(603 days)
Intended to provide a pathway through which a physician can introduce therapeutic devices into the general and neurovasculature.
The AURORA is a single lumen radiopaque catheter with a proximal Luer fitting. The AURORA is pakaged sterile and is intended for single use only.
The provided documentation for the AURORA™ Guide Catheter (K972065) is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through extensive clinical studies, especially for Class II devices like guide catheters.
Therefore, the information required to populate the fields in your request, such as a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for training and test sets, is not typically found in a 510(k) submission for a device like this.
Here's why and what can be extracted from the document:
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Focus of 510(k) for this device: The 510(k) process for a Class II device like a guide catheter primarily relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This usually involves bench testing and material biocompatibility rather than large-scale clinical trials or detailed performance metrics against specific acceptance thresholds in human subjects.
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"Acceptance Criteria" and "Device Performance": In this context, "acceptance criteria" most likely refer to the performance specifications developed by the manufacturer for their own product, which are then verified through bench testing. These are not typically made public in detail within a 510(k) summary, as the FDA reviewer examines the full submission for conformance.
Let's break down what is available and explain why other information is missing:
Summary of Available Information (and reasons for missing info):
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Table of Acceptance Criteria and Reported Device Performance: This specific table is not present.
- Explanation: For a 510(k) of a guide catheter, the "acceptance criteria" are internal product specifications (e.g., burst pressure, torque response, flow rate requirements). The document mentions "Product testing was conducted to evaluate conformance to product specification. Testing included flow rate, torque, static pressure, bond strength and demensional equivalence." However, the specific values for these specifications (the acceptance criteria) and the results (reported device performance) are not detailed in this publicly available summary. The FDA generally reviews these detailed bench test reports internally.
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Sample size used for the test set and the data provenance: Not explicitly stated for specific tests.
- Explanation: The testing mentioned ("flow rate, torque, static pressure, bond strength and demensional equivalence") would have involved a certain number of devices tested. This sample size would be part of the manufacturer's internal test protocols and reports submitted to the FDA, but not typically summarized in the public 510(k) summary. Data provenance would be from internal lab testing at Neurovena.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not stated.
- Explanation: "Ground truth" established by experts is relevant for diagnostic devices or AI algorithms where interpretive accuracy is key. For a mechanical device like a guide catheter, "ground truth" is established by engineering measurements (e.g., a pressure gauge measures static pressure, a flow meter measures flow rate) against established engineering standards or internal specifications, not by human experts interpreting clinical data.
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Adjudication method for the test set: Not applicable/not stated.
- Explanation: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human experts when establishing ground truth for subjective assessments, primarily in clinical studies of diagnostic or AI-assisted devices. This is not relevant for the bench testing of a guide catheter.
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If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
- Explanation: An MRMC study is a clinical study design used to evaluate the performance of diagnostic devices or AI algorithms, often comparing human reader performance with and without AI assistance. This is not applicable to a guide catheter, which is an interventional tool, not a diagnostic one. The 510(k) focuses on substantial equivalence via bench testing and material biocompatibility, not clinical comparative effectiveness in this manner.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No.
- Explanation: "Standalone performance" refers to the performance of an algorithm without human intervention, again primarily relevant for AI/diagnostic devices. This is not applicable to a mechanical guide catheter.
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The type of ground truth used: Engineering measurements against product specifications.
- Explanation: As discussed in point 3, the "ground truth" for a guide catheter's performance would be derived from objective physical measurements (e.g., actual flow rates, actual torque response, actual bond strength) validated against predefined engineering specifications and industry standards.
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The sample size for the training set: Not applicable.
- Explanation: "Training set" refers to data used to train machine learning models. This is not relevant for a mechanical medical device like a guide catheter, which does not involve AI or algorithms requiring training.
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How the ground truth for the training set was established: Not applicable.
- Explanation: See point 8.
Conclusion:
The provided K972065 document for the AURORA™ Guide Catheter describes a 510(k) submission, confirming the device's substantial equivalence to a predicate device based primarily on bench testing and material biocompatibility. It does not include the detailed clinical study data, expert consensus, or performance metrics against specific acceptance criteria that would be found for a diagnostic device or an AI-enabled product. The "testing" mentioned refers to internal product verification against specifications, the details of which are not public in this summary.
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JAN 27 1999
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | AURORA™ Guide Catheter |
| Submitter | Neurovena1879 Buerkle RoadWhite Bear Lake, MN 55110(612) 777-3700 |
| Contact | Jim Segermark |
|---|---|
| Vice President |
Intended Use
The AURORA is intended to provide a pathway through which a physician can introduce therapeutic devices into the general and neurovasculature.
Predicate Devices
FasGuide Catheter from Target Therapeutics, Inc.
Device Description
The AURORA is a single lumen radiopaque catheter with a proximal Luer fitting. The AURORA is pakaged sterile and is intended for single use only.
Materials
All materials used in the manufacture of the AURORA are biocompatible and have been used in numerous previously cleared products.
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Testing
Product testing was conducted to evaluate conformance to product specification. Testing included flow rate, torque, static pressure, bond strength and demensional equivalence.
Summary of Substantial Equivalence
The AURORA is equivalent to the predicate productfrom Target Therapeutics. The clinical indications for use, basic overall function, · methods of manufacturing, and materials used are substantially equivalent. Neurovena believes the AURORA Guide Catheter is substantially equivalent to existing marketed devices.
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JAN 27 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann Quinlan-Smith Vice President, Quality Assurance and Regulatory Affairs Microvena Corporation 1861 Buerkle Road White Bear Lake, Minnesota 55110
Re:
K972065 Trade Name: MICROVENA Aurora™ Guide Catheter Regulatory Class: II Product Code: DQY Dated: November 23, 1998 Received: November 24, 1998
Dear Ms. Quinlan-Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Ann Quinlan-Smith
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
pcoelle
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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AURORA Guide Catheter
Indications for Use
510(k) Number (if known):
:
This application
Device Name:
Indications for Use:
Intended to provide a pathway through physician can introduce which a therapeutic devices into the general and neurovasculature.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription UseX OR Over-The-Counter Use_
(Per 21 CFR 801.109) (Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices R972065
510(k) Number
§ 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).