The NC Euphora™ Rapid Exchange Balloon Dilatation catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter is also indicated for post deployment expansion of balloon expandable stents.

Device Description

The NC Euphora™ RX Balloon Dilatation catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure as defined in the product labelling. The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guidewire to position the catheter. Radiopaque balloon marker bands enable accurate placement. Shaft markers for brachial and femoral techniques are in place. The NC Euphora device is available in balloon diameters of 2.0mm to 5.0mm and in balloon lengths of 6mm to 27mm. The NC Euphora device has a nominal pressure of 12atm and a rated burst pressure of 20atm.

AI/ML Overview

This document is a 510(k) summary for the Medtronic NC Euphora Rapid Exchange Balloon Dilatation Catheter, demonstrating its substantial equivalence to a predicate device. It focuses on non-clinical performance and biocompatibility rather than clinical studies.

Here's an analysis based on your request, structured to address the points directly from the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance values for each test. Instead, it states that the device met all specified design and performance requirements.

Acceptance Criteria (Implied)	Reported Device Performance
Design Verification In-vitro Testing:
Effective length performance specifications	Met all specified requirements
Catheter Profile	Met all specified requirements
System Pressure Capability & System Pressure Capability (in Stent)	Met all specified requirements
Balloon Fatigue & Balloon Fatigue (in Stent)	Met all specified requirements
Balloon Compliance	Met all specified requirements
Balloon Inflation and Deflation Time	Met all specified requirements
Catheter Bond Strength	Met all specified requirements
Coating Integrity	Met all specified requirements
Coating Particulate Evaluation	Met all specified requirements
Flexibility and Kink	Met all specified requirements
Torque Strength	Met all specified requirements
Biocompatibility Testing (for an external communicating device with limited exposure ≤ 24 hours):
Cytotoxicity Study using ISO MEM Elution method	Met all specified requirements
ISO Maximisation Sensitisation Study	Met all specified requirements
ISO Acute Intracutaneous Reactivity	Met all specified requirements
ISO Acute Systemic Toxicity	Met all specified requirements
USP Material Mediated Pyrogen Study in Rabbits	Met all specified requirements
In Vivo Thromboresistance Study	Met all specified requirements
ASTM In-vitro Haemolysis	Met all specified requirements
ASTM Partial Thromboplastin Time (PTT) Coagulation Testing	Met all specified requirements
C3a Complement Activation Assay Study	Met all specified requirements
Sc5b-9 Complement Activation Assay Study	Met all specified requirements
USP Physicochemical Tests	Met all specified requirements
Sterilization Validation:
Achieved minimum Sterility Assurance Level (SAL) of 10-6	Validated for E-beam sterilization in accordance with ISO11137, EN556 and TIR33 to achieve a minimum SAL of 10-6.

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

Sample Size: The document does not specify the sample sizes used for the in-vitro bench tests or biocompatibility tests. It only lists the types of tests performed.
Data Provenance:
- Country of Origin: The applicant is Medtronic, Inc., Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. This suggests the testing was either conducted in Ireland or sponsored by the Irish entity.
- Retrospective or Prospective: The testing described (in-vitro bench tests, biocompatibility tests, pre-clinical in-vivo (non-GLP) studies) are inherently prospective tests performed to qualify the device.

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)

This information is not applicable and not provided in the document. The document describes non-clinical testing (bench, biocompatibility, non-GLP in-vivo for radiopacity) rather than studies that would involve human expert interpretation for ground truth establishment (e.g., image analysis by radiologists).

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

This information is not applicable and not provided in the document. Adjudication methods typically apply to clinical studies where multiple human readers assess a common set of cases, and a process is used to resolve disagreements or establish a consensus ground truth. The presented studies are non-clinical.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical investigation has been performed for this device." The device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic tool, so such a study would not be relevant.

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

This question is not applicable. The device is a physical medical catheter, not an algorithm. Standalone performance typically refers to the performance of an AI algorithm independent of human intervention.

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

Since this submission is for a physical device and relies on non-clinical testing for substantial equivalence, the "ground truth" refers to established engineering specifications, material standards, and biological safety standards.

For design verification in-vitro testing: Engineering specifications, recognized industry standards, and regulatory guidance documents (e.g., "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010").
For biocompatibility testing: International standards (e.g., ISO10993-1:2009, USP, ASTM) define the acceptance criteria for biological safety.
For pre-clinical in-vivo (non-GLP) studies for radiopacity: Visual assessment by trained personnel against a defined standard for visibility.

8. The sample size for the training set

This information is not applicable and not provided. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The device's design is based on engineering principles and previous device experience.

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

This question is not applicable for the reasons stated above (not an AI/ML device requiring a training set). The "ground truth" for the device's design and manufacturing is established through engineering design specifications, material science, and manufacturing process controls.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of three human profiles facing right, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the top of the seal.

