FineCross M3
Device Facts
| Record ID | K203521 |
|---|---|
| Device Name | FineCross M3 |
| Applicant | Ashitaka Factory of Terumo Corporation |
| Product Code | DQY · Cardiovascular |
| Decision Date | Mar 3, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The product (FineCross M3) is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.
Device Story
FineCross M3 is a single-use microcatheter used during percutaneous coronary intervention (PCI). It features a three-layer construction: stainless steel mesh braid between polyester elastomer and polytetrafluoroethylene layers, with a hydrophilic coating. Operated manually by a physician in a clinical setting, the device is introduced percutaneously into coronary blood vessels to support a guidewire (up to 0.014") and facilitate the injection of radiopaque contrast media for angiography. The device assists the physician in navigating coronary vasculature, improving guidewire placement and procedural visualization. It is sterilized via ethylene oxide.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including radio-detectability, tensile force, leakage, flow rate, torque strength, kink resistance, coating integrity, and simulated use usability testing. Biocompatibility was verified per ISO 10993-1.
Technological Characteristics
Three-layer catheter shaft: stainless steel mesh braid, polyester elastomer, and polytetrafluoroethylene. Hydrophilic polymer coating. Distal 1.8 Fr / Proximal 2.5 Fr. Max guidewire 0.014". Sterilized via ethylene oxide (ISO 11135:2018).
Indications for Use
Indicated for patients undergoing percutaneous coronary intervention (PCI) requiring guide wire support and radiopaque contrast media injection. Contraindicated for use in cerebral and peripheral vessels.
Regulatory Classification
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.
Predicate Devices
- FINECROSS MG Coronary Micro-Guide catheter (K082519)
Reference Devices
Submission Summary (Full Text)
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March 3, 2021
Terumo Medical Corporation Vaibhav Sivaramakrishan Regulatory Affairs Specialist II 265 Davidson Ave., Suite 320 Somerset, New Jersey 08873
Re: K203521
Trade/Device Name: FineCross M3 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 30, 2020 Received: December 1, 2020
Dear Vaibhav Sivaramakrishan:
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/cfpmp/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 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
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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 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 medical devices and radiation-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-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 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
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# Indications for Use
510(k) Number (if known) K203521
Device Name FineCross M3
Indications for Use (Describe)
The product (FineCross M3) is intended to be percutaneously into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.
Type of Use (Select one or both, as applicable)
| <div><span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> |
|-------------------------------------------------------------------------------------------------|
| <div><span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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## 510(K) SUMMARY
### A. SUBMITTER INFORMATION (807.92(a)(1))
Prepared by: Vaibhav Sivaramakrishan Regulatory Affairs Specialist II Terumo Medical Corporation Tel. (609) 613-3958 Fax (410) 398-6079
| Prepared for: | Owner/Operator |
|---------------|--------------------------------|
| | Terumo Corporation |
| | 44-1, 2-Chome, Hatagaya |
| | Shibuya-Ku, Tokyo |
| | Japan 151-0072 |
| | Owner/Operator Number: 8010026 |
Manufacturer and Sterilization Facility (Applicant) Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya, Shizuoka 418-0015, Japan Registration Number: 9681834
- Contact Person: Vaibhav Sivaramakrishan Regulatory Affairs Specialist II Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel. (609) 613-3958 Fax (410) 398-6079 E-mail: vai.sivaramakrishan@terumomedical.com
Date prepared: November 30, 2020
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## B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | FineCross M3 |
|-----------------------|------------------------|
| Common Name: | Microcatheter |
| Classification Name: | Catheter, Percutaneous |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1250 |
| Product Code: | DQY |
| Classification: | Class II |
## C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device to which substantial equivalence is claimed is:
Predicate Device: K082519 - FINECROSS MG Coronary Micro-Guide catheter, manufactured by Ashitaka Factory of Terumo Corporation.
Reference Devices:
- 1. K152447: ASAHI Caravel, Asahi Intecc co., ltd.
- 2. K191560: Turnpike LP Catheter, Vascular Solution LLC.
## D. REASON FOR 510(k) SUBMISSION
This traditional 510(k) for FineCross M3 is being submitted for the new device for the purposes of establishing substantial equivalence to a legally marketed predicate device.
## E. DEVICE DESCRIPTION (807.92(a)(4))
## Principle of Operation Technology
FineCross M3 submitted in this 510(k) and its predicate (K082519) are operated by a manual process.
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### Design/Construction
FineCross M3 is a single use, ethylene oxide sterilized device that is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography.
FineCross M3 features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyester elastomer and an inner layer of polytetrafluoroethylene. The outer surface of the catheter is coated with hydrophilic polymer.
