speX Support Catheter

K173662 · Reflow Medical, Inc. · DQY · Dec 20, 2017 · Cardiovascular

Device Facts

• Record ID: K173662
• Device Name: speX Support Catheter
• Applicant: Reflow Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 20, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The speX 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 other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

Device Story

The speX Support Catheter is a percutaneous catheter used by physicians to support steerable guidewires during peripheral vascular procedures. The device features a polymer shaft with a through-lumen, allowing for guidewire passage, exchange of interventional devices, and delivery of diagnostic or therapeutic agents. It is inserted over-the-wire to reach target sites. The distal end includes a shapeable region with gold plating to enhance radiovisibility under fluoroscopy, assisting the physician in precise placement. By providing structural support and torque control, the catheter facilitates lesion crossing and navigation through complex vasculature. The device is intended for use in clinical settings.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including simulated use testing, component/assembly integrity testing, corrosion resistance testing, and lubricity testing. All tests met specified acceptance criteria.

Technological Characteristics

Polymer catheter shaft; gold plating at distal end for radiovisibility; through-lumen design. Compatible with .014" and .018" guidewires. Over-the-wire percutaneous delivery. 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 (K141649)

Reference Devices

• Wingman 14 Crossing Catheter (K132420)
• Wingman 18 Crossing Catheter (K151880)

Submission Summary (Full Text)

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December 20, 2017

ReFlow Medical, Inc. Ms. Rebecca Pine Vice President, Regulatory, Quality and Clinical Affairs 1003 Calle Sombra San Clemente, California 92673

Re: K173662

Trade/Device Name: speX Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 28, 2017 Received: November 29, 2017

Dear Ms. Pine:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K173662

Device Name speX Support Catheter

Indications for Use (Describe)

The speX 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 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)

| <span style="font-size:10pt;"> <span style="font-family:Wingdings;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|----------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:10pt;"><span style="font-family:Wingdings;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## K173662 510(k) Summarv

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## 510(k) Summary

#### I. SUBMITTER

ReFlow Medical, Inc. 1003 Calle Sombra San Clemente, CA 92673

Contact person: Rebecca K Pine Phone: [phone] Fax: [phone] Date prepared: March 31, 2017

#### II. DEVICE

Name of the device: speX Support Catheter Common of usual name: Support Catheter Classification name: Percutaneous Catheter Regulatory Class: 2 Product Code: DQY

#### III. PREDICATE DEVICE

speX Support Catheter (K141649) This predicate has not been subject to a design-related recall The Wingman 14 Crossing Catheter (K132420) and Wingman 18 Crossing Catheter (K151880) were used as reference predicates in this submission

#### IV. DEVICE DESCRIPTION

The speX Support 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 body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

#### V. INDICATIONS FOR USE

The speX 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.

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### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the modified speX Support Catheter are highly analogous to the technological characteristics of the speX Support Catheter previously cleared (K141649) version of the device.

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
- I 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 I the torque and push movements associated with lesion crossing

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

- The speX Support Catheter incorporates a gold plating within the shapeable region at the distal end of the catheter for increased radiovisibility
- Additional product diameters have been incorporated into the product family to facilitate use with .014" and .018" guidewires.

#### VII. PERFORMANCE DATA

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

- l Simulated Use Testing
- l Component/Assembly Integrity Testing
- l Corrosion Resistance Testing
- Lubricity Testing

The modified speX Support Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the modified speX Support Catheter was found to be substantially equivalent to the predicate device.

#### VIII. CONCLUSIONS

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