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.

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.

AI/ML Overview

The provided text describes the FlowCardia FlowMate Injector, an accessory intended for use with the FlowCardia CROSSER CTO Recanalization System as a sterile saline injector.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it describes a comparative bench testing approach to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance:
- Infuse saline at a specified rate	- Designed to infuse saline at a rate of 0.3ml/sec (18 ml/min).
- Withstand maximum back pressure	- Designed to operate at a maximum back pressure of 200 PSI.
- Compatibility with disposable syringe	- Compatible for use with a 150ml disposable sterile syringe.
- Operation via footswitch	- Operated by a footswitch.
- Integration with CROSSER System Generator	- Jumper cable supplied for connection to the CROSSER System Generator. Programmed to first start the Injector, then the CROSSER System Generator each time the footswitch is depressed.
Safety Performance:
- Electrical safety and electromagnetic compatibility compliance	- Electrical safety and electromagnetic compatibility tests were performed. (Implies compliance, but no specific results given).
- Alarm and safety function verification	- Alarm and safety function verification was performed. (Implies satisfactory performance, but no specific details).
Other:
- Design validation	- Design validation tests were performed. (Implies compliance).
- Installation and set-up verification	- Installation and set-up verification tests were performed. (Implies compliance).
- Output volume verification	- Output volume verification tests were performed. (Implies accurate volume delivery).
- Life cycle testing	- Life cycle testing was performed. (Implies durability and longevity meet requirements).
- Substantial equivalence to predicate device	- "Based upon technological and physical comparisons 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..."

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "comparative bench testing" and lists several functional and safety tests. However, it does not specify the sample size used for these tests. The data provenance is described as "bench testing," indicating laboratory-based studies rather than patient data. No information on country of origin for data is provided, but since it's bench testing, it's typically conducted internally or by a contracted lab. The studies would be considered prospective in nature, as they were conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies described are bench tests of a physical device's performance (e.g., flow rate, pressure, electrical safety) rather than studies requiring expert interpretation of medical data (like radiology images or pathology slides) to establish "ground truth." The "truth" in these tests is objective measurement against specified parameters.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Bench testing of device performance does not typically involve adjudication methods like those used for interpreting medical images or clinical outcomes.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-reader Multi-case (MRMC) comparative effectiveness study was not done. The study described is a bench performance evaluation, not a clinical study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable in the context of this device. The FlowMate Injector is a physical medical device, not an algorithm or AI system that would have a "standalone" algorithmic performance. The tests performed are of the device's functional and safety characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests consisted of objective engineering specifications and measurements (e.g., whether the device infused saline at 0.3ml/sec, whether it withstood 200 PSI, electrical safety standards compliance). It does not involve expert consensus, pathology, or outcomes data, as it's a non-AI, non-diagnostic device.

8. The Sample Size for the Training Set

This information is not applicable. The FlowMate Injector is not an AI/ML device, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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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 AvenueSunnyvale, CA 94085Ph: (408) 617-0352
Contact Person:	Dustin Michaels, Vice President of CR/QA/RAPh: (408) 617-0352 x302Fax: (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

K062868, K072776, K080765

DQY

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Predicate Device

The Mark V Plus Angiographic Injection System manufactured by Medrad, Inc. (K903390)

Device Description

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.

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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.

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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

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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)

Dina R. Lames
(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_ko90G Z

Regulation Number and Section

§ 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.