This microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.

This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.

Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

Device Description

The ASAHI Caravel consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Caravel has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.

The microcatheter also contains wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for the ASAHI Caravel microcatheter. It focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical effectiveness through a study with human readers or AI. Therefore, most of the requested information regarding AI performance, human expert adjudication, and MRMC studies is not applicable to this particular document.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The in vitro bench tests demonstrated that the ASAHI Caravel met all acceptance criteria and performed similarly to the predicate devices." However, it does not provide a specific table with numerical acceptance criteria and corresponding performance metrics for each test. Instead, it lists the types of tests performed.

Test Performed	Reported Device Performance	Acceptance Criteria (Not Explicitly Stated Numerically)
Appearance/Dimensions	Met all acceptance criteria	Implicitly, within specified design tolerances
Corrosion Resistance	Met all acceptance criteria	Implicitly, no significant corrosion observed
Force at Break	Met all acceptance criteria	Implicitly, sufficient mechanical strength
Liquid Leakage under Pressure	Met all acceptance criteria	Implicitly, no leakage under specified pressure
Air Leakage	Met all acceptance criteria	Implicitly, no air leakage
Leak and Damage under High Static Pressure	Met all acceptance criteria	Implicitly, integrity maintained under pressure
Radio-Detectability	Met all acceptance criteria	Implicitly, visible under fluoroscopy
Slide Durability	Met all acceptance criteria	Implicitly, maintained functional sliding over time
Kink Resistance	Met all acceptance criteria	Implicitly, resisted kinking under expected conditions
Shaft Flexibility	Met all acceptance criteria	Implicitly, possessed appropriate flexibility
Biocompatibility (Cytotoxicity, Intracutaneous Study, Sensitization, Systemic Toxicity, Hemolysis, In Vivo Thromboresistance, Partial Thromboplastin Time, C3a Complement Activation, Sc5b-9 Complement Activation, USP Pyrogen)	Found to be biocompatible (in accordance with ISO 10993)	Implicitly, no adverse biological reactions

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

Sample Size for Test Set: The document does not specify the exact sample size for each bench test conducted. It generally refers to "non clinical laboratory testing."
Data Provenance: The tests were "non clinical laboratory testing" performed by the applicant (ASAHI Intecc Co., Ltd.), which is a Japanese company with research facilities and factories in various locations including Japan and Thailand. The data is retrospective in the sense that it was generated prior to this submission for regulatory approval.

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

Not Applicable. This document describes bench testing of a microcatheter, not an AI device requiring expert ground truthing of medical images or diagnoses.

4. Adjudication Method for the Test Set:

Not Applicable. As per point 3, no expert adjudication was involved in establishing ground truth for this type of device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance:

Not Applicable. This document is for a medical device (microcatheter), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was performed or reported.

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

Not Applicable. This is not an AI device.

7. The Type of Ground Truth Used:

For the non-clinical bench tests (e.g., Force at Break, Corrosion Resistance, Leakage), the "ground truth" would be established by the physical and chemical properties of the materials and device design, measured directly or through standardized test methods.
For Biocompatibility, the ground truth was established by adherence to ISO 10993 standards and the results of various biological tests.

8. The Sample Size for the Training Set:

Not Applicable. This document does not describe the development or testing of an AI algorithm, so there is no "training set."

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

Not Applicable. As per point 8, no training set was used.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.

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

January 22, 2016

Asahi Intecc Co. Ltd. c/o Candace Cederman CardioMed Device Consultants LLC 5523 Research Park Drive, Suite 205 Baltimore, MD 21228

Re: K152447

Trade/Device Name: Asahi Caravel Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: December 18, 2015 Received: December 22, 2015

Dear Candace Cederman:

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. Iisting 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (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

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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 below.

510(k) Number (if known) K152447

Device Name ASAHI Caravel

Indications for Use (Describe)

This microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.

This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.

Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

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 pata 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 nurmber."

