(102 days)
No
The device description and performance studies focus on mechanical and electrical functions, with no mention of AI/ML algorithms or data processing.
Yes
The device is an accessory intended to be used with the FlowCardia CROSSER CTO Recanalization System, which is a therapeutic system for recanalizing chronic total occlusions. Therefore, the FlowMate Injector is part of a therapeutic system.
No
The device is described as a sterile saline injector that is an accessory to a recanalization system. Its function is to infuse saline, not to diagnose a condition or disease.
No
The device description clearly states it is a sterile saline injector, which is a hardware component. It also mentions compatibility with a disposable sterile syringe and operation by a footswitch, further indicating a physical device. While it is programmed, the primary function is mechanical fluid delivery, not software processing of data.
Based on the provided information, the FlowCardia FlowMate Injector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "sterile saline injector for use as an accessory to the FlowCardia CROSSER CTO Recanalization System." This describes a device used in vivo (within the body) during a medical procedure, not for testing samples in vitro (outside the body).
- Device Description: The description details its function as an injector for saline, its connection to a system used for recanalization (opening blocked blood vessels), and its operation via a footswitch. This aligns with a device used in a clinical setting for a therapeutic or interventional procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The FlowMate Injector's function is to deliver saline during a procedure, not to perform diagnostic testing on a sample.
N/A
Intended Use / Indications for Use
The FlowCardia FlowMate Injector is intended for use as a sterile saline injector for use as an accessory to the FlowCardia CROSSER CTO Recanalization System.
Product codes
DXT
Device Description
The FlowMate Injector is a sterile saline injector intended to be used as an accessory to the CROSSER CTO Recanalization System. The CROSSER System consists of a Generator, footswitch, and disposable catheter. The FlowMate Injector is designed to infuse saline at a rate of 0.3ml/sec (18 ml/min) at a maximum back pressure of 200 PSI. The FlowMate Injector is compatible for use with a 150ml disposable sterile syringe and is operated by a footswitch. A jumper cable is supplied with the FlowMate Injector to allow connection to the CROSSER System Generator. The FlowMate Injector is programmed to first start the Injector, and then the CROSSER System Generator each time the footswitch is depressed.
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
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
Design analysis and comparative bench testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia FlowMate Injector met the acceptance criteria and performed similarly to the predicate device. The following functional and safety tests were performed: design validation, installation and set-up verification, output volume verification, alarm and safety function verification, electrical safety and electromagnetic compatibility, life cycle testing and CROSSER System Generator integration verification.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows the logo for Flowcardia, Inc. The logo features the company name in bold, capitalized letters. Underneath the name is a horizontal line that extends into a sine wave pattern, terminating in a heart shape on the right side of the image. The text "K090621" is written in cursive above the sine wave.
5) 510(k) Summary
Regulatory Class:
Product Code:
.
:
510(k) numbers:
This summary of 510(k) information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21CFR807.92.
| 510(k) Number | |
|---|---|
| Applicant Information | |
| Date Prepared: | March 6, 2009 |
| Name and Address: | FlowCardia, Inc. |
| 745 N. Pastoria Avenue | |
| Sunnyvale, CA 94085 | |
| Ph: (408) 617-0352 | |
| Contact Person: | Dustin Michaels, Vice President of CR/QA/RA |
| Ph: (408) 617-0352 x302 | |
| Fax: (408) 617-9198 |
JUN 19 2009
| Device Information | |
|---|---|
| Trade / Device Name: | The FlowCardia FlowMate Injector |
| Regulation Number: | 21 CFR 880.1650 |
| Device Classification Name: | Angiographic injector and syringe |
| Regulatory Class: | II |
| Product Code: | DXT |
Since the FlowCardia FlowMate Injector is intended to be an accessory to the
FlowCardia CROSSER System, the device information of the CROSSER is referenced below:
| Trade / Device Name: | The CROSSER System |
|---|---|
| Regulation Number: | 21 CFR 870.1250 |
| Device Classification Name: | Percutaneous Catheter |
II
DQY
1
Predicate Device
The Mark V Plus Angiographic Injection System manufactured by Medrad, Inc. (K903390)
Device Description
The FlowMate Injector is a sterile saline injector intended to be used as an accessory to the CROSSER CTO Recanalization System. The CROSSER System consists of a Generator, footswitch, and disposable catheter. The FlowMate Injector is designed to infuse saline at a rate of 0.3ml/sec (18 ml/min) at a maximum back pressure of 200 PSI. The FlowMate Injector is compatible for use with a 150ml disposable sterile syringe and is operated by a footswitch. A jumper cable is supplied with the FlowMate Injector to allow connection to the CROSSER System Generator. The FlowMate Injector is programmed to first start the Injector, and then the CROSSER System Generator each time the footswitch is depressed.
Technological Characteristics
The FlowCardia FlowMate Injector is substantially equivalent to the predicate device. The predicate and FlowCardia FlowMate Injector are substantially equivalent with respect to meeting performance specifications and meeting electrical and safety standards. Both devices are intended for infusion using a 150 ml disposable syringe. In addition, both the FlowMate Injector and the predicate may be used to control other electromechanical equipment (the FlowCardia CROSSER System Generator and radiographic imaging systems, respectively).
Physical Test Data
Design analysis and comparative bench testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia FlowMate Injector met the acceptance criteria and performed similarly to the predicate device. The following functional and safety tests were performed: design validation, installation and set-up verification, output volume verification, alarm and safety function verification, electrical safety and electromagnetic compatibility, life cycle testing and CROSSER System Generator integration verification.
Conclusion
Based upon technological and physical comparisons the FlowCardia FlowMate Injector is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle.
JUN 19 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FlowCardia, Inc. c/o Mr. Dustin Michaels Vice President, Clinical, Ouality & Regulatory Affairs 745 North Pastoria Ave. Sunnyvale, CA 94085
Re: K090621
Trade/Device Name: FlowMate Injector Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: June 12, 2009 Received: June 16, 2009
Dear Mr. Michaels:
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 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.
3
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/CDRHQffices/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Vochines
Image /page/3/Picture/5 description: The image shows a close-up of a handwritten symbol or character. The symbol consists of a curved line that forms a loop at the top, followed by a downward stroke that ends in a horizontal line. The symbol is drawn in black ink on a white background. The symbol is simple and abstract, and it is difficult to determine its meaning without additional context.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number (if known):
8090621
Device Name:
FlowCardia FlowMate Injector
Indications for Use:
The FlowCardia FlowMate Injector is intended for use as a sterile saline injector for use as an accessory to the FlowCardia CROSSER CTO Recanalization System.
Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (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)
g
Dina R. Lames
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_ko90G Z