The OTW 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

OTW Takeru PTCA Balloon Dilatation Catheter (OTW Takeru) is an over-the-wire balloon dilation catheter, which consists of a distal tube, mid tube, proximal tube, balloon, guidewire transition tube, radiopaque marker(s), manifold, 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 manifold at the proximal end. OTW Takeru has a lumen at the distal end of the catheter through which a guidewire can be inserted. This lumen extends from the distal end of the catheter to the guidewire port on the manifold for the guidewire.

The maximum compatible diameter of a guidewire used together with OTW 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 OTW 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 is a 510(k) premarket notification for the OTW Takeru PTCA Balloon Dilatation Catheter. It describes the device, its indications for use, and its comparison to predicate devices, along with performance and biocompatibility testing. The document states that the device met all predetermined acceptance criteria, but it does not provide specific acceptance criteria or detailed study results for a device that involves AI (artificial intelligence) or includes human-in-the-loop performance. This device is a physical medical device (catheter) and the testing described is related to its physical properties and biocompatibility.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details related to AI or human-in-the-loop performance, as this information is not present in the provided text.

Based on the provided text, here is the information related to the device's acceptance criteria and the studies conducted:

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

The document broadly states: "The OTW Takeru met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, specific numerical acceptance criteria and their corresponding reported device performance values are not provided in this summary.

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

The document describes "in vitro tests" and "biocompatibility testing." These are laboratory, bench-top, and biological tests, not clinical studies involving data from patients or human subjects in the typical sense of AI studies. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they apply to clinical data or AI model evaluation are not applicable to the testing described here. No specific sample sizes for these bench tests are mentioned in the summary.

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 question is related to establishing ground truth for clinical data, usually in the context of AI model development or evaluation where human experts annotate or interpret data. This is not applicable to the performance testing described for this physical medical device.

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

This question is related to how discrepancies in expert ground truth assessment are resolved in clinical data annotation for AI. This is not applicable to the performance testing described for this physical medical device.

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

The document does not describe an MRMC comparative effectiveness study. This type of study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks, which is not applicable to the evaluation of this balloon dilatation catheter.

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

The device is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not applicable.

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

For the performance testing mentioned (e.g., "Balloon Rated Burst Pressure"), the "ground truth" would be established by validated measurement methods and engineering standards, not through expert consensus or pathology in a clinical data context. For biocompatibility, the ground truth is established by the results of standardized biological tests.

8. The sample size for the training set

This question is relevant for AI model development. This is not applicable as the device is a physical medical device, not an AI system.

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

This question is relevant for AI model development. This is not applicable as the device is a physical medical device, not an AI system.

Summary

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March 19, 2018

Kaneka Corporation % Christopher Sloan Principal Consultant Quintiles IMS 1801 Rockville Pike, Suite 300 Rockville, Maryland 20852

Re: K172264

Trade/Device Name: OTW 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 2, 2018 Received: March 6, 2018

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 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 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);

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Page 2 - Christopher Sloan

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

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Indications for Use

510(k) Number (if known) K172264

Device Name

OTW Takeru PTCA Balloon Dilatation Catheter

Indications for Use (Describe)

The OTW 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.

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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510(K) SUMMARY 5.1

OTW Takeru PTCA Balloon Dilatation Catheter

510(k) Submitter

Kaneka Corporation Medical Devices Solutions Vehicle 1-12-32, Akasaka, Minato-ku Tokyo, Japan Contact Person: Toshihiko Motomine Telephone: +81-3-5574-8023 Email:

Official Correspondent

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

Date Prepared: February 23, 2018

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Subject Device Name:

Trade Name	OTW Takeru
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: RX Takeru PTCA Balloon Dilatation Catheter or "RX Takeru" [K163372 (Kaneka Corporation)]
· Apex™ Over-The-Wire PTCA Dilatation Catheter or "Apex Over-The-Wire" [P860019/S208 (Boston Scientific Corporation)]

Reference Device:

· Crosstella OTW PTA Balloon Dilatation Catheter or "Crosstella OTW" [K160004 (Kaneka Corporation)]

Device Description:

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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.

Indications for Use

The OTW 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.

Comparison of Indications for Use to Predicate Devices

The OTW Takeru has the same intended use (percutaneous transluminal coronary angioplasty) as the RX Takeru and the Apex Over-The-Wire. The indications for use of the OTW Takeru are identical to that of the RX Takeru and comparable to that of Apex Over-The-Wire. Therefore, the subject device, OTW 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 OTW Takeru and the predicate devices. PTCA is based on the use of Percutaneous Coronary Intervention (PCI) devices for the purpose of myocardial perfusion.

The OTW 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 or manifold, hydrophilic coating
Shaft type – over the wire (same as the Apex Over-The-Wire)
Concomitantly used devices guidewire, guiding catheter, inflation device ●

There are following minor technological differences between OTW Takeru and the RX Takeru and/or Apex Over-The-Wire:

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

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Performance Testing

To demonstrate substantial equivalence of OTW Takeru to the predicate devices, the technological characteristics and performance criteria were evaluated the 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, Coating Integrity, Particulate Evaluation, Balloon Rated Burst Pressure (in Stent), and Balloon Fatigue (Repeat Balloon Inflations; in Stent), and Shelf Life Testing.

The results from these tests demonstrate that the technological characteristics and performance of the OTW Takeru are substantially equivalent to the predicate devices.

Biocompatibility:

To demonstrate the biological safety of the body-contacting materials and substantial equivalence of the OTW Takeru to the predicate devices, the following biocompatibility testing was performed in accordance with the FDA Guidance Document "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, Intracutaneous Reactivity, Sensitization, Material-mediated Pyrogen, Hemocompatibility (hemolysis), and Acute Systemic Toxicity

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

Conclusions:

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