(135 days)
Cardiva Medical Boomerang™ Catalyst II System (K072297)
Not Found
No
The description focuses on mechanical and material properties (wire, clip, coating with Protamine Sulfate) for hemostasis, with no mention of AI or ML.
Yes
The device is intended to promote hemostasis and provide temporary hemostasis, which directly addresses a health condition (bleeding at an arteriotomy site) and is therefore therapeutic.
No
The device is intended to promote hemostasis (stop bleeding) after femoral artery catheterization procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (wire, clip, disc) and a biocompatible coating, indicating it is a hardware-based medical device.
Based on the provided information, the Cardiva Catalyst™ III System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Cardiva Catalyst™ III System Function: The description clearly states that the Cardiva Catalyst™ III System is a device used directly within the body (intravascularly) to promote hemostasis at an arteriotomy site. It is a mechanical device with a coating, not a device that analyzes biological specimens outside the body.
The device's function is to physically interact with the blood vessel to aid in stopping bleeding, which is a therapeutic/procedural function, not a diagnostic one based on analyzing samples.
N/A
Intended Use / Indications for Use
The Cardiva Catalyst™ III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst™ III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.
Product codes
DXC
Device Description
The Cardiva Catalyst™ III System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst III system includes a design modification which involves the addition of Protamine Sulfate to the existing Boomerang Catalyst II System coating to further minimize ocze from the tissue tract and promote the hemostasis process in heparinized patients. The Cardiva Catalyst III System maintains the same indication for use as the Boomerang Catalyst System family of devices.
The Cardiva Catalyst III System consists of a sterile disposable Cardiva Catalyst III wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III System is specifically designed for use with heparinized patients. In conjunction with manual compression, the Cardiva Catalyst III System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Cardiva Catalyst III wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Cardiva Catalyst III wire is deployed, which opens the flat, low-profile Catalyst Disc within the lumen of the femoral artery. During dwell, natural recoil of the smooth muscle of the vessel wall occurs at the arteriotomy site. A biocompatible coating on the Cardiva Catalyst III Wire aides the body's natural hemostatic process and promotes ease of removal. Specifically, the Cardiva Catalyst III System's biocompatible coating includes a minimal amount of Protamine Sulfate to further aid the body's natural hemostatic process in heparinized patients. Following the procedure, the Catalyst Disc is collapsed and the Cardiva Catalyst III wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Cardiva Catalyst III System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral artery
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
All necessary bench testing was conducted on the Cardiva Catalyst III System to support a determination of substantial equivalence to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Cardiva Medical Boomerang™ Catalyst II System (K072297)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
CARDIVA MEDICAL, INC.
Cardiva Catalyst™ III System TRADITIONAL 510(k) PREMARKET NOTIFICATION
SECTION 6 510(k) SUMMARY
510(k) Notification K082930
GENERAL INFORMATION
Applicant:
Cardiva Medical, Inc. 2585 Leghorn Street Mountain View, CA 94043 Phone: 650-964-8900 Facsimile: 650-964-8911
Contact Person:
Kit Cariquitan Regulatory Consultant Experien Group, LLC Phone: 408-400-0856 Facsimile: 408-400-0865 Email: kitc@experiengroup.com
Date Prepared: September 30, 2008
Classification: 21 CFR §870.4450, Class II
Product Code: DXC
Trade Name: Cardiva Catalyst™ III System
Generic/Common Name: Vascular Clamp
PREDICATE DEVICE
Cardiva Medical Boomerang™ Catalyst II System (K072297)
INTENDED USE
The Cardiva Catalyst™ III System with Protamine Sulfate is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression in heparinized patients. The Cardiva Catalyst™ III System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.
FEB 1 3 2009
1
CARDIVA MEDICAL, INC.
Cardiva Catalyst™ III System TRADITIONAL 510(k) PREMARKET NOTIFICATION
SECTION 6 510(k) SUMMARY (CONT.)
PRODUCT DESCRIPTION
The Cardiva Catalyst™ III System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst III system includes a design modification which involves the addition of Protamine Sulfate to the existing Boomerang Catalyst II System coating to further minimize ocze from the tissue tract and promote the hemostasis process in heparinized patients. The Cardiva Catalyst III System maintains the same indication for use as the Boomerang Catalyst System family of devices.
The Cardiva Catalyst III System consists of a sterile disposable Cardiva Catalyst III wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst III System is specifically designed for use with heparinized patients. In conjunction with manual compression, the Cardiva Catalyst III System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Cardiva Catalyst III wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Cardiva Catalyst III wire is deployed, which opens the flat, low-profile Catalyst Disc within the lumen of the femoral artery. During dwell, natural recoil of the smooth muscle of the vessel wall occurs at the arteriotomy site. A biocompatible coating on the Cardiva Catalyst III Wire aides the body's natural hemostatic process and promotes ease of removal. Specifically, the Cardiva Catalyst III System's biocompatible coating includes a minimal amount of Protamine Sulfate to further aid the body's natural hemostatic process in heparinized patients. Following the procedure, the Catalyst Disc is collapsed and the Cardiva Catalyst III wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Cardiva Catalyst III System.
SUBSTANTIAL EQUIVALENCE
The Cardiva Catalyst III System is substantially equivalent to the predicate device with regard to function, intended use, and physical characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the Cardiva Catalyst III System is substantially equivalent to the predicate device.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION All necessary bench testing was conducted on the Cardiva Catalyst III System to support a determination of substantial equivalence to the predicate device.
SUMMARY
The Cardiva Catalyst III System is substantially equivalent to the predicate device.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2009
Experien Group LLC c/o Mr. Kit Cariquitan Regulatory Consultant for Cardiva Medical 155 Moffett Park Drive, Suite A.2IO Sunnyvale, CA 94089
Re: K082930
Cardiva Catalyst™ III System with Protamine Sulfate Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: January 21, 2009 Received: January 22, 2009
Dear Mr. Cariquitan:
This letter corrects our substantially equivalent letter of April 23, 2009.
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 (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 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
3
Page 2 - Mr. Kit Cariquitan
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
R. Lachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Page 3 - Mr. Kit Cariquitan
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,
R. Zukerman, M.D.
Bram D. Zuckerman, M.D. Director! Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health