The FlowCardia MicroSheath™ XL is a single lumen catheter that is available in four lengths: 53cm, 73cm, 93cm or 123cm, and three different tip configurations: vertebral, internal mammary artery, and multipurpose. All MicroSheath XL catheters have a standard lucr fitting at the proximal end. A radiopaque distal tip aids in fluoroscopic visualization. The distal tip is atraumatic to help facilitate vessel navigation. The MicroSheath XL is also 7F Sheath compatible.

AI/ML Overview

The provided text is a 510(k) summary for the FlowCardia MicroSheath XL Catheters. It details the device's design, intended use, and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and device performance in the context of an AI/algorithm or similar medical device.

Therefore, the requested information elements related to AI/algorithm performance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and sample sizes for test/training sets are not applicable to this document.

However, I can extract the information that is relevant to the "acceptance criteria" and "study" as presented in this 510(k) summary for a traditional medical device.

Acceptance Criteria and Study for FlowCardia MicroSheath XL Catheters

The FlowCardia MicroSheath XL Catheters demonstrate substantial equivalence to predicate devices through various physical and bench test data, rather than clinical study data with statistical acceptance criteria as would be found for an AI model.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Study Type)	Reported Device Performance
Physical Test Data:
Dimensional Verification	Met acceptance criteria
Tensile Strength	Met acceptance criteria and performed similarly to predicate devices
Tip Flexibility	Met acceptance criteria and performed similarly to predicate devices
Access and Navigation Bench Modeling	Met acceptance criteria and performed similarly to predicate devices
Critical Bend Testing	Met acceptance criteria and performed similarly to predicate devices
Leak and Pressure Testing	Met acceptance criteria and performed similarly to predicate devices
Torque Strength	Met acceptance criteria and performed similarly to predicate devices
Material Equivalence:
Materials	Equivalent to VP Sheath (predicate)
Manufacturing Methods	Equivalent to VP Sheath (predicate)
Sterilization	Equivalent to VP Sheath (predicate)
Biocompatibility Testing:	Met relevant guidance document requirements
Intended Use Comparison:	Substantially equivalent to all three predicate devices

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

Not applicable for this type of device and submission. The "test set" here refers to physical devices undergoing bench testing. The data provenance is from internal FlowCardia, Inc. testing.

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

Not applicable. Ground truth for physical tests is established by engineering specifications and direct measurement, not expert review.

4. Adjudication Method for the Test Set

Not applicable. Physical tests follow defined protocols; there is no expert adjudication process.

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

Not applicable. This is not an AI/algorithm-based device.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

For physical tests, the "ground truth" is based on:

Engineering specifications and design requirements.
Measurements and observations against established standards and predicate device performance.

8. The Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of machine learning.

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

Not applicable. This device does not use a "training set."

Summary

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FLOWCARDIA, INC.

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

Applicant Information

Date Prepared: November 20, 2007

Name and Address:	FlowCardia, Inc.
	745 N. Pastoria Avenue
	Sunnyvale, CA 94085
	Ph: (408) 617-0352
Contact Person:	Dustin Michaels, Sr. Director of RA/QA/CR
	Ph: (408) 617-0352 x302
	Fax: (408) 617-0198

Device Information

Classification:	DQY
Trade Name:	MicroSheath XL Catheters
Common Name:	Percutaneous Catheter
Classification Name:	Percutaneous Catheter, 74 DQY / 21 CFR 870.1250

Predicate Devices

The VP Shcath manufactured by FlowCardia, Inc. (K051580) Viking 6Fr Guiding Catheters manufactured by Guidant (K972484) Zuma 6Fr Guiding Catheters manufactured by Mcdtronic (K981198)

Device Description

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Intended Use:

The MicroSheath XL is a single lumcn catheter intended to create a pathway for other devices in the peripheral vasculature.

Technological Characteristics

The MicroSheath XL is equivalent to the VP Sheath with respect to materials, manufacturing methods and sterilization. It is also substantially equivalent to the Viking and Zuma guiding catheters in terms of catheter stiffness, tensile strength, torque strength, and tip shapes. The MicroSheath XL is substantially cquivalent to all three predicate devices when comparing intended use.

Physical Test Data

Design analysis, bench, and biocompatibility testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia MicroSheath XL Catheters met the acceptance criteria and performed similarly to the predicate devices. In addition to dimensional verification, the following functional tests were performed and compared to the predicates: Tensile Strength, Tip Flexibility, Access and Navigation Bench Modeling, Critical Bend Testing, Leak and Pressure Testing, Tensile Testing, and Torque Strength.

Conclusion

Based upon these comparisons the MicroSheath XL is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that converge to form the body and wings of the bird.

Public Health Service

JAN 11 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FlowCardia, Inc. c/o Mr. Dustin Michaels Sr. Director 745 N. Pastoria Avenue Sunnyvale, CA 94085

Re: K073289 MicroSheath XL Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: November 20, 2007 Received: November 21, 2007

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 such 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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Page 2 - Mr. Dustin Michaels

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Dona R. Vochmel

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):

KO 73289

Device Name:

MicroSheath XL Catheters

Indications for Use:

The MicroSheath XL is a single lumen catheter intended to create a pathway for other devices in the peripheral vasculature.

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)

Duna R. Jame

Division of Carakorasoular Devices

510(k) Number K073289

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).