### Materials
The materials for FineCross M3 are provided in Table 5.1.
| No. | Raw material | Patient Contact |
|-----|--------------------------------------------------------|-----------------|
| 1* | Polyester elastomer<br>Colorant | Direct |
| 2 | Stainless steel | Non-contact |
| 3* | Polytetrafluoroethylene | Direct |
| 4 | Au (Gold) | Non-contact |
| 5* | Dimethyl acrylamide-glycidyl<br>methacrylate copolymer | Direct |
| 6 | Acrylic resin | Non-contact |
| 7* | Polyamide | Indirect |
| 8 | Polyester elastomer<br>Colorant | Non-contact |
#### Table 5.1: List of Materials
* Blood contacting material (External communicating Device, Circulating Blood, Limited Contact (<24 hours)
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## Specifications
The specifications for FineCross M3 are provided in Table 5.2.
| Part | Specifications |
|-----------------------------------|----------------------------------------|
| Catheter Size: | Distal 1.8 Fr. / Proximal 2.5Fr. |
| Catheter OD: | Distal OD 0.61mm<br>Proximal OD 0.84mm |
| Catheter Effective Lengths*: | 1300mm, 1500mm |
| Hydrophilic Coating Length: | 750mm, 950mm |
| Maximum guidewire outer diameter: | 0.014" |
| Table 5.2: FineCross M3 Specifications | | |
|----------------------------------------|--|--|
|----------------------------------------|--|--|
*The length from the proximal anti-kink protector to distal end of catheter shaft.
### F. INDICATIONS FOR USE (807.92(a)(5))
The product (FineCross M3) is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.
The indications for use are equivalent to the predicate (K082519).
### G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
FineCross M3, the subject of this Traditional 510(k), is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate, K082519 - FINECROSS MG Coronary Micro-Guide catheter, manufactured by Ashitaka Factory of Terumo Corporation.
In addition to the above-listed primary predicate, Terumo has identified the following reference devices. These are market leading devices with the same intended use and basic design as the subject device. Since these devices are frequently used in clinical practice, Terumo felt it was appropriate to use them as references when setting the acceptance criteria for FineCross M3 performance testing.
- 1. Asahi Intecc co., Itd. ASAHI Caravel (K152447)
- 2. Vascular Solution LLC., Turnpike LP Catheter (K191560)
The comparison of the technological characteristics is summarized in Table 5.3.
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| Table 5.3: Summary of Comparative Information | | | | |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristic | Subject Device:<br>FineCross M3 | Predicate Device:<br>FINECROSS MG Coronary<br>Micro-Guide catheter<br>(K082519) | Reference Device #1:<br>ASAHI Caravel<br>(K152447) | Reference Device #2:<br>Turnpike LP Catheter<br>(K191560) |
| Manufacturer | Ashitaka Factory of Terumo<br>Corporation | Same | Asahi Intecc co., ltd. | Vascular Solution LLC. |
| Intended Use<br>/Indications for<br>Use | The product (FineCross M3) is<br>intended to be percutaneously<br>introduced into blood vessels<br>and support a guide wire while<br>performing PCI (percutaneous<br>coronary intervention). The<br>product is also intended for<br>injection of radiopaque<br>contrast media for<br>angiography. The product<br>should not be used in cerebral<br>and peripheral vessels. | The product (Finecross™ MG)<br>is intended to be<br>percutaneously introduced into<br>blood vessels and support a<br>guide wire while performing<br>PCI (percutaneous coronary<br>intervention. The product is<br>also intended for injection of<br>radiopaque contrast media for<br>angiography. | This microcatheter is<br>intended to provide support<br>to facilitate the placement<br>of guide wires in the<br>coronary and peripheral<br>vasculatures, and can be<br>used to exchange one guide<br>wire for another.<br>This microcatheter is also<br>intended to assist in the<br>delivery of contrast media<br>into the coronary and<br>peripheral vasculatures.<br>Do not use this<br>microcatheter other than<br>for use in the coronary and<br>peripheral vasculatures. | The Turnpike catheters are<br>intended to be used to access<br>discrete regions of the<br>coronary and/or peripheral<br>vasculature.<br>They may be used to facilitate<br>placement and exchange of<br>guidewires and to<br>subselectively infuse/deliver<br>diagnostic and therapeutic<br>agents. |
| Operation<br>Principle | Manual | Same | Same | Same |
| Device<br>Characteristic | Subject Device:<br>FineCross M3 | Predicate Device:<br>FINECROSS MG Coronary<br>Micro-Guide catheter<br>(K082519) | Reference Device #1:<br>ASAHI Caravel<br>(K152447) | Reference Device #2:<br>Turnpike LP Catheter<br>(K191560) |
| Design/<br>Construction | Three layer construction<br>catheter shaft with hydrophilic<br>coating, distal tip and hub | Same | Multi layers construction<br>catheter shaft with<br>hydrophilic coating, distal<br>tip and hub | Multi layers construction<br>catheter shaft with hydrophilic<br>coating, distal tip and hub |
