(603 days)
DQY
Not Found
No
The 510(k) summary describes a simple catheter and does not mention any AI/ML terms, image processing, or performance studies related to algorithmic analysis.
No
The device is intended to provide a pathway for introducing therapeutic devices, rather than being therapeutic itself.
No
Explanation: The intended use states that the device is "intended to provide a pathway through which a physician can introduce therapeutic devices," indicating a therapeutic purpose rather than a diagnostic one. No diagnostic functions are mentioned in the description or performance studies.
No
The device description clearly states it is a "single lumen radiopaque catheter," which is a physical hardware device. The performance studies also focus on physical properties like flow rate, torque, and bond strength.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a pathway through which a physician can introduce therapeutic devices into the general and neurovasculature." This describes a device used in vivo (within the body) for delivering other devices.
- Device Description: The description of a "single lumen radiopaque catheter with a proximal Luer fitting" is consistent with a device used for accessing blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests outside the body on biological samples. This device is clearly intended for use inside the body.
N/A
Intended Use / Indications for Use
The AURORA is intended to provide a pathway through which a physician can introduce therapeutic devices into the general and neurovasculature.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general and neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Product testing was conducted to evaluate conformance to product specification. Testing included flow rate, torque, static pressure, bond strength and demensional equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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).
0
JAN 27 1999
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | AURORA™ Guide Catheter |
| Submitter | Neurovena |
| 1879 Buerkle Road | |
| White 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.
1
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.
2
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.
3
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
4
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