(30 days)
No
The device description and performance studies focus on the physical properties and hemostatic function of the bandage, with no mention of AI or ML.
Yes
The device is indicated for the local management and control of surface bleeding, which is a therapeutic action.
No
Explanation: The device is a hemostatic bandage used to control surface bleeding, which is a therapeutic function, not a diagnostic one. It does not identify or characterize a disease or condition.
No
The device description clearly states it is a kit consisting of a hemostatic pad (kaolin impregnated gauze) and an adhesive bandage, 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 for the "local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes". This describes a direct application to the body to control bleeding, which is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a hemostatic bandage with a pad and adhesive. This is a physical device designed to stop bleeding, not to analyze samples from the body for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
QuikClot® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.
Product codes
QSY, FRO
Device Description
QuikClot® Interventional™ hemostatic bandage is a kit that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® 4" x 4-3/4" bandage (reference K973036). The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by 1 ½" wide by ½" thick multi-layer pad. The pad is held secured in place by stitching with polyester thread. QuikClot® Interventional™ hemostatic bandage is packaged in a plastic tray within a peelable foil pouch and irradiated to a SAL of 104.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription 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
In pre-clinical porcine model testing, QuikClot® Interventional™ hemostatic bandage has demonstrated hemostasis following the removal of percutaneous vascular access catheters. The dressing successfully controlled all bleeding following 25 vascular access procedures when either an 8French or a 12French tissue dilator was used. QuikClot® Interventional™ hemostatic bandage controlled bleeding as effectively as the ChitoFlex-Surgical dressing and the D-Stat Dry™ Hemostatic Bandage predicate devices. QuikClot® Interventional™ hemostatic bandage is composed of identical materials as the QuikClot® eX™ device, therefore the successful biocompatibility testing for QuikClot® eX™ device (MEM Elution, Kligman Maximization, and Intracutaneous Injection) also applies to the QuikClot® Interventional™ hemostatic bandage.
Key Metrics
Not Found
Predicate Device(s)
QuikClot® eX™ (K072474), D-Stat Dry™ Hemostatic Bandage (K061219), ChitoFlex-Surgical dressing (K080818)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which 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.
July 28, 2023
Z-Medica Corporation c/o Ronald E. Peterson Director of Quality Assurance and Regulatory 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K090620 Trade/Device Name: Quikclot® Inteventional™ Regulatory Class: Unclassified Product Code: QSY
Dear Ronald E. Peterson:
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 8, 2009. 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
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2009
Z-Medica Corporation % Mr. Ronald E. Peterson Director of Ouality Assurance and Regulatory 4 Fairfield Boulevard Wallingford, Connecticut 06492
Re: K090620
Trade/Device Name: QuikClot® Interventional™ Regulatory Class: Unclassified Product Code: FRO Dated: March 5, 2009 Received: March 9, 2009
Dear Mr. Peterson:
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
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Page 2 - Mr. Ronald E. Peterson
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Sincerely yours,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K090620 510(k) Number (if known):
Device Trade Name: QuikClot® Interventional™
Indications for Use:
QuikClot® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
Image /page/3/Picture/8 description: The image contains a white square with a black border. The square appears to be a checkbox, and it is not filled in. The checkbox is likely part of a form or survey where the user can select or deselect an option.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for MXM
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K090620
March 5, 2009 Z-Medica Corporation 4 Fairfield Blvd., Wallingford, CT 06492, Tel: +1.203.294.0000, Fax: +1.203.294.0688
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510(k) Summary
APR - 8 2009
| Trade Name: | QuikClot® Interventional™ hemostatic bandage |
|---|---|
| Device Class: | Unclassified |
| Classification Panel: | General and Plastic Surgery |
| Classification Name: | Dressing |
| Classification Code: | FRO |
| Predicate Device(s): | QuikClot® eX™ (K072474) |
| D-Stat Dry™ Hemostatic Bandage (K061219) | |
| ChitoFlex-Surgical dressing (K080818) | |
| Submitted By: | Ronald E. Peterson, Dir. of QA and Regulatory |
| Company Name: | Z-Medica Corporation |
| Company Address: | 4 Fairfield Blvd., Wallingford, CT 06492 |
| Company Phone: | +1-203-294-0000 x262 |
| Prepared: | March 5, 2009 |
Description of Device
QuikClot® Interventional™ hemostatic bandage is a kit that consists of a hemostatic pad and an adhesive bandage. The adhesive bandage is a 3M Tegaderm® 4" x 4-3/4" bandage (reference K973036). The hemostatic pad is a hemostatic dressing made of soft, white, kaolin impregnated gauze, configured in a 1 ½" long by 1 ½" wide by ½" thick multi-layer pad. The pad is held secured in place by stitching with polyester thread. QuikClot® Interventional™ hemostatic bandage is packaged in a plastic tray within a peelable foil pouch and irradiated to a SAL of 104.
Intended Use of Device
Prescription Use: QuikClot® Interventional™ hemostatic bandage is applied topically as an adjunct to manual compression and is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 12 Fr.
Discussion of Data to Support Substantial Equivalence
In pre-clinical porcine model testing, QuikClot® Interventional™ hemostatic bandage has demonstrated hemostasis following the removal of percutaneous vascular access catheters. The dressing successfully controlled all bleeding following 25 vascular access procedures when either an 8French or a 12French tissue dilator was used. QuikClot® Interventional™ hemostatic bandage controlled bleeding as effectively as the ChitoFlex-Surgical dressing and the D-Stat Dry™ Hemostatic Bandage predicate devices. QuikClot® Interventional™ hemostatic bandage is composed of identical materials as the QuikClot® eX™ device, therefore the successful biocompatibility testing for QuikClot® eX™ device (MEM Elution, Kligman Maximization, and Intracutaneous Injection) also applies to the QuikClot® Interventional™ hemostatic bandage.
Conclusion
Based on the in-vivo test data and the device description, the QuikClot® Interventional™ hemostatic bandage is substantially equivalent in indications for use and technology to the predicate devices (QuikClot® eX™ (K072474), D-Stat Dry™ Hemostatic Bandage (K061219) and ChitoFlex-Surgical dressing (K080818)).