PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

The PCI Guide Wires are not intended for use in the neurovasculature.

Device Description

The MINAMO consists of a hybrid NiTi and stainless-steel core wire and a coil assembly on the distal end of the device. The coil assembly is soldered to the NiTi portion of the core. In addition, coatings are applied on the surface of the MINAMO. The proximal portion is coated with PTFE. The distal section is coated with hydrophilic coating, with the distal tip coated with silicone. The MINAMO is available in both 190cm and 300cm lengths and with different tip shapes.

AI/ML Overview

The MINAMO is a coronary guide wire. The 510(k) summary provides details about non-clinical testing performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The in vitro bench tests demonstrated that the MINAMO met all acceptance criteria and performed similarly to the predicate devices." Specific numerical acceptance criteria values and reported device performance values are generally not detailed in 510(k) summaries for non-clinical tests. This is a common practice, as the focus is on demonstrating that the device meets established performance thresholds and is comparable to previously cleared devices.

Test / Assessment	Acceptance Criteria (General Description)	Reported Device Performance (General Description)
Dimensional verification / Appearance	Met specified dimensions and visual criteria.	Met all acceptance criteria.
Tensile Strength	Met specified strength requirements, comparable to predicate.	Met all acceptance criteria.
Torque Strength	Met specified torque performance requirements, comparable to predicate.	Met all acceptance criteria.
Torqueability	Demonstrated appropriate torque transmission, comparable to predicate.	Met all acceptance criteria.
Tip Flexibility	Met specified flexibility characteristics, comparable to predicate.	Met all acceptance criteria.
Coating Adhesion	Met specified adhesion strength requirements, comparable to predicate.	Met all acceptance criteria.
Catheter Compatibility	Demonstrated compatibility with standard catheters.	Met all acceptance criteria.
Lubricity	Met specified lubricity requirements, comparable to predicate.	Met all acceptance criteria.
Corrosion Resistance	Demonstrated resistance to corrosion under specified conditions.	Met all acceptance criteria.
Kink Resistance	Met specified kink resistance requirements, comparable to predicate.	Met all acceptance criteria.
Radiodetectability	Demonstrated adequate visibility under fluoroscopy.	Met all acceptance criteria.
Coating Integrity / Acute Particulate Characterization	Maintained coating integrity and minimal particulate release.	Met all acceptance criteria.
Packaging / Transportation assessment	Maintained device integrity through packaging and simulated transport.	Met all acceptance criteria.
Biocompatibility Tests (Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, USP Rabbit Pyrogen, Material Mediated, Hemolysis, Partial Thromboplastin Time, In Vivo Thromboresistance, Sc5b-9 Complement Activation)	Met international standards for biocompatibility (e.g., ISO 10993).	Met all acceptance criteria.

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

The document does not specify the exact sample sizes used for each individual non-clinical test. It generally refers to "non-clinical laboratory testing." For medical devices, these tests are typically performed in a laboratory setting, and the provenance is the company's internal R&D or a contract testing lab. These are all retrospective tests conducted on manufactured device samples. There is no information regarding country of origin for the data for non-clinical bench testing, but the applicant's headquarters are in Japan.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to the non-clinical bench testing described. These tests do not involve human interpretation or the establishment of ground truth by clinical experts in the same way an AI diagnostic device would. Performance is measured against physical and chemical specifications.

4. Adjudication Method:

This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers, which is not the nature of the reported performance data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not done. The device is a physical medical instrument (guide wire), not an AI diagnostic tool.

6. Standalone Performance Study:

A standalone performance study was not done in the context of an AI algorithm. The reported tests are for the physical properties and performance of the guide wire itself. The document describes "non-clinical laboratory testing" which inherently is a standalone evaluation of the device against predefined specifications.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is established by:

Engineering Specifications: Predetermined physical and chemical properties that an equivalent guide wire must possess (e.g., specific tensile strength, flexibility parameters, corrosion resistance).
International Standards: Adherence to relevant ISO standards (e.g., for biocompatibility, sterility) or equivalent national standards.
Predicate Device Performance: Demonstrating comparable performance to legally marketed predicate devices through comparative bench testing.

8. Sample Size for the Training Set:

This information is not applicable. The MINAMO is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable, as there is no training set for a physical guide wire.

Summary

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August 1, 2019

Asahi Intecc Co., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants, LLC 3168 Braverton Street, Suite 200 Edgewater, Maryland 21037

Re: K190176

Trade/Device Name: Minamo Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: July 2, 2019 Received: July 3, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/ training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Kenneth Cavanaugh, Ph.D. Director (Acting) DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190176

Device Name MINAMO

Indications for Use (Describe)

PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

The PCI Guide Wires are not intended for use in the neurovasculature.

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

(as required by 21 CFR 807.92)

SAHI INTECC CO.,LTD.

