(91 days)
Not Found
No
The summary describes a receive-only MR coil system and its intended use and performance testing, with no mention of AI or ML technologies for image processing, analysis, or other functions.
No.
The device is described as an accessory for producing images for diagnosis, not for treating any condition.
Yes
Explanation: The coils are accessories to Philips 1.5T MR scanners, which are explicitly described as "Magnetic Resonance Imaging (MRI) magnet systems." MRI is a diagnostic imaging modality used to produce images for diagnostic purposes. The coils receive signals to create "high resolution imaging" of anatomical regions, and the produced DICOM files were reviewed by a radiologist who confirmed "the image quality is suitable for clinical applications." Furthermore, the "Summary of Performance Studies" references "Guidance for Industry: Guidance for the Submission of Premarket Notification for Magnetic Resonance Diagnostic Devices," directly linking the device to a diagnostic context.
No
The device description explicitly details physical coil components designed for use with MRI systems, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the coils are used "to produce images of the head, spine and torso." This is a function of medical imaging, not in vitro testing of biological samples.
- Device Description: The description details how the coils work with an MRI system to receive RF signals from the body for imaging purposes. This is consistent with an imaging accessory.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to facilitate the creation of medical images, which are then interpreted by a physician.
N/A
Intended Use / Indications for Use
The coils are indicated for use on the order of a physician, in conjunction with Philips 1.5T MR scanners as accessories to produce images of the head, spine and torso.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The SENSE Head-Spine-Torso (HST) MR Coil System includes 16 channel coil components that are designed for use with Philips 16-Channel 1.5T Magnetic Resonance Imaging (MRI) magnet systems. The coils work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coils may receive the resultant RF signal from the excited nuclei. The coils are receive-only coils for high resolution imaging of thorax (including heart), abdomen, cervical, lumbar, and thoracic regions of the spine and the head, neck regions. The coils provide unilateral images of the anatomy of interest. The SENSE HST coils are designed to be used together and separately as follows:
Head + Spine + Torso - All three coils may be used together.
Head + Spine - Head Coil does not function unless it is connected to the Spine Coil.
Spine + Torso - Spine and Torso may be used together without the Head Coil
Spine - Spine Coil may be used alone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head, spine and torso (thorax (including heart), abdomen, cervical, lumbar, and thoracic regions of the spine and the head, neck regions)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Per Guidance for Industry: Guidance for the Submission of Premarket Notification for Magnetic Resonance Diagnostic Devices', the following preclinical testing was performed per the standards listed below and supports substantial equivalency to the predicate device: Signal to Noise Ratio (SNR), Image Uniformity, Characterization of for Diagnostic MR Images and IEC 60601 safety evaluation . DICOM files from the 510(k) subject device were reviewed by a radiologist who confirmed the image quality is suitable for clinical applications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary of Safety and Effectiveness SENSE Head-Spine-Torso (HST) MR Coils
| Submitted By: | Invivo Corporation
3545 SW 47th Avenue
Gainesville, FL 32608 | DEC 21 2012 |
|------------------------------------|---------------------------------------------------------------------------------------------|-------------|
| Date: | December 20, 2012 | |
| Contact Person: | Lance Aulabaugh, Quality Engineer
Tel: (352) 336-0010, ext. 156 Fax: (352) 336-1410 | |
| Proprietary Name: | SENSE Head-Spine-Torso MR Coil System:
SENSE Spine 16
SENSE Head 16
SENSE Torso 16 | |
| Common Name: | Coil, Magnetic Resonance, Specialty | |
| Classification Name and Reference: | 21 CFR 892 1000 | |
A magnetic resonance diagnostic device, 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, class II.
Device Product Code and Panel Code: MOS / Radiology / 90
Indications for Use:
The coils are indicated for use on the order of a physician, in conjunction with Philips 1.5T MR scanners as accessories to produce images of the head, spine and torso.
Device Description:
The SENSE Head-Spine-Torso (HST) MR Coil System includes 16 channel coil components that are designed for use with Philips 16-Channel 1.5T Magnetic Resonance Imaging (MRI) magnet systems. The coils work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coils may receive the resultant RF signal from the excited nuclei. The coils are receive-only coils for high resolution imaging of thorax (including heart), abdomen, cervical, lumbar, and thoracic regions of the spine and the head, neck regions. The coils provide unilateral images of the anatomy of interest. The SENSE HST coils are designed to be used together and separately as follows:
| Coil Models | Comments |
|---|---|
| Head + Spine + Torso | All three coils may be used together. |
| Head + Spine | Head Coil does not function unless it is connected to the Spine Coil. |
| Spine + Torso | Spine and Torso may be used together without the Head Coil |
| Spine | Spine Coil may be used alone. |
Section 005 Page 1 of 3
1
510(k) Summary of Safety and Effectiveness SENSE Head-Spine-Torso (HST) MR Coils
Substantial Equivalence Discussion:
When compared to the predicate devices, the SENSE Head-Spine-Torso system is substantially equivalent to the 1.5T 8-Channel Medium General Purpose Flex Coil (K093842, clearsd March 5, 2010). Substantial equivalence is based on design rationale, safety features, magnet system. compatibility and overall intended use. The indications for use statements differ with respect to the target anatomies; however, the predicate and new device system both fall within the same FDA class II product code, MOS and have the same fundamental intended use. I.ille the predicate, the proposed devices are receive-only MRI coils that are designed for use with Philips 1.5T magnet systems. The electrical isolation methods, decoupling method and housing material flammability ratings are the same for the predicate and new device.
