The Arrow GPSCath™ Balloon Dilatation Catheter (150 cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Device Description

The Arrow GPSCath Balloon Dilatation Catheter (150cm) is an 0.014" quidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows injection of fluids through the inflation lumen without removal of the guidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers indentify the valve to aid in angiographic placement. The proximal portion of the catheter includes an inflation female luer lock hub on the side of the handle and a guidewire female luer lock hub in the proximal end of the handle.

Balloon inflation function is achieved using an angioplasty balloon mounted to the catheter shaft like a typical PTA balloon catheter. The fluid injection function is achieved through a valve at the proximal end of the balloon that is controlled through the device handle.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria in a clinical setting. Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, ground truth methodology, expert qualifications, and MRMC studies) are not applicable or explicitly stated in this type of regulatory submission.

However, based on the provided text, I can infer and extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with specific quantitative acceptance criteria or performance metrics directly from a clinical study for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). Instead, it states that the device underwent in vitro preclinical tests to verify safety and effectiveness and assure substantial equivalence to a predicate device.

The "acceptance criteria" for this device, as described, are passing various functional and safety tests, demonstrating biocompatibility, and achieving a certain sterility assurance level. The "reported device performance" is the successful completion of these tests.

Acceptance Criteria Category	Reported Device Performance
Physical and Mechanical Performance (In vitro)	Passed all functional destructive testing post validated EtO sterilization cycle exposure.
Packaging Integrity	Packaging can withstand the effects of transit and environmental conditions and remain intact and sterile.
Visual Inspection	Product not damaged through sterilization cycle and packing testing; handle markings legible.
Dimensional Accuracy	Product meets all dimensional performance attributes post validated EtO sterilization cycle exposure.
Simulated Use Performance	Performed and met functional attributes in an anatomically relevant model; no corrosion growth.
Flow Rate & Power Injection Capability	Tested and characterized (specific values not provided, but implies satisfactory performance).
Biocompatibility	Passed all biocompatibility testing per ISO 10993-1.
Sterility	Achieved a Sterility Assurance Level (SAL) of 1 x 10^-6 post EtO sterilization.

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

Sample Size for Test Set: The document does not specify the exact sample sizes used for each of the in vitro preclinical tests. It mentions "devices" being tested, implying a quantity greater than one, but no specific number.
Data Provenance: The data provenance is "in vitro preclinical tests" conducted by Hotspur Technologies, Inc., a subsidiary of Teleflex Medical, Inc. The location (country of origin) is not explicitly stated but is implied to be within the US, given the submission to the FDA. The tests are prospective in the sense that they were designed and executed to evaluate the new device.

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

Number of Experts & Qualifications: Not applicable. The "ground truth" for the in vitro tests would be the established engineering and biological standards (e.g., ISO 10993-1, FDA Guidance for PTCA Catheters) and the objective measurements demonstrating compliance. There were no human experts establishing a "ground truth" in the diagnostic sense for these device performance tests.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. As these were in vitro engineering and biological tests, the data would have been analyzed against pre-defined quantitative and qualitative specifications. There's no mention of an adjudication process by human reviewers for these types of tests.

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:

MRMC Study: No. This document is for a medical device (a catheter), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

Standalone Performance: Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent in its design and manufacturing, tested through in vitro methods.

7. The type of ground truth used:

Type of Ground Truth: The ground truth for these in vitro tests were established engineering specifications, regulatory standards (e.g., ISO 10993-1), and documented procedures based on FDA guidance for PTCA Catheters. For example, for biocompatibility, the ground truth is compliance with ISO 10993-1. For sterility, reaching an SAL of 1 x 10^-6.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device. There is no "training set" in this context. The device's design is based on engineering principles and knowledge, not data training.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set mentioned or relevant for this type of device submission.

Summary

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Hotspur Technologies, Inc., A Subsidiary of Telefiex Medical, Inc. Traditional 510(k) Notification Arrow GPSCath Balloon Dilatation Catheter (150 cm)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS . SECTION 5.0:

A. Submitter Information

Submitter's Name:

Hotspur Technologies, Inc. A Subsidiary of Teleflex Medical, Inc.

