The RX Takeru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion. This product (balloon models 2.0-5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.

Device Description

Rx Takeru PTCA Balloon Dilatation Catheter (Rx Takeru) is a rapid exchange type of balloon dilation catheter, which consists of a distal tube, guidewire transition tube, balloon, radiopaque marker(s), mid tube, proximal tube, core wire, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Rx Takeru has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube to the guidewire port for the exit of a guidewire.

The maximum compatible diameter of a guidewire used together with Rx Takeru in a PTCA procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 5 or 6 Fr have been deemed to be compatible with Rx Takeru. The nominal inflated balloon diameters range from 1.5 mm to 5.0 mm with balloon working lengths of 6 mm to 30 mm. The catheter working length is 1450 mm.

AI/ML Overview

This document describes the performance testing and acceptance criteria for the RX Takeru PTCA Balloon Dilatation Catheter.

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

The document states that the RX Takeru "met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." Specific numerical acceptance criteria and reported performance values are not provided in the given text.

The performance tests conducted include:

Test Type	Acceptance Criteria Not Explicitly Stated but "Met"	Reported Performance Not Explicitly Stated but "Adequate"
Dimensional Verification	Met	Adequate for intended use
Balloon Preparation	Met	Adequate for intended use
Deployment and Retraction	Met	Adequate for intended use
Balloon Rated Burst Pressure	Met	Adequate for intended use
Balloon Fatigue (Repeat Inflations)	Met	Adequate for intended use
Balloon Compliance	Met	Adequate for intended use
Balloon Inflation and Deflation Time	Met	Adequate for intended use
Catheter Bond Strength	Met	Adequate for intended use
Flexibility and Kink Test	Met	Adequate for intended use
Torque Strength	Met	Adequate for intended use
Radiopacity	Met	Adequate for intended use
Coating Integrity	Met	Adequate for intended use
Particulate Evaluation	Met	Adequate for intended use
Balloon Rated Burst Pressure (in Stent)	Met	Adequate for intended use
Balloon Fatigue (Repeat Inflations; in Stent)	Met	Adequate for intended use
Transportation Testing	Met	Adequate for intended use
Shelf Life Testing	Met	Adequate for intended use
Biocompatibility Tests:
Cytotoxicity	Met	Biocompatible for intended use
Sensitization	Met	Biocompatible for intended use
Intracutaneous Reactivity	Met	Biocompatible for intended use
Acute Systemic Toxicity	Met	Biocompatible for intended use
Pyrogen	Met	Biocompatible for intended use
Hemocompatibility (in vivo thromboresistance, hemolysis, complement)	Met	Biocompatible for intended use
Genotoxicity (mouse lymphoma, bacterial reverse mutation, in vivo cytogenetics assay)	Met	Biocompatible for intended use

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each of the performance or biocompatibility tests. All the tests mentioned are "in vitro" (bench) tests and biocompatibility tests conducted according to international standards (ISO 10993-1). There is no mention of human subject data, therefore, data provenance in terms of country of origin or retrospective/prospective nature is not applicable.

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. The tests performed are laboratory-based physical and chemical tests, and biocompatibility studies. "Ground truth" in the context of expert review for diagnostic devices is not relevant here. The "truth" is established by the results of the specified test methodologies and their adherence to predetermined acceptance criteria.

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

This information is not applicable. As these are not studies involving human interpretation or subjective assessments, adjudication methods are not relevant.

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 mention of an MRMC comparative effectiveness study, AI assistance, or human reader improvement. This device is a PTCA balloon dilatation catheter, not a diagnostic imaging device with AI components.

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

This information is not applicable. The device is a physical medical device (catheter), not an algorithm or software. Therefore, standalone algorithm performance is not relevant.

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

The "ground truth" for the performance tests relies on adherence to established engineering and material science specifications, validated test methods (e.g., those recommended by FDA guidance documents like "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters"), and international standards (e.g., ISO 10993-1 for biocompatibility). The "truth" is whether the device physically performs according to these criteria.

8. The sample size for the training set

This information is not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for its development or evaluation as described in this document.

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

This information is not applicable for the same reason as point 8.