| PREDICATE | NEW DEVICE | |
|---|---|---|
| Type of Device | ||
| (FDA Product Code) | 1.5T 8-Channel Medium | |
| General Purpose Flex Coil | ||
| K093842 | ||
| Accessory to MRI Scanner | ||
| (MOS) | SENSE | |
| Head-Spine-Torso | ||
| System | ||
| Accessory to MRI Scanner | ||
| (MOS) | ||
| Indications for Use | The coil is indicated for use on | |
| the order of a physician, in | ||
| conjunction with Philips 1.5T | ||
| and 3.0T MR scanners as an | ||
| accessory to produce images | ||
| of the hip, knee, ankle, chest, | ||
| and pelvic regions, as an aid to | ||
| diagnosis. | The coils are indicated for use | |
| on the order of a physician, in | ||
| conjunction with Philips 1.5T | ||
| MR scanners as accessories to | ||
| produce images of the head, | ||
| spine and torso. | ||
| Target Anatomies | hip, knee, ankle, chest, and | |
| pelvic regions | head, spine and torso regions | |
| System Compatibility | Philips 1.5T MRI Systems | Philips 1.5T MRI Systems |
| Type of Coil | Receive-Only | Receive-Only |
| Number of Channels | 8 Channels | 16 Channels |
| Decoupling Method | LC Tank Circuit | LC Tank Circuit |
| Electrical Isolation | Plastic housing with foam | |
| insulation | Plastic housing with foam | |
| insulation | ||
| Housing Materials & | ||
| Flammability Rating | Polycarbonate | |
| Polyethylene | ||
| Rating: UL94-HF-1 | Polycarbonate | |
| Polyethylene | ||
| Rating: UL94-HF-1 | ||
| Type of MRI System | Standard | Standard |
| Connector | Multi-pin Connector | Multi pin Connector |
2
510(k) Summary of Safety and Effectiveness SENSE Head-Spine-Torso (HST) MR Coils
Summary of Non-Clinical Tests for Substantial Equivalency Determination:
Per Guidance for Industry: Guidance for the Submission of Premarket Notification for Magnetic Resonance Diagnostic Devices', the following preclinical testing was performed per the standards listed below and supports substantial equivalency to the predicate device: Signal to Noise Ratio (SNR)2, Image Uniformity3, Characterization of for Diagnostic MR Images and IEC 60601 safety evaluation . DICOM files from the 510(k) subject device were reviewed by a radiologist who confirmed the image quality is suitable for clinical applications.
Standards Referenced:
-
- Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices Issued On November 14, 1998
-
- NEMA Standards Publications MS 1-2008: Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
-
- NEMA Standards Publications MS 3-2008: Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
-
- NEMA Standards Publications MS 9-2008: Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
-
- IEC 60601 Standards:
IEC 60601-1, 1988; Medical Electrical Equipment - Part 1: General Amendment 1, 1991-11, Requirements for Safety Amendment 2, 1995. IEC 60601-1-2: 2001 Medical Electrical Equipment - Part 2: General Edition 2:2001 with Requirements for Safety Collateral Standard: Electromagnetic Compatibility-Requirements and Amendment 1:2004; Edition 2.1 (Edition:2001 consolidated with Tests Amendment 1:2004) IEC 60601-2-33: 2002 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Magnetic Resonance Amendment 1:2005 Equipment for Medical Diagnosis
Substantial Equivalency Conclusion:
Based on a comparison of technological characteristics, conformance to safety standards preclinical test results, the SENSE Head-Spine-Torso MR coil system is substantially equivalent to the 1.5T 8-Channel Medium General Purpose Flex Coil cleared via K093842.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms, representing health, services, and people. The figure is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in a sans-serif font and is arranged to follow the curve of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 21, 2012
INVIVO CORP % Mr. Lance Aulabaugh Quality Engineer 3545 SW 47th Avenue Gainesville, FL 32608
Re: K122897
Trade/Device Name:
SENSE Head-Spine-Torso MR Coil System: SENSE Head 16 SENSE Spine 16 SENSE Torso 16
Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: December 6, 2012 Received: December 7, 2012
Dear Mr. Aulabaugh:
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. Iisting 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 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
4
Page 2 - [Contact Person's Name]
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris -S
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
5
510(k) Number (if known): K122897
Device Name: SENSE Head 16, SENSE Spine 16, SENSE Torso 16
Indications for Use: The coils are indicated for use on the order of a physician, in conjunction with Philips 1.5T MR scanners as accessories to produce images of the head, spine and torso.
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)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Janine M. Morris -S 2012.12.21 16:26:13 -05'00'
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K122897 510(k):
Section 004 Page 1 of 1