1.5T 16ch Breast Coil

K182958 · Neocoil, LLC · MOS · Nov 16, 2018 · Radiology

Device Facts

• Record ID: K182958
• Device Name: 1.5T 16ch Breast Coil
• Applicant: Neocoil, LLC
• Product Code: MOS · Radiology
• Decision Date: Nov 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

To be used in conjunction with GEHC 1.5T 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 accessories, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.

Device Story

The NeoCoil 1.5T 16ch Breast Coil is a three-part, receive-only phased array coil designed for MRI imaging of the breast, axilla, and chest wall. It functions by receiving RF signals corresponding to proton precession in a 1.5T magnetic field. The device includes a coil support structure, patient support structure, biopsy components, and comfort pads. It is used in clinical settings in conjunction with GEHC 1.5T MRI scanners. The coil enables high-resolution diagnostic imaging and provides access for interventional biopsy procedures. A trained physician interprets the resulting images to inform clinical decision-making and guide interventional planning. The device benefits patients by facilitating accurate diagnostic assessment and minimally invasive biopsy procedures.

Clinical Evidence

Clinical performance testing was conducted in accordance with FDA guidance for Magnetic Resonance Diagnostic Devices. The study evaluated technical factors and anatomy. No adverse events were reported, and the device demonstrated performance adequate to support the intended use.

Technological Characteristics

Phased array receive-only coil; 1.5T field strength; tuned to Larmor frequency for 1.5T. Materials comply with ISO 10993-1. Standards: IEC 60601-1, IEC 60601-1-2 (ESD), IEC 60601-1-6 (Usability), IEC 60601-2-33, NEMA MS-6 (SNR/Uniformity). Features blocking network for transmit decoupling. Thermal safety limit <41°C.

Indications for Use

Indicated for patients requiring diagnostic or interventional planning MRI of the breast, axilla, and chest wall. Used with GEHC 1.5T MRI scanners. Compatible with biopsy accessories for interventional procedures performed by trained physicians.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• NeoCoil 3.0T 16ch Breast Coil (K173377)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 16, 2018

NeoCoil, LLC Katie Gonzalez Regulatory & Ouality Engineering Manager N27 W23910 A Paul Rd. Pewaukee, Wisconsin 53072

Re: K182958

Trade/Device Name: 1.5T 16ch Breast Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: October 22, 2018 Received: October 24, 2018

Dear Katie Gonzalez:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Hole 2. Mild

for Robert A. 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)

# K182958

Device Name 1.5T 16ch Breast Coil

Indications for Use (Describe)

To be used in conjunction with GEHC 1.5T Nagnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy accessories, 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)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: [phone] [phone] Fax:

Image /page/3/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black coil-like symbol with an arrow pointing to the right, followed by the word "NeoCoil" in blue and black. The "Neo" part of the word is in blue, while the "Coil" part is in black. The logo is simple and modern, and it is likely used to represent a company or product related to coils or other similar technology.

# 5. Traditional 510(k) Summary

- 5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA
- 5.2. Contact Katie Gonzalez Regulatory & Quality Engineering Manager 262-522-6124 (direct) 261-347-1251 (fax) [e-mail]
- 5.3. Preparation Date October 22, 2018
- 5.4. Name of Device

.

.

- Proprietary Name: ●
- Common Name:
- 1.5T 16ch Breast Coil Magnetic Resonance Specialty Coil
- Classification:
- 21 CFR 892.1000, Product Code MOS
- 5.5. Model Numbers

| NeoCoil Model<br>Number | NeoCoil Model Name |
|-------------------------|----------------------------------------|
| NC091203 | Baseplate Assy, Breast Coil, 1.5T |
| NC091200 | Medial Array, Breast Coil, 1.5T |
| NC091201 | Lateral Array, Breast Coil, 1.5T Left |
| NC091202 | Lateral Array, Breast Coil, 1.5T Right |
| NC091207 | Biopsy Array, 1.5T Left |
| NC091208 | Biopsy Array, 1.5T Right |

# 5.6. Device Description

The NeoCoil 1.5T 16ch Breast Coil is a phased array coil for imaging structures of the breast, axilla and chest wall. The 1.5T 16ch Breast Coil is a three part receive-only coil designed to provide high resolution imaging. The 1.5T 16ch Breast Coil includes a coil support structure, patient support structure, biopsy components and comfort pads.

^{© 2018} NeoCoil, LLC

{4}------------------------------------------------

N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: [phone] Fax: [phone]

Image /page/4/Picture/1 description: The image contains the logo for NeoCoil. The logo consists of a black circular shape with a white swirl inside, and a black arrow pointing to the right. To the right of the logo is the word "NeoCoil" in blue. The word "Neo" is in a lighter shade of blue than the word "Coil".

The NeoCoil 1.5T 16ch Breast Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.

The NeoCoil 1.5T 16ch Breast Coil is intended for use in a manner that is identical to the predicate device described in this submission.

- 5.7. Predicate Device
- NeoCoil 3.0T 16ch Breast Coil, K173377, as cleared on 11/28/2017. ●

### 5.8. Comparison to Predicate

The NeoCoil 1.5T 16ch Breast Coil is similar in physical, performance, design and material characteristics to the legally marketed device, the NeoCoil 3.0T 16ch Breast Coil, K173377, as cleared on 11/28/2017.

With the exception of the field strength, the Indications for Use are identical with the predicate device, the NeoCoil 3.0T 16ch Breast Coil, K173377, as cleared on 11/28/2017.

Clinical testing demonstrates that the differences in the field strength of 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 coniunction with GEHC 1.5T 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 accessories, 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 1.5T 16ch Breast Coil is safe and effective. The device's performance meets the requirements of pre-defined acceptance criteria and intended uses.

| Test | Pass/Fail Criteria | Result |
|----------------------------------|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Unplugged Surface<br>Temperature | Acceptable level of risk | Pass: Surface temperature is not greater than<br>41°C when the coil is left unplugged in the MRI<br>scanner. |
| Surface Temperature | Pre-defined<br>performance standards | Pass: RF and Eddy current heating is not<br>greater than 41°C. |
| Blocking Network<br>Analysis | Adequate transmit<br>decoupling | Pass: Blocking network demonstrates<br>adequate active and passive transmit<br>decoupling. |
| B1 Field Distortion | Pre-defined<br>performance standards | Pass: B1 field inhomogeneity meets<br>performance requirements and demonstrates<br>adequate active and passive transmit<br>decoupling. |

### Performance testing - Bench:

© 2018 NeoCoil, LLC

{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 swirl inside and an arrow pointing to the right. To the right of the shape is the word "NeoCoil" in a sans-serif font. The "Neo" part of the word is in blue, while the "Coil" part is in black.

| Test | Pass/Fail Criteria | Result |
|----------------|--------------------------------------|----------------------------------------------------------------------------------------------------|
| NEMA MS 6-2008 | Pre-defined<br>performance standards | Pass: SNR and Image Uniformity are<br>consistent with the requirements for indications<br>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 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 1.5T 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 1.5T 16ch Breast Coil is equivalent to the predicate, NeoCoil 3.0T 16ch Breast Coil, K173377, as cleared on 11/28/2017.

^{© 2018} NeoCoil, LLC