The Pirouette 035 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 quidewire lumen allowing the catheter to track over a quidewire 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 .035 inch (0.89 mm) wire guides. The Pirouette 035 PTA Catheter Family includes multiple balloon sizes ranging from 3 to 12 mm in diameter and 20 to 200mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the quidewire hub of the manifold. The effective lengths of the catheter are 75cm and 130cm.

AI/ML Overview

The provided text is a 510(k) summary for the Pirouette 035 Percutaneous Transluminal Angioplasty (PTA) Catheter. It describes the device, its intended use, and compares it to a predicate device (Pirouette 018). The core of the performance data section relies on non-clinical bench testing and leveraging data from the predicate device for biocompatibility, sterilization, shelf life, and packaging. No clinical studies were performed for the purpose of obtaining safety and effectiveness data for the Pirouette 035.

Therefore, I cannot provide information on acceptance criteria and study details related to AI or human expert performance, as the device is a physical medical catheter, not an AI-powered diagnostic or assistive tool. The concept of "acceptance criteria" in this context refers to engineering specifications and performance benchmarks for the physical device.

However, I can extract the relevant information from the document regarding the non-clinical testing and general acceptance criteria for this type of medical device.

Here's a breakdown based on the provided document, addressing the closest equivalent concepts:

Acceptance Criteria and Device Performance (Non-Clinical)

The document describes various non-clinical tests performed on the Pirouette 035 catheter. The acceptance criteria for these tests are generally stated as the device "met the pre-determined acceptance criteria," implying that the device demonstrated performance within specified engineering tolerances for each test. The document does not provide specific numerical thresholds or target values for these criteria, but rather lists the types of tests conducted.

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

Since specific numerical acceptance criteria are not provided in the document, the table will reflect the types of tests performed and the general statement of performance.

Parameter/Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance	Met pre-determined engineering specifications for each test.	Met all pre-determined acceptance criteria.
Dimensional Verification	Within specified manufacturing tolerances.	Passed.
Balloon Prep, Pushability, Trackability, Deployment, Withdrawal, Reinsertion	Performed as intended without failure.	Passed.
Balloon Rated Burst Pressure (RBP)	Maintained integrity at/above specified pressure.	Passed.
Balloon Fatigue	Withstood repeated inflations without failure.	Passed.
Balloon Compliance	Maintained specified compliance at nominal and RBP.	Passed.
Balloon Inflation/Deflation Time	Within specified time limits.	Passed.
Catheter Bond Strength	Maintained integrity at specified force/stress.	Passed.
Flexibility and Kink Test	Demonstrated adequate flexibility and resistance to kinking.	Passed.
Torque Strength	Maintained integrity and responsiveness to torque.	Passed.
Radiopacity	Visible under fluoroscopy as specified.	Passed.
Coating Integrity	Coating remained intact and functional.	Passed.
Particulate Evaluation	Within acceptable limits for particulate burden.	Passed.
Guidewire Compatibility	Compatible with specified guidewires.	Passed.
Introducer Sheath Compatibility	Compatible with specified introducer sheaths.	Passed.
Biocompatibility	Meets ISO 10993-1:2009 standards for limited contact with blood.	Passed all tests leveraging Pirouette 018 data.
MTT Cytotoxicity	Non-cytotoxic.	Passed (leveraged from Pirouette 018).
ISO Maximization Sensitization	Non-sensitizing.	Passed (leveraged from Pirouette 018).
ISO Intracutaneous	Non-irritating.	Passed (leveraged from Pirouette 018).
ISO Systemic Toxicity	Non-systemically toxic.	Passed (leveraged from Pirouette 018).
ASTM Hemolysis	Acceptable hemolytic index.	Passed (leveraged from Pirouette 018).
Complement Activation Assay (C3a, SC5b-9)	Acceptable levels of complement activation.	Passed (leveraged from Pirouette 018).
ASTM Partial Thromboplastin Time	Acceptable impact on coagulation.	Passed (leveraged from Pirouette 018).
In Vivo Thromboresistance	Demonstrates acceptable thrombogenicity.	Passed (leveraged from Pirouette 018).
Pyrogenicity	Non-pyrogenic.	Passed (leveraged from Pirouette 018).
Sterilization, Shelf Life, Packaging	Meets relevant standards for sterility, shelf life, and packaging integrity.	All criteria determined to be met.
EO Sterilization Validation	Sterility maintained effectively.	Passed.
EO/ECH Residues	Residues within acceptable limits.	Passed.
Shelf Life Testing	Sterility and functionality maintained over shelf life.	Passed (leveraged from Pirouette 018).
Packaging Validation	Integrity maintained in specified conditions; protects sterility.	Passed (leveraged from Pirouette 018).

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

Sample Size for Test Set: The document does not specify the sample sizes for any of the non-clinical tests (e.g., how many catheters were burst tested). It only lists the types of tests.
Data Provenance: The bench testing (non-clinical tests) was performed by ArraVasc Limited (the manufacturer). The company is based in Ireland (2 Ballybrit Business Park, Galway, Ireland). The data is prospective in the sense that the tests were conducted specifically for the submission of the Pirouette 035.

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

This question is not applicable to this type of device and study. "Ground truth" established by human experts, especially for image interpretation or diagnosis, is a concept relevant to AI/ML or diagnostic devices. For a physical catheter, the "ground truth" and performance evaluation are based on objective engineering measurements and laboratory tests against predefined physical and chemical specifications, not subjective expert assessment. The experts involved would be engineers and lab technicians.