| Materials | - Polyester elastomer w/<br>pigment*<br>- Stainless steel<br>- Polytetrafluoroethylene*<br>- Au (Gold)<br>- Dimethyl acrylamide-<br>glycidyl methacrylate<br>copolymer*<br>- Polyamide*<br>- Polyester elastomer w/<br>pigment<br>- Acrylic resin<br><br>* blood contacting material | - Polyester elastomer w/<br>pigment*<br>- Stainless steel<br>- Polytetrafluoroethylene*<br>- Au (Gold)<br>- Dimethyl acrylamide-<br>glycidyl methacrylate<br>copolymer*<br>- Polyamide*<br>- Polyester elastomer w/<br>pigment<br>- Acrylic resin<br><br>*blood contacting material | Information not publicly<br>available. | Information not publicly<br>available. |
| Package | • Individual package on which<br>the product label and the | Same | Same | Same |
| Device<br>Characteristic | Subject Device:<br>FineCross M3 | Predicate Device:<br>FINECROSS MG Coronary<br>Micro-Guide catheter<br>(K082519) | Reference Device #1:<br>ASAHI Caravel<br>(K152447) | Reference Device #2:<br>Turnpike LP Catheter<br>(K191560) |
| | peel-off labels are attached<br>• 1 unit per package | | | |
| Specifications | • Effective lengths:<br>1300mm, 1500mm<br>• Catheter size:<br>Distal 1.8 Fr. / Proximal<br>2.5Fr.<br>• Catheter OD:<br>Distal:0.61mm<br>Proximal:0.84mm<br>• Maximum guidewire outer<br>diameter: 0.014" | • Effective lengths:<br>1300mm,<br>1500mm<br>• Catheter size:<br>Distal 1.8 Fr. / Proximal<br>2.6Fr.<br>• Catheter OD:<br>Distal:0.60mm<br>Proximal:0.87mm<br>• Maximum guidewire<br>outer diameter: 0.014" | • Effective lengths:<br>1350mm,<br>1500mm<br>• Catheter size:<br>Distal 1.9 Fr. /<br>Proximal 2.6Fr.<br>• Catheter OD:<br>Distal:0.62mm<br>Proximal:0.85mm<br>• Maximum guidewire<br>outer diameter:<br>Unknown | • Effective lengths:<br>1350mm,<br>1500mm<br>• Catheter size:<br>Distal 2.2 Fr. / Proximal<br>2.9Fr.<br>• Catheter OD:<br>Distal:0.74mm<br>Proximal:0.97mm<br>• Maximum guidewire<br>outer diameter: 0.014" |
| Sterilization | Ethylene oxide | Same | Same | Same |
| Shelf life | 24 months | Same | unknown | unknown |
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# H. NON CLINICAL TESTS (807.92(b)(1))
### Performance Testing
Performance testing was conducted to ensure the substantial equivalence of FineCross M3 throughout the shelf life and to verify conformity to the applicable external and internal standards. With the exception of the Radio-detectability and Simulated Use Usability tests, the following performance tests were performed on non-aged and accelerated aged samples. Table 5.4 provides a list of performance tests that were performed on FineCross M3.
| Test Item |
|------------------------------------------------|
| Radio-detectability |
| Surface |
| Peak tensile force |
| Freedom from leakage |
| Flowrate |
| Distal tip |
| Fluid leakage |
| Sub-atmospheric pressure air leakage |
| Stress cracking |
| Resistance to separation from axial load |
| Resistance to separation from unscrewing |
| Resistance to overriding |
| Torque strength |
| Kink strength of catheter shaft |
| Compatibility with guide wire |
| Product dimension |
| Exterior sliding characteristics (early phase) |
| Particulate evaluation |
| Coating Integrity |
| Butting resistance |
| Strength of distal part |
| Simulated use Usability test |
Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.
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## Biocompatibility
In accordance with ISO 10993-1, FineCross M3 is classified as: Externally Communicating Device, Circulating Blood, Limited Contact (<24 hours). The finished device's patient contacting parts were tested in accordance with the tests recommended in the FDA Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Screening tests were performed on accelerated aged devices to show that the biocompatibility is maintained throughout the shelf life of the product. The table below provides a list of biocompatibility tests conducted on FineCross M3.
| Non-aged, sterile, whole device |
|--------------------------------------------------------|
| Cytotoxicity |
| Sensitization |
| Intracutaneous Reactivity |
| Acute Systemic Toxicity |
| Pyrogenicity |
| Hemolysis |
| Thrombogenicity (with and without anticoagulant agent) |
| Complement Activation (C3a and SC5b-9) |
| Physicochemical Profile (Physicochemical and FT-IR) |
| Accelerated-aged (2 years), sterile, whole device |
| Cytotoxicity |
| Hemolysis |
| Physicochemical Profile (Physicochemical and FT-IR) |
### Table 5.5: Summary of ISO 10993 Biocompatibility Testing
Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.
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# Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2018, Sterilization of Health Care Products – Ethylene Oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices, to provide a Sterility Assurance Level (SAL) of 10-6.
# I. CLINICAL TESTS (807.92(b)(2))
This 510(k) does not include data from clinical tests.
# J. CONCLUSION (807.92(b)(3))
In summary, FineCross M3, subject of this 510(k), is substantially equivalent in its intended use, technology/principle of operation, materials, and performance to the predicate, K082519 - FINECROSS MG Coronary Micro-Guide catheter, manufactured by Ashitaka Factory of Terumo Corporation.
