(91 days)
No
The device description and performance studies focus on the hemostatic properties of the kaolin-bound gauze and do not mention any computational or algorithmic components.
Yes
The device is used for temporary control of bleeding (a medical condition) in various types of wounds, which is a therapeutic intervention.
No
The device is a hemostatic dressing used to control bleeding, not to diagnose a condition. Its function is therapeutic rather than diagnostic.
No
The device description clearly states it is a "non-absorbable device containing kaolin (hemostatic agent) bound to gauze," indicating it is a physical medical device, not software.
Based on the provided information, the QuikClot Control+® Hemostatic Dressing is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information about a patient's health.
- QuikClot Control+® Function: The description clearly states that QuikClot Control+® is a hemostatic dressing used for the temporary control of bleeding. It is applied directly to the wound or internal organ space to stop bleeding. This is a therapeutic or interventional device, not a diagnostic test performed on a sample.
- Intended Use: The intended use is to control bleeding, not to diagnose a condition or provide information about a patient's health status through analysis of a sample.
Therefore, the QuikClot Control+® Hemostatic Dressing falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
QuickClot 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.
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. 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, surgical wounds, traumatic injuries.
Indicated Patient Age Range
Not Found
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)
The QuikClot Control+® Hemostatic Dressing complies with the special controls identified in 21 CFR 878.4454. All of the size offerings are the manufactured with the same exact materials and formulation. The device meets the following performance specifications:
- Biocompatibility as per ISO 10993-1 for a device with prolonged patient contact duration (>24 hours to 30 days) for external communicating device with tissue/bone/dentin contact.
- Cytotoxicity (L929 Neutral Red Uptake Method)
- Irritation (Intracutaneous Injection)
- Sensitization (Guinea Pig Maximization Sensitization Test)
- Systemic Injection (Intravenous Injection and Intraperitoneal Injection – Acute Systemic Toxicity)
- Implantation (Rabbit Implantation Tests Tissue, Muscle, and Bone)
- 4-week implantation study in subcutaneous tissue
- 1-week implantation study in muscle
- 4-week implantation study in muscle
- 4-week implantation study in bone
- 8-week implantation study in bone
- Genotoxicity
- Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay
- Chromosomal Aberration Study in Mammalian Cells
- Peripheral Blood Micronucleus Study in Mouse
- Additional Supporting Tests
- Carcinogenicity (Clonal Transformation Assay using SHE Cells for 7-days
- Repeat Exposure System Toxicity for Kaolin (6month animal survival study, custom test)
- Systemic Intravenous Injection for Kaolin Extract
- Systemic Intraperitoneal Injection for Kaolin Extract
- Pyrogen Test
- X-Ray Detectable Material - meets required specifications.
- Bench – the device meets the required specifications and acceptance criteria for tensile strength, elongation, clotting, and kaolin release.
- Preclinical Animal Study – Three GLP large animal (swine), to include a survival model, and one non-GLP study demonstrated the safety and effectiveness of QuikClot Control+. The studies included assessments such as hemostasis. In addition to hemostasis assessments, the animal survival study also conducted evaluations for blood chemistry (hematology, serum, coagulation), and macroscopic and microscopic tissue/organ examinations (adhesion, thromboembolism, kaolin migration). The cumulative animal study results support the substantial equivalence of the device.
- Stability - testing supports a 39-month expiration date.
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.
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 23, 2020
Z-Medica, LLC Soraya King Director, Regulatory Affairs 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K200167
Trade/Device Name: QuikClot Control+ Regulation Number: 21 CFR 878.4454 Regulation Name: Non-Absorbable, Hemostatic Gauze For Temporary Internal Use Regulatory Class: Class II Product Code: POD Dated: March 26, 2020 Received: March 27, 2020
Dear Soraya King:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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
1
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 (OS) 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,
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K200167
Device Name QuickClot Control+@ Hemostatic Dressing
Indications for Use (Describe)
QuickClot 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.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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SECTION 5: 510(k) SUMMARY (K200167)
510(k) Number:
| Submitter: | Z-Medica, LLC
4 Fairfield Boulevard
Wallingford, CT 06492 |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Soraya King, Director Regulatory Affairs |
| Preparation Date: | 21 January 2020 |
| Trade/Device Name: | QuikClot Control+® Hemostatic Dressing |
| Regulatory Description
and Classification: | Common Name: Temporary, Internal Use Hemostatic Wound Dressing
Generic Name: Non-absorbable, hemostatic gauze for temporary
internal use.
