(20 days)
QuikClot® Brand Hemostatic Agent is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
The new bead form of QuikClot® Brand Hemostatic Agent, also called "Advanced Beaded Formulation", is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss. The beads consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion. Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function. The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation. Used in conjunction with direct pressure, QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds.
The provided document is a 510(k) premarket notification for a medical device (QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation). It describes the device, its intended use, and claims substantial equivalence to a predicate device.
However, the document does not contain the acceptance criteria and study details as typically understood for AI/ML device performance evaluation studies. The information present pertains to the regulatory clearance process for a physical hemostatic agent, not an AI/ML algorithm.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training) are not applicable or cannot be extracted from this document as these are specific to AI/ML device evaluations.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics within a table in this document. The document relies on equivalence to a predicate device.
- Reported Device Performance:
- Claimed Performance: "performs at least as well as the current granular product in the swine femoral artery model."
- Mechanism of Action: Accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site, and the exothermic adsorption process increases temperature, which increases clotting rates and platelet aggregation/adhesion.
- Clinical Goal: "reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds."
2. Sample sized used for the test set and the data provenance
- Sample Size: "In-Vivo testing on swine was performed". No specific number of subjects (swine) is given in this summary.
- Data Provenance:
- Country of Origin: Performed at the Portsmouth Naval Hospital in Virginia (USA).
- Retrospective or Prospective: Implied to be prospective in-vivo testing as it was "performed" for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is for an in-vivo animal study of a physical device, not an AI/ML algorithm requiring expert interpretation of data.
4. Adjudication method for the test set
- Not Applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is for a physical medical device, not an AI/ML algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is for a physical medical device.
7. The type of ground truth used
- Ground Truth: The "ground truth" in this context would likely be direct physiological measurements of hemostasis and blood loss in the swine model, assessed by animal researchers/veterinarians. No specific methodology for ground truth establishment (e.g., pathology, outcomes data) is detailed beyond "In-Vivo testing on swine."
8. The sample size for the training set
- Not Applicable. This refers to a physical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of what is present:
- Device: QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation (a physical hemostatic product).
- Indication: Emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
- Study Type: In-Vivo testing on swine.
- Outcome Claim: Performs at least as well as the predicate (granular) product in the swine femoral artery model.
- Basis of Clearance: Substantial equivalence to a legally marketed predicate device (QuikClot® Brand Hemostatic Granules, K013390).
- Additional Tests (for biocompatibility, likely related to the predicate): Agar Overlay Cytotoxicity Test, Water Adsorption Rate, Skin Sensitization, Skin Irritation, Intracutaneous Test, Muscle Implant, Long-Term Muscle Implant.
To reiterate, the provided text is a 510(k) summary for a physical hemostatic agent and does not contain the detailed performance study information typically requested for AI/ML devices.
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June 11, 2023
Z-Medica Corporation Robert V. Packard Quality Assurance Manager 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K050769 Trade/Device Name: QuikClot® Brand Hemostatic Agent Regulatory Class: Unclassified Product Code: QSY
Dear Robert V. Packard:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 14, 2005. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Image /page/0/Picture/7 description: The image shows the signature block of Julie A. Morabito, Ph.D., who is the Assistant Director at DHT4B: Division of Infection Control and Plastic Surgery Devices. She also works at OHT4: Office of Surgical and Infection Control Devices. Her office is the Office of Product Evaluation and Quality, Center for Devices and Radiological Health. The letter begins with the salutation, "Sincerely,"
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2005
Mr. Robert V. Packard Quality Assurance Manager Z-Medica Corporation 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K050769
Trade/Device Name: QuickClot® Brand Hemostatic Agent Regulatory Class: Unclassified Product Code: FRO Dated: March 23, 2005 Received: March 25, 2005
Dear Mr. Packard:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Robert V. Packard
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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10
STATEMENT OF INDICATIONS FOR USE
QuikClot® Brand Hemostatic Agent is intended for emergency use only as an external temporary traumatic wound treatment to achieve hemostasis for moderate to severe bleeding.
Prescription Use ) (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nostorative
Page 1 of
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K050769 A
APR 1 4 2005
QuikClot® Advanced Beaded Formulation Trade Name: Class 1 Device Class: General and Plastic Surgery Classification Panel: Traumatic Wound Dressing Common Name: Dressing Classification Name: FRO Classification Code: OuikClot® Brand Hemostatic Granules Predicate Device: 510(k) No. K013390 Robert V. Packard, QA Manager Submitted By: Z-Medica Corporation Company Name: 4 Fairfield Blvd., Wallingford, CT 06492 Company Address: (203) 294-0000 Company Phone: March 23, 2005 Prepared:
510(k) Summary
Device Description
The new bead form of QuikClot® Brand Hemostatic Agent, also called "Advanced Beaded Formulation", is intended for emergency use as an external temporary traumatic wound treatment to achieve hemostasis and prevent blood loss.
The beads consist of a synthetic molecular sieve (zeolite) that accelerates the body's natural clotting processes by increasing the concentration of platelets and clotting factors at the wound site. Individual sieve particles of the hemostatic agent adsorb water molecules. As the water is removed from the blood, the platelets and clotting factors are concentrated. The platelets have been activated by the normal response to injury. This adsorption process is exothermic. The resultant increase in temperature at the site of application increases the rate of the clotting reactions and platelet aggregation and adhesion.
Both of the mechanisms described above, concentration of clotting factors and the increase in rates of platelet aggregation/adhesion, work together to increase the clotting rate. This would be consistent with what is known about the effects of temperature and concentration on coagulation enzyme activity and platelet function.
The product is designed and packaged to be easily packed, carried and applied using only one hand. It is well suited for moderate to large eviscerating wounds, to create hemostasis by coagulation.
Used in conjunction with direct pressure, QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation reduces blood loss dramatically, and significantly increases survivability of high volume catastrophic wounds.
In-Vivo testing on swine was performed at the Portsmouth Naval Hospital in Virginia. Tests demonstrated that the bead form performs at least as well as the current
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K050769 page 2/2
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granular product in the swine femoral artery model. A summary of that testing is included with this pre-market submission.
This application for Special 510(k) clearance concerns the same hemostatic agent in two different physical sizes with a round bead shape instead of granular. The intended use of the product, however, is the same: temporary external use only. The granular and bead forms have the same chemical composition. but the physical size and shape are different. Chemical analysis, performed by the manufacturer of the synthetic molecular sieve, verified the compositions of both sizes of round beads are identical to the current granular product. Therefore, Z-Medica Corporation has determined that repeating the biocompatibility testing is not required. The original biocompatibility testing was completed by ISO 17025 Certified MicroTest Laboratories, Inc., of Agawam, Mass. The tests included:
| Test | Sample # | Dated |
|---|---|---|
| Agar Overlay Cytotoxicity Test | 02-00480 | 01/29/02 |
| Water Adsorption Rate | 02-00254 | 01/21/02 |
| Skin Sensitization | 01-06556 | 12/21/01 |
| Skin Irritation | 01-06555 | 12/07/01 |
| Intracutaneous Test | 01-06554 | 11/30/01 |
| Muscle Implant | 01-06476 | 01/08/02 |
| Long-Term Muscle Implant | 03-01247 | 11/13/03 |
QuikClot® Brand Hemostatic Agent, Advanced Beaded Formulation is a safe, effective, low cost traumatic wound dressing which is substantially alike in purpose, characteristic, process, and result to the QuikClot® Brand Hemostatic Granules, and thereby eligible for approval under 510(k).
N/A