(26 days)
Not Found
No
The device description and performance studies focus on the chemical and physical properties of zeolite beads for hemostasis, with no mention of AI or ML.
Yes
The device is intended to control traumatic bleeding, which is a therapeutic intervention.
No
The device is described as treating traumatic bleeding by promoting clotting, not diagnosing any condition.
No
The device description clearly states it is a mesh bag containing zeolite beads, which are physical components, not software. The performance studies also focus on the physical properties and effects of the material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for temporary external use to control traumatic bleeding." This describes a device used directly on the body to treat a physical condition (bleeding).
- Device Description: The device is a mesh bag containing zeolite beads, applied externally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a person's health status, diagnose diseases, or monitor treatments. This device does not involve the analysis of specimens.
The device described is a hemostatic agent, used to stop bleeding externally.
N/A
Intended Use / Indications for Use
This device is intended for temporary external use to control traumatic bleeding.
Product codes
QSY, FRO
Device Description
QuikClot 1* Response™ and QuikClot ACS+'" are essentially the same device, but in two different sizes. Both devices are 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
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
ISO Standard 10993-1:1997 was followed for demonstrating biocompatibility of the component materials and the finished device—all passed. In order to substantiate that the risk of burns has been eliminated, in-vitro and in-vivo temperature measurements were made. In in-vitro testing, an excess of zeolite was mixed with water. The peak temperature was reduced from 190 F (predicate device) to 90 F (device modification). Care givers that evaluated the product in a preclinical animal wound model experienced a peak temperature of 106 F and agreed that the risk of burns was eliminated. Care givers described the heat generated as "warm".
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 the reformulated zeolite took less than 3 minutes to form a clot, while whole blood without zeolite took longer than 6 minutes to form a clot. In-vivo testing in various swine models was used to demonstrate substantial equivalence to the predicate device.
Key Metrics
Peak temperature in in-vitro testing: reduced from 190 F (predicate device) to 90 F (device modification).
Peak temperature in preclinical animal wound model: 106 F.
Clotting time of whole blood with zeolite (device modification and predicate): less than 3 minutes.
Clotting time of whole blood without zeolite: longer than 6 minutes.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 11, 2023
Z-Medica Corporation c/o Robert V. Packard Director of Regulatory Affairs 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K061767 Trade/Device Name: QuikClot 1st ResponseTM & QuikClot ACS+TM 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 July 19, 2006. 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: This image shows the closing of a letter, including the name and title of the sender. The sender is Julie A. Morabito, Ph.D., who is the Assistant Director of DHT4B: Division of Infection Control and Plastic Surgery Devices. The letter also includes the sender's office, which is OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality, and Center for Devices and Radiological Health.
1
Image /page/1/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
JUL 1 9 2006
Z-Medica Corporation % Mr. Robert V. Packard Director of Regulatory Affairs 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K061767
Trade/Device Name: QuikClot 1st Response™ & QuikClot ACS+"" Regulatory Class: Unclassified Product Code: FRO Dated: June 22, 2006 Received: June 23, 2006
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. 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
2
Page 2 - Mr. Robert V. Packard
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 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,
Barbara Buechner
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 Ko 61-76 7
Device Trade Names: QuikClot 1st Response™ & QuikClot ACS+""
Device Common Name: Advanced Clotting Sponge
Indications For Use:
This device is intended for temporary external use to control traumatic bleeding.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchmo
Division Sign Off
Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K061767
4
510(k) Summary for QuikClot 1* Response™ & QuikClot ACS+™
Page 1 of 2
510(k) Summary
| JUL 19 2006 | |||
|---|---|---|---|
| Trade Names: | QuikClot 1st Response™ & QuikClot ACS+™ | ||
| Device Class: | Class 1 | ||
| Classification Panel: | General and Plastic Surgery | ||
| Common Name: | Traumatic Wound Dressing | ||
| Classification Name: | Dressing | ||
| Classification Code: | FRO | ||
| Predicate Device: | QuikClot ACS™ Advanced Clotting Sponge | ||
| 510(k) No. K051955 | |||
| Submitted By: | Robert V. Packard, Dir. of Regulatory Affairs | ||
| Company Name: | Z-Medica Corporation | ||
| Company Address: | 4 Fairfield Blvd., Wallingford, CT 06492 | ||
| Company Phone: | +1-203-294-0000 x262 | ||
| Prepared: | June 22, 2006 |
Description of Device
QuikClot 1* Response™ and QuikClot ACS+'" are essentially the same device, but in two different sizes. Both devices are mesh bags containing zeolite beads. The devices are vacuum packed in multi-layer pouches to ensure sterility and efficacy. Product attributes of the two sizes are provided in the table below.
| Attribute | QuikClot 1st Response™ | QuikClot ACS+™ |
|---|---|---|
| Intended Use | For Temporary External Use To | |
| Control Traumatic Bleeding | For Temporary External Use To | |
| Control Traumatic Bleeding | ||
| Mesh Bags Per | ||
| Unit | One | One |
| Net Weight of | ||
| Zeolite | 0.88oz | 3.5oz |
| Mesh Bag | ||
| Dimensions | 3.5"x3.5" | 10"x5" |
| Baffling | No baffles – 1 compartment with | |
| 3.5oz of zeolite | 3 baffles – creating 4 compartments | |
| with 0.88oz of zeolite each | ||
| Primary | ||
| Packaging | 4.5"x4.5" multi-layer pouch, | |
| vacuum-packed | 6"x6.5" 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 control traumatic bleeding (prescription only).
5
Page 2 of 2
Summary of Technological Characteristics Compared to Predicate Device
This is a device modification of QuikClot ACS™ Advanced Clotting Sponge (K051955). Both sizes of the device modification 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 improvements made to the predicate device:
-
- The zeolite beads were reformulated to reduce the heat of adsorption. Although generation of heat remains an intimate part of zeolite's mechanism of action, the risk of burns to caregivers and patients has been eliminated by the device modification.
-
- A blue silicone rod, Class VI medical grade, with barium sulfate has been added to each mesh bag. This change allows medical personnel to locate the mesh bag with an X-ray if accidentally left in a wound.
- Baffles were added to the larger size mesh bag, 10″x5″, to facilitate application of the 3. zeolite beads to larger wounds.
- Directions for use were simplified from the directions for the predicate device. The 4. predicate device instructed the care giver to use pressure to control the bleeding first, and then apply the product if pressure failed to control bleeding. Since this device modification eliminates the risk of burns, the care giver is not instructed to control bleeding with pressure alone first.
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—all passed. In order to substantiate that the risk of burns has been eliminated, in-vitro and in-vivo temperature measurements were made. In in-vitro testing, an excess of zeolite was mixed with water. The peak temperature was reduced from 190 F (predicate device) to 90 F (device modification). Care givers that evaluated the product in a preclinical animal wound model experienced a peak temperature of 106 F and agreed that the risk of burns was eliminated. Care givers described the heat generated as "warm".
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 the reformulated zeolite took less than 3 minutes to form a clot, while whole blood without zeolite took longer than 6 minutes to form a clot. In-vivo testing in various swine models was used to demonstrate substantial equivalence to the predicate device.
Conclusions
Based on the design, biocompatibility data, in-vitro test data, pre-clinical test results, and intended use, QuikClot 1* Response™ and QuikClot ACS+™ are substantially equivalent to the predicate device (QuikClot ACS™ - Advanced Clotting Sponge K051955).