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

This question is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth from multiple human readers in AI/imaging studies. For bench testing of a physical device, results are objective measurements against specifications, not subjective reads requiring adjudication.

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:

No. This type of study (MRMC, AI assistance) is not applicable as the device is a physical catheter, not an AI or diagnostic tool. The document explicitly states: "No clinical studies were performed for the purpose of obtaining safety and effectiveness data."

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

No. This question is not applicable as the device is a physical catheter, not an algorithm. Bench testing evaluates the physical device's performance standalone.

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

The "ground truth" for the non-clinical tests is the objective engineering specifications and industry standards (e.g., ISO 10555-1, ISO 10555-4, ISO 10993-1). The device's performance is measured directly against these benchmarks.

8. The sample size for the training set:

This question is not applicable. "Training set" refers to data used to train an AI model. For a physical device, there is no AI training set.

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

This question is not applicable for the same reason as #8.

Summary

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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other.

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

July 30, 2016

ArraVasc Limited % Patsy J. Trisler, JD, RAC Qserve Group US, Inc. 5600 Wisconsin Avenue Chevy Chase, MD 20815

Re: K161427

Trade/Device Name: Pirouette 035 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 6, 2016 Received: July 6, 2016

Dear Ms. Trisler:

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

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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.

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,

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) K161427

Device Name Pirouette 035

Indications for Use (Describe)

Piroutte 035 PTA Catheter is intended for balloon of the iliac, femoral, popliteal, infra-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
Date Prepared:	13 June 2016

5.2 Device

Device Trade Name:	Pirouette 035
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

Primary predicate:	Pirouette 018 OTW PTA Catheter
	ArraVasc Ltd.
	510(K) number: K151153
Reference Device	Advance 35LP Low Profile PTA balloon Dilation Catheter
	Cook Inc.
	510(k) number K132020

5.4 Device Description Device Description: The Pirouette 035 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 quidewire lumen allowing the catheter to track over a quidewire 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 .035 inch (0.89 mm) wire guides. The Pirouette 035 PTA Catheter Family includes multiple balloon sizes ranging from 3 to 12 mm in diameter and 20 to 200mm in length. The nominal balloon diameter (mm) and the balloon length (mm) are inscribed on the quidewire hub of the manifold. The effective lengths of the catheter are 75cm and 130cm. Physical Description: Percutaneous Transluminal Angioplasty Catheter (PTA Catheter). Indication for use Indications for Use Pirouette 035 is intended for balloon dilation of the iliac, femoral, Statement: popliteal, infra-popliteal and renal arteries.

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5.5 Comparison with the predicate device

The Pirouette 035 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 predicate device.

Table 1 Comparison of Pirouette 035 to Pirouette 018 (predicate)

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: 3 - 12 mm versus 2 - 9 mmfor the predicate device
Balloon length	Comparable range of balloon lengths: 20 – 200 versus 20 - 300mm forthe predicate device
Nominal pressure (atm)	Same nominal pressure: 8 atm.
Rated burst pressure(atm)	Comparable rated burst pressure: 16atm (2.0-5.0mm balloondiameter) / 14atm (6.0mm balloon diameter) / 12atm (7.0-10.0mmballoon diameter) / 10atm (12.0mm)
Radiopaque	Two Markerbands, one at distal and one at proximal side of theballoon, with the same function.
Marker bands	Same material
Outer shaft	Same material
Catheter shaftouter diameter	Comparable catheter diameter: 5.2 Fr - 5.4 Fr versus: 3.6 – 4.2 Fr forthe Predicate
Catheter UsableLengths (cm)	Comparable range of usable lengths: 75 cm and 130 cm versus 45 -150cm for the Predicate device.
RecommendedIntroducer Sheathcompatibility	Comparable size: 5 - 7 Fr versus 4 – 5 Fr for the Predicate device.
RecommendedGuidewire diameter	Maximum 0.035"" 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

Performance Data 5.6

As per ArraVasc Risk Analysis procedures, the Pirouette 035 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 consideration of the recommendations outlined in the applicable FDA guidance documents, tests recommended in ISO 1055-1, 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:

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Non-Clinical Tests:

Dimensional verification ●
Balloon preparation, pushability, trackability, deployment, withdrawal and balloon reinsertion ●
Balloon rated burst pressure (RBP) .
. Balloon fatique (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 035 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 035 is classified as an externally communicating device, which contacts circulating blood during a limited contact duration (≤24hours). For reason that the Pirouette 035 has the same indication, general design, materials, and packaging, the Biocompatibility tests with the Pirouette 018 were considered valid for the Pirouette 035. 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 Juqular Vein ●
Pyrogenicity ●

Sterilization, Shelf life tests and Packaging validation:

EQ sterilzation validation by an adoption validation using a sub-lethal cycle approach; ●
. EO/ECH residues of Pirouette 035 were tested;
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 035 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 035 has been approved for marketing in the European Union (CE certified) in 2015, and has been marketed in the EU thereafter.

5.7 Conclusions

Based upon the intended use, fundamental scientific technology, performance characteristics, nonclinical performance testing, and comparison to legally marketed devices, it is concluded that the Pirouette 035 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).