(134 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of the guide wire, with no mention of AI or ML technology.
No
The PCI Guide Wires are intended to facilitate the placement of other devices (balloon dilatation catheters) during medical procedures (PCI and PTA), rather than directly treating a disease or condition themselves.
No
Explanation: The device, a guide wire, is intended to facilitate the placement of balloon dilatation catheters during procedures like PCI and PTA. Its primary function is to guide other medical instruments, not to diagnose a medical condition. While it aids in procedures that might follow a diagnosis, the guide wire itself does not provide diagnostic information.
No
The device description clearly details a physical guide wire made of stainless steel, nitinol, and platinum nickel, with specific dimensions and coatings. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that the PCI Guide Wires are intended to "facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA)." This is a surgical or interventional procedure, not a diagnostic test performed on a specimen outside the body.
- Input: The device uses X-ray fluoroscopy for visualization during the procedure, which is an imaging modality used in vivo (within the living body), not for analyzing in vitro specimens.
- Bench Testing: While the performance was evaluated with "in vitro bench tests," this refers to testing the physical properties and performance of the device itself in a laboratory setting, not diagnostic testing of biological samples.
The device is a medical device used in a clinical procedure, but it does not fit the definition of an In Vitro Diagnostic.
Yes
The section "Predetermined Change Control Plan (PCCP) - All Relevant Information" explicitly states: "FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP)." This directly indicates that the device has an authorized PCCP.
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
DQX
Device Description
The basic structure of the MINAMO blue / viola consists of a hybrid stainless steel and nitinol (Ni-Ti) core wire, with a stainless steel distal inner rope coil. Surrounding the inner rope coil and the distal core wire is a radiopaque platinum nickel / stainless steel outer coil. The outer and inner coils are soldered to the tapered core wire. A similar coil design is used with other ASAHI guide wires, such as the predicate MINAMO (K190176). In addition, coatings are applied on the surface of the product. The coil portion is coated with a silicone and hydrophilic coating. The proximal side of the core wire is coated with PFA, silicone and PTFE.
The nominal outer diameter of the MINAMO is 0.36 mm. The devices are available in three lengths: 190 cm, 235 cm and 300 cm.
The MINAMO blue / viola radiopaque distal tip enables the user to view the position of the tip under X-ray fluoroscopy.
All sizes are available with a straight, pre-shape, and J-shape design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray fluoroscopy
Anatomical Site
percutaneous coronary and peripheral (not neurovasculature)
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)
The substantial equivalence of the MINAMO blue and MINAMO viola was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 10, October 2019.
- Tensile Strength
- Torque Strength
- Torqueability
- Tip Flexibility
- Coating Integrity
- Lubricity
- Visual Inspection
- Corrosion Resistance
- Kink Resistance
- Radiopacity
- Dimensional Verification
- Simulated use in a clinically relevant mode
- Coating Integrity/Particulate Evaluation in a clinically relevant mode
The in vitro bench tests demonstrated that the MINAMO blue and MINAMO viola 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 device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MINAMO (K190176)
Reference Device(s)
CROSSLEAD Peripheral Guide Wire (K213315), ASAHI PTCA Guide Wire SION blue (K122468, K191464)
Predetermined Change Control Plan (PCCP) - All Relevant Information
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
§ 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
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June 21, 2024
Asahi Intecc Co., Ltd % C. Cynthia Valenzuela Director, Quality & Regulatory Asahi Intecc USA, Inc. 3002 Dow Avenue Suite 212 Tustin, California 92780
Re: K240387
Trade/Device Name: MINAMO blue; MINAMO viola Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: February 8, 2024 Received: February 8, 2024
Dear C. Cynthia Valenzuela:
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 (the 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 available 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.
1
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device. or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
(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-comprehensive-regulatoryassistance/contact-us-division-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. Lydia S. Glaw -S
Digitally signed by Lydia S. Glaw -S Date: 2024.06.21 10:27:46 -04'00'
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240387
Device Name MINAMO blue; MINAMO viola
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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4
510(k) Summary
[as required by 21CFR § 807.92(c)]
^SAHI INTECC CO.,LTD. Global Headquarters and R&D Center 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan TEL : +81-561-48-5551 FAX : +81-561-48-5552 http://www.asahi-intecc.co.jp/
MINAMO blue, MINAMO viola
510(k)
| DATE PREPARED: | 31 January 2024 |
|---|---|
| APPLICANT: | ASAHI INTECC CO., LTD. |
| 3-100 Akatsuki-cho, Seto | |
| Aichi 489-0071, Japan | |
| PRIMARY CONTACT: | Mrs. Cynthia Valenzuela |
| Director, Regulatory Affairs | |
| ASAHI INTECC USA, INC. | |
| 3002 Dow Avenue, Suite 212 | |
| Tustin, California 92780 | |
| Phone: (714) 442 0575 | |
| Fax: (949) 377 3255 | |
| Email: cynthiav@asahi-intecc-us.com | |
| ALTERNATE CONTACT: | Mr. Hiroshi Obara |
| Manager, Regulatory, Affairs | |
| ASAHI INTECC CO., INC. | |
| 3-100 Akatsuki-cho | |
| Seto, Aichi, Japan 489-0071 | |
| Email: hiroshi.obara@asahi-intecc.com | |
| TRADE NAME: | MINAMO blue, MINAMI viola |
| DEVICE CLASSIFICATION: | Class II, 21CFR § 870.1330 |
| CLASSIFICATION NAME: | Catheter Guide Wire |
| PRODUCT CODE: | DQX |
| PREDICATE DEVICE(S): | MINAMO (K190176) |
| REFERENCE DEVICE(S): | CROSSLEAD Peripheral Guide Wire (K213315) |
| ASAHI PTCA Guide Wire SION blue (K122468, K191464) |
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.
