(94 days)
Not Found
No
The description focuses on mechanical and electrical components and their function, with no mention of AI or ML.
No
The device is used to facilitate the placement of guidewires to treat coronary artery blockages and is not itself a therapeutic device.
No
Explanation: The device is described as facilitating the placement of guidewires beyond chronic total occlusions, which is an interventional or therapeutic function, not a diagnostic one. No mention of diagnosis or assessment is found.
No
The device description clearly outlines multiple hardware components including a generator, foot switch, transducer, and catheter. The performance studies also describe testing of physical properties and components.
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 describes a therapeutic or interventional procedure performed directly on a patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a system designed to generate mechanical vibrations to assist in navigating blockages within blood vessels. This is consistent with a medical device used for treatment or intervention, not for analyzing biological samples.
- Anatomical Site: The device is used in "coronary arteries," which are part of the human circulatory system. IVDs typically analyze samples like blood, urine, tissue, etc., which are taken from the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function and intended use clearly fall outside of that definition.
N/A
Intended Use / Indications for Use
The CROSSER LP 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, highfrequency Transducer, and single-use CROSSER LP 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 LP 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 LP 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, Shelf Life and Package Integrity Testing. Animal studies were conducted with the CROSSER LP to establish initial safety and performance.
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
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Image /page/0/Picture/0 description: The image shows the logo for Flowcardia, Inc. along with the date JUN 20 2008. The logo includes a stylized heart with a sine wave running through it. The company name is written in a bold, serif font.
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 | K080765 |
|---|---|
| --------------- | --------- |
Applicant Information
| Date Prepared: | March 17, 2008 | FDA CDRH DMC MAR 18 2008 |
|---|---|---|
| Name and Address: | FlowCardia, Inc. | |
| 745 N. Pastoria Avenue | ||
| Sunnyvale, CA 94085 | ||
| Ph: (408) 617-0352 | Received | |
| 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 LP 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, highfrequency Transducer, and single-use CROSSER LP 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 LP 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 LP System is substantially equivalent to the predicate device. The predicate and CROSSER LP System catheters are substantially equivalent with respect to materials, design construction and performance. Both devices are indicated for use in coronary chronic occlusions. Both utilize the same CROSSER Electronics for operation. The main difference between the two devices is the diameter of the distal tip. The CROSSER LP has a 0.6mm distal tip while the predicate device has a 1.1mm tip.
Physical Test Data
Design analysis, bench, and biocompatibility testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia CROSSER LP 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, Shelf Life and Package Integrity Testing. Animal studies were conducted with the CROSSER LP to establish initial safety and performance.
Conclusion
Based upon device physical comparisons the CROSSER System is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine. The caduceus in the logo is depicted with a modern, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2008
FlowCardia Inc. c/o Mr. Dustin Michaels Vice President of CR/QA/RA 745 N. Pastoria Avenue Sunnyvalc, CA 94085
Re: K080765
Trade Name: Percutaneous Catheter Regulation Number: 21 CFR 870.1330 Regulation Name: Cather Guide Wire Regulatory Class: Class II (two) Product Codc: DQX Dated: March 17, 2008 Received: March 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 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.
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
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Page 2 - Mr. Dustin Michaels
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 (OS) 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 Biometrics' (OSB) 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,
Bram/D. Zuckerman, M.D. Director Division of Cardiovascular Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number (if known):
Device Name:
The CROSSER LP System
Indications for Use:
The CROSSER LP 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)
WL
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