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" guidewire 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

This document is a 510(k) summary for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). It is a "Special 510(k)", which means it refers to a previously cleared predicate device (K140351 from Hotspur Technologies). The submission focuses on minor changes and an update to performance data rather than a complete re-evaluation of the device's safety and effectiveness from scratch.

Therefore, the study details you are asking for, particularly related to clinical performance, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance, are not directly applicable or available within this specific 510(k) submission because it relies heavily on the predicate device's existing clearance.

However, I can extract the information that is present concerning the changes and the performance data provided for those changes.

Here's a breakdown based on the provided text, heavily emphasizing that clinical effectiveness studies for a new device are not detailed here because this is a Special 510(k) relying on a predicate:

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

The document mentions "additional testing of key performance data" for an update. It doesn't present a formal table of acceptance criteria and performance results in this summary. Instead, it states that the testing "result[ed] in an update to the Arrow GPSCath Balloon Dilatation Catheter (150cm) Compliance Chart and introducer sheath compatibility."

The "key performance data" tested includes:

Balloon compliance: (No specific acceptance criteria or reported values are provided in this summary, only that it was tested and updated).
Balloon rated burst pressure: (No specific acceptance criteria or reported values are provided in this summary, only that it was tested and updated).
Crossing profile: (No specific acceptance criteria or reported values are provided in this summary, only that it was tested and updated).

Note: For a Class II peripheral transluminal angioplasty catheter, the FDA typically references a set of recognized standards and guidance documents (e.g., ISO, ASTM, FDA guidance for PTA balloon catheters) that would define acceptance criteria for these physical/mechanical properties. This summary implies these tests were done to those standards, but the specific details are not published here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not specified in this summary. The testing was for "key performance data, including balloon compliance, balloon rated burst pressure, and crossing profile." These are bench/mechanical tests, not clinical studies with human subjects.
Data Provenance: The testing was conducted by Hotspur Technologies, Inc. (a subsidiary of Teleflex Medical, Inc.) in the USA. These are laboratory/engineering tests not related to patient data.
Retrospective or Prospective: These are laboratory tests, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable. The "ground truth" for mechanical properties like compliance, burst pressure, and crossing profile is established through validated test methods and engineering calculations, not through expert consensus in the medical sense.
Qualifications of Experts: Not applicable for this type of testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. This is not a clinical study involving human assessment or interpretation for which adjudication would be required.

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: Not applicable. This device is a balloon dilatation catheter, a physical medical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant.

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

Standalone Performance: Not applicable. This device is a physical medical device, not an algorithm.

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

Type of Ground Truth: For the mechanical tests (balloon compliance, burst pressure, crossing profile), the "ground truth" would be the scientifically measured and validated physical properties of the device, determined by standardized engineering testing methods and equipment. This is not medical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is a physical medical device. There is no "training set" in the context of machine learning or AI.

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

Training Set Ground Truth Establishment: Not applicable.

Summary Explanation:

This 510(k) submission (K142300) is a "Special 510(k)" for the Arrow GPSCath Balloon Dilatation Catheter (150 cm). These submissions are used when a modification to an already cleared device does not raise new questions of safety and effectiveness and the modified device remains substantially equivalent to the predicate.

The "study" cited here refers to additional engineering and bench testing conducted to update the device's "Compliance Chart and introducer sheath compatibility" due to a change in the product (presumably a minor manufacturing update or material change that impacted these specific physical properties).

The document explicitly states: "All other performance data applicable to the subject device is the same as for the predicate device (K140351) since there has been no change to the device design, materials, manufacturing processes, or sterilization cycle." This means the original predicate device (K140351) would have had the comprehensive performance data and potentially other studies (e.g., biocompatibility, sterilization validation, aging) to demonstrate its safety and effectiveness. This current submission only addresses the specific changes mentioned.

Therefore, questions related to clinical trials, expert adjudication, AI performance, or large clinical data sets are outside the scope of this specific Special 510(k) summary.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 image of a human figure, represented by three overlapping profiles, suggesting a sense of community and support.

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

September 17, 2014

Hotspur Technologies, Inc. Mr. Eric Ankerud Regulatory and Quality Consultant 880 Maude Avenue, Suite A Mountain View, CA 94043

Re: K142300

Trade/Device Name: Arrow GPSCath Balloon Dilatation Catheter (150 cm) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: August 14, 2014 Received: August 18, 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 (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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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.

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/Resourcesfor You/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,

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

{2}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):_ K142300

Device Name:

Arrow® GPSCath™ Balloon Dilatation Catheter (150 cm)

Indications for Use:

ア Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

A. Submitter Information

Submitter's Name:	Hotspur Technologies, Inc.A Subsidiary of Teleflex Medical, Inc.
Address:	880 Maude Avenue, Suite AMountain View, CA 94043
Telephone:	978-302-9467
Fax:	408-608-1597
Contact Person:	Eric Ankerud
Date of Preparation:	August 11, 2014
Subject Device
Trade Name:	Arrow® GPSCath™ Balloon Dilatation Catheter(150cm)
Common/Usual Name:	Balloon Catheter
Classification Name:	21 CFR 870.1250, Catheter, Angioplasty,Peripheral, Transluminal/Percutaneous Catheter
Class:	II
Product Code:	LIT

C. Predicate Device Name(s):

Arrow GPSCath™ Balloon Dilatation Catheter (150cm), K140351 (Hotspur Technologies)

{4}------------------------------------------------

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 Reference:

The Arrow GPSCath Balloon Dilatation Catheter (150cm) which is the subject of this Special 510(k) is substantially equivalent in its intended use, principle of operation, and technological characteristics to the Arrow GPSCath Balloon Dilatation Catheter (150cm) that was previously cleared under K140351.

G. Performance Data:

Additional testing of key performance data, including balloon compliance, balloon rated burst pressure, and crossing profile was conducted at time zero for performance qualification resulting in an update to the Arrow GPSCath Balloon Dilatation Catheter (150cm) Compliance Chart and introducer sheath compatibility, which is the subject of this Special 510(k). All other performance data applicable to the subject device is the same as for the predicate device (K140351) since there has been no change to the device design, materials, manufacturing processes, or sterilization cycle.

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 the existing legally marketed Arrow GPSCath Balloon Dilatation Catheter (150cm) device.

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).