(28 days)
Not Found
No
The device description focuses on mechanical and electronic components that generate high-frequency vibrations. There is no mention of AI, ML, image processing, or data-driven decision-making within the system's operation. The performance studies are based on bench testing and material properties, not algorithmic performance.
Yes
The device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions, which is a direct medical intervention.
No.
The device facilitates the placement of guidewires to treat chronic total occlusions, indicating a therapeutic or interventional purpose rather than diagnosis.
No
The device description explicitly lists multiple hardware components: a re-usable electronic Generator, Foot Switch, high-frequency Transducer, and single-use CROSSER Catheter.
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 peripheral artery chronic total occlusions." This describes a therapeutic intervention performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device description details a system that uses mechanical vibrations to assist in navigating through blockages in blood vessels. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used to physically interact with and treat a condition within the body.
N/A
Intended Use / Indications for Use
The CROSSER® System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.
The CROSSER® Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.
Product codes
DQY, PDU
Device Description
The CROSSER® System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER Catheter. The CROSSER Over the Wire Catheter is available in two variations:
- CROSSER 14P OTW (014 guidewire compatible flexible), .
- CROSSER 14S OTW (014 guidewire compatible supportive). .
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 Titanium 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
peripheral artery
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 Over the Wire Catheters 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 15 2009
FLOWCARDIA, INC.
4) 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 K091119
Applicant Information
April 16, 2009 Date Prepared:
- Name and Address: FlowCardia, Inc. 745 N. Pastoria Avenue Sunnyvale, CA 94085 Ph: (408) 617-0352
- Dustin Michaels, Vice-President of CR/QA/RA Contact Person: 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. (K072776)
Device Description
The CROSSER® System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER Catheter. The CROSSER Over the Wire Catheter is available in two variations:
- CROSSER 14P OTW (014 guidewire compatible flexible), .
- CROSSER 14S OTW (014 guidewire compatible supportive). .
1
K091119 page 2 of 2
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 Titanium 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.
Indications for Use
The CROSSER® System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.
The CROSSER® Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.
Technological Characteristics
The FlowCardia CROSSER Over the Wire Catheters are substantially equivalent to the predicate device. The prodicate and CROSSER Over the Wire Catheters are identical with respect to indications for use and performance. The main difference is a rapid-exchange (RX) guidewire rail system in the predicate versus a conventional over-the-wire (OTW) guidcwire rail system. With respect to materials and design, the CROSSER Over the Wire Catheters are substantially equivalent to the predicate device with the exception of the catheter effective length (140 vs. 146cm) and guidewire lumen matcrials.
Physical Test Data
Design analysis, bench, and biocompatibility testing were conducted according to the relevant guidance documents to demonstrate that the FlowCardia CROSSER Over the Wire Catheters 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/Integrily, Bench top Simulated Efficiency, Catheter Fatigue Testing, Biocompatibility, and Shcif Life Testing.
Conclusion
Based unon the aforementioned compurison testing, the CROSSER Over the Wire Catheters are substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
FlowCardia, Inc. Mr. Dustin Michaels Vice President, Clinical, Quality & Regulatory Affairs 745 N. Pastoria Ave. Sunnyvale, CA 94085
Re: K091119
Trade/Device Name: The Crosser System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: April 16, 2009 Received: April 17, 2009
SEP 1 8 2013
Dear Mr. Michaels:
This letter corrects our substantially equivalent letter of May 15, 2009.
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
3
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Z.M.Z.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ﺟ ﺗﺤ
3) Statement of Indications for Use
510(k) Number (if known):
K091119
Device Name:
The CROSSER® System
Indications for Use:
The CROSSER® System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.
The CROSSER® Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper usc.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
Division of
s : Ofic; Numbe
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)
(Division Sign-Off)