(123 days)
No
The summary describes a mechanical catheter and its intended use and performance testing, with no mention of AI or ML capabilities.
No
The device facilitates access and delivery of substances or other devices, but it does not directly treat a condition or provide a therapeutic effect itself.
No
The device is described as an interventional catheter used to facilitate guidewire placement and deliver saline or diagnostic contrast, but not to diagnose conditions itself.
No
The device description clearly states it is a physical catheter with a handle and a radiopaque tip, indicating it is a hardware device. The performance studies also focus on physical properties like leak testing, kink resistance, and bond testing, which are relevant to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The coraCross Catheter is used inside the body (in vivo) to access and navigate blood vessels. It facilitates the placement of other devices and the delivery of substances directly into the vasculature.
- Intended Use: The intended use clearly describes its function within the peripheral and coronary vasculature, which is an in-vivo application.
- Device Description: The description focuses on its physical structure and how it interacts with guidewires and delivers substances within the body.
The device's purpose is to assist in interventional procedures within the circulatory system, not to perform diagnostic tests on samples taken from the body.
N/A
Intended Use / Indications for Use
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.
Product codes
DQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and/or coronary vasculature
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Wingman 14C Crossing Catheter (K190393)
Reference Device(s)
speX LP 14 Support Catheter (K200094), coraForce/ coraFlex (K201811), Wingman 18C (K160848)
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 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
#100
San Clemente, CA 92672
Contact person: Krystal Santiago
Phone: (949) 481-0399 |
|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | February 17, 2021 |
| Device | Name of the device: coraCross Catheter
Common of usual name: Crossing Catheter
Classification name: Percutaneous Catheter
Regulatory Class: 2
Product Code: DQY |
| Legally marketed device
to which your firm is
claiming equivalence | Wingman 14C Crossing Catheter (K190393)
This predicate has not been subject to a design-related recall
Reference 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 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. |
| Intended use of the
device | 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 guidewires and other interventional devices and provide a conduit for
the 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)