speX LP Support Catheter

K200094 · Reflow Medical · DQY · Mar 18, 2020 · Cardiovascular

Device Facts

• Record ID: K200094
• Device Name: speX LP Support Catheter
• Applicant: Reflow Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 18, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The speX LP Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral 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/therapeutic agents.

Device Story

Support catheter used in peripheral vasculature; facilitates guidewire placement/exchange and delivery of diagnostic/therapeutic agents. Device consists of polymer catheter shaft with luer end; through-lumen design allows guidewire passage. Operated by clinicians during percutaneous interventional procedures. Provides additional support to steerable guidewires for lesion crossing. Benefits patient by enabling access to discrete vascular regions and simplifying device exchange.

Clinical Evidence

Bench testing only. Simulated use testing performed to validate performance characteristics against predicate device. No clinical data provided.

Technological Characteristics

Polymer catheter shaft; through-lumen design; luer end. Distal tip features three low-profile radiopaque markers. Over-the-wire percutaneous delivery. Mechanical device; no energy source or software.

Indications for Use

Indicated for use in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature, facilitate placement/exchange of guidewires and interventional devices, and provide a conduit for saline or diagnostic/therapeutic agents.

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 Support Catheter (K173662)

Submission Summary (Full Text)

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March 18, 2020

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

Re: K200094

Trade/Device Name: speX LP Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 26, 2020 Received: February 27, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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)

K200094

Device Name speX LP Support Catheter

#### Indications for Use (Describe)

The speX LP Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral 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/therapeutic agents.

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

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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 | January 15, 2020 |
| Device | Name of the device: speX LP Support Catheter<br>Common of usual name: Support 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 | speX Support Catheter (K173662)<br>This predicate has not been subject to a design-related recall |
| Description of the device | The speX LP Support Catheter is a device intended to provide additional<br>support to a steerable guidewire when accessing discrete regions of the<br>peripheral and/or coronary vasculature.<br><br>The device consists of a support catheter body with a luer end. The<br>through-lumen of the device can serve as a conduit for the delivery of<br>diagnostic and therapeutic agents |
| Intended use of the<br>device | The speX LP Support Catheter is intended to be used in conjunction with<br>steerable guidewires to access discreet regions of the peripheral<br>vasculature. It may be used to facilitate placement and exchange of<br>guidewires and other interventional devices and provide a conduit for the<br>delivery of saline solutions or diagnostic/therapeutic agents. |
| Summary of the technological characteristics of your device compared to the predicate device | |
| The speX LP Support Catheter is nearly identical to the speX Support Catheter previously cleared<br>(K173662) 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 | |
| ● all have a polymer catheter shaft with specific geometry to control the torque and push<br>movements associated with lesion crossing | |

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

- The distal tip of the speX LP support catheter has been modified to replace the one (1) ● radiopaque marker with three (3) lower profile markers.

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### A brief discussion of the nonclinical tests submitted

The following performance data were provided in support of the substantial equivalence.

- Simulated Use Testing .
The speX LP Support Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the speX LP Support Catheter was found to have a safety and effectiveness profile that is similar to the predicate device.

### Conclusions

The design testing performed for the speX LP Support Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices.