(92 days)
No
The device description and intended use focus on the physical characteristics and function of a catheter for supporting a guide wire and injecting contrast media. There is no mention of any computational or analytical capabilities that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
Explanation: The device is used to support a guidewire and inject contrast media during PCI, which is a diagnostic and interventional procedure, but the device itself does not directly treat a disease or condition. It is an accessory to a therapeutic procedure rather than a therapeutic device.
No
The device description indicates it is a catheter used to support a guide wire and for contrast media injection during PCI, which are interventional procedures, not diagnostic ones. While it mentions injection for angiography, the primary stated use is for supporting a guide wire during PCI, and the device itself does not interpret or analyze diagnostic information.
No
The device description clearly indicates it is a physical catheter with a specific material construction (stainless steel mesh, polyester elastomer, polytetrafluoroethylene) and a hydrophilic coating, intended for percutaneous introduction into blood vessels. This is a hardware device, not software.
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 introduced percutaneously into blood vessels to support a guide wire during PCI and for injecting contrast media for angiography. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The description reinforces the in vivo nature of the device, detailing its construction for insertion into blood vessels.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing on samples outside the body.
The device is a medical device used for a therapeutic and diagnostic procedure performed directly on the patient's circulatory system.
N/A
Intended Use / Indications for Use
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.
Product codes
DQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood vessels (specifically excluding cerebral and peripheral vessels)
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
Performance Testing:
- Study Type: Non-clinical performance testing
- Sample Size: Not specified, "non-aged and accelerated aged samples"
- Key Results: Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life.
- Tests Performed: 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.
Biocompatibility:
- Study Type: Biocompatibility testing in accordance with ISO 10993-1
- Sample Size: Not specified, "finished device's patient contacting parts"
- Key Results: Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product.
- Tests Performed (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).
- Tests Performed (Accelerated-aged (2 years), sterile, whole device): Cytotoxicity, Hemolysis, Physicochemical Profile (Physicochemical and FT-IR).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are displayed side-by-side.
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
1
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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:
-
- K152447: ASAHI Caravel, Asahi Intecc co., ltd.
-
- 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 | |
| Colorant | Direct | |
| 2 | Stainless steel | Non-contact |
| 3* | Polytetrafluoroethylene | Direct |
| 4 | Au (Gold) | Non-contact |
| 5* | Dimethyl acrylamide-glycidyl | |
| methacrylate copolymer | Direct | |
| 6 | Acrylic resin | Non-contact |
| 7* | Polyamide | Indirect |
| 8 | Polyester elastomer | |
| Colorant | Non-contact |
Table 5.1: List of Materials
- Blood contacting material (External communicating Device, Circulating Blood, Limited Contact (