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

August 14, 2014

Medtronic Inc. Ms. Gerardine Finn VP of Regulatory Affairs - Coronary and RDN Cardiac & Vascular Group 3576 Unocal Place Santa Rosa, CA 95403

Re: K141090

Trade/Device Name: NC Euphora Rapid Exchange Balloon Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: July 16, 2014 Received: July 18, 2014

Dear Ms. Finn,

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

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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/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 yours,

M. A. Hillebrenner

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141090

Device Name

NC Euphora™ Rapid Exchange Balloon Dilatation Catheter

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary per 21 CRF 807.92

Date Prepared:	August 15th, 2014
Applicant:	Medtronic, Inc.Medtronic IrelandParkmore Business Park WestGalwayIreland
OfficialCorrespondent:	Caitriona ReganSenior Regulatory Affairs SpecialistMedtronic IrelandParkmore Business Park WestGalwayIrelandPhone: (353) 91 708842Fax: (353) 91 708672Email: caitriona.regan@medtronic.com
ProprietaryName:	NC Euphora™ Rapid Exchange Balloon Dilatation Catheter
CommonName:	Percutaneous Transluminal Coronary Angioplasty (PTCA)Catheter
DeviceClassification:	Class II (special controls)
RegulationNumber:	21 CFR 870.5100
ClassificationName:	Percutaneous Transluminal Coronary Angioplasty (PTCA)Catheter
Product Code:	LOX
DeviceDescription:	The NC Euphora™ RX Balloon Dilatation catheter is aPercutaneous Transluminal Coronary Angioplasty (PTCA) RapidExchange System. The balloon at the distal end of the cathetercan be inflated to a defined diameter at a specific pressure asdefined in the product labelling. The proximal end of the catheterhas a female luer for attachment to an inflation device. Thecatheter provides a lumen which enables the use of a guidewire toposition the catheter. Radiopaque balloon marker bands enableaccurate placement. Shaft markers for brachial and femoraltechniques are in place.The NC Euphora device is available in balloon diameters of2.0mm to 5.0mm and in balloon lengths of 6mm to 27mm. TheNC Euphora device has a nominal pressure of 12atm and a ratedburst pressure of 20atm.
Indications ForUse:	The NC Euphora™ RX Balloon Dilatation catheter is indicatedfor balloon dilatation of the stenotic portion of a coronary arteryor bypass graft stenosis for the purpose of improving myocardialperfusion. The balloon dilatation catheter is also indicated forpost deployment expansion of balloon expandable stents.
SubstantiallyEquivalentDevice:	The NC Euphora™ RX Balloon Dilatation Catheter is similar tothe following predicate device with respect to intended use,design and technology:Medtronic NC Sprinter® RX Balloon Dilatation Catheter(P790017/S095, approved October 10, 2008)
Summary ofTechnologicalDifferences tothe PredicateDevice:	The Euphora™ RX Balloon Dilatation Catheter represents aseries of incremental performance improvements over itspredicate device NC Sprinter® RX Balloon Dilatation Catheter,with primary attributes including lower balloon radial growth andhigher nominal and rated burst pressure. The NC Euphoracatheter is also offered in more balloon sizes compared to itspredicate and the 2.0mm diameter size is indicated for postdeployment expansion of balloon expandable stents.

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Summary of	Design Verification in-vitro testing:
Non-ClinicalData:	The following in-vitro bench tests were completed on the NCEuphoraTM RX Balloon Dilatation Catheter in accordance withthe requirements of Guidance for Industry and FDA Staff - ClassII Special Controls Guidance Document for CertainPercutaneous Transluminal Coronary Angioplasty (PTCA)

Effective length ●
performance specifications:
Catheter Profile ●
System Pressure Capability & System Pressure Capability (in ● Stent)

Catheters, September 8, 2010 and verify that it meets the required

Balloon Fatigue & Balloon Fatigue (in Stent)
Balloon Compliance ●
Balloon Inflation and Deflation Time
Catheter Bond Strength ●
Coating Integrity
Coating Particulate Evaluation ●
Flexibility and Kink ●
Torque Strength

Pre-Clinical Study (non-GLP):

Medtronic Ireland conducted pre-clinical in-vivo (non-GLP) studies for evaluation of the Radiopacity attribute of the NC Euphora™ RX Balloon Dilatation Catheter.

Biocompatibility Testing:

Biocompatibility testing for the NC Euphora™ RX Balloon Dilatation Catheter has been completed in accordance with the recommendations of Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010 and International Standard ISO10993-1:2009, Biological Evaluation of Medical devices-Part 1: Evaluation and Testing for an external communicating device with limited exposure i.e. whose contact with circulating blood is ≤ 24 hours.

The following Biocompatibility tests were performed to support the NC Euphora™ RX Balloon Dilatation Catheter:

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Cytotoxicity Study using ISO MEM Elution method ●
ISO Maximisation Sensitisation Study ●
ISO Acute Intracutaneous Reactivity ●
ISO Acute Systemic Toxicity ●
USP Material Mediated Pyrogen Study in Rabbits
In Vivo Thromboresistance Study .
ASTM In-vitro Haemolysis ●
ASTM Partial Thromboplastin Time (PTT) Coagulation ● Testing
C3a Complement Activation Assay Study ●
Sc5b-9 Complement Activation Assay Study ●
USP Physicochemical Tests ●

The NC Euphora™ RX Balloon Dilatation Catheter met all specified design and performance requirements. No new safety or effectiveness issues were raised during the testing. The bench testing qualification and biocompatibility testing demonstrated that the subject device NC Euphora" RX Balloon Dilatation Catheter is substantially equivalent in terms of safety and effectiveness to the predicate device.

No clinical investigation has been performed for this device. Summary of

Clinical Data:

Sterilization The NC Euphora™ RX Balloon Dilatation Catheter will be Validation: sterilized and validated for E-beam sterilization in accordance with ISO11137, EN556 and TIR33 to achieve a minimum Sterility Assurance Level (SAL) of 10-9.
Through the data and information presented, Medtronic Ireland Conclusion: considers the NC Euphora™ RX Balloon Dilatation Catheter to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.