This document describes a 510(k) premarket notification for a medical device called the "Pirouette 018," which is a Percutaneous Transluminal Angioplasty (PTA) Catheter. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "The results showed that the Pirouette 018 met the pre-determined acceptance criteria." However, it does not provide a specific table detailing the acceptance criteria for each test or the quantitative reported device performance against those criteria. It lists the tests performed, implying satisfactory results.

Here's a table based on the provided text, outlining the tests and the general outcome, but without specific numerical acceptance criteria or performance values:

Test Category	Specific Tests Performed	Reported Device Performance
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 018 met the pre-determined acceptance criteria." (Specific numerical results and acceptance criteria are not provided)
Biocompatibility Tests	- 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	"The test results show that the Pirouette 018 is biocompatible." (Specific numerical results and acceptance criteria are not provided)
Sterilization, Shelf Life, and Packaging Validation	- EtO sterilization validation- EtO/ECH residue determination- Shelf life testing- Packaging validation	"Test results show that the Pirouette 018 is sterile and 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. EtO/ECH residues." (Specific numerical results and acceptance criteria are not provided)

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

The document explicitly states: "No clinical studies were performed for the purpose of obtaining safety and effectiveness data."

Therefore, there is no "test set" in the context of human clinical data or patient outcomes. The testing described is entirely non-clinical (bench testing) and biocompatibility. The sample sizes for these bench tests are not provided in the document.

Data provenance (country of origin, retrospective/prospective) is not applicable, as no clinical data was used for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. As no clinical studies were performed, there was no "test set" requiring expert ground truth establishment for patient data. The non-clinical tests rely on established engineering and materials science principles, and the biocompatibility tests on standardized laboratory protocols.

4. Adjudication Method for the Test Set

Not applicable. No clinical data and no "test set" from human participants means no adjudication method was needed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical studies were performed for the purpose of obtaining safety and effectiveness data." Therefore, no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical catheter, not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical tests, the "ground truth" is defined by the pre-determined acceptance criteria and the recommendations outlined in applicable FDA guidance documents, ISO 10555-1, and 10555-4. For biocompatibility, it's defined by ISO 10993-1:2009 standards. These standards and internal specifications serve as the "ground truth" against which the device performance was measured. No patient-specific ground truth (like pathology or outcomes data) was used for this submission.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.

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

August 20, 2015

ArraVasc Limited c/o Jan-Paul van Loon Qserve Group US Inc. P.O Box 940 Charlestown, NH 03603

Re: K151153

Trade/Device Name: Pirouette 018 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 9, 2015 Received: July 13, 2015

Dear Jan-Paul van Loon:

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

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

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 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

510(k) Number (if known) K151153

Device Name Pirouette 018

Indications for Use (Describe)

Pirouette 018 is intended for balloon dilation of the iliac, femoral, popliteal and renal arteries.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary

1. Submitter

Submitter Address:	ArraVasc Limited2 Ballybrit Business Park,GalwayIreland
Phone Number:	+353-91-758939
Fax Number:	+353-91-758930
Contact Person:	Máiréad McCaffrey
Date Prepared:	15 April 2015

2. Device

Device Trade Name:	Pirouette 018
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

3. Predicate Devices

Primary predicate:	Bantam and Bantam OTW PTA CatheterClearstream Technologies Ltd.510(K) number: K112335/K093139
Secondary predicate:	SABER IM PTA Dilation CatheterCordis Corporation510(K) number: K133843

4. Device Description

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

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

5. Indication for use

Indications for Use	Pirouette 018 is intended for balloon dilation of the iliac, femoral,popliteal, infra-popliteal and renal arteries.
Statement:

6. Comparison of technological characteristics with the predicate device

Summary ofTechnologicalCharacteristics	The Pirouette 018 incorporatessubstantially equivalent design, packaging, fundamental technology,materials, manufacturing, sterilization and intended use as thosefeatured in the primary predicate Bantam and Bantam OTW PTAcatheters and contains a hydrophilic coating substantially equivalent tothe secondary predicate SABERTM PTA catheter.
------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Table 1 Summary of general and technical characteristics against the predicate devices.

Parameter	Characteristics
Classification	Class II, 21 CFR 870.1250
	Same Classification as predicate devices.
Intended Use	Same intended use of balloon dilatation of the femoral, popliteal and
	infra-popliteal arteries with additional vessels; iliac and renal indicated.
Balloon material	Same type of material
Balloon diameter	Same range of balloon diameters: 2 - 9 mm
Balloon length	Comparable range of balloon lengths: 20 - 300mm
Nominal pressure (atm)	Same or higher nominal pressure: 8 atm.
Rated burst pressure	Comparable rated burst pressure: 16atm (2.0-5.0mm balloon
(atm)	diameter) / 14atm (6.0mm balloon diameter) / 12atm( 7.0-9.0mm
	balloon diameter)
Radiopaque	Two Markerbands, one at distal and one at proximal side of the
Marker bands	balloon, with the same function.
Outer shaft	Same type material

Catheter shaft	Same diameter or lower: 3.6 . 4.2 Fr
outer diameter
Catheter Usable	Comparable range of usable lengths: 45 - 150cm
Lengths (cm)
Recommended	Comparable size or lower: 4 . 5 Fr
Introducer Sheath
compatibility
Recommended	Same compatibility; maximum 0.018+
Guidewire diameter
Catheter strain relief &	Same type of material, with the same function.
manifold material
Catheter manifold	Same design, dual lumen Y design, with the same function.
design
Catheter coating	Similar type of coating.
Sterilization Method	Same method; Ethylene Oxide.
Single Use / Reusable	Single Use

{5}------------------------------------------------

7. Performance Data

The Pirouette 018 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 quidance 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 the 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 018 met the pre-determined acceptance criteria.

Biocompatibility Tests:

Per ISO10993-1:2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the Pirouette 018 is classified as an externally communicating device, which contacts circulating blood during a limited contact duration (m24hours). Biocompatibility testing conducted on Pirouette 018 per ISO 10993-1:2009 included the following:

. 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

The test results show that the Pirouette 018 is biocompatible.

{6}------------------------------------------------

Sterilization, Shelf life tests and Packaging validation:

. EtO sterilzation validation
. EtO/ECH residue determination
. Shelf life testing
. Packaging validation

Test results show that the Pirouette 018 is sterily 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. EtO/ECH residues.

Clinical Performance Data:

No clinical studies were performed for the purpose of obtaining safety and effectiveness data. .
The Pirouette 018 has been approved for marketing in the European Union (CE certified) in 2014. . and has been marketed in the EU for since then.

8. Conclusions

The performance testing presented above establishes that the Pirouette 018 is as safe and effective for its intended use as the predicate device. The comparison tabulated above demonstrates that the Pirouette 018 device is substantially equivalent to the predicate devices.

Information contained within this submission demonstrates that the Pirouette 018:

. Has legally marketed predicate devices;
Has identical indications for use as the identified primary predicate devices; ●
Incorporates the same fundamental technology, and uses accepted scientific methods and international standards to evaluate device safety and effectiveness;
Demonstrates that the design and performance of the Pirouette 018 has equivalent safety and performance characteristics of predicate devices, and does not raise different questions of safety and effectiveness.

Based upon the; intended use, design, performance characteristics, non-clinical performance testing performed, and comparison to legally marketed devices, it is concluded that the Pirouette 018 is appropriate for its intended use, and is substantially equivalent to the predicate devices.

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).