(23 days)
Not Found
No
The description focuses on the hardware (coil) and its physical components for imaging and biopsy access. There is no mention of software processing, AI, ML, or related terms.
No
The device is used to produce diagnostic and interventional planning images, not to treat any 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 mentioning the production of diagnostic images.
No
The device description explicitly details hardware components like a coil support structure, patient support structure, biopsy components, and comfort pads, and the performance studies include bench testing of physical properties like temperature and field distortion.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "phased array coil for imaging structures of the breast, axilla and chest wall." It is used in conjunction with an MRI scanner to produce images.
- Intended Use: The intended use is to "produce diagnostic and interventional planning images of the breast" and to "permit access to the breast anatomy for interventional procedures." This involves imaging the body directly, not analyzing samples taken from the body.
Therefore, the NeoCoil 1.5T 16ch Breast Coil is a medical device used for in vivo imaging and interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MOS
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
breast, axilla and 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
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.
Performance testing - Bench:
- Test: Unplugged Surface Temperature
- Pass/Fail Criteria: Acceptable level of risk
- Result: Pass: Surface temperature is not greater than 41°C when the coil is left unplugged in the MRI scanner.
- Test: Surface Temperature
- Pass/Fail Criteria: Pre-defined performance standards
- Result: Pass: RF and Eddy current heating is not greater than 41°C.
- Test: Blocking Network Analysis
- Pass/Fail Criteria: Adequate transmit decoupling
- Result: Pass: Blocking network demonstrates adequate active and passive transmit decoupling.
- Test: B1 Field Distortion
- Pass/Fail Criteria: Pre-defined performance standards
- Result: Pass: B1 field inhomogeneity meets performance requirements and demonstrates adequate active and passive transmit decoupling.
- Test: NEMA MS 6-2008
- Pass/Fail Criteria: Pre-defined performance standards
- Result: Pass: SNR and Image Uniformity are consistent with the requirements for indications for use.
Published Standards testing:
- Standard: IEC 60601-1
- Purpose: Electromechanical safety
- Standard: IEC 60601-1-2
- Purpose: ESD
- Standard: IEC 60601-1-6
- Purpose: Usability
- Standard: IEC 60601-2-33
- Purpose: Electromechanical safety
- Standard: ISO 10993-1
- Purpose: Biocompatibility
- Standard: NEMA MS-6
- Purpose: 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.
Key Metrics
Not Found
Predicate Device(s)
NeoCoil 3.0T 16ch Breast Coil, K173377
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
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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 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) Katie.Gonzalez@neocoil.com
- 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
| 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: (262) 347-1250 Fax: (262) 347-1251
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 | ||
| 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 | |
| performance requirements and demonstrates | ||
| adequate active and passive transmit | ||
| decoupling. |
Performance testing - Bench:
© 2018 NeoCoil, LLC
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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 | |
| 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 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