether
adhesions elicited by
QuikClot Control+
Dressing are
equivalent to those
caused by control
materials. QuikClot Control+
Dressing is not
absorbable and must
be removed from the
wound prior to
wound closure. Read all package
insert warnings,
precautions, and | Product is not
absorbable and must
be removed from the
wound prior to
wound closure. The D2 Hemostatic
Dressing is not
intended as a
substitute for
meticulous surgical
technique, the use of
sterile procedures,
and the proper
application of
ligatures or other
conventional
procedures to
control bleeding. The D2 Hemostatic
Dressing must not
remain in the wound
for longer than 24
hours. Avoid contact with
eyes. The safety and
effectiveness of the
D2 Hemostatic
Dressing for use in | The Warnings are in
line with the
Primary Predicate.

Addition of
"QuikClot Control+TM is not to be
blindly inserted into
a non-compressible
internal wound." |
| Parameter | Proposed Device(K243553)
QuikClot Control+TM
Hemostatic Device | Secondary Predicate
Device - K140757
D2 Hemostatic Dressing | Comparison |
| | instructions prior to
use. Failure to do so
may result in severe
patient injury or
death.

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.

Table 2. Substantial Equivalence Comparison to Secondary Predicate

10

11

12

13

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

14

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.