(64 days)
K032576, K041
Not Found
No
The summary describes a receive-only MRI coil and its intended use, focusing on hardware performance metrics like SNR and image uniformity. There is no mention of AI, ML, or any software processing that would suggest the use of these technologies.
No
The device is described as an accessory to produce images of the breast, chest wall and axillary tissue to aid diagnosis and permit MR-guided biopsy and localization of lesions, indicating it is a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the coil is "as an aid to diagnosis," and the "Device Description" mentions "high resolution diagnostic imaging."
No
The device description explicitly states it is a "coil," which is a hardware component used in MRI systems to receive RF signals. It is not solely software.
Based on the provided information, 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 about a person's health.
- Device Function: The description clearly states that this device is a coil used with an MRI system to produce images of the breast, chest wall, and axillary tissue. It receives radio frequency signals to create images.
- No Sample Testing: There is no mention of the device performing any tests on biological samples. Its function is solely related to image acquisition for diagnostic purposes.
Therefore, this device falls under the category of a medical imaging accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the breast, chest wall and axillary tissue, as an aid to diagnosis. The coil permits MR-guided breast biopsy and localization of lesions.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The dS Breast 16ch I/T 1.5T and dS Breast 16ch I/T 3.0T coils are designed for use with a Magnetic Resonance Imaging (MRI) system. The coil is designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei. The coils are designed as receive only coil for high resolution diagnostic imaging and intervention of breast. The coil provides both unilateral and bilateral images (Left, Right and Both) of the anatomy of interest and permits MR-guided biopsy and localization of lesions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
breast, chest wall and axillary tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
on the order of a 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)
Supporting product evaluations includes Signal-to-Noise (SNR) ratio, Image Uniformity and assessment of clinical images. Additionally, the new devices passed electrical safety testing in accordance with IEC standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K032576, K041
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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510(k) Summary of Safety and Effectiveness dS Breast 16ch I/T
Submitted By: Invivo Corporation 3545 SW 47th Avenue Gainesville, FL 32608 2 899 1 NOV August 29, 2012 Date: Contact Person: Lisa Simpson, Regulatory Affairs Engineer Tel: (352) 336-0010, ext. 164 Fax: (352) 336-1410 Proprietary Names: dS Breast 16ch I/T 1.5T dS Breast 16ch I/T 3.0T Common Name: Coil, Magnetic Resonance, Specialty Classification Name and Reference: 21 CFR 892.1000
A magnetic resonance diagnostic device, 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, class II.
Device Product Code and Panel Code: MOS / Radiology / 90
Device Description:
The dS Breast 16ch I/T 1.5T and dS Breast 16ch I/T 3.0T coils are designed for use with a Magnetic Resonance Imaging (MRI) system. The coil is designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei. The coils are designed as receive only coil for high resolution diagnostic imaging and intervention of breast. The coil provides both unilateral and bilateral images (Left, Right and Both) of the anatomy of interest and permits MR-guided biopsy and localization of lesions.
Indications for Use:
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the breast, chest wall and axillary tissue, as an aid to diagnosis. The coil permits MR-guided breast biopsy and localization of lesions.
Technological Characteristics:
The fundamental scientific technology of a radio frequency (RF) coil is that the coil receives radio frequency signals from the tissue of interest.
Substantial Equivalence Information:
When compared to the predicate Breast Biopsy Coil (BBC) devices (K032576 and K041), substantial equivalence of the dS Breast 16ch (1.5 T & 3.0T) devices is based on similarities in intended use, design features, and technological characteristics. Supporting product evaluations includes Signal-to-Noise (SNR) ratio, Image Uniformity and assessment of clinical images. Additionally, the new devices passed electrical safety testing in accordance with IEC standards.
Section 005 Page 1 of 1
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Lisa Simpson Regulatory Engineer Invivo Corporation 3545 S.W. 47th Avenue GAINESVILLE FL 32608
NOV - 2 2012
Re: K122646
Trade/Device Name: dS Breast 16ch I/T 1.5T and dS Breast 16ch I/T 3.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: August 29, 2012 Received: August 30, 2012
Dear Ms. Simpson:
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 class II (Special Controls), it may be subject to such additional-controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of - .
2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
3
Indications for Use Form
510(k) Number (if known): K122646
Device Name:
dS Breast 16ch I/T 1.5T dS Breast 16ch I/T 3.0T
Indications for Use:
The coil is indicated for use on the order of a physician, in conjunction with Philips 1.5T and 3.0T MR scanners as an accessory to produce images of the breast, chest wall and axillary tissue, as an aid to diagnosis. The coil permits MR-guided breast biopsy and localization of lesions.
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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Murhus Dökken
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K122646