The 0.018" 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 .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) is an 0.018" guidewire compatible PTA balloon catheter consisting of a semi-compliant angioplasty balloon fixed at the distal tip and a novel valve technology that allows iniection of fluids through the inflation lumen without removal of the quidewire. Two radiopaque markers identify the balloon working length and two radiopaque markers identify 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 quidewire 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 Hotspur Technologies, Inc. 0.018" Arrow GPSCath™ Balloon Dilatation Catheter (150 cm). It describes the device, its intended use, and substantial equivalence to a predicate device based on performance data.

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list numerical acceptance criteria in a table format. Instead, it describes categories of in vitro preclinical tests performed and states that the product passed these tests. The reported device performance is qualitative, indicating compliance with established procedures and attributes.

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Visual Testing	Product not damaged post-sterilization and packing; handle markings legible.	Performed to ensure product hasn't been damaged and handle markings are legible, and passed.
Dimensional Testing	Product meets all dimensional performance attributes post-validated EtO sterilization cycle.	Performed to ensure product meets all dimensional performance attributes post-validated EtO sterilization cycle exposure, and passed.
Performance Testing	Product passes all functional destructive testing post-validated EtO sterilization cycle.	Performed to ensure product passes all functional destructive testing post-validated EtO sterilization cycle exposure, and passed.
Simulated Use Testing	Product performs and meets functional attributes in an anatomically relevant model.	Performed in an anatomically relevant model to ensure product performs and meets functional attributes, and passed.
Biocompatibility	Meets requirements of ISO 10993-1.	Testing completed per requirements of ISO 10993-1.
Sterilization	Achieves a sterility assurance level (SAL) of 1 x 10^-6^ for EtO sterilization. (Validation performed on predicate is applicable).	Sterilization validation performed on the predicate device is applicable due to similarity; demonstrated SAL of 1 x 10^-6^.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the exact sample sizes (number of units tested) for each type of in vitro preclinical test. It generally states that "tests were performed" or "testing was conducted" without providing quantitative details on the number of samples.

The data provenance is in vitro preclinical tests. There is no mention of human subject data, animal studies, or specific geographic origin of the testing. The tests are described as being "in accordance with the FDA's Guidance for PTCA Catheters."

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 as the studies described are in vitro preclinical tests and do not involve human diagnostic or clinical evaluation where expert interpretation of ground truth would be required. The "ground truth" for these tests would be the established engineering specifications, material properties, and functional performance requirements of the device.

4. Adjudication Method for the Test Set

This information is not applicable for the in vitro preclinical tests described. Adjudication methods (like 2+1, 3+1) are typically used for clinical studies involving expert disagreement on a diagnosis or outcome.

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

There is no MRMC comparative effectiveness study mentioned. The device is a physical medical device (balloon dilatation catheter), not an AI/software-as-a-medical-device (SaMD) that assists human readers.

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

This information is not applicable as the device is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the in vitro preclinical tests, the "ground truth" implicitly used would be:

Engineering specifications and design requirements: For dimensional testing, visual inspection, and functional performance.
Established standards: Such as ISO 10993-1 for biocompatibility and validation protocols for sterilization (ensuring SAL).
Functional performance criteria: For simulated use testing, ensuring the device operates as intended in a model.

There is no mention of expert consensus, pathology, or outcomes data as type of ground truth for these specific tests.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a physical medical device submission based on in vitro testing and substantial equivalence to a predicate, not an AI or machine learning model.

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 submission.

Summary

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

June 24, 2015

Hotspur Technologies. Inc., a Subsidiary of Teleflex Medical. Inc. Eric Ankerud, J.D. Regulatory and Quality Consultant 880 Maude Avenue, Suite A Mountain View, CA 94043

Re: K143093

Trade/Device Name: 0.018" 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: May 7, 2015 Received: May 12, 2015

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

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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,

Brian D. Pullin -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) K143093

Device Name

0.018" Arrow® GPSCath™ Balloon Dilatation Catheter (150 cm)

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

A. Submitter Information Hotspur Technologies, Inc. Submitter's Name: A Subsidiary of Teleflex Medical, Inc. Address: 880 Maude Avenue, Suite A Mountain View, CA 94943 Telephone: 978-302-9467 Fax: 408-608-1597 Contact Person: Eric Ankerud Date of Preparation: October 23, 2014 B. Subject Device Trade Name: 0.018" Arrow® GPSCath™ Balloon Dilatation Catheter (150 cm) Common/Usual Name: Balloon Catheter Classification Name: 21 CFR 870.1250, Catheter, Angioplasty, Peripheral, Transluminal/Percutaneous Catheter Class: ll

Product Code:

C. Predicate Device Name(s):

0.014" Arrow® GPSCath™ Balloon Dilatation Catheter (150 cm), K140351 and K42300 (Hotspur Technologies)

LIT

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Hotspur Technologies, Inc., A Subsidiary of Teleflex Medical, Inc. Traditional 510(k) Notification .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm)

D. Indication for Use:

The .018" 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.

E. Device Description:

F. Predicate Device(s) Reference:

The .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) was shown to be substantially equivalent in intended use, principle of operation, and technological characteristics to the previously cleared device: .014" Arrow® GPSCath™ Balloon Dilatation Catheter (150 cm), (K140351 with a subsequent labeling change per K142300).

G. Performance Data:

In vitro preclinical tests were performed to verify and validate the substantial equivalence of the 0.018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) to the predicate device. Functional testing of the .018" 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:

. Visual Testing was 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 was performed to ensure that the product meets all ●

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dimensional performance attributes post the validated EtO sterilization cycle exposure.

. Performance Testing was conducted to ensure that the product passes all functional destructive testing post the validated EtO sterilization cycle exposure.
Simulated Use Testing was performed in an anatomically relevant model . to ensure that the product performs and meets functional attributes.

The proposed .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) and the predicate .014" Arrow GPSCath Balloon Dilatation Catheter (150 cm) are both balloon angioplasty catheters with equivalent operating principles and intended use. Due to similarities in materials and shared components of the proposed device to the predicate device, certain tests were not repeated. Packaging testing performed to ensure that the product packaging can with stand the effects of transit and environmental conditions and still remain intact and sterile were not repeated since the predicate and proposed devices share identical packaging components.

Biocompatibility testing of the .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) was completed per the requirements of ISO 10993-1, Biological Evaluation of Medical Devices.

The .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) is a single use device that is supplied sterile. The sterilization performed on the predicate device, the .014" Arrow GPSCath Balloon Dilatation Catheter (150 cm) is applicable to the proposed device, the .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) due the similarity in design, materials, and construction. The sterilization validation performed demonstrated that the device is able to be EtO sterilized to achieve a sterility assurance level (SAL) of 1 x 106 See Section 11.0 of this submission for additional detail.

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, the .018" Arrow GPSCath Balloon Dilatation Catheter (150 cm) is determined to be substantially equivalent to an existing legally marketed 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).