(29 days)
Not Found
No
The description focuses on the hardware components and physical properties of an MRI coil, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as producing "diagnostic and interventional planning images" and enabling "access to the breast anatomy for interventional procedures," indicating it is used for diagnosis and guiding procedures, not directly treating a condition.
Yes
The "Intended Use / Indications for Use" states that the device is "to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician," explicitly indicating its role in diagnosis.
No
The device description explicitly states it is a "phased array coil" and includes physical components like a "coil support structure, patient support structure, biopsy components and comfort pads." This indicates it is a hardware device, not software-only.
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.
- Device Function: The NeoCoil 3.0T 16ch Breast Coil is a component of a Magnetic Resonance (MR) imaging system. It is a physical coil that receives radiofrequency signals from the patient's body during an MRI scan.
- Intended Use: The intended use is to produce diagnostic and interventional planning images of the breast, axilla, and chest wall. This involves imaging the internal structures of the body directly, not analyzing samples taken from the body.
The device is used in vivo (within the living body) to generate images, which is characteristic of imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy components, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.
Product codes
MOS
Device Description
The NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 3.0T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The.3.0T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.
The NeoCoil 3.0T 16ch Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanners (MRI)
Anatomical Site
breast, axilla, chest wall
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
Bench testing and Clinical performance testing were conducted.
Bench Tests:
- Unplugged Surface Temperature: Pass - Surface temperature is not greater than 41°C when the coil is left unplugged in the MRI scanner.
- Surface Temperature: Pass - RF and Eddy current heating is not greater than 41°C.
- Blocking Network Analysis: Pass - Blocking network demonstrates adequate active and passive transmit decoupling.
- B1 Field Distortion: Pass - B1 field inhomogeneity meets Toshiba performance requirements and demonstrates adequate active and passive transmit decoupling.
- NEMA MS 6-2008: Pass - SNR and Image Uniformity are consistent with the requirements for indications for use.
Published Standards Testing:
- IEC 60601-1: Electromechanical safety
- IEC 60601-1-2: ESD
- IEC 60601-1-6: Usability
- IEC 60601-2-33: Electromechanical safety
- ISO 10993-1: Biocompatibility
- NEMA MS-6: SNR and Image Uniformity
Clinical Performance Testing:
The clinical data exhibits a mix of technical factors and anatomy in the axial, sagittal and coronal planes as recommended in the FDA guidance, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices issued November 18, 2016." No adverse events were reported; the 3.0T 16ch Breast Coil demonstrated performance adequate to support the Indications for Use.
Key Metrics
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
November 28, 2017
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are both in color and are placed side-by-side.
NeoCoil, LLC % Mr. Michael Leigh Director, Regulatory Affair N27 W23910A Paul Road PEWAUKEE WI 53072
Re: K173377
Trade/Device Name: 3.0T 16ch Breast Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 26, 2017 Received: October 31, 2017
Dear Mr. Leigh:
We have reviewed vour 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name 3.0T 16Ch Breast Coil
Indications for Use (Describe)
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy components, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:
Image /page/3/Picture/2 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape with a white crescent moon shape inside, and a black arrow pointing to the right. To the right of the circular shape is the word "NeoCoil" in blue and black font. The "Neo" part of the word is in blue, and the "Coil" part is in black.
5. Traditional 510(k) Summary
- 5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA
- 5.2. Contact Michael Leigh Director, Regulatory 262-522-6127 (direct) 261-347-1251 (fax) Mike.leigh@neocoil.com
- 5.3. Preparation Date October 23, 2017
- 5.4. Name of Device
- Proprietary Name: 3.0T 16ch Breast Coil ●
- . Common Name:
- Magnetic Resonance Specialty Coil 21 CFR 892.1000, Product Code MOS
- Classification: .
- 5.5. Model Numbers
| NeoCoil Model
| Number | NeoCoil Model Name |
|---|---|
| NC088203 | Baseplate Assy, Breast Coil, 3.0T |
| NC088200 | Medial Array, Breast Coil, 3.0T |
| NC088201 | Lateral Array, Breast Coil, 3.0T Left |
| NC088202 | Lateral Array, Breast Coil, 3.0T Right |
| NC088207 | Biopsy Array, 3.0T Left |
| NC088208 | Biopsy Array, 3.0T Right |
5.6. Device Description
The NeoCoil 3.0T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 3.0T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The.3.0T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.
