(8 days)
Not Found
No
The description focuses solely on the physical design and technical specifications of an MRI coil, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to produce diagnostic images, not to treat a condition.
No
The device is an accessory (coil) for an MRI scanner that produces diagnostic images but does not, itself, interpret or diagnose.
No
The device description clearly details physical hardware components including housings, antennas, cables, and a junction box, which are integral to its function as an MRI coil. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic Array Coil is a component of a Magnetic Resonance Imaging (MRI) system. Its function is to receive radiofrequency signals from the patient's body during an MRI scan to produce diagnostic images. This process happens within the body (in vivo).
- Intended Use: The intended use is to "produce diagnostic images... that can be interpreted by a trained physician." This is a characteristic of imaging devices, not IVDs.
The device is an accessory for an imaging system used for in-vivo diagnostic imaging.
N/A
Intended Use / Indications for Use
To be used in conjunction with 1.5T GE HD series Magnetic Resonance scanners to produce diagnostic images of the chest, abdominal, and pelvic regions that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdominal, and pelvic regions in Magnetic Resonance Imaging Systems. Compared to predicate device, the submitted device offers greater lateral coverage (60 cm v. 42 cm). The submitted device consists of two dependent housings; an anterior and a posterior. The anterior housing consists of 11 antennas. It is rigid in the middle, below the covers, and laterally flexible to permit it to wrap about the patient. The posterior consists of 5 antennas. It is made of a hard plastic housing. A single cable connects the posterior housing to the junction box, which provides the interface with the anterior housing. The junction box provides the inter-connection for the anterior and posterior housings, which are mutually dependant, and the GE Healthcare 1.5T Signa Excite MRI scanner. The antennas are uniquely positioned with the appropriate overlap to cancel out mutual coupling effects from adjacent antennas. Pre-amplifier decoupling reduces any remaining coupling between the antennas. The posterior housing is covered with a padded surface, of the same foam material as the anterior housing (flexible region). Hospital gowns, sheets, and/or patient street clothing separate the patient from direct contact with the coil and housing materials. The flexible portion of the anterior secures, about the patient, to the posterior with the provided straps. The posterior housing nests securely in the MRI scanner patient table. To ensure safety, each antenna is equipped with active and passive transmit decoupling circuits. Active decoupling is achieved via diodes that receive signals from the scanner to turn the coil to a high impedance state during system RF transmit. Crossed diodes are installed on each antenna acting as passive switches. These passive switches provide additional safety in case the active circuitry does not receive signal from the scanner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
chest, abdominal, and pelvic regions
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
SNR and image uniformity testing was performed which support the conclusion that the submitted device satisfies design objectives.
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.
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K073181
Page 1 of 2
510(k) Summary of Safety and Effectiveness
.
:
| Device Name: | NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic Array Coil | |||
|---|---|---|---|---|
| Proprietary Name: | NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic Array Coil | |||
| Common/Usual Name: | Magnetic Resonance Specialty Coil | |||
| Classification Name: | Magnetic Resonance Specialty Coil | |||
| Classification Number: | 892.1000 | |||
| Classification Panel: | Radiology Device Panel | |||
| CDRH Product Code: | MOS | |||
| Regulatory Class: | II | NOV 2 1 2007 | ||
| Reason for 510(k): | New device | |||
| Applicant: | Brian Brown | |||
| Executive Director | ||||
| NeoCoil | ||||
| N27 W23910A Paul Rd | ||||
| Pewaukee, WI 53072 | ||||
| 262-347-1250 x 12 (office) | ||||
| 261-347-1251 (fax) | ||||
| brian.brown@neocoil.com | ||||
| Preparation date: | 9/28/2007 | |||
| Est. Registration No: | 3006369484 | |||
| Intended Use: To be used in conjunction with 1.5T GE HD series Magnetic | ||||
| Resonance scanners to produce diagnostic images of the chest, abdominal, and | ||||
| pelvic regions that can be interpreted by a trained physician. | ||||
| Standards: | ||||
