The Pirouette 014 Percutaneous Transluminal Angioplasty (PTA) Catheter Family are standard over the wire (OTW), semi-compliant, coaxial design catheters with a balloon mounted on the distal tip. The distal portion of the catheter has a hydrophilic coating.

The manifold connector and shaft design consists of a guidewire lumen allowing the catheter to track over a guidewire and an inflation lumen, used to inflate and deflate the balloon. Radiopaque markers are positioned on the shaft within the balloon to enable visualization of the catheter/balloon under fluoroscopy. The catheter is compatible with .014 inch (0.356 mm) wire guides.

The Pirouette 014 PTA Catheter Family includes multiple balloon sizes ranging from 1.25 mm to 4.0 mm in diameter and 15 mm to 300 mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the guidewire hub of the manifold. The effective lengths of the catheter are 90 cm, 130 cm and 150 cm.

AI/ML Overview

This document describes the Pirouette 014 PTA Catheter, a medical device for balloon dilation of arteries. However, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered medical device. Instead, it describes a conventional medical device (a catheter) and its non-clinical performance testing.

Therefore, I cannot fulfill the request as it pertains to an AI/ML powered device, an acceptance criteria table, or a study demonstrating AI performance.

The information given is about:

Device Name: Pirouette 014
Device Type: Percutaneous Transluminal Angioplasty (PTA) Catheter
Intended Use: Balloon dilation of the iliac, femoral, popliteal, infra-popliteal, and renal arteries.
Predicate Device: Pirouette 018 OTW PTA Catheter (K151153) and Bantam α PTA Catheter (K093139)
Performance Data: Non-clinical bench tests, biocompatibility tests, sterilization, shelf-life, and packaging validation were conducted. No clinical studies were performed. The results from these tests "showed that the Pirouette 014 met the pre-determined acceptance criteria," but the specific acceptance criteria or the reported performance values are not detailed in a quantitative table.

To answer your prompt for an AI/ML powered device, I would need a different type of document specifically detailing the performance of an AI/ML algorithm.

Summary

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

November 22, 2016

ArraVasc Ltd. Ms. Aoife Donoghue Regulatory and Design Assurance Manager 2 Ballybrit Business Park Galway, Ireland

Re: K162316

Trade/Device Name: Pirouette 014 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: October 25, 2016 Received: October 31, 2016

Dear Ms. Donoghue:

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 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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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,

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) K162316

Device Name Pirouette 014

Indications for Use (Describe)

The Pirouette 014 PTA Catheter is intended for balloon dilation of the illac, femoral, popliteal, and renal arteries.

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

5.1 Submitter

Submitter Address:	ArraVasc Limited2 Ballybrit Business Park,GalwayIreland
Phone Number:	+353-91-758939
Fax Number:	+353-91-758930
Contact Person:	Aoife Donoghue Regulatory & Design Assurance Manager
Date Prepared:	04 Aug 2016

5.2 Device

Device Trade Name:	Pirouette 014
Common Name:	OTW PTA catheter
Classification Name:	Peripheral Transluminal Angioplasty Catheter
Classification number:	21 CFR 870.1250
Product code:	LIT
Class:	II
Classification Panel:	Cardiovascular

5.3 Predicate Device

Predicate:	Pirouette 018 OTW PTA CatheterArraVasc Ltd.510(K) number: K151153
Reference Device:	Bantam α PTA CatheterClearStream Technologies Ltd510(K) number: K093139

5.4 Device Description

Device Description:

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Percutaneous Transluminal Angioplasty Catheter (PTA Catheter). Physical Description:

5.5 Indication for use

The Pirouette 014 PTA Catheter is intended for balloon dilation of the iliac, Indications for Use femoral, popliteal, infra-popliteal, and renal arteries. Statement:

5.6 Comparison with the predicate device

The Pirouette 014 is substantially equivalent to the predicate device in design, materials, packaging, fundamental scientific technology, manufacturing, sterilization and intended use. The following table provides a summary of general and technical characteristics as compared to the primary predicate device and predicate device.

