(123 days)
The coraCross Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewire and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic contrast.
The coraCross Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic contrast.
This document is an FDA 510(k) Premarket Notification summary for the coraCross Catheter. It focuses on demonstrating substantial equivalence to a predicate device, not on proving performance against specific acceptance criteria for an AI/ML-based device or diagnostic study.
Therefore, the requested information regarding acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment for a device performance study (especially one involving AI/ML) is not available in the provided text.
The document primarily describes:
- Device Name: coraCross Catheter
- Intended Use: Used with steerable guidewires to access peripheral/coronary vasculature, facilitate placement/exchange of guidewires/interventional devices, and provide a conduit for saline/contrast.
- Predicate Device: Wingman 14C Crossing Catheter (K190393)
- Technological Comparison: States the coraCross Catheter is "nearly identical" to the predicate, listing identical technological elements (over-the-wire, through lumen, smooth inner lumen, polymer catheter shaft) and minor differences (inner catheter leveraged from another device, beveled tip attachment method, hydrophilic coating length).
- Nonclinical Tests: Lists various performance tests conducted (Simulated Use Testing, Leak, Kink Resistance, Corrosion, Bond, Component Integrity, Particulate, Torque, Catheter Flow/Burst, Lubricity Testing).
- Conclusion: The device "met all specified criteria and did not raise new safety or performance questions" and "was found to be equivalent to the predicate device."
In summary, there is no information in this document that directly addresses the specific points requested for a study proving a device meets acceptance criteria related to AI/ML or diagnostic performance. The submission is for a medical device (catheter) based on substantial equivalence to an existing predicate, and the "acceptance criteria" referred to are likely engineering and performance specifications for the catheter itself, rather than diagnostic accuracy metrics.
{0}------------------------------------------------
May 28, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Reflow Medical Jeff Vander Hoek Director RA/QA 208 Avenida Fabricante #100 San Clemente, California 92672
Re: K210188
Trade/Device Name: coraCross Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 22, 2021 Received: January 25, 2021
Dear Jeff Vander Hoek:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
{1}------------------------------------------------
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K210188
Device Name coraCross
Indications for Use (Describe)
The coraCross Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewire and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic contrast.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) SUMMARY
| Contact | Reflow Medical, Inc.208 Avenida Fabricante#100San Clemente, CA 92672Contact person: Krystal SantiagoPhone: (949) 481-0399 |
|---|---|
| Date Prepared | February 17, 2021 |
| Device | Name of the device: coraCross CatheterCommon of usual name: Crossing CatheterClassification name: Percutaneous CatheterRegulatory Class: 2Product Code: DQY |
| Legally marketed deviceto which your firm isclaiming equivalence | Wingman 14C Crossing Catheter (K190393)This predicate has not been subject to a design-related recallReference Devices:speX LP 14 Support Catheter (K200094)coraForce/ coraFlex (K201811)Wingman 18C (K160848) |
| Description of the device | The coraCross Catheter is a device intended to provide additional supportto a steerable guidewire when accessing discrete regions of the peripheraland/or coronary vasculature.The device consists of a support catheter, with a concealed radiopaquebeveled guide-tip, and activating handle. The through-lumen of thedevice can serve as a conduit for the delivery of diagnostic contrast. |
| Intended use of thedevice | The coraCross Catheter is intended to be used in conjunction withsteerable guidewires to access discreet regions of the peripheral and/orcoronary vasculature. It may be used to facilitate placement and exchangeof guidewires and other interventional devices and provide a conduit forthe delivery of saline solutions or diagnostic contrast. |
| Summary of the technological characteristics of your device compared to the predicate device |
The coraCross Catheter is nearly identical to the Wingman 14C previously cleared (K190393) version of the device.
The subject and predicate devices are based on the following identical technological elements:
- all delivered to the target site using an over-the-wire percutaneous technique
- all have a through lumen to allow passage and exchange of guidewires ●
- . all have a smooth inner lumen to provide reduced friction for guidewire movement
coraCross Crossing Catheter Special 510(k)
{4}------------------------------------------------
-
all have a polymer catheter shaft with specific geometry to control the torque and push movements associated with lesion crossing
The following technological differences exist between the subject and predicate devices: -
The inner catheter of the device is leveraged from the Spex LP catheter (K200094) ●
-
The beveled tip attachment method ●
-
Hydrophilic Coating Length ●
A brief discussion of the nonclinical tests submitted
The following performance data were provided in support of the substantial equivalence.
- Simulated Use Testing -
- -Leak Testing
- -Kink Resistance
- Corrosion Testing -
- -Bond Testing
- -Component Integrity Testing
- Particulate Testing -
- -Torque Testing
- Catheter Flow/Burst Testing -
- -Lubricity Testing
The coraCross Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the coraCross Catheter was found to be equivalent to the predicate device.
Conclusions
The design testing performed for the coraCross Catheter demonstrated equivalence to the legally marketed predicate device.
coraCross Crossing Catheter Special 510(k)
§ 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).