(15 days)
Not Found
No
The summary describes a mechanical device for breast immobilization and biopsy guidance during MR scans. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML for image analysis, diagnosis, or guidance beyond physical positioning.
No.
The device is used for imaging, immobilization, and guiding biopsy/localization procedures, not for treating a disease or condition.
No
The device is an accessory used during MR-guided breast biopsy and wire localization, primarily for immobilizing and shaping breast tissue and guiding needle placement. It does not perform any diagnostic function itself, such as interpreting images or identifying diseases. The diagnostic task (identifying lesions) is performed by a physician using the MR scanner.
No
The device description clearly indicates it is a physical breast immobilization and biopsy accessory used in conjunction with an MR scanner, involving shaping breast tissue and needle positioning devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is an accessory used during an imaging procedure (MR scan) to immobilize and position the breast for biopsy or wire localization. It facilitates a procedure performed on the patient, not a test performed on a sample from the patient.
- Intended Use: The intended use clearly states it's for "MR guided breast biopsy and wire localization of lesions," which are procedures performed directly on the patient.
- No Sample Analysis: There is no mention of the device analyzing any biological samples.
Therefore, based on the provided information, this device falls under the category of a medical device used in a surgical or interventional procedure, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Breast Immobilization and Biopsy Device Models Bl 160-O, Bl 160-PA, and Bl 160-CC are used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and wire localization of lesions that can be performed and interpreted by a trained physician.
Product codes
90 LNH, LNH, MOS
Device Description
The BI 160-O, BI 160-PA, and Bl 160-CC device is a breast immobilization and biopsy accessory compatible with breast array coils and has the benefit of shaping the breast tissue into a "brick" shape, through mild compression. This allows for more efficient slice utilization. (i.e., fewer slices are needed to image the same amount of tissue).
The needle positioning devices allow the needle to be aimed at the lesion identified on the MR scan. Either MR compatible biopsy needles or MR compatible wire localization needles may be used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
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)
No accuracy claims are made for the device. Slice warp in the MR image, needle deflection, and other factors will affect the accuracy of placing the needle into the breast lesion of interest. It is imperative that the clinician perform a scan with the needle in the breast to ensure that the needle has indeed entered the lesion of interest.
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
NOV - 8 2005
510(k) Summary of Safety & Effectiveness
(as required by 21 CFR 807.92c)
Date Prepared:
October 11, 2005
Submitter's Information:
NORAS RONTGEN-UND MEDIZINTECHNIK GMBH Leibnizstrasse 4 97204 Hochberg Germany Phone: 49-931-299270
Trade Name, Common Name, Classification:
| Trade name: | Breast Immobilization and Biopsy Device BI 160-O, BI
160-PA, and BI 160-CC |
|----------------------|-------------------------------------------------------------------------------|
| Common name: | Breast Immobilization and Biopsy Device |
| Classification name: | Magnetic resonance diagnostic device |
| Product Code: | 90 LNH |
Predicate Device:
| DEVICE CLASSIFICATION
NAME | system, nuclear magnetic resonance
imaging |
|-------------------------------|------------------------------------------------------------------|
| REGULATION NUMBER | 892.1000 |
| 510(K) NUMBER | K010570 |
| DEVICE NAME | BREAST IMMOBIIZATION AND
BIOPSY DEVICE MR-BIOPSY MR
BI 160 |
| APPLICANT | MRI Devices Corporation |
| PRODUCT CODE | LNH |
| DECISION DATE | 04/09/2001 |
Device Description:
The BI 160-O, BI 160-PA, and Bl 160-CC device is a breast immobilization and biopsy accessory compatible with breast array coils and has the benefit of shaping the breast tissue into a "brick" shape, through mild compression. This allows for more efficient slice utilization. (i.e., fewer slices are needed to image the same amount of tissue).
The needle positioning devices allow the needle to be aimed at the lesion identified on the MR scan. Either MR compatible biopsy needles or MR compatible wire localization needles may be used.
1
(as required by 21 CFR 807.92c)
Indications for Use:
The Breast Immobilization and Biopsy Device Models Bl 160-O, Bl 160-PA, and Bl 160-CC are used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and wire localization of lesions that can be performed and interpreted by a trained physician.
Performance Data:
The BI 160-O. BI 160-PA, and BI 160-CC does not alter the performance of the coil in which it is placed.
No accuracy claims are made for the device. Slice warp in the MR image, needle deflection, and other factors will affect the accuracy of placing the needle into the breast lesion of interest. It is imperative that the clinician perform a scan with the needle in the breast to ensure that the needle has indeed entered the lesion of interest.
Conclusion:
The Breast Immobilization and Biopsy Device BI 160-O, BI 160-PA, and BI 160-CC is a modification of the MR BI 160 K010570.
Similar to the predicate device, the BI 160-O, BI 160-PA, and BI 160-CC does not control any life sustaining functions or services. The unmodified and modified device does not alter the performance of the MR coil in which it is placed.
Any differences between the predicate and subject devices will not affect safety or efficacy.
Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is facing left. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and "INSTITUTE OF HEALTH."
Public Health Service
NOV - 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Noras Rontgen-Und Medizintechnik GMBH Re.: % Carl Alletto 1600 Manchester Way CORINTH TX 76210
K052987 Trade/Device Name: Breast Immobilization and Biopsy Device. Models BI 160-O, BI 160-PA and BI 160-CC Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Regulation Number: 21 CFR 892.1000 Regulatory Class: II Product Code: MOS Dated: October 10, 2005 Received: October 24, 2005
Dear Mr. Alletto:
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 (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 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 (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
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 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" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Name.
Breast Immobilization and Biopsy Device Models BI 160-O, BI 160-PA, and BI 160-CC
Indications for Use:
The Breast Immobilization and Biopsy Device Models BI 160-O, Bl 160-PA, The Breast In mobilization and Gritic Resonance Scanner and DF 100 OO are acca in sonjary and wire localization of lesions that can be to pormed and interpreted by a trained physician.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (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.)
Nancy C. Broadon
lon of Reproductive, Abdominal, and Radiological De 510(k) Number
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