Parameter	Characteristics
Classification	Class II, 21 CFR 870.1250Same Classification as predicate devices.
Intended Use	Same intended use: balloon dilatation of the iliac, femoral, poplitealand infra-popliteal arteries and renal arteries.
Balloon material	Same material
Balloon diameter	Comparable range of balloon diameters: 1.25 mm - 4.0 mm versus2.0 mm - 9.0 mm for the predicate device
Balloon length	Comparable range of balloon lengths: 15 mm - 300 mm versus 20mm - 300 mm for the predicate device
Nominal pressure (atm)	Same nominal pressure: 8 atm.
Rated burst pressure(atm)	Same rated burst pressure: 16 atm
Radioopaquemarkerbands	Two Markerbands, one at distal and one at proximal side of theballoon, with the same function
Outer shaft	Same material
Catheter shaftouter diameter	Comparable catheter diameter: 2-7-3.6 Fr versus: 3.6 – 4.2 Fr for thePredicate
Catheter Usablelengths (cm)	Comparable range of usable lengths: 90 cm - 150 cm versus 45 cm -150cm for the Predicate device
RecomendedIntroducer Sheath Sizecompatibility	Comparable size: 4 Fr versus 4 - 5 Fr for the Predicate device
RecommendedGuidewire diameter	Maximum 0.014" versus; maximum 0.018"
Catheter strain relief &manifold material	Same material, with the same function
Catheter manifolddesign	Same design, dual lumen Y design, with the same function
Catheter coating	Same coating
Sterilization Method	Same method; Ethylene Oxide
Single Use / Reusable	Single Use

Table 1 Comparison of Pirouette 014 to Pirouette 018 (Predicate)

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5.7 Performance Data

As per ArraVasc Risk Analysis procedures, the Pirouette 014 was thoroughly tested on the bench to evaluate and verify that it meets the required performance specifications and to support a determination of substantial equivalence. The bench testing plan was developed with the recommendations outlined in the applicable FDA guidance documents, tests recommended in ISO 10555-1, Intravascular catheters-Sterile and single-use catheters - Part 1: General Requirements, and 10555-4, Intravascular catheters-Sterile and single-use catheters - Part 4: Balloon dilatation catheters. Testing performed on Pirouette included the following:

Non-Clinical Tests:

. Dimensional verification
Balloon preparation, pushability, trackability, deployment, withdrawal and balloon reinsertion .
Balloon rated burst pressure (RBP) .
Balloon fatigue (repeated balloon inflations)
. Balloon Compliance at nominal and rated burst inflation pressure
Balloon Inflation/Deflation Time ●
Catheter Bond Strength (Tip to balloon, balloon to proximal shaft, shaft to manifold) ●
. Flexibility and Kink test
Torque Strength ●
Radiopacity ●
. Coating Integrity
. Particulate evaluation
Guide wire compatibility ●
. Introducer sheath compatibility

The results showed that the Pirouette 014 met the pre-determined acceptance criteria. No new safety or effectiveness issues were raised during this testing.

Biocompatibility Tests:

Per ISO10993-1:2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the Pirouette 014 is classified as an externally communicating device, which contacts circulating blood during a limited contact duration (≤24hours). For reason that the Pirouette 014 has the same indication, general design, materials, and packaging, the Biocompatibility tests with the Pirouette 018 were considered valid for the Pirouette 014. Biocompatibility testing with the Pirouette 018 was conducted per ISO 10993-1:2009 were completed and passed:

MTT Cytotoxicity Study ●
ISO Maximization Sensitization Study .
ISO Intracutaneous Study .
ISO Systemic Toxicity Study ●
ASTM Hemolysis .
C3a Complement Activation Assay .
SC5b-9 Complement Activation Assay ●
ASTM Partial Thromboplastin Time ●
In Vivo Thromboresistance Study - Jugular Vein
. Pyrogenicity

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Sterilization, Shelf life tests and Packaging validation:

EO sterilzation validation by an adoption validation using a sub-lethal cycle approach; .
EO/ECH residues of Pirouette 035 (K161427) were tested (largest surface area of Pirouette . family, therefore worst case);
. Shelf life testing was leveraged from the data on the Pirouette 018;
. Packaging validation was leveraged on the data of the Pirouette 018.

The results show that the Pirouette 014 is sterility is maintained by the packaging during the entire shelf life of the device. From the results it was also concluded that the device meets the criteria for Residual Testing, i.e. EO/ECH residues.

Clinical Performance Data:

. No clinical studies were performed for the purpose of obtaining safety and effectiveness data.
. The Pirouette 014 is approved for marketing in the European Union (CE certified).

5.8 Conclusions

Based upon the intended use, fundamental scientific technology, performance characteristics, non-clinical performance testing, and comparison to legally marketed devices, it is concluded that the Pirouette 014 is appropriate for its intended use, and is substantially equivalent to the predicate 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).