(24 days)
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.
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.
The provided text describes a 510(k) premarket notification for the FINECROSS™ MG Coronary Micro-Guide catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics typically associated with AI/software as a medical device (SaMD) clearances.
Therefore, many of the requested elements for an AI/SaMD study, such as sample size for test and training sets, expert qualifications, and adjudication methods, are not applicable or explicitly mentioned in this document. The device is a physical medical instrument, not an AI algorithm.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for a physical medical device, specific "acceptance criteria" and "device performance" in the context of an AI algorithm's metrics (e.g., sensitivity, specificity) are not present. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various specifications and bench testing.
| Criterion Type | Description |
|---|---|
| Substantial Equivalence | The FINECROSS™ MG Coronary Micro-Guide catheter is substantially equivalent in intended use, design, principle of operation/technology, materials, and performance to the predicate devices (Rapidtransit and Tornus). |
| Bench Testing | Performance was shown through bench testing, demonstrating equivalence to the predicate devices. The specific tests and their outcomes are not detailed, but they would typically cover aspects like mechanical strength, lubricity, guidewire support, and contrast injection capability. |
| Biocompatibility | Blood contacting materials were tested in accordance with ISO 10993 and found to be biocompatible for "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". |
| Sterilization | Validated in accordance with EN ISO 11135-1 to provide a Sterility Assurance Level of 10-6. |
| Physical Specifications | - Usable length: 1300 and 1500mm - Outer diameter (distal end): 1.8Fr (0.60mm) - Outer diameter (proximal end): 2.6Fr (0.870mm) - Inner diameter: 0.018" (0.45mm) to 0.0221" (0.55mm) - Radiopaque markers: 1 |
| Expiration Dating | 2 years. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device. The "test set" in this context would refer to physical prototypes undergoing bench testing, not a dataset for an AI algorithm. The document states "bench testing" was performed, but does not specify sample sizes or data provenance for these physical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of AI refers to expert-labeled data. For a physical device, testing is typically against engineering specifications and predicate device performance, not expert-established ground truth in the AI sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a method for resolving discrepancies in expert labeling for AI ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is a physical catheter, not an AI or software assistant for human readers. Therefore, an MRMC study related to AI assistance would not be performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, the "ground truth" would be established by engineering specifications, validated test methods, and direct comparison to the performance characteristics of the legally marketed predicate devices, rather than expert consensus on medical images or pathology.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this physical device.
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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.
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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.
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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.
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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
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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
§ 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).