(36 days)
Not Found
Not Found
No
The summary describes a physical device for breast biopsy and localization, with no mention of AI, ML, or image processing capabilities.
No.
The device is used for guidance during breast biopsy and localization of lesions, which are diagnostic and procedural aids, not direct therapeutic interventions.
No
The device is described as an "Immobilization and Biopsy Device" used in conjunction with a Magnetic Resonance Scanner for MR-guided breast biopsy and localization of lesions. Its function is to facilitate a procedure (biopsy and localization) rather than to diagnose a condition itself. The diagnosis is performed and interpreted by a trained physician.
No
The device description explicitly states "Model BBD Breast Immobilization and Biopsy Device," which strongly suggests a physical hardware component used for immobilization and biopsy procedures, not solely software.
No, this device 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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states the device is used "in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and localization of lesions." This describes a device used during a medical procedure performed on the patient's body, not a test performed on a sample from the body.
- Input Modality: The input is a Magnetic Resonance Scanner, which is an imaging modality used to visualize structures within the body.
- Anatomical Site: The anatomical site is the breast, indicating the device is used directly on or around the patient's breast.
This device is a medical device used for guiding a procedure (biopsy) and localizing lesions within the body using imaging. It does not perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
To be used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.
Product codes
MOS
Device Description
Model BBD Breast Immobilization and Biopsy Device
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)
Not Found
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
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
NOV - 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas E. Tynes Director, Interventional MRI Business Group Invivo Corporation N27 W23676 Paul Road PEWAUKEE WI 53072 Re: K052704
Trade/Device Name: Model BBD Breast Immobilization and Biopsy Device Regulation Number: 21 CDR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 26, 2005
Received: September 29, 2005
Dear Mr. Tynes:
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 (21 CFR Part 820); and if applicable. the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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
2
Section C - Statement of Indications for Use
Applicant: Invivo Corporation 510(k) number (if known): Model BBD Breast Immobilization and Biopsy Device Device Name:
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to permit MR guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
or
Nancy Broadon
(Division Sign Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K052704