The CROSSER® System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.

The CROSSER® Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

Device Description

The CROSSER® System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER Catheter. The CROSSER Over the Wire Catheter is available in two variations:

CROSSER 14P OTW (014 guidewire compatible flexible), .
CROSSER 14S OTW (014 guidewire compatible supportive). .

Each Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high frequency mechanical vibrations which are propagated through a Nitinol core wire to the Titanium tip of the CROSSER Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FLOWCARDIA, INC. CROSSER System, based on the provided text:

Acceptance Criteria and Device Performance

The documents do not provide a table with specific numerical or quantified acceptance criteria for each test (e.g., "Tensile Strength must be > X Newtons"). Instead, they state that the tests were conducted "to demonstrate that the FlowCardia CROSSER Over the Wire Catheters met the acceptance criteria and performed similarly to the predicate device."

Therefore, the table below reflects the types of tests performed and the general statement of meeting criteria, rather than specific performance metrics.

Acceptance Criterion (Test Type)	Reported Device Performance
Dimensional Verification	Met acceptance criteria (implicitly, as it passed testing)
Tensile Strength	Met acceptance criteria
Torque Strength	Met acceptance criteria
Torqueability	Met acceptance criteria
Tip Flexibility	Met acceptance criteria
Coating Adherence/Integrity	Met acceptance criteria
Benchtop Simulated Efficiency	Met acceptance criteria
Catheter Fatigue Testing	Met acceptance criteria
Biocompatibility	Met acceptance criteria
Shelf Life Testing	Met acceptance criteria
Similarity to Predicate Device	Performed similarly to the predicate device

Study Details

Sample size used for the test set and the data provenance:
- The document mentions "Design analysis, bench, and biocompatibility testing," but does not specify the sample sizes for these tests.
- The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It appears to be bench testing performed by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The testing appears to be primarily engineering and physical testing, not dependent on expert medical interpretation for ground truth.
Adjudication method for the test set:
- This information is not provided, as the tests are physical/bench tests rather than clinical evaluations requiring adjudication of expert opinions.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is a mechanical catheter system, not an AI-powered diagnostic or assistive technology for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a mechanical catheter and does not involve an algorithm for standalone performance.
The type of ground truth used:
- For the physical tests, the "ground truth" would be established by engineering specifications, standard test methods, and potentially the performance of the predicate device. For biocompatibility, it would be based on established international standards (e.g., ISO 10993).
The sample size for the training set:
- This question is not applicable. This device is a mechanical catheter and does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- This question is not applicable for the reasons mentioned above.

Summary

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MAY 15 2009

FLOWCARDIA, INC.

4) 510(k) Summary

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 K091119

Applicant Information

April 16, 2009 Date Prepared:

Name and Address: FlowCardia, Inc. 745 N. Pastoria Avenue Sunnyvale, CA 94085 Ph: (408) 617-0352
Dustin Michaels, Vice-President of CR/QA/RA Contact Person: Ph: (408) 617-0352 x302 Fax: (408) 617-9198

Device Information

Classification:	DQY
Trade Name:	The CROSSER System
Common Name: .	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 74 DQY / 21 CFR 870.1250

Predicate Device

The CROSSER System manufactured by FlowCardia, Inc. (K072776)

Device Description

CROSSER 14P OTW (014 guidewire compatible flexible), .
CROSSER 14S OTW (014 guidewire compatible supportive). .

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K091119 page 2 of 2

Indications for Use

The CROSSER® Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

Technological Characteristics

The FlowCardia CROSSER Over the Wire Catheters are substantially equivalent to the predicate device. The prodicate and CROSSER Over the Wire Catheters are identical with respect to indications for use and performance. The main difference is a rapid-exchange (RX) guidewire rail system in the predicate versus a conventional over-the-wire (OTW) guidcwire rail system. With respect to materials and design, the CROSSER Over the Wire Catheters are substantially equivalent to the predicate device with the exception of the catheter effective length (140 vs. 146cm) and guidewire lumen matcrials.

Physical Test Data

Design analysis, bench, and biocompatibility testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia CROSSER Over the Wire Catheters met the acceptance criteria and performed similarly to the predicate device. In addition to dimensional verification, the following functional tests were performed: Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence/Integrily, Bench top Simulated Efficiency, Catheter Fatigue Testing, Biocompatibility, and Shcif Life Testing.

Conclusion

Based unon the aforementioned compurison testing, the CROSSER Over the Wire Catheters are 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 features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

FlowCardia, Inc. Mr. Dustin Michaels Vice President, Clinical, Quality & Regulatory Affairs 745 N. Pastoria Ave. Sunnyvale, CA 94085

Re: K091119

Trade/Device Name: The Crosser System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: April 16, 2009 Received: April 17, 2009

SEP 1 8 2013

Dear Mr. Michaels:

This letter corrects our substantially equivalent letter of May 15, 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 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Z.M.Z.

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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3) Statement of Indications for Use

510(k) Number (if known):

K091119

Device Name:

The CROSSER® System

Indications for Use:

The CROSSER® Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper usc.

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

Division of

s : Ofic; Numbe

AND/OR

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)

(Division Sign-Off)

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).