| Performance: | No applicable performance standards have been issued under Section 514 of the | |||
| Food, Drug and Cosmetic Act. | ||||
| Voluntary: | IEC 60601-1 | Medical Electrical Equipment-Part 1: General | ||
| Requirements for Safety | ||||
| IEC 60601-2-33 | Medical Electrical Equipment-Part 2: | |||
| Particular Requirements for the Safety of | ||||
| Magnetic Resonance Equipment for Medical Diagnosis | ||||
| NEMA MS-6 | Characterization of Special Purpose Coils for | |||
| Diagnostic Magnetic Resonance Images | ||||
| Device Description: | The NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic Array Coil is a multi- | |||
| element phased array receive only coil used for obtaining diagnostic images of | ||||
| the chest, abdominal, and pelvic regions in Magnetic Resonance Imaging | ||||
| Systems. Compared to predicate device, the submitted device offers greater | ||||
| lateral coverage (60 cm v. 42 cm). | ||||
| The submitted device consists of two dependent housings; an anterior and a | ||||
| posterior. The anterior housing consists of 11 antennas. It is rigid in the middle, | ||||
| below the covers, and laterally flexible to permit it to wrap about the patient. The | ||||
| posterior consists of 5 antennas. It is made of a hard plastic housing. A single | ||||
| cable connects the posterior housing to the junction box, which provides the | ||||
| interface with the anterior housing. The junction box provides the inter- |
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KD 7315/
Page 2 of 2
| connection for the anterior and posterior housings, which are mutually
| dependant, and the GE Healthcare 1.5T Signa Excite MRI scanner. | |
|---|---|
| The antennas are uniquely positioned with the appropriate overlap to cancel out | |
| mutual coupling effects from adjacent antennas. Pre-amplifier decoupling | |
| reduces any remaining coupling between the antennas. | |
| The posterior housing is covered with a padded surface, of the same foam | |
| material as the anterior housing (flexible region). Hospital gowns, sheets, and/or | |
| patient street clothing separate the patient from direct contact with the coil and | |
| housing materials. | |
| The flexible portion of the anterior secures, about the patient, to the posterior with | |
| the provided straps. The posterior housing nests securely in the MRI scanner | |
| patient table. | |
| To ensure safety, each antenna is equipped with active and passive transmit | |
| decoupling circuits. Active decoupling is achieved via diodes that receive signals | |
| from the scanner to turn the coil to a high impedance state during system RF | |
| transmit. Crossed diodes are installed on each antenna acting as passive | |
| switches. These passive switches provide additional safety in case the active | |
| circuitry does not receive signal from the scanner. | |
| Predicate Device: | IGC-Medical Advances Inc, Model 558GE-64 Torso Array Coil (K041185). |
| Comparison to Predicate: | It is our opinion that the NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic |
| Array Coil in this submission is substantially equivalent to the previously cleared | |
| IGC-Medical Advances Inc, Model 558GE-64 Torso Array Coil (K041185). | |
| Summary of Studies: | In all material respects, the NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic |
| Array Coil is substantially equivalent to the referenced predicate device. SNR | |
| and image uniformity testing was performed which support the conclusion that the | |
| submitted device satisfies design objectives. | |
| Conclusion: | The NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic Array Coil is |
| substantially equivalent to the predicate device. Use of the NeoCoil 1.5T 16- | |
| Channel Cardiac-Abdominal-Pelvic Array Coil does not result in any new potential | |
| hazards and does not alter the safety of the MRI scanner. |
・・
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
NOV 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NeoCoil LLC % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087
Re: K073181
Trade/Device Name: NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 8, 2007 Received: November 13, 2007
Dear Mr. Lehtonen:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: NeoCoil 1.5T 16-Channel Cardiac-Abdominal-Pelvic Array Coil
Indications For Use:
To be used in conjunction with 1.5T GE HD series Magnetic Resonance scanners to produce diagnostic images of the chest, abdominal, and pelvic regions that can be interpreted by a trained physician.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and | |
| Radiological Devices | |
| 510(k) Number | K073181 |
Concurrence of CDRH, Office of Device Evaluation (ODE)
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