The FlowCardia MicroSheath LP a single lumen catheter, 123 cm in length, with a standard luer fitting at the proximal end. The catheter is available in two tip shapes, straight and angled. The distal tip is atraumatic to help facilitate vessel navigation. A single radiopaque marker on the straight version of the MicroSheath LP and five radiopaque markers on the angled version aid in fluoroscopic visualization. The MicroSheath LP is 6F Sheath/7Fr Guide compatible.

AI/ML Overview

The provided text describes a 510(k) summary for the FlowCardia MicroSheath LP Catheters, comparing it to a predicate device, the VP Sheath. The text focuses on establishing substantial equivalence rather than a clinical study with human readers or AI. Therefore, much of the requested information (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, human reader improvement with AI) is not applicable or cannot be extracted from this document.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Dimensional Verification	Met specifications (implied by "dimensional verification")	Performed similarly to predicate devices
Tensile Strength	Similar to predicate device	Performed similarly to predicate devices
Tip Flexibility	Similar to predicate device	Performed similarly to predicate devices
Access and Navigation Bench Modeling	Successful creation of a pathway for other devices (implied)	Performed similarly to predicate devices
Critical Bend Testing	Similar to predicate device	Performed similarly to predicate devices
Leak and Pressure Testing	Met safety/performance standards (implied)	Performed similarly to predicate devices
Torque Strength	Similar to predicate device	Performed similarly to predicate devices
Biocompatibility	Met relevant guidance documents	Testing conducted according to relevant guidance documents. Assumed to meet.
Materials	Equivalent to predicate device	Equivalent to predicate device
Manufacturing Methods	Equivalent to predicate device	Equivalent to predicate device
Sterilization	Equivalent to predicate device	Equivalent to predicate device
Catheter Stiffness	Substantially equivalent to predicate device	Substantially equivalent to predicate device

Note: The document primarily states that the device "met the acceptance criteria and performed similarly to the predicate devices" without explicitly listing numerical acceptance criteria for each test. The acceptance criteria are largely implied as being "similar to" or "equivalent to" the predicate device and meeting relevant guidance documents for safety and efficacy.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable or not specified. The study involved bench testing and design analysis, not a clinical test set with patient data.
Data Provenance: Not applicable, as no human data or clinical study is described. The tests are physical and bench-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts & Qualifications: Not applicable. The ground truth for engineering and material performance tests is established through objective measurements and accepted engineering standards, not expert consensus on interpretations.

4. Adjudication method for the test set

Adjudication method: Not applicable. There was no clinical test set requiring adjudication. The evaluation was based on objective physical and mechanical testing.

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

MRMC Study: No. This document describes the 510(k) clearance process for a physical medical device (catheter), not an AI-powered diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Standalone Study: No. This is not an algorithm or AI device.

7. The type of ground truth used

Ground Truth Type: For the physical tests, the "ground truth" would be the objective measurements of the device's physical properties (e.g., tensile strength in Newtons, precise dimensions, flexibility measurements) and their comparison to established engineering standards, regulatory requirements, and the characteristics of the predicate device. For biocompatibility, it would be compliance with biological safety standards.

8. The sample size for the training set

Training Set Sample Size: Not applicable. There is no AI or machine learning component described, so no training set was used.

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

Training Set Ground Truth: Not applicable, as there was no training set.

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. A horizontal line extends from the end of the company name, transitioning into a sine wave pattern that terminates in a stylized heart shape.

5) 510(k) Summary

JUL 2 5 2008

This summary of 510(k) summary information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21CFR807.92.

510(k) Number Ko8 0849

Applicant Information

Date Prepared: March 25, 2008

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

Predicate Devices

The VP Sheath manufactured by FlowCardia, Inc. (K051580)

Device Description

Intended Use:

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

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Technological Characteristics

The MicroSheath LP is equivalent to the VP Sheath with respect to materials, manufacturing methods and sterilization. It is also substantially equivalent to the predicate in terms of catheter stiffness, tensile strength, and torque strength. The MicroSheath LP and predicate device have the same 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 LP 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 LP 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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Flowcardia, Inc. c/o Mr. Dustin Michaels Vice President of CR/QA/RA 745 N. Pastoria Avenue Sunnyvalc, CA 94085

JUL 2 5 2008

K080849 Re: MicroSheath LP Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Percutaneous Regulatory Class: Class II Product Code: DQY Dated: July 17, 2008 Received: July 18, 2008

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 ass battle 11 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 rr your de fiel to such additional controls. Existing major regulations affecting your device can be fray of babyer 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 r fouse be advisou and 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.

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Page 2 – Mr. Dustin Michaels

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,

Dina R. Lochner

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):

K080849

Device Name:

MicroSheath LP Catheters

Indications for Use:

The MicroSheath LP is a single lumen catheter intended to create a pathway for other devices in the coronary or 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)

Dona R. LaClair

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 080899

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).