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1703 Wakita-cho, Moriyama-ku, Nagoya, Aichi 463 Tel. +81-52-768-1211 Fax. +81-52-768-1221 Branch offices: Tokyo, Nagoya, Osaka, Hong Kong, Amsterdam, Singapore, Beijing Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi

510(k) Summary [as required by 21 CFR 807.92(c)]

ASAHI Caravel

510(k) K152447

DATE PREPARED:	August 26, 2015
APPLICANT	ASAHI Intecc Co., Ltd.1703 Wakita-cho, Moriyama-kuNagoya, Aichi 463-0024, Japan
OFFICIAL CORRESPONDENT	Yoshi TeraiPresident, CEOASAHI Intecc USA, Inc.2500 Red Hill Avenue, Suite 210Santa Ana, CA 92705Tel: (949) 756-8252FAX: (949) 756-8165e-mail: ASAHI.ra-fda@ASAHI-intecc.com
TRADE NAME:	ASAHI Caravel
DEVICE CLASSIFICATION:	Class 2 per 21 CFR §870.1250
CLASSIFICATION NAME:	Percutaneous Catheter
PRODUCT CODE	DQY- Catheter, Percutaneous
PREDICATE DEVICES:	ASAHI Corsair Microcatheter (K151103)

Intended Use/Indications for Use

This microcatheter is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.

This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures.

Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

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DESCRIPTION:

The microcatheter also contains wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.

COMPARISON WITH PREDICATE DEVICES:

Comparisons of the ASAHI Caravel and predicate devices show that the technological characteristics of the ASAHI Caravel such as the components, design, materials, sterilization method, shelf life and operating principle are identical or similar to the currently marketed predicate devices.

The intended use/indications of the Subject Device are a subset of the primary predicates. There are specific design features of the Subject device that are similar to the primary predicate but not identical. Additional reference devices have been used to demonstrate equivalence for these similar features.

Name of Device	ASAHI Caravel	ASAHI Corsair Microcatheter
510(k)	Current Application	K151103
Intended Use andIndications	This microcatheter is intended toprovide support to facilitate theplacement of guide wires in thecoronaryand peripheralvasculatures, and can be used toexchange one guide wire foranother.This microcatheter is also intendedto assist in the delivery of contrastmedia into the coronary andperipheral vasculatures.Do not use this microcatheter otherthan for use in the coronary andperipheral vasculatures.	The ASAHI Corsair Microcatheter isintended to provide support tofacilitate the placement of Guidewires in the coronary and peripheralvasculatures and can be used toexchange one guide wire foranother.The Corsair Microcatheter is alsointended to assist in the delivery ofcontrast media into the coronary,peripheral,andabdominalvasculatures.
Sterilization	Provided sterile via Ethylene Oxide to SAL10-6
Target BodyLocation	Peripheral, Coronary	Coronary, PeripheralAbdominal (contrast media only)
Hydrophiliccoating	Yes
Effective Length	1350 – 1500 mm	900 - 1500mm
Nominal OD	Distal : 0.62mm, Proximal : 0.85mm	Distal : 0.75mm, Proximal : 1.0mm
Catheter ShaftMat'l	PolyamidePolyamide-elastomer Polyurethane	Polyamide-elastomer

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Non Clinical testing / Performance Data:

Non clinical laboratory testing was performed on the ASAHI Caravel to determine substantial equivalence. The following testing/assessments were performed:

Appearance/Dimensions ●
Corrosion Resistance ●
Force at Break ●
Liquid Leakage under Pressure ●
Air Leakage ●
Leak and Damage under High Static Pressure ●
Radio-Detectability
Slide Durability ●
Kink Resistance ●
Shaft Flexibility ●

The in vitro bench tests demonstrated that the ASAHI Caravel met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices.

BIOCOMPATIBILITY:

The ASAHI Caravel was tested in accordance with ISO 10993, and found to be biocompatible. The following tests were performed: Cytotoxicity

Intracutaneous Study ●
Sensitization ●
o Systemic Toxicity
Hemolysis
o In Vivo Thromboresistance
Partial Thromboplastin Time ●
C3a Complement Activation ●
Sc5b-9 Complement Activation ●
USP Pyrogen o

CONCLUSION:

The ASAHI Caravel has identical intended use, a subset of the indications, and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended. Therefore, the ASAHI Caravel 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).