© 2017 NeoCoil, LLC
4
N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:
Image /page/4/Picture/1 description: The image contains the logo for NeoCoil. The logo consists of a black circular shape with a white crescent shape inside, and a black arrow pointing to the right. To the right of the logo is the word "NeoCoil" in blue and black lettering. The word "Neo" is in blue, and the word "Coil" is in black.
The NeoCoil 3.0T 16ch Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 3 tesla magnetic field, which is governed by the Larmor equation.
The NeoCoil 3.0T 16ch Breast Coil are intended for use in a manner that is similar to the predicate device described in this submission.
- 5.7. Predicate Device
- 3.0T HD Breast Array, K052585, as cleared on 10/04/2005. ●
5.8. Comparison to Predicate
The NeoCoil 3.0T 16ch Breast Coil is similar in physical, performance, design and material characteristics to the legally marketed device, the 3.0T HD Breast Array, K052585, as cleared on 10/04/2005.
The Indications for Use are consistent with the capabilities of the predicate device, the USA Instruments 3.0T HD Breast Array, K052585 as cleared on 10/04/2005, and marketed by GEHC as the 8 Ch Breast Coil.
Clinical testing demonstrates that the differences in the devices do not affect the safety and/or the effectiveness of the device when used as labeled.
- 5.9. Indications for Use
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy components, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.
5.10. Intended Use
Intended use is identical to that of routine imaging; specifically to produce diagnostic and interventional planning images of the breasts. axilla and chest wall. Use of the device in conjunction with an MRI scanner is unchanged.
- 5.11. Testing
The following data has been submitted, referenced or relied on to demonstrate that the NeoCoil 3.0T 16ch Breast Coil is safe and effective. The devices' performance meets the requirements of pre-defined acceptance criteria and intended uses.
| Test | Pass/Fail Criteria | Result |
|---|---|---|
| Unplugged Surface | ||
| Temperature | Acceptable level of risk | Pass: Surface temperature is not greater than |
| 41°C when the coil is left unplugged in the MRI | ||
| scanner. | ||
| Surface Temperature | Pre-defined | |
| performance standards | Pass: RF and Eddy current heating is not | |
| greater than 41°C. | ||
| Blocking Network | ||
| Analysis | Adequate transmit | |
| decoupling | Pass: Blocking network demonstrates | |
| adequate active and passive transmit | ||
| decoupling. | ||
| B1 Field Distortion | Pre-defined | |
| performance standards | Pass: B1 field inhomogeneity meets Toshiba | |
| performance requirements and demonstrates | ||
| adequate active and passive transmit | ||
| decoupling. |
Performance testing - Bench:
5
Image /page/5/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape with a white crescent shape inside, and a black arrow pointing to the right. To the right of the circular shape is the word "NeoCoil" in blue and black lettering. The "Neo" part of the word is in blue, and the "Coil" part is in black.
| Test | Pass/Fail Criteria | Result |
|---|---|---|
| NEMA MS 6-2008 | Pre-defined | |
| performance standards | Pass: SNR and Image Uniformity are | |
| consistent with the requirements for indications | ||
| for use. |
Published Standards testing:
| Standard | Purpose |
|---|---|
| IEC 60601-1 | Electromechanical safety |
| IEC 60601-1-2 | ESD |
| IEC 60601-1-6 | Usability |
| IEC 60601-2-33 | Electromechanical safety |
| ISO 10993-1 | Biocompatibility |
| NEMA MS-6 | SNR and Image Uniformity |
Performance testing - Clinical:
The clinical data in this section exhibits a mix of technical factors and anatomy in the axial, sagittal and coronal planes as recommended in the FDA guidance, • Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices issued November 18, 2016.
No adverse events were reported during clinical performance testing; the 3.0T 16ch Breast Coil demonstrated performance adequate to support the Indications for Use.
5.12. Conclusion
This submission demonstrates that the Indications for Use are in line with the predicate device to produce diagnostic images of the breasts, axilla and chest wall and are as safe and effective as the predicate device. As such, the 3.0T 16ch Breast Coil is equivalent to the predicate, USA Instruments 3.0T HD Breast Array, K052585 as cleared on 10/04/2005, and marketed by GEHC as the 8 Ch Breast Coil.
© 2017 NeoCoil, LLC