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.

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 vasculature. The device is an over the wire single lumen catheter with a proximal female hub and a distal flexible part with a radiopaque tapered tip. The distal end of the catheter has a lubricious coating. The speX Support Catheter is 0.035" guidewire compatible and has working lengths of: 50cm, 90c, 135cm and 150cm.

AI/ML Overview

This document describes the speX Support Catheter, a medical device, and the testing conducted to demonstrate its substantial equivalence to predicate devices, as required for 510(k) premarket notification. The information provided focuses on various performance tests to ensure the device meets predefined criteria.

Here's an analysis of the provided text to extract the requested information:

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

The document states that "The speX Support Catheter met all specified criteria and did not raise new safety or performance questions." This implies that for each test listed, there were predefined acceptance criteria, and the device successfully met them. However, the specific quantitative acceptance criteria for each test are not explicitly detailed in the provided text, nor are the precise performance results for each test (e.g., "Tensile Strength: X N met requirement of >Y N").

Acceptance Criteria (General)	Reported Device Performance
Meet specified criteria for:	Met all specified criteria
- Simulated Use (baseline, aged)	- Passed
- Tensile Strength (baseline, aged)	- Passed
- Torque (baseline, aged)	- Passed
- Pressure Test (baseline, aged)	- Passed
- Coating verification (baseline, aged)	- Passed
- Corrosion Test (baseline, aged)	- Passed
- Luer Verification (baseline, aged)	- Passed
- Dimensional verification and visual inspections (baseline, aged)	- Passed
- Sterilization Validation	- Passed
- Biocompatibility (Cytotoxicity, Irritation, Sensitization, Materials Mediated Pyrogenicity, Acute Systemic Tox, Hemolysis, PTT, Complement Activation, Thrombosis)	- Passed all biocompatibility tests (did not raise new safety or performance questions)
Not raise new safety or performance questions	Did not raise new safety or performance questions

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

The document mentions that "All testing was performed on test units representative of finished devices." However, it does not specify the sample size (N) used for any of the individual tests. It also does not provide information on the data provenance such as country of origin or whether the studies were retrospective or prospective. These are typically bench or lab tests, not clinical studies with human subjects in the context of device performance evaluation for 510(k) clearance.

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

This information is not applicable to the type of device performance testing described. The tests listed (e.g., tensile strength, pressure test, biocompatibility) are laboratory-based engineering and biological evaluations, not studies requiring expert interpretation of diagnostic images or clinical outcomes to establish a "ground truth." The ground truth is established by the validated test methods themselves.

4. Adjudication method for the test set:

This information is not applicable to the type of device performance testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic accuracy, which is not the case here.

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

This information is not applicable. The speX Support Catheter is a physical medical device (a catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

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

This information is not applicable. As stated above, this is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth for the device performance tests is based on established engineering and biological standards and specifications for medical devices. For example, tensile strength would be measured against a predefined minimum force it must withstand, biocompatibility against established limits for toxicity, irritation, etc. These are objective measurements and comparisons to predefined critical values, not expert consensus, pathology, or outcomes data in the typical sense for diagnostic or prognostic devices.

8. The sample size for the training set:

This information is not applicable. The speX Support Catheter is a manufactured device, not a machine learning model. Therefore, there is no "training set."

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

This information is not applicable as there is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 5, 2014

ReFlow Medical Ms. Rebecca Pine VP. Regulatory/Clinical Affairs & Quality Assurance 1003 Calle Sombra San Clemente, CA 92673

Re: K141649 Trade/Device Name: speX Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: October 2, 2014 Received: October 2, 2014

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

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)

K141649

Device Name

speX Support Catheter, 50cm, 300006; speX Support Catheter, 90cm, 300007; speX Support Catheter, 135cm, 300008; speX Support Catheter. 150cm. 300009

Indications for Use (Describe)

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

스 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Bram D. Zuckerman -S 2014.11.05 06:17:25 -05'00'

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510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	ReFlow Medical
DATE PREPARED:	October 1, 2014
CONTACT PERSON:	Rebecca K PineReFlow Medical1003 Calle SombraSan Clemente, CA 92673Phone: (760) 809.5178
TRADE NAME:	speX Support Catheter
COMMON NAME:	Guide Catheter
CLASSIFICATION NAME:	Percutaneous Catheter
DEVICE CLASSIFICATION:	Class 2, per 21 CFR 870.1250
PRODUCT CODE	DQY
PREDICATE DEVICES:	Volcano Valet Microcatheter (K112035)Quickcross Support Catheter (K072750)Minnie Support Catheter (K082337)

Substantially Equivalent To:

The speX Support Catheter is substantially equivalent in intended use, principal of operation and technological characteristics to the Volcano Valet Microcatheter (K112035), QuickCross Support Catheter (K072750), and the Minnie Support Catheter (K082337).

