(11 days)
Not Found
No
The document describes a physical device (patient rest, coil, biopsy unit) for MR imaging and biopsy guidance. There is no mention of software features, image processing, or any terms related to AI/ML.
No.
The device is described as a diagnostic imaging device for the female breast and for MR-guided breast biopsy/wire localization, not for therapeutic purposes.
Yes
This device is explicitly stated to be "indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast." These images, when interpreted by a trained physician, provide information useful in determining diagnosis, which is the definition of a diagnostic device.
No
The device description clearly outlines physical hardware components including a patient rest, immobilization and biopsy unit, and a 4-channel phased array receive-only coil with cables and connectors. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Noras MR-BI320-PA 1.5T is a medical imaging device used in conjunction with an MRI scanner. It produces images of the internal structures of the female breast. While these images are used for diagnosis, the device itself is not analyzing biological specimens in vitro.
- Biopsy Unit: The included biopsy unit facilitates the collection of tissue samples, but the device's primary function is imaging and guiding the biopsy procedure, not the in vitro analysis of the collected sample.
The device falls under the category of medical imaging equipment used for diagnostic purposes, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Noras MR-BI320-PA 1.5T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The included Breast Biopsy Unit Bl160-2 permits MR guided breast biopsy, wire localization of lesions that can be performed by a trained physician.
Product codes
90MOS, LNH
Device Description
The MR-BI320-PA 1.5T is a patient rest with a immobilization- and biopsy unit and a 4-channel phased array receive only coil.
The coil is factory pre-tuned to the fixed load and no further tuning or matching is required for the patient.
The coil is divided into two spherical parts. Each half contains a 2 channel receive only arrav.
The upper coil is connected with a cable and a plug with the insertion coil. The insertion plate coil is connected to the scanner with a cable connection.
The insertion plate coil is designed to enable insertion of immobilization and biopsy system and is inserted into the patient rest.
The upper coil (patient pad coil) serves as a positioning pad for the patient at the same time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
female breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained 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)
Not Found
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
Section 9 510(k) summary
MAY - 2 2008
SECTION 9
510(K) SUMMARY
Noras 510(k) Premarket Notification April 04, 2008 MR-BI320-PA 1.5T
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MR-BI320-PA 1.5T
Date of Summary Preparation: April 4, 2008
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
1. General Information
Importer/Distributor
Name and Address
Siemens Medical Solutions, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Establishment Registration Number
2240869
Manufacturing Site
Name and Address
Noras MRI products GmbH
Leibnizstrasse 4
97204 Höchberg
Germany
Establishment Registration Number
Establishment Registration 3004929307
Owner/Operator 9071737
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2. Contact Person
Martin Hempel Noras Röntgen- und Medizintechnik GmbH Leibnizstr. 4 97204 Höchberg, Germany
Telephone: (+49) 931/29927-29
Fax: (+49) 931/29927-20
Email Address: martin.hempel@noras.de
3. Device Name and Classification
| Trade Name: | Noras Patient Rest MR BI320 1.5T |
|---|---|
| Common Name: | MR-BI320-PA 1.5T |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| Classification Panel: | Radiology |
| CFR Number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Product Code: | 90MOS and LNH |
4. Device Description
The MR-BI320-PA 1.5T is a patient rest with a immobilization- and biopsy unit and a 4-channel phased array receive only coil.
The coil is factory pre-tuned to the fixed load and no further tuning or matching is required for the patient.
The coil is divided into two spherical parts. Each half contains a 2 channel receive only arrav.
The upper coil is connected with a cable and a plug with the insertion coil. The insertion plate coil is connected to the scanner with a cable connection.
The insertion plate coil is designed to enable insertion of immobilization and biopsy system and is inserted into the patient rest.
The upper coil (patient pad coil) serves as a positioning pad for the patient at the same time.
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ﻡ ﺍ
5. Intended Use
The intended use of the Noras MR-BI320-PA 1.5T is, in conjunction with a Magnetic sa a discussion in the MR examination of the female breast. It is indicated for use images of the imaging device to produce transverse, sagittal, coronal and obligue images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The included Breast Biopsy Unit Bl160-2 permits MR guided breast biopsy and wire localization of lesions that can be performed by a trained physician.
