(254 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical efficacy of a hemostatic dressing containing kaolin, with no mention of AI or ML technology.
Yes
The device is indicated for "temporary control of internal organ space bleeding" and "control of severely bleeding wounds," which are therapeutic applications.
No
This device is a hemostatic dressing designed to control bleeding, not to diagnose a medical condition. Its function is therapeutic rather than diagnostic.
No
The device is described as a physical dressing containing kaolin bound to gauze, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The QuikClot Control+® Hemostatic Dressing is a physical dressing containing kaolin bound to gauze. It is applied directly to bleeding sites.
- Intended Use: The intended use is for the temporary control of bleeding in various surgical and traumatic settings. This is a direct therapeutic intervention, not a diagnostic test performed on a specimen.
- Mechanism of Action: The device works by promoting blood clotting through the action of kaolin, which is a topical hemostatic agent. This is a physical/chemical interaction at the site of bleeding, not an analysis of a biological sample.
The information provided clearly describes a device used for direct treatment of bleeding, which falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
POD
Device Description
QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes and configurations. The device is available in single or multipacks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Internal organ space, severely bleeding wounds (surgical wounds and traumatic injuries), cardiac surgical procedures, bone surfaces following a sternotomy.
Indicated Patient Age Range
The eligible subject population were ≥ 18 years of age.
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-Clinical Animal Studies:
- Study type: Five GLP preclinical studies (four GLP large animal (swine) studies including several survival models and a 12-week bone evaluation study conducted on rabbits). An additional non-GLP was also executed.
- Sample size: Not specified per study, but combined from five studies.
- Key results: The preclinical animal studies demonstrated the safety and performance of QuikClot Control+®. The studies included assessments such as hemostasis, bone regrowth, addition to hemostasis assessments, the animal survival study also conducted evaluations for blood chemistry (hematology, serum, coagulation), and macroscopic tissue/organ examinations (adhesion, thromboembolism, kaolin migration). The cumulative animal study results support substantial equivalence of the device.
Clinical Study:
- Study type: Prospective, randomized, open-label, multicenter, pivotal, evaluation of subjects undergoing elective cardiac surgical procedures (IDE #G200086).
- Sample size: 231 subjects were randomized and treated at a 2:1 ratio (test article to control). 153 subjects were treated with QuikClot Control+® (test article) and 78 subject with standard gauze (control). In addition, 21 roll-in subjects, 3 per site, were not randomized and treated with QuikClot Control+®.
- Key results: QuikClot Control+® achieved clinical hemostasis in cardiac surgery for mild to moderate bleeding as compared to control (i.e., standard gauze). The safety of QuikClot Control+® was comparable to control (i.e., standard gauze). The clinical investigation evaluated the expanded indications for use and intended uses described in Table 1 above with confirmation that the subject device is substantially equivalent for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2022
Z-Medica, LLC Rachel Rehl Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd Suite 600 Morrisville, North Carolina 27560
Re: K220971
Trade/Device Name: QuikClot Control+® Hemostatic Dressing Regulation Number: 21 CFR 878.4454 Regulation Name: Non-Absorbable, Hemostatic Gauze For Temporary Internal Use Regulatory Class: Class II Product Code: POD Dated: November 11, 2022 Received: November 14, 2022
Dear Rachel Rehl:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 medical devices and radiation-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.
Katherine N. Trivedi -5
Katherine Trivedi Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220971
Device Name QuikClot Control+® Hemostatic Dressing
Indications for Use (Describe)
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.
