(22 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of zeolite beads for hemostasis and antimicrobial action, with no mention of AI or ML.
Yes
The device is intended for temporary external use to stop bleeding, which is a therapeutic action aimed at treating an injury.
No
Explanation: The "Intended Use" clearly states the device is for "temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions." This describes a therapeutic, not a diagnostic, function. The device description and performance studies further support its role in promoting clotting.
No
The device description clearly states the device consists of "mesh bags containing zeolite beads," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stop bleeding of superficial wounds, minor cuts, and abrasions." This is a direct therapeutic action on the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device consists of "mesh bags containing zeolite beads" applied externally. This is a physical hemostatic agent, not a reagent or instrument used to analyze biological samples.
- Performance Studies: The performance studies described are "in-vitro test data measuring the clotting time of whole blood" and "in-vitro testing using cultures of S. aureus, E. coli, P. aeruginosa, and C. albicans." While these are in-vitro tests, they are used to demonstrate the efficacy of the device in promoting clotting and its antimicrobial properties, not to diagnose a condition or provide information about a patient's health status.
- Lack of Diagnostic Indicators: There is no mention of the device being used to detect, measure, or analyze any biological markers, substances, or characteristics to provide diagnostic information.
In summary, the QuikClot Sport™ and QuikClot Sport Silver™ are topical hemostatic agents used to control bleeding, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
QuikClot Sport™ & QuikClot Sport Silver™ are intended for temporary external use to stop bleeding of superficial wounds. minor cuts, and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
OSY, FRO
Device Description
QuikClot Sport™ and QuikClot Sport Silver™ are OTC versions of Z-Medica's prescription product: QuikClot 1st Response™ (K061767). These new devices consist of mesh bags containing zeolite beads. The devices are vacuum-packed in multi-layer pouches to ensure sterility and efficacy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
ISO Standard 10993-1:1997 was followed for demonstrating biocompatibility of the component materials and the finished device. In-vitro test data measuring the clotting time of whole blood was used to demonstrate that the device modification is not inferior in efficacy to the predicate device. The zeolite formulation used in the predicate device and these two new OTC products took less than 5 minutes to form a clot, while whole blood without zeolite took longer than 9 minutes to form a clot. Antimicrobial properties were demonstrated by in-vitro testing using cultures of S. aureus, E. coli, P. aeruginosa, and C. albicans (common infectious microorganisms). Exposure to QuikClot Sport Silver™ resulted in a greater than a 4-log reduction in viable organisms within 60 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Whole blood clotting time: Less than 5 minutes with zeolite, longer than 9 minutes without zeolite.
Antimicrobial properties (QuikClot Sport Silver™): greater than a 4-log reduction in viable organisms within 60 minutes for S. aureus, E. coli, P. aeruginosa, and C. albicans.
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
N/A
0
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June 11, 2023
Z-Medica Corporation c/o Giacomo Basadonna, M.D., Ph.D. 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K070010 Trade/Device Name: QuikClot Sport™ and QuikClot Sport Silver™ Regulatory Class: Unclassified Product Code: OSY
Dear Giacomo Basadonna, M.D., Ph.D.:
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 January 25, 2007. 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.
Sincerely, Julie A. Morabito -S
Julie Morabito, Ph.D. 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
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Z-Medica Corporation % Giacomo Basadonna, M.D., Ph.D. 4 Fairfield Boulevard Wallingford, Connecticut 06492
JAN 2 5 2007
Re: K070010
Trade/Device Name: QuikClot Sport™ and Quikclot Sport Silver™ Regulatory Class: Unclassified Product Code: FRO Dated: December 29, 2006 Received: January 3, 2006
Dear Dr. Basadonna:
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.