5
Description:
The basic structure of the MINAMO blue / viola consists of a hybrid stainless steel and nitinol (Ni-Ti) core wire, with a stainless steel distal inner rope coil. Surrounding the inner rope coil and the distal core wire is a radiopaque platinum nickel / stainless steel outer coil. The outer and inner coils are soldered to the tapered core wire. A similar coil design is used with other ASAHI guide wires, such as the predicate MINAMO (K190176). In addition, coatings are applied on the surface of the product. The coil portion is coated with a silicone and hydrophilic coating. The proximal side of the core wire is coated with PFA, silicone and PTFE.
The nominal outer diameter of the MINAMO is 0.36 mm. The devices are available in three lengths: 190 cm, 235 cm and 300 cm.
The MINAMO blue / viola radiopaque distal tip enables the user to view the position of the tip under X-ray fluoroscopy.
All sizes are available with a straight, pre-shape, and J-shape design.
Accessory
Some model of the MINAMO blue / viola are packaged with a shaping device. The shaping device can be used to facilitate shaping distal end of the guide wire.
Comparison with Predicate Device and Reference Device:
| Predicate | Device Name | 510(k) Number |
|---|---|---|
| Primary Predicate | MINAMO | K190176 |
| Reference Device | CROSSLEAD Peripheral Guide Wire | K213315 |
| ASAHI PTCA Guide Wire SION blue | K122468 | |
| K191464 |
The subject device has the following similarities to those which previously received 510(k) clearance.
- Have the similar intended use and indications for use ●
- Use the same operating principle
- . Incorporate the same basic designs
- Incorporate the same materials
6
| Comparison with Predicate Device and Reference Device | ||||
|---|---|---|---|---|
| ------------------------------------------------------- | -- | -- | -- | -- |
| | MINAMO blue
MINAMO viola
Subject | MINAMO
Predicate | CROSSLEAD
Peripheral Guide Wire
Reference | ASAHI PTCA Guide
Wire SION blue
Reference | Comparison |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| 510(k) | TBD | K190176 | K213315 | K122468, K191464 | -- |
| Manufacturer | ASAHI INTECC | ASAHI INTECC | ASAHI INTECC | ASAHI INTECC | -- |
| Regulation Number | 21 CFR 830.1330 | 21 CFR 830.1330 | 21 CFR 830.1330 | 21 CFR 830.1330 | Same |
| Regulation Name | Catheter Guide Wire | Catheter Guide Wire | Catheter Guide Wire | Catheter Guide Wire | Same |
| Regulatory Class | II | II | II | II | Same |
| Product code | DQX | DQX | DQX | DQX | Same |
| Indications for Use | PCI Guide Wires are
intended to facilitate the
placement of balloon
dilatation catheter
during percutaneous
coronary intervention
(PCI) and percutaneous
transluminal angioplasty
(PTA).
