coraForce and coraFlex Support Catheters

K201811 · Reflow Medical, Inc. · DQY · Oct 26, 2020 · Cardiovascular

Device Facts

• Record ID: K201811
• Device Name: coraForce and coraFlex Support Catheters
• Applicant: Reflow Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

Cora Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.

Device Story

Support catheters (coraForce/coraFlex) provide additional support to steerable guidewires during coronary and peripheral vascular procedures; used to facilitate guidewire/device placement and exchange; serve as conduit for saline or diagnostic contrast delivery. Device consists of catheter body with luer end and distal tip (polymer for coraFlex; metallic for coraForce). Operated by physicians in clinical settings; delivered to target site via over-the-wire percutaneous technique. Through-lumen allows guidewire passage; smooth inner lumen reduces friction. Coiled shaft design enhances flexibility; torque and push movements controlled via shaft geometry. Device aids lesion crossing; benefits patient by enabling access to complex vascular regions.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by bench testing only, including simulated use, flow rate, burst testing, kink resistance, lubricity, coating integrity, particulate characterization, component integrity, bond testing, torque testing, packaging qualification, sterilization adoption, and biocompatibility assessment.

Technological Characteristics

Catheter shaft: polymer with coiled design; distal tip: polymer (coraFlex) or metallic (coraForce, stainless steel with gold plating). Materials: stainless steel, PTFE coating, polymers. Dimensions: 135cm/150cm length, max 0.032" OD. Energy source: none (mechanical). Connectivity: none. Sterilization: Ethylene Oxide.

Indications for Use

Indicated for patients requiring access to discrete regions of coronary and peripheral vasculature to facilitate guidewire/interventional device placement, exchange, 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

• Spex 14/18 Support Catheters (K193012)

Reference Devices

• Spex 35 (K173662)
• Spex LP 14/18 Support Catheters (K200094)
• Wingman 14C (K190393)

Submission Summary (Full Text)

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October 26, 2020

Reflow Medical, Inc. Krystal Santiago Director RA/QA 208 Avenida Fabricante #100 San Clemente, California 92672

## Re: K201811

Trade/Device Name: coraForce and coraFlex Support Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 30, 2020 Received: July 1, 2020

## Dear Krystal Santiago:

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/cfpmn/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

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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 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 mediation-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,

Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional 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) K201811

#### Device Name

coraForce and coraFlex Support Catheters

#### Indications for Use (Describe)

Cora Catheters are intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic contrast.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: line-through;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# SECTION 5 - 510(K) SUMMARY

| Submitter | Reflow Medical, Inc.<br>208 Avenida Fabricante<br>#100<br>San Clemente, CA 92672<br>Contact person: Krystal Santiago<br>Phone: [phone] |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | October 26, 2020 |
| Device | Name of the device: coraForce and coraFlex Support Catheters<br>Common of usual name: Percutaneous Catheter<br>Classification name: Percutaneous Catheter<br>Regulatory Class: 2<br>Product Code: DQY |
| Legally marketed device to<br>which your firm is claiming<br>equivalence | Predicate -<br>Spex 14/18 Support Catheters - K193012<br>Reference Devices -<br>Spex 35 – K173662<br>Spex LP 14/18 Support Catheters - K200094<br>Wingman 14C – K190393 |
| Description of the device | The coraForce and coraFlex Support Catheters are devices intended to provide<br>additional support to a steerable guidewire when accessing discrete regions of the<br>peripheral and coronary vasculature.<br><br>The device consists of a support catheter body with a luer end and a polymer tip<br>(coraFlex) or metallic tip (coraForce). The through-lumen of the device can serve<br>as a conduit for the delivery of diagnostic contrast. |
| Intended use of the device | Cora Catheters are intended to be used in conjunction with steerable guidewires<br>to access discrete regions of the coronary and peripheral vasculature. They may<br>be used to facilitate placement and exchange of guidewires and other<br>interventional devices and provide a conduit for delivery of saline solutions or<br>diagnostic contrast. |
| Summary of the technological characteristics of your device compared to the predicate device | |
| The technological characteristics of the subject coraForce and coraFlex Support Catheters are similar to the<br>technological characteristics of the Spex 14/18 Support Catheters previously cleared under K173662 (14/18<br>approval), K193012 (coronary indication), and K200094 (low profile models). | |

At a high level, the subject and predicate devices are based on the following same 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 ●
- all have a polymer catheter shaft with specific geometry to control the torque and push movements ● associated with lesion crossing
- all use a specialized distal tip to facilitate crossing of the lesion ●

The following technological differences exist between the subject and predicate devices:

- Coiled catheter shaft to promote additional flexibility ●
- . Differentiated distal tip in a flexible polymer (coraFlex) or metallic (coraForce)

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| | Cora Support Catheter | Spex 14/18 Support Catheter<br>(K193012) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Cora Catheters are intended to be used<br>in conjunction with steerable guidewires to<br>access discrete regions of the coronary and<br>peripheral vasculature. They may be used<br>to facilitate placement and exchange of<br>guidewires and other interventional<br>devices and provide a conduit for delivery<br>of saline solutions or diagnostic contrast. | The Spex 14/18 Support Catheter is intended<br>to be used in conjunction with steerable<br>guidewires to access discreet regions of the<br>peripheral and coronary vasculature. It may<br>be used to facilitate placement and exchange<br>of guidewires and other interventional<br>devices and provide a conduit for the<br>delivery of saline solutions or diagnostic<br>contrast. |
| Guidewire<br>Compatibility | 0.014" | 0.014"/0.018" |
| Sheath<br>Compatibility | Identical | 4F |
| Catheter<br>Length | 135cm/150cm | 90cm/135cm/150cm |
| Catheter Shaft<br>OD | Max 0.032" (nominal 0.029") | Spex 14 - Max 0.034"<br>Spex 18 - Max 0.038" |
| Tip | Rigid (coraForce)<br>Flexible (coraFlex) | Shapeable Hypotube |
| Component<br>Materials | Stainless Steel w/PTFE Coating<br>Stainless steel with gold<br>plating(coraForce)<br>Polymers | Stainless Steel<br>Stainless Steel w/gold plating<br>Polymers |
| Coating<br>Material | Identical | Identical |
| Coating Length | 60cm | 40cm |
| Packaging<br>Configuration | Identical (new backer card) | HDPE backer card and coil in a single<br>poly/Tyvek pouch |
| Sterilization<br>Method | Identical | Ethylene Oxide |
| A brief discussion of the nonclinical tests submitted | | |
| • | A full bench testing package is provided with the following data:<br>Simulated Use | • Flow Rate and Burst Testing |
| • | Kink Resistance | • Lubricity and Coating Integrity Testing |
| • | Corrosion Resistance | • Particulate Characterization |
| • | Component Integrity | • Usability Verification |
| • | Bond Testing | • Sterilization Adoption |
| • | Packaging Qualification | • Biocompatibility Assessment |
| • | Torque Testing | |
| The coraForce and coraFlex Support Catheters met all specified criteria and did not raise new safety or<br>performance questions. Based on the performance testing the coraForce and coraFlex Support Catheters were | | |
| found to have a safety and effectiveness profile that is similar to the predicate device. | | |
| A brief discussion of the clinical data submitted | | |
| No clinical data is submitted. | | |
| Conclusions | | |

The conclusions drawn from the nonclinical testing demonstrate that the device is substantially equivalent to the legally marketed devices identified.