(99 days)
Not Found
No
The document describes a passive MRI coil and its intended use for imaging and biopsy guidance. There is no mention of any software, algorithms, or processing that would suggest the use of AI or ML.
No.
The device is used to obtain images for diagnostic purposes and to aid in biopsy guidance, not to treat a condition.
Yes
The device aids in obtaining MR images and guiding biopsy procedures, and these images, when interpreted by a trained physician, yield information useful in determining a diagnosis.
No
The device description clearly states it is a physical MRI coil with a supporting base, coil chambers, and plastic housing, indicating it is a hardware device.
Based on the provided information, 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.
- Device Function: The Open Breast Coil with Biopsy Plates is an accessory for an MRI scanner. Its function is to acquire magnetic resonance images of the breast and aid in guiding biopsy procedures. It does not perform any tests on biological samples.
- Intended Use: The intended use is to obtain MR images and aid in biopsy guidance, which are imaging and procedural functions, not diagnostic testing of samples.
- Device Description: The description details the physical components of an MRI coil, not a device for analyzing biological samples.
Therefore, the Open Breast Coil with Biopsy Plates falls under the category of a medical imaging accessory and a procedural aid, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil, used for obtaining MR images of the breast and auxiliary tissue. The biopsy plate allows access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Open Breast Coil with Biopsy Plates. The indications for use are the same as for standard MR Imaging. The Open Breast Coil with Biopsy Plates is designed for use with the 0.3T Airis-Elite MRI scanner manufactured by Hitachi Medical System.
The Open Breast Coil with Biopsy Plates is designed to provide Magnetic Resonance Images of the breast anatomy and aid in quidance during biopsy procedures. The Open Breast Coil with Biopsy Plates is designed for use with the Hitachi Airis Elite .3T scanner.
Anatomic Regions: Breast Anatomy
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Airis Elite .3T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Product codes
MOS
Device Description
The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil. The coil consists of three sections: a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a ridged plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The Open Breast coil with Biopsy plates is designed to offer optimized imaging capabilities and maximum lateral access to each breast for biopsy procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
breast and auxiliary tissue
Breast Anatomy
soft tissue structure of the head and whole body
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)
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
K050128-21
r
SUMMARY OF SAFETY AND EFFECTIVENESS
.
| 1. Device Name: | Magnetic Resonance Image Accessory |
|---|---|
| 2. Proprietary Name: | Open Breast Coil with Biopsy Plates |
| 3. Classification: | Class II |
| 4. Establishment Registration #: | 1529041 |
| 5. Manufacture Facility Location: | USA Instruments, Inc., 1515 Danner Drive, |
| Aurora, Ohio 44202, USA | |
| Telephone: 330-995-8572; Fax: 330-562-1422. | |
| 6. Performance Standard: | No applicable performance standards have been |
| issued under Section 514 of the Food, Drug and | |
| Cosmetic Act. | |
| 7. Intended Use: | The Open Breast Coil with Biopsy Plates is a phased |
| array, receive-only MRI coil, used for obtaining MR | |
| images of the breast and auxiliary tissue. The biopsy | |
| plate allows access to the breast anatomy during | |
| biopsy procedures. No biopsy needles are included | |
| with, or packaged with the Open Breast Coil with | |
| Biopsy Plates. The indications for use are the same | |
| as for standard MR Imaging. The Open Breast Coil | |
| with Biopsy Plates is designed for use with the 0.3T | |
| Airis-Elite MRI scanner manufactured by Hitachi | |
| Medical System. | |
| 8. Device Description: | The Open Breast Coil with Biopsy Plates is a phased |
| array, receive-only MRI coil. The coil consists of | |
| three sections: a supporting base and two insulating | |
| coil chambers, one for each breast. Each of the | |
| hollow coil chambers houses two coil elements that | |
| are insulated from the patient by a ridged plastic | |
| housing. The coil housing is made of plastic | |
| materials, which are fire rated and have high impact | |
| and tensile strength. The Open Breast coil with | |
| Biopsy plates is designed to offer optimized imaging | |
| capabilities and maximum lateral access to each | |
| breast for biopsy procedures. |