The PCI Guide Wires
are not intended for use
in the neurovasculature. | 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. | This product is
designed to direct a
catheter to the desired
anatomical location in
the peripheral
vasculature during
diagnostic or
interventional
procedures. | 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 to be used in the
neurovasculature | Same to Predicate |
7
| | MINAMO blue
MINAMO viola | MINAMO | CROSSLEAD
Peripheral Guide Wire | ASAHI PTCA Guide
Wire SION blue | Comparison |
|---------------------------------|------------------------------------|------------------------------------|------------------------------------|------------------------------------|-----------------------------------|
| Nominal Outer
Diameter | 0.36 mm (0.014 inch) | 0.36 mm (0.014 inch) | 0.89 mm (0.035 inch) | 0.36 mm (0.014 inch) | Same to Predicate |
| Overall Length | 190 cm, 235 cm, 300
cm | 190 cm, 300 cm | 200 cm, 300 cm | 180 cm, 190 cm, 300
cm | Within the range of
Predicate |
| Outer Coil | Pt-Ni
Stainless steel | Pt-Ni
Stainless steel | Stainless Steel | Pt-Ni
Stainless steel | Same to Predicate |
| Tapered Core Wire | Ni-Ti
Stainless steel | Ni-Ti
Stainless steel | Ni-Ti | Stainless steel | Same to Predicate |
| Inner Coil | Stainless steel | Stainless steel | Stainless steel | Stainless steel | Same to Predicate |
| Tip Shape | Straight, Pre-shape,
J-shape | Straight, Pre-shape,
J-shape | Straight, Angled | Straight, Pre-shape,
J-shape | Same to Predicate |
| Coating | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic | Hydrophilic
Hydrophobic | Same to Predicate or
Reference |
| Solder | Au-Sn
Ag-Sn | Ag-Sn | Ag-Sn | Au-Sn
Ag-Sn | Same to Predicate or
Reference |
| Pipe joint section
structure | Ni-Ti pipe
Stainless steel coil | Ni-Ti pipe
Stainless steel coil | - | - | Same to Predicate |
| Sterilization | Ethylene oxide
SAL 10-6 | Ethylene oxide
SAL 10-6 | Ethylene oxide
SAL 10-6 | Ethylene oxide
SAL 10-6 | Same |
The subject MINAMO blue / MINAMO viola has very similar technological characteristics to the predicate, with minor differences in the construction of the distal tip and in the addition of a hydrophobic coating in the guidewire. The biocompatibility and mechanical testing shows the devices to have equivalent performance.
8
Non Clinical Testing / Performance Data:
The substantial equivalence of the MINAMO blue and MINAMO viola was evaluated in bench testing that followed the recommendations in the FDA guidance document; Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 10, October 2019.
- Tensile Strength ●
- Torque Strength ●
- Torqueability ●
- Tip Flexibility ●
- . Coating Integrity
- Lubricity .
- . Visual Inspection
- Corrosion Resistance
- Kink Resistance ●
- Radiopacity ●
- Dimensional Verification .
- Simulated use in a clinically relevant mode
- Coating Integrity/Particulate Evaluation in a clinically relevant mode ●
The in vitro bench tests demonstrated that the MINAMO blue and MINAMO viola 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 device.
9
BIOCOMPATIBILITY:
The MINAMO blue and MINAMO viola was tested in accordance with ISO 10993, and found to be biocompatible. The following tests were performed:
| Test | Test Summary | Conclusion |
|---|---|---|
| Cytotoxicity - ISO 10993-5 | ||
| L929 cells/MEM Elution Test | The test system is considered suitable if no | |
| signs of cellular reactivity (Grade 0) are noted | ||
| for both the negative control article and the | ||
| medium control. | Non-cytotoxic | |
| Sensitization - ISO 10993-10 | ||
| KLIGMAN Maximization Test | The extracts should show no evidence of | |
| causing delayed dermal contact sensitization | ||
| in the guinea pig. | Non-sensitizer | |
| Irritation - ISO 10993-23 | ||
| Intracutaneous Injection Test | The test extract and the negative control must | |
| exhibit similar edema and erythema scores. | Non-irritant | |
| Systemic Toxicity - ISO 10993-11 | ||
| Acute System Toxicity Test | The test article must not show significantly | |
| greater biological activity than the control. | Non-toxic | |
| Systemic Toxicity - ISO 10993-11 | ||
| Rabbit Pyrogen Test (material | ||
| mediated) | The test article should not increase the rectal | |
| temperature of any of the animals by more | ||
| than 0.5 degrees Celsius. | Non-pyrogenic | |
| Hemocompatibility - ISO 10993-4 | ||
| Rabbit Blood Hemolysis Test | Test article in direct contact with blood and | |
| test article extract must be non-hemolytic. | Non-hemolytic | |
| Hemocompatibility - ISO 10993-4 | ||
| Partial Thromboplastin Time Test | The PTT of the plasma exposed to test article | |
| extract should not significantly decreased | ||
| when compared to untreated and negative | ||
| controls. | Not an activator | |
| Hemocompatibility - ISO 10993-4 | ||
| Complement Activation Assay | ||
| (SC5b-9) | The plasma exposed to test article must | |
| exhibit no significant increase in SC5b-9 when | ||
| compared to activated NHS and negative | ||
| control after 60 minutes exposure. | Not an Activator | |
| Hemocompatibility - ISO 10993-4 | ||
| Thrombogenicity Study in Dogs | Compare results of test article to predicate | |
| control for Thrombogenici response. | ||
| Determine acceptability of results as part of | ||
| risk management. | Thromboresistant |
Biocompatibility Results (brief)
CONCLUSION:
The MINAMO blue and MINAMO viola have similar 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 device. Performance data demonstrates that the device functions as intended.
Therefore, the MINAMO blue and MINAMO viola are substantially equivalent to the predicate device.