6. Substantial Equivalence
Noras believes that, within the meaning of the Safe Medical Devices Act of 1990, the 4channel phased array Breast Coil 1.5T of the MR-BI320-PA 1.5T is substantially equivalent to the following coil;
| Coil Name | Premarket Notification | Clearance Date |
|---|---|---|
| MRI Devices Corporation | ||
| (Now Known as Invivo | ||
| Corporation) | K002602 | September 08, 2000 |
| Breast Array Coil | ||
| Model OBC-63 ME |
The immobilization and biopsy unit BI160-2 is a redesigned model due to the dimensions of the patient rest of the following Noras Immobilization and Biopsy units.
| Immobilization and Biopsy
| Unit | Premarket Notification | Clearance Date |
|---|---|---|
| Noras Immobilization and | ||
| Biopsy Unit | ||
| Model BI160 | K010570 | April 09, 2001 |
| Noras Immobilization and | ||
| Biopsy Unit | ||
| Model BI160-PA | K052987 | November 08,2005 |
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The immobilization and biopsy unit BI320-DC is a redesigned model of the predicate devices mentioned before to achieve a cranial access to both breast at one time,
| Immobilization and Biopsy
| Unit | Pemarket Notification | Clearance Date |
|---|---|---|
| Noras Immobilization and | ||
| Biopsy Unit | ||
| Model BI160 | K010570 | April 09, 2001 |
| Noras Immobilization and | ||
| Biopsy Unit | ||
| Model BI160-PA | K052987 | November 08,2005 |
7. Summary of Technological Characteristics of the Principal Device as Compared with the predicate Devices
The MRI (now Invivo) 4 channel OBC (Open Breast Coil) has been designed to examine the female breast. The patient lies in prone position on top of the coil, which is designed as a patient rest. Cushions complete the set for a comfortable patient positioning. In combination with the Noras BI160 the immobilization of the breast it is achieved to avoid moving artifacts during the scan. A biopsy can be taken by using the post and piller or grid localization system to guide the needle under MR control to the lesion.
The Noras BI160-PA is a patient rest, including a immobilization and biopsy unit without an integrated coil. To get MR Images it is mandatory to use the loop coils of the MRT System manufacturer. The approach of this new product was, to give the physician a more comfortable access to the region of interest in the female breast (medial, cranial and lateral). and even the higher, alary near positions.
The Noras MR-BI320-PA 1.5T comes along with a 4 channel breast coil for 1.5T Siemens MRT systems (Avanto, Espree, Tim Symphony, Sonata and Symphony). The dedicated 4 channel 1.5T breast coil enables a MR guided biopsy under comparable picture quality as the MRI OBC coil (see Appendix C Test Protocols, due to Standard NEMA MS 6-2001) and the advantages on the intervention side of the Noras BI160-PA.
Today it becomes more and more common to use vacuum biopsy systems to get the tissue samples out of the region of interest for examination in the laboratory. Therefore different interfaces or adapters have been developed for the Noras biopsy units. These accessories are equal to the standard parts, with the exception of the hole diameters.
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8. General Safety and Effectiveness Concerns
The complete system MR-BI320-PA 1.5T will conform the harmonized standard of IEC 60601-1 3rd edition, Medical electrical equipment - General requirements for basic safety and essential performance.
The MR-BI320-PA 1.5T coil will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standards for safety issues with the Magnetic Resonance Imaging Devices, IEC 60601-2-33: 2002. This will assure that the performance of this device can be considered safe and effective when used with the currently available MAGNETOM 1.5T systems.
All tests are performed on the Siemens Avanto. This is the most critical engine for safety and performance of the Siemens 1.5T series. Passing these tests gives the Siemens approval for the complete 1.5T series.
9. Conclusion as to Substantial Equivalence
Noras believes that, within the definition of the Safe Medical Devices Act of 1990, the Noras 4-channel phased array Breast coil 1.5T with its patient rest and immobilization and biopsy units is substantially equivalent to the predicate devices list and milli
Signature
Hubert Noras President
April 4, 2008
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular seal that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2008
Noras MRI Products GmbH % Mr. Stefan Preiss Responsible Third Party Official TÜV SÜD Am erica 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
Re: K081118
Trade/Device Name: Noras MR-BI320-PA 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 16, 2008 Received: April 21, 2008
Dear Mr. Preiss:
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,
7
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 this 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 one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |
|---|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | |
| Other | 240-276-0100 |
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 Biometric's (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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.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
8
Indications for Use
510(k) Number (if known):
Device Name: __Noras MR-BI320-PA 1.5T
Indications for Use:
The intended use of the Noras MR-BI320-PA 1.5T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the female breast. It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the female breast. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The included Breast Biopsy Unit Bl160-2 permits MR guided breast biopsy, wire localization of lesions that can be performed by a trained physician.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nomithmthn
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
(Posted November 13, 2003)