Summary

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

April 7, 2017

Kaneka Corporation c/o Christopher M. Sloan Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20851

Re: K163372

Trade/Device Name: RX Takeru PTCA 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: March 9, 2017 Received: March 10, 2017

Dear Christopher Sloan:

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 mav 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 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" (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,

Fernando Aguel -

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) K163372

Device Name

RX Takeru PTCA Balloon Dilatation Catheter

Indications for Use (Describe)

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)

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5.0 510(K) SUMMARY

Rx Takeru PTCA Balloon Dilatation Catheter

510(k) Submitter

Kaneka Corporation Medical Device Division 1-12-32, Akasaka, Minato-ku Tokyo, Japan Contact Person: Toshihiko Motomine Telephone: +81-3-5574-8023 Email: Toshihiko.Motomine@kaneka.co.jp

Official Correspondent

Christopher M. Sloan Principal Consultant Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852 Phone: (301) 272-3114 Email: chris.sloan@quintilesims.com

Date Prepared: February 27, 2017

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Subject Device Name:

Trade Name	Rx Takeru PTCA Balloon Dilatation Catheter
Common or usual name	Percutaneous Transluminal CoronaryAngioplasty (PTCA) catheter
Classification name	Percutaneous Transluminal CoronaryAngioplasty (PTCA) catheter [21 CFR870.5100; product code LOX]
Class	II
Classification Panel	Cardiovascular (74)

Predicate Devices:

· Primary predicate device: Apex™ Monorail PTCA Dilatation Catheter or "Apex" [P860019/S208 (Boston Scientific Corporation)]
· Euphora™ Rapid Exchange Balloon Dilatation Catheter or "Euphora" [K143480 (Medtronic Inc.)]

Device Description:

Indications for Use

The RX Takeru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion.

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This product (balloon models 2.0-5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.

Comparison of Indications for Use to Predicate Devices

The RX Takeru has the same intended use (percutaneous transluminal coronary angioplasty) as the Apex and Euphora. The indications for use of the RX Takeru is similar to that of the Apex and Euphora. Therefore, the subject device, RX Takeru, may be considered substantially equivalent to the predicate devices.

Comparison of Technological Characteristics to Predicate Devices

Percutaneous Transluminal Coronary Angioplasty (PTCA) is the technological principle for both RX Takeru and the predicate devices. PTCA is based on the use of Percutaneous Coronary Intervention (PCI) devices for the purpose of myocardial perfusion.

The RX Takeru and predicate devices have following same technological elements:

. Operating principle - balloon dilatation of stenotic portion by pressurization of inflation medium
Fundamental catheter design balloon, shaft, radiopaque marker, hub, hydrophilic ● coating
. Shaft type - rapid exchange
Concomitantly used devices guidewire, guiding catheter, inflation device ●
Sterilization Ethylene oxide .

There are following minor technological differences between RX Takeru and predicate devices:

. Combination of balloon diameter and balloon length
Shaft diameter ●
Catheter effective length ●
Nominal Pressure and Rated Burst Pressure of certain balloon sizes .

Performance Testing

To demonstrate substantial equivalence of RX Takeru to the predicate devices, the technological characteristics and performance criteria were evaluated using the bench testing recommendations outlined in the FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters'' dated September 8, 2010. The following in vitro tests were performed on the subject device:

Dimensional Verification, Balloon Preparation, Deployment and Retraction, Balloon Rated Burst Pressure, Balloon Fatigue (Repeat Balloon Inflations), Balloon Compliance, Balloon Inflation and Deflation Time, Catheter Bond Strength, Flexibility and Kink Test. Torque Strength. Radiopacity, Coating Integrity,

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Particulate Evaluation, Balloon Rated Burst Pressure (in Stent), and Balloon Fatigue (Repeat Balloon Inflations; in Stent), Transportation and Shelf Life Testing.

The results from these tests demonstrate that the technological characteristics and performance criteria of the RX Takeru are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use.

Biocompatibility:

To demonstrate the biological safety of the body-contacting materials and substantial equivalence of the RX Takeru to the predicate devices, the following biocompatibility testing was performed in accordance with "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff" (dated June 16, 2016):

Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen, Hemocompatibility (in vivo thromboresistance, hemolysis, and complement), and Genotoxicity (mouse lymphoma, bacterial reverse mutation and in vivo cytogenetics assay)

The results from these tests demonstrate that the RX Takeru is biocompatible for its intended use similar to the predicate devices.

Conclusions:

The RX Takeru met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The RX Takeru PTCA Balloon Dilatation Catheter is substantially equivalent to legally marketed predicate devices.

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.