(30 days)
No
The device description focuses on mechanical and electrical components and their interaction to generate vibrations. There is no mention of AI, ML, image processing, or data analysis for decision-making or control.
Yes
The device is indicated for facilitating the intra-luminal placement of conventional guidewires beyond chronic total occlusions in coronary arteries, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is indicated to facilitate the intra-luminal placement of guidewires, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists hardware components such as a Generator, Foot Switch, Transducer, and Catheter, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions" in coronary arteries. This is a therapeutic/interventional procedure performed directly on the patient's body.
- Device Description: The device description details a system that uses mechanical vibrations to assist in navigating through blockages within blood vessels. This is a physical intervention, not a diagnostic test performed on samples outside the body.
- Anatomical Site: The device is used in "coronary arteries," which are part of the living patient's circulatory system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and procedural.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CROSSER® System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Avenue
Sunnyvale, CA 94085
Ph: (408) 617-0352 |
|-------------------|-----------------------------------------------------------------------------------------------|
| Contact Person: | Dustin Michaels, Vice-President of CR/QA/RA
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. (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.
1
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.
2
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
3
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
4
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)