16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil

Q: Who is the manufacturer of 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil?

Neocoil, LLC filed the 510(k) submission for 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil (K222407).

Q: What is the FDA product code for 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil?

MOS. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil?

3.0T 16ch Breast Coil (K173377).

Q: Who can help prepare an FDA 510(k) submission like 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K222407 · Neocoil, LLC · MOS · Oct 14, 2022 · Radiology

Device Facts

Record ID	K222407
Device Name	16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
Applicant	Neocoil, LLC
Product Code	MOS · Radiology
Decision Date	Oct 14, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The NeoCoil 16ch Breast Coils are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended for use by trained medical professionals, in combination with and controlled by compatible 1.5T or 3T/3.0T MRI system software. The NeoCoil 16ch Breast Coils can be used with compatible ancillary components, accessories, and/or devices to provide access to breast anatomy for diagnostic or interventional planning/procedures. When used as intended, the 16ch Breast Coil provides information used by the MRI system to produce diagnostic and/or interventional planning images of the breast, axilla, and chest wall. The images produced are interpreted by medical professionals as part of clinical decision making.

Device Story

Phased array, receive-only RF coils for MRI imaging of breast, axilla, and chest wall; available in 1.5T and 3T configurations. Device consists of medial, lateral, and biopsy arrays, baseplate, and accessories (biopsy grids/drapes). Operates by receiving magnetic resonance signals from hydrogen nuclei in anatomy while blocking high-frequency fields from the MRI scanner; signals are amplified and transferred to the MRI scanner for image reconstruction. Used in clinical settings by trained medical professionals. Output is tomographic images (axial, sagittal, coronal oblique) used for diagnostic or interventional planning. Benefits include high-resolution imaging for clinical decision-making.

Clinical Evidence

No clinical performance testing performed. Substantial equivalence established via non-clinical bench testing, including biocompatibility, electrical safety (IEC 60601-1, 60601-2-33, 60601-1-2), usability, surface temperature, blocking network analysis, B0/B1 field distortion, and NEMA MS 6-2008 image quality metrics (SNR, uniformity).

Technological Characteristics

Phased array, receive-only RF coils. Materials assessed for biocompatibility. Energy source: MRI scanner (no internal power). Dimensions/form factor: contoured for breast anatomy. Connectivity: system cable to MRI scanner. Tuning: 1.5T or 3T field strengths. Includes antenna fuses, preamplifiers, and decoupling circuitry.

Indications for Use

Indicated for use by trained medical professionals to provide diagnostic or interventional planning images of the breast, axilla, and chest wall anatomy in patients undergoing MRI procedures using compatible 1.5T or 3T MRI systems.

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

3.0T 16ch Breast Coil (K173377)

Reference Devices

1.5T 16ch Breast Coil (K182958)