1
9. Safety and Effectiveness
ﺮ
・
| Modified Device Features | Comparison to Baseline Device |
|---|---|
| Intended Use: Breast imaging for | |
| diagnostic purposes. The coil has a | |
| biopsy plate that allows access to the | |
| breast. | -Similar to Liberty 5000 Breast Coil with Disposable |
| Biopsy Plate manufactured by USA Instruments, | |
| Inc. (K022007) | |
| Indications for Use: Identical to routine | |
| MRI imaging. | -Similar to Liberty 5000 Breast Coil with Disposable |
| Biopsy Plate manufactured by USA Instruments, | |
| Inc. (K022007) | |
| Coil Enclosure Material: Polyurethane | |
| Plastic, ABS Plastic, Polycarbonate and | |
| Delrin. | -Similar to Liberty 5000 Breast Coil with Disposable |
| Biopsy Plate manufactured by USA Instruments, | |
| Inc. (K022007) | |
| Coil Design: Receive-only phased array | |
| design. | -Similar to Liberty 5000 Breast Coil with Disposable |
| Biopsy Plate manufactured by USA Instruments, | |
| Inc. (K022007) | |
| Decoupling: RF Chock with Switching | |
| Diode. | -Similar to Liberty 5000 Breast Coil with Disposable |
| Biopsy Plate manufactured by USA Instruments, | |
| Inc. (K022007) | |
| Prevention of RF Burns: Does not | |
| transmit RF power; decoupling isolates | |
| the coil elements from RF fields during | |
| RF transmission; coil elements and | |
| circuitry are enclosed in a non- | |
| conductive housing. | -Similar to Liberty 5000 Breast Coil with Disposable |
| Biopsy Plate manufactured by USA Instruments, | |
| Inc. (K022007) | |
| Radio Frequency Absorption: Coil is a | |
| receive-only coil and does not transmit | |
| RF power: power deposition during | |
| imaging is limited by SAR algorithm. | -Similar to Liberty 5000 Breast Coil with Disposable |
| Biopsy Plate manufactured by USA Instruments, | |
| Inc. (K022007) | |
| Formation of Resonant Loop: | |
| Decoupling isolates coil elements from | |
| RF fields during RF transmission; length | |
| of cable and stiffness does not permit | |
| looping. | -Similar to Liberty 5000 Breast Coil with Disposable |
| Biopsy Plate manufactured by USA Instruments, | |
| Inc. (K022007) |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, with three lines extending from the eagle's head.
Food and Drug Administration 9200 Côrporate Boulevard Rockville MD 20850
Mr. David S. Brown Manager, QA/RA USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K050728 Trade/Device Name: Open Breast Coil with Biopsy Plates Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: MOS Dated: June 6, 2005 Received: June 10, 2005
Dear Mr. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have icenced your bettler. been) programially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cherosate) to regally mant date of the Medical Device Amendments, or to devices that have been May 20, 1770, the chavinent 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 do fiot require approval or a provisions of the Act. The general controls provisions of the Act device, subjoct to the generation, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
JUN 2 8 2005
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your de roo be subject to such additional controls. Existing major regulations affecting your / Ipplo vary, it ifal 70 od ot 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 I Toase of determination that your device complies with other requirements of the Act or any I Dri has made a advertising administered by other Federal agencies. You must comply with all the I carrar suiteres and regulating, 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) (21 CFF CFR 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) I hils letter witi anow you to organization of substantial equivalence of your device to a legally prematice notification: - The sification 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 If you desire specific ac no 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 Also, proase note the regulation on your responsibilities under the Act from the 807.77). Tou may ooum ourers, 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
Page 1 of 1
510(k) Number (if known):_ ズクイップし
Device Name: Open Breast Coil with Biopsy Plates
Indications for Use: The Open Breast Coil with Biopsy Plates is designed to provide Magnetic Resonance Images of the breast anatomy and aid in quidance during biopsy procedures. The Open Breast Coil with Biopsy Plates is designed for use with the Hitachi Airis Elite .3T scanner.
Anatomic Regions: Breast Anatomy Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Airis Elite .3T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The-Counter Use
| (Optional Format 1-2-96) | |
|---|---|
| -------------------------------------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K050728 |