The CROSSER S6 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 S6 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 S6 System consists of a re-usable electronic Generator, Foot Switch, high-frequency Transducer, and single-use CROSSER S6 Catheter.

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 stainless steel 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

This document describes the FlowCardia CROSSER S6 System, a medical device designed to assist in navigating guidewires beyond chronic total occlusions in peripheral arteries. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics.

Based on the provided information, a clinical study proving the device meets specific acceptance criteria in the context of human performance, as would be typical for an AI/ML device, was not conducted or reported in this 510(k) summary. This summary focuses on physical and bench testing to demonstrate substantial equivalence to previously cleared devices.

Here's an breakdown of the information that can be extracted and what is NOT available:

1. Table of acceptance criteria and reported device performance:

Test	Acceptance Criteria	Reported Device Performance
Design analysis	Met relevant guidance documents to demonstrate substantial equivalence to predicate device.	Performed similarly to predicate device.
Bench testing	Met relevant guidance documents to demonstrate substantial equivalence to predicate device.	Performed similarly to predicate device.
Biocompatibility testing	Met relevant guidance documents to demonstrate substantial equivalence to predicate device.	Met acceptance criteria.
Dimensional Verification	Not explicitly stated, but implied to meet design specifications.	Not explicitly stated, but implied to meet design specifications.
Tensile Strength	Not explicitly stated, but implied to meet safety and performance standards.	Tested
Torque Strength	Not explicitly stated, but implied to meet safety and performance standards.	Tested
Torqueability	Not explicitly stated, but implied to meet safety and performance standards.	Tested
Tip Flexibility	Not explicitly stated, but implied to meet safety and performance standards.	Tested
Coating Adherence/Integrity	Not explicitly stated, but implied to meet safety and performance standards.	Tested
Bench top Simulated Efficiency	Not explicitly stated, but implied to meet safety and performance standards.	Tested
Catheter Fatigue Testing	Not explicitly stated, but implied to meet safety and performance standards.	Tested
Shelf Life Testing	Not explicitly stated, but implied to meet safety and performance standards.	Tested
Animal studies (using predicate device)	Established initial safety and performance.	Performed (with CROSSER LP predicate device).

Note: The acceptance criteria are broadly described as meeting "relevant guidance documents" and performing "similarly to the predicate device." Specific numerical or qualitative targets for each test are not provided in this summary.

Regarding a "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (which this is not) or human clinical performance, the following points are largely absent or not applicable:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable for a clinical test set in this 510(k) summary. The testing documented here is primarily physical and bench testing. Animal studies were conducted with a predicate device, but no details on sample size or provenance are provided for those.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable for this 510(k) summary. This type of information would be relevant for clinical studies involving expert interpretation, which is not the focus here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for this 510(k) summary. Adjudication methods are typically used in clinical trials to establish ground truth for ambiguous cases, which is not described.

5. 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 or reported. This device is a physical catheter system, not an AI/ML diagnostic tool meant to assist human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a medical device (catheter system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the physical tests, the "ground truth" would be established by engineering specifications, material science standards, and performance characteristics of the predicate device.
For animal studies (with the predicate device), the ground truth for safety and performance would have been established through direct observation, physiological measurements, and potentially necropsy, but no details are provided.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set.

In summary: The provided document is a 510(k) summary for a physical medical device. It details a series of physical, bench, and biocompatibility tests designed to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating human-machine interaction or AI performance against specific clinical acceptance criteria. The acceptance criteria are generally framed as meeting relevant guidance documents and performing similarly to the predicate.

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, uppercase letters, with a horizontal line underneath. To the right of the name, there is a stylized image of a heart connected to a sine wave, possibly representing blood flow or cardiac activity.

5) 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	K092175
Applicant Information	FEB 1 7 2010
Date Prepared:	July 16, 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
Device Information
Classification:	DQY

Classification:	DQY
Trade Name:	The CROSSER S6 System
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 74 DQY / 21 CFR 870.1250

Predicate Devices

The CROSSER LP System manufactured by FlowCardia, Inc. (K080765) The CROSSER System manufactured by FlowCardia, Inc. (K072776)

Device Description

The CROSSER S6 System consists of a re-usable electronic Generator, Foot Switch, high-frequency Transducer, and single-use CROSSER S6 Catheter.

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is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

Indications For Use

The CROSSER S6 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 S6 System is substantially equivalent to the predicate devices. The predicate CROSSER LP Catheter (K080765) and CROSSER S6 Catheter are substantially equivalent with respect to materials, design, construction, and performance. The CROSSER S6 System has the same indication as the predicate CROSSER System (K072776). All CROSSER Systems utilize the same CROSSER Electronics (Generator, transducer, foot switch) for operation.

Physical Test Data

Design analysis, bench, and biocompatibility testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia CROSSER S6 System 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/Integrity, Biocompatibility, Bench top Simulated Efficiency, Catheter Fatigue Testing, and Shelf Life Testing. Animal studies were conducted with the CROSSER LP predicate device to establish initial safety and performance.

Conclusion

Based upon device physical comparisons, the CROSSER S6 System is substantially equivalent to the predicate devices.

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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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

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: K092175

Trade/Device Name: Crosser S6 Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: December 4, 2009 Received: December 7, 2009

SEP 1 8 2013

Dear Mr. Michaels:

This letter corrects our substantially equivalent letter of February 17, 2010.

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 Amendmonts 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. 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/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Z.M.Z.

Image /page/3/Picture/8 description: The image shows the word "for" written in cursive. The letters are connected and slightly slanted to the right. The word is written in a dark color, possibly black or dark blue, against a white background.

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):

K092195

Device Name:

The CROSSER S6 System

Indications for Use:

The CROSSER S6 Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

unar R. Vadner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 09217 5

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).