(181 days)
No
The summary describes a physical guide wire and its materials and coatings. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device facilitates the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA), which are medical procedures aimed at treating cardiovascular conditions.
No
The device is a guide wire intended to facilitate the placement of balloon dilatation catheters, which is an interventional/treatment function, not a diagnostic one.
No
The device description clearly details physical components like a core wire, coil assembly, coatings, and different lengths and tip shapes, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA)." This describes a device used in vivo (within the body) for a medical procedure.
- Device Description: The description details a physical guide wire with a core wire, coil assembly, and coatings, designed to be inserted into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. This guide wire is a surgical/interventional tool used directly within the body.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ASAHI SION blue PTCA Guidewire, K122468
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Terumo Runthrough NS, K063695, Abbott Balance Middleweight (BMW), K021228
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
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 Terai |
| President/CEO | |
| ASAHI INTECC USA, Inc. | |
| 3002 Dow Avenue, Suite 212 | |
| Tustin, CA 92780 | |
| Tel: (949) 756-8252, FAX: (949) 756-8165 | |
| e-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, K063695 |
| Abbott 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:
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.
4
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 and | ||||
| Indications | 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. | ASAHI PTCA Guide Wires are | |||
| intended to facilitate the | ||||
| placement of balloon dilatation | ||||
| catheters during percutaneous | ||||
| transluminal coronary | ||||
| angioplasty (PTCA and | ||||
| percutaneous transluminal | ||||
| angioplasty (PTA). | ||||
| The ASAHI PTCA GUIDE | ||||
| WIRES are not intended for | ||||
| use in the cerebral blood | ||||
| vessels. | The Runthrough NS are used | |||
| to facilitate placement of | ||||
| balloon dilatation catheters for | ||||
| percutaneous transluminal | ||||
| coronary angioplasty (PTCA | ||||
| and/or percutaneous | ||||
| transluminal angioplasty | ||||
| (PTA). | To facilitate the placement of | |||
| balloon dilatation catheters | ||||
| during percutaneous | ||||
| transluminal coronary | ||||
| angioplasty (PTCA) and | ||||
| percutaneous transluminal | ||||
| angioplasty (PTA) and | ||||
| compatible stent devices | ||||
| during therapeutic | ||||
| intravascular 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 and | |||
| Stainless Steel | Platinum-Nickel and | |||
| Stainless Steel | Platinum-Nickel and | |||
| Stainless Steel | Platinum-Nickel and | |||
| Stainless Steel | ||||
| Tapered Core Wire | Nitinol and | |||
| Stainless Steel | Stainless Steel | Nitinol and | ||
| Stainless Steel | Nitinol and | |||
| Stainless Steel | ||||
| Inner Structure | Stainless Steel Coil | Stainless Steel Coil | NA | SUS Shaping Ribbon |
| Tip Shape | Straight | |||
| Preshape | ||||
| J-tip | Straight | |||
| J-tip | Straight | Straight, J-tip | ||
| Coating | Hydrophilic | |||
| Hydrophobic | Hydrophilic | |||
| Hydrophobic | Hydrophilic | |||
| Hydrophobic | Hydrophilic | |||
| Hydrophobic | ||||
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
5
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.