(89 days)
Not Found
No
The description focuses on mechanical components, a position display unit, and a target planning application based on a 3D MR-visible crosshair and stage movement. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies.
No
The device is intended to aid in the performance of minimally invasive diagnostic procedures, specifically for guiding interventional devices, rather than directly providing therapy.
No
The document states that the System is “an optional accessory to the Aurora Imaging Technology, Inc., Magnetic Resonance Diagnostic Device,” indicating it aids in procedures but is not the diagnostic device itself. Its purpose is to guide interventional procedures, not to diagnose.
No
The device description explicitly lists four major subsystems, including a "Base plate system and components," a "Needle guidance stage and components," and a "Position display unit (PDU)," which are all hardware components. While it includes a "Target Planning Application (software)," it is part of a larger system that incorporates physical hardware.
Based on the provided information, the Aurora® MR-Guided Interventional System is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- Device function: The Aurora® System is an accessory used during a minimally invasive diagnostic procedure (biopsy) to guide an interventional device (like a needle) to a target within the breast. It aids in the performance of the procedure, not in the analysis of a sample taken from the body.
- Intended Use: The intended use clearly states it's "intended to aid in the performance of minimally invasive diagnostic procedures." It doesn't mention analyzing samples.
- Device Description: The description focuses on the mechanical and software components used for targeting and guidance, not for analyzing biological samples.
Therefore, the Aurora® MR-Guided Interventional System is a medical device used for image-guided intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Aurora® MR-Guided Interventional System (the System) is an optional accessory to the Aurora Imaging Technology, Inc., Magnetic Resonance Diagnostic Device. The System is intended to aid in the performance of minimally invasive diagnostic procedures of the lateral or medial side of either breast and adjacent anatomies, which may be facilitated by MR guidance. Such procedures must be performed with MR-compatible devices as selected and evaluated by the clinical user.
Product codes
90 LNH
Device Description
The use and operation of the Aurora® MR-Guided Interventional System and other MR-guided biopsy systems is based on the well-known method of target planning to determine the desired placement of an interventional device in three dimensions from an MR image. The basic targeting technique uses a three-dimensional MR-visible crosshair mounted near the needle guide in a fixed and known location. The stage is moved so that the needle guide and, consequently, the marker are moved to the general vicinity of the lesion to be targeted. The Aurora® MR-Guided Interventional System consists of four major subsystems: (1) Base plate system and components, (2) Needle guidance stage and components, (3) Position display unit (PDU), and (4) Target Planning Application (software).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR image
Anatomical Site
lateral or medial side of either breast and adjacent anatomies
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Aurora® MR-Guided Interventional System was tested to and demonstrated in compliance with design and performance specifications and included biocompatibility testing, reprocessing validation, and verification/validation testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K62 3686
JAN 2 9 2003
510(k) Summary Aurora Imaging Technology, Inc. Aurora® MR-Guided Interventional System
SPONSOR 1.
Aurora Imaging Technology, Inc. 39 High Street North Andover, MA 01845
Contact Person: Alan Oslan Telephone: 987-975-7530, Ext. 4326
Date Prepared: October 31, 2002
2. DEVICE NAME
Proprietary Name: Common/Usual Name: Classification Name:
Aurora® MR-Guided Interventional System MR-Guided lesion localization system Accessory to a magnetic resonance device
3. PREDICATE DEVICES
- MRI Devices Breast Immobilization and Biopsy Device MR-Biopsy 160 ● (K010570)
- Philips Stereotactic Localization Device (K000832) ●
4. DEVICE DESCRIPTION
The use and operation of the Aurora® MR-Guided Interventional System and other MR-guided biopsy systems is based on the well-known method of target planning to determine the desired placement of an interventional device in three dimensions from an MR image. The basic targeting technique uses a three-dimensional MR-visible crosshair mounted near the needle guide in a fixed and known location. The stage is moved so that the needle guide and, consequently, the marker are moved to the general vicinity of the lesion to be targeted. The Aurora® MR-Guided Interventional System consists of four major subsystems: (1) Base plate system and components, (2) Needle guidance stage and components, (3) Position display unit (PDU), and (4) Target Planning Application (software).
1
ર. INTENDED USE
The Aurora® MR-Guided Interventional System (the System) is an optional accessory to the Aurora Imaging Technology, Inc., Magnetic Resonance Diagnostic Device. The System is intended to aid in the performance of minimally invasive diagnostic procedures of the lateral or medial side of either breast and adjacent anatomies, which may be facilitated by MR guidance. Such procedures must be performed with MR-compatible devices as selected and evaluated by the clinical user.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Aurora® MR-Guided Interventional System is substantially equivalent to cited predicate devices in intended use, indications for use, design, and operation. The major difference between the Aurora® System and cited predicates is the ability to move the needle guidance stage in three directions.
7. PERFORMANCE TESTING
The Aurora® MR-Guided Interventional System was tested to and demonstrated in compliance with design and performance specifications and included biocompatibility testing, reprocessing validation, and verification/validation testing.
October 31, 2002
Page G-2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Alan Oslan Program Manager, Interventional Systems Aurora Imaging Technology 39 High Street NORTH ANDOVER MA 01845
Re: K023686 Trade/Device Name: Aurora® MR-Guided Interventional System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: October 31, 2002 Received: November 1, 2002
Dear Mr. Oslan:
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 reguirements for annual registration. Iisting 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 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); 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.
JAN 2 9 2003
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Aurora® MR-Guided Interventional System
Indications for Use:
The Aurora® MR-Guided Interventional System (the System) is an optional accessory to the Aurora Imaging Technology, Inc., Magnetic Resonance Diagnostic Device. The System is intended to aid in the performance of minimally invasive diagnostic procedures of the lateral or medial side of either breast and adjacent anatomies, which may be facilitated by MR guidance. Such procedures must be performed with MR-compatible devices as selected and evaluated by the clinician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seymm
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Aurora Imaging Technology, Inc., Traditional 510(k) Aurora® MR-Guided Interventional System
October 31, 2002
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