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) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other
2
Page 2 - Giacomo Basadonna, M.D., Ph.D.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Muller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number (if known): TBD KO70010
Device Trade Names: QuikClot Sport™ & QuikClot Sport Silver™
Device Common Name: Advanced Clotting Sponge
Indications For Use:
QuikClot Sport™ & QuikClot Sport Silver™ are intended for temporary external use to stop bleeding of superficial wounds. minor cuts, and abrasions.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, C
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K070010
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510(k) Summary for QuikClot Sport™ & QuikClot Sport Silver™
Page 1 of 2
2070010 Page 1/2
510(k) Summary
| Trade Name: | QuikClot Sport™ and QuikClot Sport Silver™ | |
|---|---|---|
| Device Class: | Class 1 | |
| Classification Panel: | General and Plastic Surgery | |
| Common Name: | JAN 2 5 2007 | |
| Wound Dressing | ||
| Classification Name: | Dressing | |
| Classification Code: | FRO, UNClassified | |
| Predicate Device: | Hemosorb™ Granular Hemostatic Agent (K021581) | |
| QuikClot 1st Response™ Hemostatic Agent (K061767) | ||
| Submitted By: | Dr. Giacomo Basadonna, M.D., Ph.D. | |
| Company Name: | Z-Medica Corporation | |
| Company Address: | 4 Fairfield Blvd., Wallingford, CT 06492 | |
| Company Phone: | (203) 294-0000 x233 | |
| Prepared: | December 29, 2006 | |
Description of Device
QuikClot Sport™ and QuikClot Sport Silver™ are OTC versions of Z-Medica's prescription product: QuikClot 1st Response™ (K061767). These new devices consist of mesh bags containing zeolite beads. The devices are vacuum-packed in multi-layer pouches to ensure sterility and efficacy. Product attributes of the two new OTC product versions are provided in the table below.
| Attribute | QuikClot Sport™ | QuikClot Sport Silver™ |
|---|---|---|
| Antimicrobial | No | Silver causes >4-log reduction of S. aureus, E. coli, P. aeruginosa, and C. albicans within 60 minutes of exposure |
| Net Weight of | ||
| Zeolite Beads | 0.88oz & 1.75oz sizes available | 0.88oz & 1.75oz sizes available |
| Mesh Bag | ||
| Dimensions | 3.5"x3.5" (0.88oz) & 5"x5" (1.75oz) | 3.5"x3.5" (0.88oz) & 5"x5" (1.75oz) |
| Primary | ||
| Packaging | Individually packaged in multi- | |
| layer pouch, vacuum-packed | Individually packaged in multi- | |
| layer pouch, vacuum-packed | ||
| Sterilization | gamma sterilization – 25-50kGy | |
| (SAL = 10-6) | gamma sterilization – 25-50kGy | |
| (SAL = 10-6) |
Intended Use of Device
For temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions (Over-The-Counter Use).
5
510(k) Summary for QuikClot 1st Response™ & QuikClot ACS+"
Page 2 of 2
page 2/2
Summary of Technological Characteristics Compared to Predicate Devices
This is a device modification of QuikClot 1st Response™ Advanced Clotting Sponge (K061767). QuikClot Sport™ and QuikClot Sport Silver™ contain the same zeolite technology that Z-Medica Corporation has incorporated into previous QuikClot® brand hemostatic agents, granular QuikClot® (K013390/K021581) and QuikClot ACS™ (K051955), but this product uses zeolite that has been reformulated to reduce the heat of adsorption. The risk of burns to caregivers and the injured person has been eliminated by the zeolite reformulation.
Both sizes of QuikClot Sport™ and QuikClot Sport Silver™ make use of the same mesh fabric used for the predicate device, the same primary package construction, and the same production process. The following are modifications have been made to the predicate device:
- The X-ray detectable element has been eliminated (unnecessary for OTC version). 1.
- Directions for use were clarified from the directions for the predicate device. 2. Instructions now include diagrams for each step of the instructions to assist untrained users.
- The Silver version of the product contains silver that may reduce the risk of infection. 3.
Discussion of Data to Support Substantial Equivalence
ISO Standard 10993-1:1997 was followed for demonstrating biocompatibility of the component materials and the finished device. In-vitro test data measuring the clotting time of whole blood was used to demonstrate that the device modification is not inferior in efficacy to the predicate device. The zeolite formulation used in the predicate device and these two new OTC products took less than 5 minutes to form a clot, while whole blood without zeolite took longer than 9 minutes to form a clot. Antimicrobial properties were demonstrated by in-vitro testing using cultures of S. aureus, E. coli, P. aeruginosa, and C. albicans (common infectious microorganisms). Exposure to QuikClot Sport Silver™ resulted in a greater than a 4-log reduction in viable organisms within 60 minutes.
Conclusions
Based on the design, biocompatibility data, in-vitro test data, and intended use, QuikClot Sport™ and QuikClot Sport Silver™ are substantially equivalent to the predicate device (QuikClot 1* Response™ (K061767) and granular QuikClot®/Hemosorb™ (K013390/K021581).