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
QuikClot Control+® Hemostatic Dressing - Expanded Indications
1. Submitter Information
| Name: | Z-Medica, LLC |
|---|---|
| Address: | 4 Fairfield Boulevard |
| Wallingford, CT 06492 | |
| Contact Person: | Rachel Rehl |
| Telephone Number: | (919) 433-2588 |
| Email: | rachel.rehl@teleflex.com |
Date Prepared: November 7, 2022
2. Device Name
| Device Trade Name: | QuikClot Control+® Hemostatic Dressing |
|---|---|
| Common Name: | Temporary, Internal Use Hemostatic Wound Dressing |
| Classification Name: | Non-absorbable, hemostatic gauze for temporary internal use |
| (Class II, POD, 21 CFR 878.4454) |
3. Predicate Device
QuikClot Control+® Hemostatic Dressing (K200167)
4. Device Description and Mechanism of Action
Device Description
QuikClot Control+® Hemostatic Dressing is a prescription use non-absorbable device containing kaolin (hemostatic agent) bound to gauze. The hemostatic dressings are x-ray detectable and are provided as a single-use sterile device available in various sizes and configurations. The device is available in single or multipacks.
Mechanism of Action
The QuikClot Control+® Hemostatic Dressings 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 dressing can be used. Hemostasis is achieved through the activity of the hemostatic agent kaolin bound to the gauze in conjunction with compression.
5. Indications for Use
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.
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6. Technological Characteristics and Substantial Equivalence
The proposed device is identical to the predicate device described in K200167 in design, materials of construction, functional performance, principles of operation, manufacturing, packaging, sterilization, and shelf life.
The change to the device is an expansion of the indication for use. Table 1 below provides a comparison of the proposed and predicate devices.
| Table 1. Substantial Equivalence Comparison to Predicate | |||
|---|---|---|---|
| Proposed Device | Predicate Device – K200167 | Comparison | |
| QuikClot Control+® | |||
| Hemostatic Dressing | |||
| (Expanded Indications) | QuikClot Control+® | ||
| Hemostatic Dressing | |||
| Indications for | |||
| Use | 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. | 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. | Addition of
indication for
cardiac surgical
procedures and
bone surfaces.
Indications align
with proposed
indications
under IDE
G200086. |
| Intended Use | To control internal and external
bleeding
To control bone surface bleeding at the
sternotomy access site.
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 | To control internal and external
bleeding | Addition of
specific
intended
use for
cardiac
surgical
procedures
and bone
surfaces
that aligns
with
intended
use under
IDE
G200086. |
| | Proposed Device
QuikClot Control+®
Hemostatic Dressing
(Expanded Indications) | Predicate Device – K200167
QuikClot Control+®
Hemostatic Dressing | Comparison |
| | epicardial repairs with or without
sutures.
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'.
To be used with or without
autotransfusion (blood salvage)
equipment.
To be used on patients on
anticoagulation / antiplatelet
medication | | |
| Contraindication | Do not leave QuikClot Control+® in
place for more than 48 hours.
QuikClot Control+® is not indicated for
intraluminal vascular use. | Do not leave QuikClot Control+® in
place for more than 48 hours.
QuikClot Control+® is not indicated for
intraluminal vascular use. | Same |
| 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
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
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 yds, 1 ply | Addition of 1
proposed size
(3" x 2 yards, 1
ply). |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Same |
| Shelf-life | 39 months | 39 months | Same |
| Single Use | Yes | Yes | Same |
| | Proposed Device
QuikClot Control+®
Hemostatic Dressing
(Expanded Indications) | Predicate Device – K200167
QuikClot Control+®
Hemostatic Dressing | Comparison |
| 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 Predicate
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7. Pre-Clinical Animal Studies
Five GLP preclinical studies were conducted supporting the use of the device. This includes four GLP large animal (swine) studies including several survival models and a 12-week bone evaluation study conducted on rabbits. An additional non-GLP was also executed. The preclinical animal studies demonstrated the safety and performance of QuikClot Control+®. The studies included assessments such as hemostasis, bone regrowth, addition to hemostasis assessments, the animal survival study also conducted evaluations for blood chemistry (hematology, serum, coagulation), and macroscopic tissue/organ examinations (adhesion, thromboembolism, kaolin migration). The cumulative animal study results support substantial equivalence of the device.
