(30 days)
The CROSSER® System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.
The CROSSER® System consists of a re-usable electronic Generator, Foot Switch, high-frequency Transducer, and single-use CROSSER 14 Over the Wire Catheter.
The CROSSER 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.
The provided text describes a medical device, the FlowCardia CROSSER 14 Over the Wire Catheter, and its 510(k) submission for demonstrating substantial equivalence to a predicate device. However, it does not describe an AI/ML-driven device or a study involving AI for diagnostic or predictive purposes. Therefore, most of the requested information regarding AI acceptance criteria, training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable based on the provided text.
The document primarily focuses on physical testing and substantial equivalence to a physical predicate device, not an AI algorithm.
Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text generally states that the device met acceptance criteria, but it does not detail specific quantitative acceptance criteria or their corresponding performance results in a tabular format as would be typical for an AI/ML device. Instead, it lists functional tests and a general conclusion of similarity to the predicate device.
| Test Type | Acceptance Criteria (Not explicitly stated with thresholds in text) | Reported Device Performance |
|---|---|---|
| Dimensional verification | (Implied: Conformance to specifications, similar to predicate) | Met acceptance criteria |
| Tensile Strength | (Implied: Sufficient strength, similar to predicate) | Met acceptance criteria |
| Torque Strength | (Implied: Sufficient strength, similar to predicate) | Met acceptance criteria |
| Torqueability | (Implied: Adequate maneuverability, similar to predicate) | Met acceptance criteria |
| Tip Flexibility | (Implied: Appropriate flexibility for navigation, similar to predicate) | Met acceptance criteria |
| Coating Adherence/Integrity | (Implied: Durable and effective coating, similar to predicate) | Met acceptance criteria |
| Bench top Simulated Efficiency | (Implied: Efficient operation in simulated use, similar to predicate) | Met acceptance criteria |
| Catheter Fatigue Testing | (Implied: Durability over expected lifespan, similar to predicate) | Met acceptance criteria |
| Biocompatibility | (Implied: Non-toxic, compatible with human tissue) | Met acceptance criteria |
| Shelf Life Testing | (Implied: Maintains integrity and function over shelf life) | Met acceptance criteria |
| Overall Conclusion | Substantially equivalent to predicate device FlowCardia CROSSER 14 Catheter in design, construction, and performance. | CROSSER 14 Over the Wire Catheter is substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This document describes physical device testing, not a dataset for an AI/ML model. The tests listed (Tensile Strength, Torque Strength, etc.) would involve a sample of physical catheters, but the exact number for each test is not specified.
- Data Provenance: Not applicable. This is not a study using clinical data or images. The "data" comes from bench testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the physical tests would be established by engineering specifications and industry standards.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert opinions or classifications.
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 document does not describe an AI device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is about a physical medical device, not an algorithm.
7. The type of ground truth used
For the physical tests, the "ground truth" would be engineering specifications, established testing protocols, and comparison to the predicate device's measured performance in similar tests.
(e.g., "Tensile Strength" would be measured by a machine to a specified breaking point).
8. The sample size for the training set
Not applicable. There is no AI/ML training set in this context.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML training set in this context.
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MAY 2 9 2009
Image /page/0/Picture/1 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 is a stylized graphic of a heart with a line running through it, creating a visual representation of blood flow.
4) 510(k) Summary
This summary of 510(k) safety and effectiveness 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: April 28, 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 |
|---|---|
| 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. (K062868)
Device Description
The CROSSER® System consists of a re-usable electronic Generator, Foot Switch, high-frequency Transducer, and single-use CROSSER 14 Over the Wire Catheter.
The CROSSER 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.
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Technological Characteristics
The FlowCardia CROSSER 14 Over the Wire Catheter is substantially equivalent to the predicate CROSSER 14 Catheter. The predicate CROSSER 14 Catheter and CROSSER 14 Over the Wire Catheter are identical with respect to indications for use, design, construction and performance. The main difference is a rapid-exchange (RX) guidewire rail system in the predicate versus a conventional over-the-wire (OTW) guidewire rail system.
Physical Test Data
Design analysis, bench, and biocompatibility testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia CROSSER 14 Over the Wire Catheter 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, Bench top Simulated Efficiency, Catheter Fatigue Testing, Biocompatibility, and Shelf Life Testing.
Conclusion
Based upon the aforementioned comparison testing the CROSSER 14 Over the Wire Catheter is substantially equivalent to the predicate device.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, depicted with three curved lines forming the body and wings.
MAY 2 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Flow Cardia, Inc. c/o Mr. Dustin Michaels Vice President, CR/QA/RA 745 North Pastoria Avenue Sunnyvale, CA 94085-2918
Re: K091254
Trade/Device Name: The CROSSER 14 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: April 28, 2009 Received: April 29, 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.
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
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Page 2 - Mr. Dustin Michaels
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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
R. R. M.D.
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):
Device Name:
The CROSSER® System
Indications for Use:
The CROSSER® System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.
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)
§ 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).