coraCross

K210188 · Reflow Medical · DQY · May 28, 2021 · Cardiovascular

Device Facts

• Record ID: K210188
• Device Name: coraCross
• Applicant: Reflow Medical
• Product Code: DQY · Cardiovascular
• Decision Date: May 28, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended 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.

Device Story

The coraCross is a percutaneous support catheter used by physicians to access peripheral and coronary vasculature. It features a concealed radiopaque beveled guide-tip and an activating handle. The device is used over-the-wire; the through-lumen allows for guidewire passage, exchange of interventional devices, and delivery of saline or diagnostic contrast. The catheter shaft is designed to control torque and push movements during lesion crossing. It functions as a mechanical conduit to provide support to steerable guidewires. No AI/ML or software components are involved.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included simulated use, leak testing, kink resistance, corrosion testing, bond testing, component integrity, particulate testing, torque testing, catheter flow/burst testing, and lubricity testing.

Technological Characteristics

Percutaneous support catheter with concealed radiopaque beveled guide-tip and activating handle. Features a polymer shaft with specific geometry for torque and push control. Includes a through-lumen for guidewire passage and fluid delivery. Utilizes a hydrophilic coating. Mechanical device; no energy source or software.

Indications for Use

Indicated for use in patients requiring access to peripheral and/or coronary vasculature to facilitate guidewire placement, exchange of interventional devices, and delivery of saline or diagnostic contrast.

Regulatory Classification

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.

Predicate Devices

• Wingman 14C Crossing Catheter (K190393)

Reference Devices

• speX LP 14 Support Catheter (K200094)
• coraForce/ coraFlex (K201811)
• Wingman 18C (K160848)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) SUMMARY

| Contact | Reflow Medical, Inc.<br>208 Avenida Fabricante<br>#100<br>San Clemente, CA 92672<br>Contact person: Krystal Santiago<br>Phone: [phone] |
|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | February 17, 2021 |
| Device | Name of the device: coraCross Catheter<br>Common of usual name: Crossing Catheter<br>Classification name: Percutaneous Catheter<br>Regulatory Class: 2<br>Product Code: DQY |
| Legally marketed device<br>to which your firm is<br>claiming equivalence | Wingman 14C Crossing Catheter (K190393)<br>This predicate has not been subject to a design-related recall<br>Reference Devices:<br>speX LP 14 Support Catheter (K200094)<br>coraForce/ coraFlex (K201811)<br>Wingman 18C (K160848) |
| Description of the device | The coraCross Catheter is a device intended to provide additional support<br>to a steerable guidewire when accessing discrete regions of the peripheral<br>and/or coronary vasculature.<br><br>The device consists of a support catheter, with a concealed radiopaque<br>beveled guide-tip, and activating handle. The through-lumen of the<br>device can serve as a conduit for the delivery of diagnostic contrast. |
| Intended use of the<br>device | The coraCross Catheter is intended to be used in conjunction with<br>steerable guidewires to access discreet regions of the peripheral and/or<br>coronary vasculature. It may be used to facilitate placement and exchange<br>of guidewires and other interventional devices and provide a conduit for<br>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)

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- 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)