8. Clinical Study
Clinical study, IDE #G200086, was conducted to support this premarket notification for the proposed expanded indications for the legally marketed QuikClot Control+® Hemostatic Dressing (K200167). The clinical trial was a prospective, randomized, open-label, multicenter, pivotal, evaluation of subjects undergoing elective cardiac surgical procedures. The objective of the study was to assess QuikClot Control+® Hemostatic Dressing in the treatment of mild and moderate bleeding during cardiac surgeries and on bone due to a sternotomy is as safe and effective as the control (standard gauze, disposable surgical sponges or lap sponges). 231 subjects were randomized and treated at a 2:1 ratio (test article to control). 153 subjects were treated with QuikClot Control+® (test article) and 78 subject with standard gauze (control). In addition, 21 roll-in subjects, 3 per site, were not randomized and treated with QuikClot Control+®.
The eligible subject population were ≥ 18 years of age, willing to give prior written informed consent, and required open heart surgery. Subject demographics were similar between groups. Mean age was 64.5 ± 12.2 years and subjects were predominantly male (68.8%) and Caucasian (94.8%). Categories of baseline medications were balanced between randomized arms. Of note, 41/153 (26.8%) QuikClot Control+® subjects and 17/78 (21.8%) control subjects were on an anticoagulant medication (P=0.258). Accordingly, a higher proportion of QuikClot Control+® subjects had baseline INR >1.1 (19/91=21%) compared to the standard gauze arm (7/47=15%). All baseline subjects completed blood count measurements and vital signs were balanced between randomized arms, except for systolic blood pressure (BP; QuikClot Control+® 135.5 ± 19.5; control: 141.4 ± 21.1; P = 0.037). The use of QuikClot Control+® Hemostatic Dressing during a sternotomy case or cardiac surgeries is intended to be used where surgical wounds result in mild and moderate bleeding throughout the procedure. As such, the surgical wounds evaluated in the trial were created at the sternotomy access site, suture lines (as part of the repair with native or synthetic material), tears, lacerations, and epicardial repairs
7
QuikClot Control+® Hemostatic Dressing - Expanded Indications Traditional 510(k)
(with or without sutures). The injury types that were evaluated in the study are typical in cardiac surgical procedures, such as:
- Coronary artery bypass graft (CABG) with or without valve repair/replacement – open heart sternotomy, thoracotomy or mini sternotomy
- Valve repair/replacement – open heart sternotomy, thoracotomy, or mini-sternotomy
- Aortic aneurysm surgery
During the mentioned surgeries, wounds that meet the mild (grade 1) or moderate (grade 2) bleeding severity criteria will have either QuikClot Control (i.e., standard gauze) applied during one of the injury types below:
- Sternal bleeding
- . Suture line bleeding (native tissue or synthetic material)
- Tears, lacerations or abrasions to include epicardial repairs with or without sutures ●
The primary and secondary endpoints are described below:
- Primary endpoint: Rate at which subjects achieve hemostasis (grade 0 bleed) through up to 10 minutes of application and compression at the bleeding site.
- . Secondary endpoint: Proportion of subjects achieving hemostasis (grade 0 bleed) measured at 5 and 10 minutes of application and compression at the bleeding site.
QuikClot Control+® achieved clinical hemostasis in cardiac surgery for mild to moderate bleeding as compared to control (i.e., standard gauze). The safety of QuikClot Control+® was comparable to control (i.e., standard gauze). The clinical investigation evaluated the expanded indications for use and intended uses described in Table 1 above with confirmation that the subject device is substantially equivalent for its intended use.
9. Conclusions
The subject device is identical to the predicate in terms of materials of construction, hemostatic agent used, formulation, performance specifications, mode of operation/mechanism of action, scientific technological characteristics, and shelf-life. Design modifications or manufacturing process changes were not required to support the additional labeling. All previously executed performance testing (animal, biocompatibility, bench, stability) remain applicable. In conclusion, the subject device is the exact same as the predicate device. The subject device retained the same device properties as the predicate. The additional and clinical studies to evaluate mild and moderate bleeding with the described following a sternotomy and/or during cardiac surgeries confirmed that QuikClot Control+® is substantially equivalent to the predicate.