The Crosstella OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapoplited and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Device Description

Crosstella OTW PTA Balloon Dilatation Catheter (Crosstella OTW) is an over-the-wire type of balloon dilation catheter, which consists of an outer tube, inner tube, balloon, radiopaque markers, manifold, outer reinforcement tube 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. Crosstella OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the inner tube to the guidewire port of the manifold for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Crosstella OTW in a PTA procedure is 0.018 inches. Additionally, the compatible size of a sheath introducer is 4 The nominal inflated balloon diameters range from 2.0 mm to 6.0 mm with balloon or 5 Fr. working lengths of 20 mm to 200 mm. Two different catheter working lengths will be provided: 900 and 1500 mm.

AI/ML Overview

Here is an analysis of the provided FDA 510(k) summary for the Crosstella OTW PTA Balloon Dilatation Catheter, focusing on acceptance criteria and study details.

Please note: This document describes a medical device (a balloon dilatation catheter) and its clearance based on substantial equivalence to a predicate device. The nature of the studies described are non-clinical bench and biocompatibility tests, not clinical trials involving human subjects to assess diagnostic accuracy or treatment efficacy in the way an AI/ML algorithm might be studied. Therefore, many of the requested points regarding AI/ML specific study design (like ground truth, expert adjudication, MRMC studies, training set details) are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Crosstella OTW PTA Balloon Dilatation Catheter were based on 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," and biocompatibility testing in accordance with "Draft Guidance for Industry and Food and Drug Administration Staff; Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"" (dated April 23, 2013).

The document states, "The Crosstella OTW met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

Below is a table summarizing the types of tests performed and the implicit reported performance against the acceptance criteria. Specific numerical values for the acceptance criteria and performance are not provided in this summary document, but the overall conclusion is that the device met these criteria.

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Performance Testing	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, 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 Crosstella OTW 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." This indicates that the device met the performance specifications derived from the FDA guidance and applicable standards for each test listed.
Biocompatibility Testing	Cytotoxicity, Sensitization, Intracutaneous reactivity (irritation), Systemic toxicity (acute), Pyrogenicity, Hemocompatibility (thrombogenicity, hemolysis, and immunology), and Genotoxicity (bacterial gene mutation assay, in vitro mammalian genotoxicity assay, and in vivo cytogenetics assay).	"The results from these tests demonstrate that the Crosstella OTW is biocompatible for its intended use similar to the predicate device." This means all biocompatibility tests passed and showed the device materials are safe for patient contact.
Overall Conclusion		"The Crosstella OTW met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." This is the ultimate statement of meeting the acceptance criteria.

Detailed Study Information (Specific to a Medical Device requiring Bench/Biocompatibility Testing)

Given that this is a 510(k) submission for a physical medical device (a catheter) and not an AI/ML algorithm, many of the requested points are not directly applicable. However, I will address them in the context of this device type where relevant, or state "Not Applicable" (N/A) if they pertain exclusively to AI/ML software.

Sample size used for the test set and the data provenance:
- Sample Size (Test Set): The specific number of individual catheters or material samples tested for each benchmark test is not explicitly stated in this summary. However, device manufacturers typically test multiple units/lots to ensure reproducibility and statistical validity according to industry standards and FDA guidance.
- Data Provenance: The tests would have been performed in a laboratory setting by Kaneka Corporation or a contracted testing facility. This is therefore prospective testing of newly manufactured devices under controlled conditions, not retrospective analysis of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. For bench and biocompatibility testing of a physical device, "ground truth" is established by direct measurement of physical properties against engineering specifications or by observing biological reactions in controlled in vitro or in vivo (animal) models. It does not involve expert interpretation of medical images or data from human patients. The "experts" would be engineers, chemists, microbiologists, etc., performing the tests and analyzing the results against predefined acceptance criteria.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data, typically in diagnostic studies. For device performance testing, results are quantitative or qualitative assessments against objective criteria. Discrepancies would be resolved through re-testing, investigation of methodology, or review by senior technical personnel, not clinical adjudication.
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: N/A. This type of study is specific to AI/ML diagnostic tools. This submission is for a physical intervention device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a physical device, not an algorithm. Bench tests are "standalone" in the sense that they assess the device's inherent properties and performance without human clinical interaction beyond the operation of test equipment.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A in the clinical sense. For this device, the "ground truth" for performance is defined by:
- Established engineering specifications and industry standards: E.g., a balloon's rated burst pressure is compared against a specified pressure.
- Biological responses in controlled environments: E.g., cell viability in cytotoxicity tests, or lack of adverse reaction in in vivo (animal, if applicable) biocompatibility tests.
- Comparison to predicate device characteristics: Demonstrating that the new device performs "similarly" or "equivalently" to the predicate device across various parameters.
The sample size for the training set: N/A. There is no "training set" as this is not an AI/ML algorithm. Device design and manufacturing processes are refined through iterative development, but this is distinct from machine learning training.
How the ground truth for the training set was established: N/A. See 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 29, 2016

Kaneka Corporation % Mr. Christopher M. Sloan Principal Consultant Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852

Re: K160004

Trade/Device Name: Crosstella OTW PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: March 29, 2016 Received: March 31, 2016

Dear Mr. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K160004

Device Name

Crosstella OTW PTA Balloon Dilatation Catheter

Indications for Use (Describe)

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)

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

Crosstella OTW PTA 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:

Official Correspondent

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

Date Prepared: March 22, 2016

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Subject Device Name:

Trade Name	Crosstella OTW
Common or usual name	Percutaneous (peripheral) transluminalangioplasty catheter
Classification name	Percutaneous catheter [21 CFR 870.1250product code LIT]
Class	II
Classification Panel	Cardiovascular (74)

Predicate Device:

PowerCross™ .018" OTW PTA Dilatation Catheter or "PowerCross" [K093286 (ev3 ● Inc.)]

Device Description:

Indications for Use

The Crosstella OTW is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

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Comparison of Indications for Use to Predicate Device

The Crosstella OTW has the same intended use (percutaneous transluminal angioplasty) as the PowerCross. The indications for use to the Crosstella OTW is similar to that of the PowerCross. Therefore, the subject device, Crosstella OTW, may be considered substantially equivalent to the predicate device.

Comparison of Technological Characteristics to Predicate Device

Technological Comparison to Predicate Device

The Crosstella OTW has the following similarities to the predicate PowerCross device:

Same intended use
Similar indications for use ●
. Same target population
Same operating principle ●
Similar materials ●
Same fundamental scientific technology
Same sterility assurance level and method of sterilization ●

Performance Testing

To demonstrate substantial equivalence of Crosstella OTW to the predicate device, 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, 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 Crosstella OTW 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.

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Biocompatibility:

To demonstrate the biological safety of the body-contacting materials and substantial equivalence of the Crosstella OTW to the predicate device, the following biocompatibility testing was performed in accordance with "Draft Guidance for Industry and Food and Drug Administration Staff; Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"" (dated April 23, 2013):

Cytotoxicity, Sensitization, Intracutaneous reactivity (irritation), Systemic toxicity (acute), Pyrogenicity, Hemocompatibility (thrombogenicity, hemolysis, and immunology), and Genotoxicity (bacterial gene mutation assay, in vitro mammalian genotoxicity assay, and in vivo cytogenetics assay)

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

Conclusions:

The Crosstella OTW met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer The Crosstella OTW PTA Balloon Dilatation Catheter is substantially equivalent to inputs. legally marketed 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).