3-100 Akatsuki-cho, Seto, Aichi 489-0071 Japan Tel. +81-561-48-5551 Fax. +81-561-48-5552 Branch office: Tokyo, Nagoya, Osaka, Hong, EU, Singapore, Beijing, India, Middle Eastern Research Facilities and Factories: Osaka, Seto, Thailand, Hanoi

MINAMO®

510(k) K190176

Date Prepared:	27 June 2019
Applicant:	ASAHI INTECC CO., LTD.3-100 Akatsuki-cho,Seto, Aichi 489-0071 Japan
Contact:	Yoshi TeraiPresident/CEOASAHI INTECC USA, Inc.3002 Dow Avenue, Suite 212Tustin, CA 92780Tel: (949) 756-8252, FAX: (949) 756-8165e-mail: ASAHI.ra-fda@ASAHI-intecc.com
Trade Name:	MINAMO®
Device Classification:	Class 2 per 21 CFR §870.1330
Classification Name:	Catheter, Guide, Wire
Product Code:	DX - Catheter Guide Wire
Predicate Devices:	ASAHI SION blue PTCA Guidewire, K122468
Reference Devices:	Terumo Runthrough NS, K063695Abbott Balance Middleweight (BMW), K021228

INTENDED USE/INDICATIONS FOR USE:

PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

The PCI Guide Wires are not intended for use in the neurovasculature.

DEVICE DESCRIPTION:

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COMPARISON WITH PREDICATE DEVICES:

Comparisons of the MINAMO® and predicate / reference devices show that the technological characteristics of the subject device such as the components, design, materials, sterliization method, shelf life and operating principle are similar to the currently marketed predicate and reference devices. The intended use of the subject device and its predicates are the same.

Name of Devices	MINAMO	ASAHI SION blue	Runthrough NS	BMW
	Subject	Predicate	Reference	Reference
510(k)	This submission	K122468	K063695	K021228
Intended Use andIndications	PCI Guide Wires are intendedto facilitate the placement ofballoon dilatation cathetersduring percutaneous coronaryintervention (PCI) andpercutaneous transluminalangioplasty (PTA).The PCI Guide Wires are notintended for use in theneurovasculature.	ASAHI PTCA Guide Wires areintended to facilitate theplacement of balloon dilatationcatheters during percutaneoustransluminal coronaryangioplasty (PTCA andpercutaneous transluminalangioplasty (PTA).The ASAHI PTCA GUIDEWIRES are not intended foruse in the cerebral bloodvessels.	The Runthrough NS are usedto facilitate placement ofballoon dilatation catheters forpercutaneous transluminalcoronary angioplasty (PTCAand/or percutaneoustransluminal angioplasty(PTA).	To facilitate the placement ofballoon dilatation cathetersduring percutaneoustransluminal coronaryangioplasty (PTCA) andpercutaneous transluminalangioplasty (PTA) andcompatible stent devicesduring therapeuticintravascular procedures.
Nominal OD	0.36mm(0.014in)	0.36mm(0.014in)	0.36mm(0.014in)	0.36mm(0.014in)
Overall Length	190, 300cm	180, 300cm	180, 300cm	190, 300cm
Outer Coil	Platinum-Nickel andStainless Steel	Platinum-Nickel andStainless Steel	Platinum-Nickel andStainless Steel	Platinum-Nickel andStainless Steel
Tapered Core Wire	Nitinol andStainless Steel	Stainless Steel	Nitinol andStainless Steel	Nitinol andStainless Steel
Inner Structure	Stainless Steel Coil	Stainless Steel Coil	NA	SUS Shaping Ribbon
Tip Shape	StraightPreshapeJ-tip	StraightJ-tip	Straight	Straight, J-tip
Coating	HydrophilicHydrophobic	HydrophilicHydrophobic	HydrophilicHydrophobic	HydrophilicHydrophobic
Sterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide

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NON-CLINICAL TESTING/PERFORMANCE DATA:

Non-clinical laboratory testing was performed on the MINAMO® to determine substantial equivalence. The following testing/assessments were performed:

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

Dimensional verification / Appearance ●
Tensile Strength ●
Torque Strength ●
Torqueability .
Tip Flexibility ●
Coating Adhesion
Catheter Compatibility ●
Lubricity
Corrosion Resistance ●
. Kink
Radiodetectability
Coating Integrity / Acute Particulate Characterization ●
. Packaging / Transportation assessment

The in vitro bench tests demonstrated that the MINAMO met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate devices.

BIOCOMPATIBILITY:

Testing was performed to assess biocompatibility of the modified coating material. The following tests were performed:

Cytotoxicity .
. Sensitization
Intracutaneous Irritation ●
Systemic Toxicity ●
USP Rabbit Pyrogen, Material Mediated ●
Hemolysis ●
Partial Thromboplastin Time ●
In Vivo Thromboresistance ●
. Sc5b-9 Complement Activation

CONCLUSION:

The MINAMO has the same intended use and the same or similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate and reference devices. Performance data demonstrates that the device functions as intended.

Therefore, the MINAMO is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.