Description of the Device Subject to Premarket Notification:

Indication for Use:

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provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

Technological Characteristics:

The speX Support Catheter has similar physical and technical characteristics to the predicate device. All devices are highly flexible with a stabilizing radiopaque distal tip. In the case of the speX Support Catheter and the Volcano Catheter, both tips are shapeable. All devices utilize a luer hub handle. All devices are fabricated from medical-grade polymers with varying stiffness shafts. All devices are provided sterile and are intended for single-use. A summary of the similarities and differences between the speX Support Catheter and the identified predicates are shown in the table below:

	speX SupportCatheter	QuickCrossSupport Catheter(K072750)	Valet Mirocatheter(K112035)	Minnie SupportCatheter(K082337)
Function	Support catheter	Support catheter	Support catheter	Support catheter
Principle ofOperation	Controlled penetrationto create a channelacross the occlusion	Controlledpenetration to createa channel across theocclusion	Controlledpenetration to create achannel across theocclusion	Controlledpenetration to create achannel across theocclusion
AnatomicalSite	Peripheral	PeripheralCoronary	PeripheralCoronary	PeripheralCoronary
Delivery toSite	Percutaneous access;over the wire	Percutaneous access;over the wire	Percutaneous access;over the wire	Percutaneous access;over the wire
Visualization	Radiographic imaging	Radiographicimaging	Radiographic imaging	Radiographic imaging
Flexibility	Highly flexible	Highly flexible	Highly flexible	Highly flexible
Workinglength	50cm90cm135cm150cm	65cm-150cm	100cm-150cm	90cm-150cm
CrossingMechanism	Distal Tip;Radiopaque;tapered	Distal Tip;Radiopaque markerTapered	Distal Tip;Radiopaquetapered	Distal Tip;Radiopaquetapered
Crossingmethod	Forward (advancement)penetration of taperedtip	Forward(advancement)penetration oftapered tip	Forward(advancement)penetration of taperedtip	Forward(advancement)penetration of taperedtip
Use interface	Luer as handle	Luer as handle	Luer as handle	Luer as handle
Luerconnector	Yes	Yes	Yes	Yes
Manuallyoperated	Yes	Yes	Yes	Yes
Tip Material	Polymer	Polymer	Polymer	Polymer
Distal Tip OD	.022"	0.02" - 0.041"	0.02"	.0205"-0.0415"
Shapeable tip	Yes	No, available instraight or angled	Yes	No, available straight
CatheterMaterial	Polymer;varying stiffness shaft;braid reinforced; PTFElining	Polymer:varying stiffnessshaft: stainless steelbraid (some models);	Polymer; varyingstiffness shaft, metalbraid	Polymer; metal braidincorporated intoshaft
Hydrophiliccoating	Yes, distal 40cm	Yes	Yes, distal 30cm	Yes, distal 40cm
	speX SupportCatheter	QuickCrossSupport Catheter(K072750)	Valet Mirocatheter(K112035)	Minnie SupportCatheter(K082337)
Catheter OD	4.6F	3.0-4.8F	1.8-3.5F	2.9-4.8F
Single use	Yes	Yes	Yes	Yes
Guidewirecompatibility	0.035"	0.014" -0.035"	0.014" -0.035"	0.014" -0.035"
Targetedinjection	Yes- saline solutions,diagnostic/therapeuticagents	Yes- saline solutions,diagnostic agents	Yes- saline solutions,contrast agents	Yes- saline solutions,diagnostic/therapeuticagents

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Performance Data:

All necessary testing has been performed for the speX Support Catheter to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.

The device design was qualified through the following tests:

Simulated Use (baseline, aged) ●
Tensile Strength (baseline, aged) ●
Torque (baseline, aged) ●
Pressure Test (baseline, aged)
Coating verification (baseline, aged)
Corrosion Test (baseline, aged)
Luer Verification (baseline, aged)
Dimensional verification and visual inspections (baseline, aged) ●
Sterilization Validation ●
Biocompatibility ●
- Cytotoxicity .
- l Irritation
- Sensitization
- Materials Mediated Pyrogenicity
- I Acute Systemic Tox
- Hemolysis (direct, indirect)
- PTT
- Complement Activation
- I Thrombosis

The speX Support Catheter met all specified criteria and did not raise new safety or performance questions.

Basis for Determination of Substantial Equivalence:

The data and information presented in this submission and the similarities and differences between the subject and predicate devices support a determination of substantial equivalence.. The speX Support Catheter is determined by ReFlow Medical, to be substantially equivalent to the identified 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).