Related Devices

K173377 — 3.0T 16ch Breast Coil · Neocoil, LLC · Nov 28, 2017
K041695 — LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE · Usa Instruments, Inc. · Jul 23, 2004
K232762 — dS Breast Coil 7ch 1.5T · Invivo Corporation (Business Trade Name: Philips) · Oct 3, 2023
K052585 — 3T HD BREAST ARRAY · Usa Instruments, Inc. · Oct 4, 2005
K213727 — dS Sentinelle Breast 16ch 3.0T Coil · Invivo Corporation (Business Trade Name: Philips) · Aug 8, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. October 14, 2022 NeoCoil, LLC % Katie Gonzalez Ouality Systems & Regulatory Manager N27 W23910A Paul Road PEWAUKEE WI 53072 Re: K222407 Trade/Device Name: 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: September 9, 2022 Received: September 15, 2022 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 {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222407 #### Device Name 16ch Breast Coils: 1.5T 16ch Breast Coil / 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil / 3T 16ch Breast Coil Indications for Use (Describe) The NeoCoil 16ch Breast Coils are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended for use by trained medical professionals, in combination with and controlled by compatible 1.5T or 373.0T MRI system software. The NeoCoil 16ch Breast Coils can be used with compatible ancillary components, accessories, and or devices to provide access to breast anatomy for diagnostic or interventional planning/procedures. When used as intended, the 16ch Breast Coil provides information used by the MRI system to produce diagnostic and or interventional planning images of the breast, axilla, and chest wall. The images produced are interpreted by medical professionals as part of clinical decision making. 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 PRAStaff(@fda.hhs.gov "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: (262) 347-1250 (262) 347-1251 Fax: Image /page/3/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape on the left, with a white curved line inside that forms an arrow pointing to the right. To the right of the shape is the word "NeoCoil" in blue. The font is sans-serif and the letters are bold. # Special 510(k) Summary K222407 Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA Contact Katie Gonzalez Quality Systems and Regulatory Manager 262-522-6124 (office) 262-347-1251 (fax) Katie.Gonzalez@neocoil.com Preparation Date August 3, 2022 ## Name of Device - . Trade/Proprietary name(s): ### 16ch Breast Coils | Submission | Device Trade/Proprietary Name | |----------------|-------------------------------| | Existing model | 3.0T 16ch Breast Coil | | Existing model | 1.5T 16ch Breast Coil | | New model | 3T 16ch Breast Coil | | New model | 1.5T 16ch Breast Coil | - Magnetic Resonance Specialty Coil ● Common name: - . Classification name: 21 CFR 892.1000, Magnetic resonance diagnostic device, Product Code MOS ### Predicate Device 3.0T 16ch Breast Coil, K173377, cleared on 11/28/2017, manufactured by NeoCoil, LLC ### Reference Device 1.5T 16ch Breast Coil, K182958, cleared on 11/16/2018, manufactured by NeoCoil, LLC ### 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, accessories and comfort pads. {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 shows the logo for NeoCoil. The logo consists of a black circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in blue. The "N" and "e" are in a lighter shade of blue, while the "o" is in a darker shade of blue. The "Coil" part of the word 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 16ch Breast Coils are intended for use in a manner that is identical to the predicate device and reference device described in this submission 3.0T 16ch Breast Coil, K173377, cleared on 11/28/2017 and 1.5T 16ch Breast Coil, K182958, cleared on 11/16/2018. The 16ch Breast Coil consists of the following arrays available in 1.5T, 3.0T and 3T field strengths: - Medial Array, Breast Coil - . Lateral Array Left, Breast Coil - Lateral Array Right, Breast Coil ● - . Baseplate Assembly, Breast Coil - Biopsy Array Left, Breast Coil ● - Biopsy Array Right, Breast Coil ● The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Head. Neck and Brachial Plexus anatomy while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The received signals are amplified before being transferred to the MRI scanner through the coil's system cable. The amplified signals are processed into tomographic images of the breast, axilla and chest wall anatomy by the MRI scanner. Images are typically generated as axial, sagittal, coronal oblique slices. Accessories associated with the 16ch Breast Coils include biopsy grids and biopsy drapes. The 1.5T Breast Coil, the 3T 16ch Breast Coil, and the 3.0T 16ch Breast Coil are tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla and 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation. The 16ch Breast Coil is intended for use in a manner that is identical to the predicate device described in this submission. Proposed labeling is documented in the Instructions for Use manual for the 16ch Breast Coil (NC149IFU-en). #### Intended Use, including indications The NeoCoil 16ch Breast Coils are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended for use by trained medical professionals, in combination with and controlled by compatible 1.5T or 3T/3.0T MRI system software. The NeoCoil 16ch Breast Coils can be used with compatible ancillary components, accessories, and/or devices to provide access to breast anatomy for diagnostic or interventional planning/procedures. When used as intended, the 16ch Breast Coil provides information used by the MRI system to produce diagnostic and/or interventional planning images of the breast, axilla, and chest wall. The images produced are interpreted by medical professionals as part of clinical decision making. #### Technological Characteristics 16ch Breast coils are similar in design, material, chemical composition and energy source to the legally marketed predicate device and reference device described in this submission 3.0T 16ch Breast Coil, K173377, cleared on 11/28/2017 and 1.5T 16ch Breast Coil, K182958, cleared on 11/16/2018. {5}------------------------------------------------ N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax: 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 moon shape inside, and a black arrow pointing to the right. To the right of the logo is the word "NeoCoil" in blue and black font. The word "Neo" is in blue, and the word "Coil" is in black. At a high level, the 16ch Breast Coils included as part of this submission, and the predicate device, 3.0T 16ch Breast Coil (K173377) are based on the following same technological elements: - Prescription use; - . Coil designs are receive-only phased array coils; - . Preamplification methodology - Decoupling methodology - Patient contacting materials and chemical composition