880 Maude Avenue, Suite A

Mountain View, CA 94943

978-302-9467

408-608-1597

Eric Ankerud

February 7, 2014

Balloon Catheter

Address:

Telephone:

Fax:

Contact Person:

Date of Preparation:

B. Subject Device

Trade Name:

Arrow GPSCath™ Balloon Dilatation Catheter (150cm)

Common/Usual Name:

Classification Name:

21 CFR 870.1250, Catheter, Angioplasty, Peripheral, Transluminal/Percutaneous Catheter

Class:

LIT Product Code:

C. Predicate Device Name(s):

.014 Monorail and OTW PTA Balloon Dilatation Catheters, K111295 (Boston Scientific)

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Hotspur Technologies, Inc., A Subsidiary of Teleflex Medical, Inc. Traditional 510(k) Notification Arrow GPSCath Balloon Dilatation Catheter (150 cm)

D. Indication for Use:

The Arrow GPSCath™ Balloon Dilatation Catheter (150cm) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

E. Device Description:

F. Predicate Device(s) Reference:

The Arrow GPSCath Balloon Dilatation Catheter (150cm), an extension of the previously 510(k) cleared Hotspur GPSCath product line (K101047 and K113769) was shown to be substantially equivalent in intended use, principle of operation, and technological characteristics to the following previously cleared device: .014 Monorail and OTW PTA Balloon Dilatation Catheters (K111295). The Arrow GPSCath Balloon Dilatation Catheter (150 cm) and the predicate device use common materials and design, with similar technological characteristics including working catheter length, catheter platform, balloon material, balloon length range, catheter introducer sheath compatibility, and balloon rated burst pressure. While both the subject and predicate devices have a PTA indication, the infusion capability of the Arrow GPSCath Balloon Dilatation Catheter (150 cm), with its proprietary valve design, provides the treating physician with the ability to infuse without removing the quidewire, a requirement when using the predicate device.

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Hotspur Technologies, Inc., A Subsidiary of Teleflex Medical, Inc. Traditional 510(k) Notification Arrow GPSCath Balloon Dilatation Catheter (150 cm)

G. Performance Data:

In vitro preclinical tests were performed to verify and validate the safety and effectiveness of the Arrow GPSCath Balloon Dilatation Catheter (150cm) and assure substantial equivalence to the predicate device. Functional testing of the Arrow GPSCath Balloon Dilatation Catheter (150 cm) was performed in accordance with the FDA's Guidance for PTCA Catheters and included passing data for the following tests conducted per documented procedures:

· Packaging Testing is performed to ensure that the product packaging can withstand the effects of transit and environmental conditions and still remain intact and sterile.
· Visual testing is performed to ensure that the product has not been damaged through sterilization cycle and packing testing and that the handle markings are legible.
· Dimensional Testing is performed to ensure that the product meets all dimensional performance attributes post the validated EtO sterilization cycle exposure.
· Performance Testing is conducted to ensure that the product passes all functional destructive testing post the validated EtO sterilization cycle exposure.
· Simulated Use Testing is performed in an anatomically relevant model to ensure that the product performs and meets functional attributes. Devices are then tested to ensure that there is no growth of any corrosion.

Testing was also conducted to characterize the flow rate and power injection capability for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). The Arrow GPSCath Balloon Dilatation Catheter (150cm) and the predicate .014 Monorail and OTW PTA Balloon Dilatation Catheters are both balloon angioplasty catheters with equivalent operating principles and intended use.

Hotspur Technologies completed with passing results all biocompatibility testing on the Arrow GPSCath Balloon Dilatation Catheter (150cm) per the requirements of ISO 10993-1, Biological Evaluation of Medical Devices.

The Arrow GPSCath Balloon Dilatation Catheter (150cm) is a single use device that is supplied sterile. A sterilization was performed on the Arrow GPSCath Balloon Dilatation Catheter (150cm) demonstrating the device is able to be EtO sterilized to achieve a sterility assurance level (SAL) of 1 x 10-6.

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Hotspur Technologies, Inc., A Subsidiary of Teleflex Medical, Inc. Traditional 510(k) Notification Arrow GPSCath Balloon Dilatation Catheter (150 cm)

H. Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation, and overall technological characteristics, Arrow GPSCath Balloon Dilatation Catheter (150cm) is determined to be substantially equivalent to an existing legally marketed device.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract design of an eagle or bird-like figure with three curved lines representing its wings or feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 2, 2014

Hotspur Technologies, Inc., a subsidiary of Teleflex Medical, Inc. Mr. Eric Ankerud. J.D. Acting Executive Vice President, Clinical, Regulatory, and Quality 880 Maude Avenue, St. A Mountain View, CA 94043

Re: K140351

Trade/Device Name: Arrow GPSCath Balloon Dilatation Catheter (150 cm) Regulation Number: 21 CFR 870.1250 Regulation Name: Perculaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: May 20, 2014 Received: May 22, 2014

Dear Mr. Ankerud:

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 (sec 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 (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Eric Ankerud, J.D.

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" (21CFR 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,

M.A. Zilleham

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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Hotspur Technologies, Inc., A Subsidiary of Teleflex Medical, Inc. Traditional 510(k) Notification Arrow GPSCath Balloon Dilatation Catheter (150 cm)

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Arrow GPSCath™ Balloon Dilatation Catheter (150 cm)

Indication for Use:

Prescription Use _ x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Zillehamm

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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).