The speX 14/18 Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and 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/therapeutic agents.

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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "speX Support Catheter." This document is a regulatory submission to the FDA for market clearance, arguing that the new device is substantially equivalent to a previously cleared predicate device.

Crucially, this document focuses on demonstrating substantial equivalence to a predicate device, not on proving that an AI/ML powered device meets specific performance criteria through a clinical study where AI assists human readers or performs standalone analysis.

Therefore, most of the requested information regarding acceptance criteria, study design (sample sizes, ground truth, experts, adjudication methods, MRMC studies, standalone AI performance), and training set details for an AI-powered device is not applicable to this document.

The document discusses performance data in general terms for a physical medical device (catheter), not a digital health/AI product. The "performance data" mentioned (Simulated Use Testing, Particulate Testing) are engineering and biocompatibility tests typical for physical medical devices, not clinical performance studies for an AI algorithm.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implicit for a medical device approval): The device must demonstrate a safety and effectiveness profile similar to the predicate device and meet "specified criteria" in performance testing. The text states: "The speX Support Catheter met all specified criteria and did not raise new safety or performance questions."
Reported Device Performance:
- "Simulated Use Testing" was performed.
- "Particulate Testing" was performed.
- Result: "The speX Support Catheter met all specified criteria and did not raise new safety or performance questions."
- Conclusion: "Based on the performance testing the speX Support Catheter was found to have a safety and effectiveness profile that is similar to the predicate device." And "The design testing performed for the speX Support Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices."

2. Sample sizes used for the test set and the data provenance:

Not applicable. This document describes testing for a physical medical device (catheter), not an AI algorithm. The "test set" concept in the context of AI (i.e., a dataset of images/cases for algorithm evaluation) is not relevant to this submission. The "Simulated Use Testing" likely involved a certain number of tests on physical prototypes, but specific sample sizes and data provenance (country of origin, retrospective/prospective) are not detailed because they are not required for this type of submission for a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in the context of medical images or diagnostic AI systems is not relevant for this physical device.

4. Adjudication method for the test set:

Not applicable. No adjudication method for a test set is mentioned, as it's not an AI study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. No MRMC study was done, as this is not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. No standalone AI algorithm performance was evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. Ground truth for diagnostic accuracy is not relevant for this physical device. The "ground truth" for a physical device's performance would be engineering specifications and safety standards, which are implicitly met.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of AI for this physical device.

9. How the ground truth for the training set was established:

Not applicable. There is no "ground truth for the training set" for this physical device.

In summary, the provided document is a regulatory filing for a physical medical device (a catheter) demonstrating substantial equivalence to a predicate device, not an AI/ML powered device. Therefore, the specific details requested about AI model validation and performance criteria are not present in this document.

Summary

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February 19, 2020

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.

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

Re: K193012

Trade/Device Name: speX Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 13, 2020 Received: January 14, 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-regulatory-assistance/contact-usdivision-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, Ph.D. 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)

K193012

Device Name speX 14/18 Support Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K193012

I. SUBMITTER

ReFlow Medical, Inc. 208 Avenida Fabricante #100 San Clemente, CA 92672

Contact person: Krystal Santiago Phone: (310) 707.5882 Date prepared: October 28, 2019

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 (K173662) This predicate has not been subject to a design-related recall
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

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICE

There are no design or material changes to the speX Support Catheter previously cleared (K173662) version of the device.

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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 movements associated with lesion crossing

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

Addition of the coronary indication .

VII. PERFORMANCE DATA

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

Simulated Use Testing ●
. Particulate Testing

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

VIII. CONCLUSIONS

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

Regulation Number and Section

§ 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).