are known materials that have ● been assessed for compliance with recognized biocompatibility standards; - Energy source for the coils is the MRI scanner; ● - Energy is not intended to be supplied by the coils; ● - . Mechanical designs are contoured for the breast anatomy; - Facilitates imaging for diagnostic and interventional planning of the breast, axilla and chest wall anatomy: - Channel count - Field strength when compared to the predicate device and reference device ● The following technological differences exist between the subject and predicate and reference devices: - MRI specific system cabling - MRI specific interface circuitry . - MRI specific RF loop and preamplifier tuning ● - Addition of fuses on antenna elements ● Testing performed per defined standards demonstrates that the safety and/or effectiveness of the 16ch Breast Coils compared to the predicate device is not adversely affected as a result of the differences. ### Testing Through NeoCoil's design controls process, a risk assessment leveraging FDA's quidance document decision trees for when to submit a new 510(k) for changes to an existing device, a summary of non-clinical performance data using well-established methodologies is included, referenced, or relied on to demonstrate that the 16ch Breast Coils are safe and effective and performs in a manner that demonstrates substantial equivalence to the predicate device and reference device described in this submission 3.0T 16ch Breast Coil, K173377, cleared on 11/28/2017 and 1.5T 16ch Breast Coil, K182958, cleared on 11/16/2018. ### Performance testing - Bench: A Test Report Summary for non-clinical Bench Testing performed, including testing to FDArecognized consensus standards identified as relevant in FDA guidance document Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016, is outlined below: | Test Performed | Objective(s) of the Test | Test Method Description | Pre-defined pass/fail criteria | Results Summary | Discussions / Conclusions | |------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility Assessment | Assess potential biological risks | Evaluation of data; historical use, biologic testing, where warranted | Acceptable level of risk | Pass | No identified significant risks. | | Test Performed | Objective(s) of the Test | Test Method Description | Pre-defined pass/fail criteria | Results Summary | Discussions / Conclusions | | Electrical Safety | Basic electrical safety/essential performance, 60601-1 | Test Lab | Pre-defined performance standards | Pass | Applicable requirements for basic electrical safety and essential performance met. | | Electrical Safety | Particular electrical requirements: MR equipment, 60601-2- 33 | Test Lab | Pre-defined performance standards | Pass | Applicable requirements of the particular standard were met. | | Electrical Safety | Collateral electrical safety/essential performance, 60601- 1-2 | Test Lab / Bench Testing | Pre-defined performance standards | Pass | Applicable requirements of the collateral standard were met. | | Usability Assessment | Devices meet customer, end user and patient needs | Actual. simulated or retrospective evaluation of the device and/or data | Pre-defined requirements | Pass | The devices met the needs of the customer, end user and patient. | | Entrapment, Trapping Zone and Cable Looping (assessment w/ scanner) | Assess the device for pinch points, entrapment, cable looping - interfacing with MRI scanner | Evaluation of coil-to-scanner entrapment, trapping and cable looping not covered by test lab assessments. | Requirements based on pre- defined requirements in 60601-1 and customer requirements | Pass | Requirements were met. | | Surface Temperature | Surface temperatures do not exceed limits | MRI scanner test | Pre-defined performance standards | Pass | Surface temperatures were within IEC limits. | | Unplugged Surface Temperature | Devices remain safe in first fault condition | MRI scanner test | Acceptable level of risk | Pass | Surface temperatures were within IEC limits when the coil is left unplugged in the MRI scanner. | | Blocking Network Analysis | Ensures devices are designed with adequate active and passive transmit decoupling | Theoretical calculations | Adequate transmit decoupling | Pass | Blocking network demonstrates adequate active and passive transmit decoupling. | | B1 Field Distortion | Measure amount of distortion produced due to presence of an RF coil in the scanner | MRI scanner test | Pre-defined performance standards | Pass | B1 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling. | | Test Performed | Objective(s) of the Test | Test Method Description | Pre-defined pass/fail criteria | Results Summary | Discussions / Conclusions | | B0 Filed Distortion | Measure amount of distortion produced due to presence of an RF coil in the scanner | MRI scanner test | Pre-defined performance standards | Pass | B0 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling. | | NEMA MS 6- 2008 | Evaluate single- channel non-volume special purpose radiofrequency (RF) coils for use with magnetic resonance (MR) imaging (MRI) systems | MRI scanner test | Pre-defined performance standards | Pass | SNR and Image Uniformity are consistent with the requirements for indications for use. | {6}------------------------------------------------ N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 Fax: (262) 347-1251 Image /page/6/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in blue. The word "Neo" is in a slightly larger font than the word "Coil". {7}------------------------------------------------ N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax: Image /page/7/Picture/1 description: The image contains the logo for NeoCoil. To the left of the company name is a black circular logo with an arrow pointing to the right. The company name is to the right of the logo, with "Neo" in blue and "Coil" in black. ## Performance testing - Clinical: Due to the substantial equivalency of the devices and the evaluation of performance testing against defined standards, no additional clinical performance testing has been performed above that present for the predicate device and reference device described in this submission 3.0T 16ch Breast Coil, K173377, cleared on 11/28/2017 and 1.5T 16ch Breast Coil, K182958, cleared on 11/16/2018. No adverse events have been reported against the predicate device and reference device described in this submission 3.0T 16ch Breast Coil, K173377, cleared on 11/28/2017 and 1.5T 16ch Breast Coil, K182958, cleared on 11/16/2018. ### Conclusion This submission demonstrates by means of nonclinical testing that the 16ch Breast Coils are substantially equivalent to and perform as well as the predicate device and reference device described in this submission 3.0T 16ch Breast Coil, K173377, cleared on 11/28/2017 and 1.5T 16ch Breast Coil, K182958, cleared on 11/16/2018.