(24 days)
No
The summary describes a mechanical catheter used for guide wire support and contrast injection during PCI. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are based on bench testing, not algorithmic performance metrics.
No.
The Finecross™ MG device is a guide catheter used to support a guidewire and inject contrast, serving as an access and delivery tool during PCI, not directly providing a therapeutic effect itself.
No
Explanation: The device is a guide catheter used during PCI and for injecting contrast for angiography. While angiography is a diagnostic procedure, the device itself is a tool for delivering the contrast and supporting a guidewire, not for interpreting medical data to form a diagnosis.
No
The device description clearly outlines physical components like a catheter shaft, hub, and anti-kink protector, indicating it is a hardware medical device.
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 "percutaneously introduced into blood vessels" and used to "support a guide wire while performing PCI" and for "injection of radiopaque contrast media for the purpose of angiography." These are all procedures performed in vivo (within the living body).
- 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.
- Device Description: The description details a catheter designed for insertion into blood vessels, not for analyzing biological samples.
Therefore, the Finecross™ MG is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The product (Finecross™ MG) 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 the purpose of angiography.
Product codes
KRA
Device Description
FINECROSS MG consists of a catheter shaft, a hub and an anti-kink protector. The catheter shaft has reinforcing braided mesh, thus achieving the high shaft strength and anti-kink characteristics. The shaft has gradual hardness change from the proximal to the distal portion. This is achieved by joining outer layers of material with different hardness. By using polytetrafluoroethylene (PTFE) as the inner layer, high inner face mobility has been achieved. The outer surface of the catheter is coated with a hydrophilic polymer, therefore, it demonstrates a high lubricity upon moistening.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood 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
The performance of the FINECROSS™ MG Coronary Micro-Guide catheter is substantially equivalent to the performance of the predicate devices. The equivalence was shown through bench testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
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SEP 2 6 2008
Terumo Corporation Premarket Notification - FINECROSS™ MG Coronary Micro-Guide catheter Section II. 510(k) Summary
SECTION II. 510(K) SUMMARY
A. DEVICE NAME
FINECROSS™ MG Coronary Micro-Guide catheter Proprietary Name: Classification Name: Catheter, Continuous Flush Common Name: Micro-Guide Catheter
B. PREDICATE DEVICE
The predicate devices are the Rapidtransit and Tornus, which are manufactured by Cordis Neurovascular Inc. and Asahi Intecc Co LTD, respectfully. The predicate devices have been cleared through the premarket notification process, Rapidtransit K972518 and Tornus K051772.
C. INTENDED USE
The product (Finecross™ MG) 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 the purpose of angiography.
DESCRIPTION D.
FINECROSS MG consists of a catheter shaft, a hub and an anti-kink protector. The catheter shaft has reinforcing braided mesh, thus achieving the high shaft strength and anti-kink characteristics. The shaft has gradual hardness change from the proximal to the distal portion. This is achieved by joining outer layers of material with different hardness. By using polytetrafluoroethylene (PTFE) as the inner layer, high inner face mobility has been achieved. The outer surface of the catheter is coated with a hydrophilic polymer, therefore, it demonstrates a high lubricity upon moistening.
1
PRINCIPLE OF OPERATION / TECHNOLOGY E.
The FINECROSS™ MG Coronary Micro-Guide catheter is operated manually or by a manual process.
F. DESIGN / MATERIALS
The FINECROSS™ MG Coronary Micro-Guide catheter uses similar materials as the predicate devices. Differences in materials between the devices do not raise any new issues of safety and effectiveness.
G SPECIFICATIONS
| Usable length of catheter: | 1300 and 1500mm |
|---|---|
| Outer diameter of catheter (distal end): | 1.8Fr (0.60mm) |
| Outer diameter of catheter (proximal end): | 2.6Fr (0.870mm) |
| Inner diameter of catheter: | 0.018" (0.45mm) to 0.0221" (0.55mm) |
| Radiopaque markers: | 1 |
H. PERFORMANCE
The performance of the FINECROSS™ MG Coronary Micro-Guide catheter is substantially equivalent to the performance of the predicate devices. The equivalence was shown through bench testing.
2
ADDITIONAL SAFETY INFORMATION 1.
Sterilization conditions have been validated in accordance with EN ISO 11135-1 "Sterilization of health care products - Ethylene Oxide - Part 1: requirements for development, validation and routine control of sterilization process for medical devices." to provide a Sterility Assurance Level of 105.
Blood contacting materials were tested in accordance with the test recommendations in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993. "Biological Evaluation of Medical Devices - Part I: Evaluation and Testing." The FINECROSS MG Coronary Micro-Guide catheter is categorized as "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". The blood contacting materials were found to be biocompatible.
Expiration dating for the FINECROSS™ MG Coronary Micro-Guide catheter will be 2 years.
SUBSTANTIAL EQUIVALENCE J.
The FINECROSS™ MG Coronary Micro-Guide catheter submitted in this 510(k) is substantially equivalent' in intended use, design, principle of operation / technology, materials and performance to the Rapidtransit and Tornus, which are manufactured by Cordis Neurovascular Inc. and Asahi Intecc Co LTD, respectfully. Differences between the devices do not raise any issues of safety or effectiveness.
1 A statement of substantially equivalence to another product is required by 21CFR807.87, and relater the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " .. a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seq. (1977)
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K. SUBMITTER INFORMATION
Name and Address
Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921 USA
Contact Person
Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist Ph: 410-392-7213 Fax: 410-398-6079 Email: mark.unterreiner@terumomedical.com
Date Prepared
August 6, 2008
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.
SEP 2 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Terumo Medical Corporation c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Rc: K082519
FINEVROSS MG Coronary Micro-Guide Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter Continuous Flush Regulatory Class: Class II Product Code: KRA Dated: September 23, 2008 Received: September 24, 2008
Dear Mr. Job:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
5
Page 2 - Mr. Mark Job
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
1682519 510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The product (Finecross™ MG) 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 the purpose of anglography.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Saldluvascular Devices 510(k) Number 160826