Device Classification: Class II
Regulation Number: 21 CFR §878.4454
Product Code: POD |
| Predicate Device: | Z-Medica, LLC QuikClot Control+® Hemostatic Dressing (DEN160012,
cleared as D2 Dressing) |
| Reference Device: | Z-Medica, LLC QuikClot Control+® Hemostatic Dressing (K140757,
cleared as D2 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. |
| 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. The device is available
in single or multipacks. |
| Special Controls: | Device complies with the requirements as per 21 CFR 878.4454 for non-
absorbable, hemostatic gauze for temporary internal use. |
| 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 |
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510(k) Summary Z-Medica, LLC QuikClot Control+® Hemostatic Dressing – Line Extension
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.
Summary of Technological The fundamental scientific and technological characteristics of the Characteristics: modified device are identical to the predicate (DEN160012). The key characteristics are as follows:
- Mechanism of Action
- Materials of Construction
- Formulation
- Packaging Materials
- Sterilization Method ●
- Performance Specifications
- Indications/Intended Uses
Performance Testing:
The QuikClot Control+® Hemostatic Dressing complies with the special controls identified in 21 CFR 878.4454. All of the size offerings are the manufactured with the same exact materials and formulation. The device meets the following performance specifications:
- . Biocompatibility as per ISO 10993-1 for a device with prolonged patient contact duration (>24 hours to 30 days) for external communicating device with tissue/bone/dentin contact.
- O Cytotoxicity (L929 Neutral Red Uptake Method)
- Irritation (Intracutaneous Injection) o
- o Sensitization (Guinea Pig Maximization Sensitization Test)
- Systemic Injection (Intravenous Injection and Intraperitoneal o Injection – Acute Systemic Toxicity)
- Implantation (Rabbit Implantation Tests Tissue, Muscle, о and Bone)
- 4-week implantation study in subcutaneous tissue
- 1-week implantation study in muscle
- 4-week implantation study in muscle
- 4-week implantation study in bone
- 8-week implantation study in bone
- Genotoxicity O
- Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay
- I Chromosomal Aberration Study in Mammalian Cells
- I Peripheral Blood Micronucleus Study in Mouse
- Additional Supporting Tests o
- 트 Carcinogenicity (Clonal Transformation Assay using SHE Cells for 7-days
- I Repeat Exposure System Toxicity for Kaolin (6month animal survival study, custom test)
- ' Systemic Intravenous Injection for Kaolin Extract
- Systemic Intraperitoneal Injection for Kaolin Extract
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510(k) Summary
Z-Medica, LLC QuikClot Control+® Hemostatic Dressing – Line Extension
' Pyrogen Test
- X-Ray Detectable Material - meets required specifications.
- . Bench – the device meets the required specifications and acceptance criteria for tensile strength, elongation, clotting, and kaolin release.
- . Preclinical Animal Study – Three GLP large animal (swine), to include a survival model, and one non-GLP study demonstrated the safety and effectiveness of QuikClot Control+. The studies included assessments such as hemostasis. In addition to hemostasis assessments, the animal survival study also conducted evaluations for blood chemistry (hematology, serum, coagulation), and macroscopic and microscopic tissue/organ examinations (adhesion, thromboembolism, kaolin migration). The cumulative animal study results support the substantial equivalence of the device.
- . Stability - testing supports a 39-month expiration date.
Conclusion The subject devices are identical to the predicate in terms of materials of construction, hemostatic agent used, mode of operation, scientific technological characteristics, indications for use and intended uses. Same as the predicate device, the new size options will be provided sterile utilizing existing validated packaging systems. The additional size offerings do not raise new types of questions of safety and effectiveness and is substantially equivalent to the predicate device.