(56 days)
Not Found
No
The description focuses on the physical design and function of the MR coils for signal reception, with image processing occurring on the main MRI system. There is no mention of AI/ML in the device description, intended use, or performance studies.
No.
The device is described as producing "diagnostic images" to "assist diagnosis and therapy planning," and "not require clinical study since substantial equivalence to the legally marketed predicate device was proven in the comparison in terms of safety and effectiveness." This indicates its purpose is for diagnosis and information gathering, not for direct therapeutic intervention or treatment.
Yes
The device is described as producing "diagnostic images" that can be "interpreted by a trained physician" to "assist diagnosis and therapy planning." The text explicitly states that the images have "sufficient quality for diagnostic use."
No
The device description explicitly details the physical components of the coils, including PU foil, flexible PCB, EVA foam, feed-board boxes, cable housing, and connectors. These are hardware components, not software. While the device interacts with an MR system that processes signals into images (which involves software), the device itself is a physical coil.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body). The Smart Fit TorsoCardiac and Smart Fit Shoulder coils are components of an MRI system that produce images of the internal structure of the body in vivo (within the body).
- The intended use is to produce diagnostic images. While these images are used for diagnosis, the device itself is not performing a test on a biological sample. It's a tool for capturing visual information about the body's internal structures.
- The device description clearly outlines its function as a receive-only coil for an MRI system. This is consistent with imaging devices, not IVDs.
Therefore, the Smart Fit TorsoCardiac and Smart Fit Shoulder coils are considered medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Smart Fit TorsoCardiac 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the torso (including chest, abdomen, pelvis), head and neck and heart that can be interpreted by a trained physician.
The Smart Fit Shoulder 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the Shoulder that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The proposed of Smart Fit Shoulder 1.5T and Smart Fit TorsoCardiac 1.5T are intended to be used in conjunction with a Philips MR-system to enable trained physicians to obtain cross-sectional images of the internal structure of the head, body, or extremities, in any orientation. These images, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning.
The proposed Smart Fit Torsocardiac 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of the torso (including chest, abdomen, pelvis), head and neck and heart. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil and PU foil (inner surface). The foam looks flat at the top surface. A few parts, two feed- board boxes, cable housing and a small connector placed across the central Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body.
The proposed Smart Fit Shoulder 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of shoulder. The coil foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Anterior-Posterior direction for patient shoulder scan. The layers from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil, EVA 30 foam, and PU foil (inner surface). A few parts, feed-board boxes, cable housing and a small connector placed across the Head-Feet axis are also at the outer surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Torso (including chest, abdomen, pelvis), head and neck, and heart (for Smart Fit TorsoCardiac 1.5T).
Shoulder (for Smart Fit Shoulder 1.5T).
Indicated Patient Age Range
Philips Rx coils are intended for any patient who requires an MR examination, and for whom the use of the coil provides an additional diagnostic benefit (in terms of Field of View or Signal-to-noise ratio) according to the clinical user. Exceptions to admissible patients relate to their physical characteristics (circumference, mass) in relation to coil dimensions.
(Predicate: Philips MR systems are designed to create images of the head, body or extremities of any patient (prenatal to geriatric) referred to an MR study by a trained physician.)
Intended User / Care Setting
Trained physician / Not Specified
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)
The performance test results demonstrate that the proposed Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T meets the acceptance criteria and adequate for its intended use. Additionally, the risk management activities show that all risks are sufficiently mitigated, that no new risks are.
The proposed Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T did not require clinical study since substantial equivalence to the legally marketed predicate device was proven in the comparison in terms of safety and effectiveness.
All clinical images on the proposed coils Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T were evaluated by qualified radiologists. No issues with the clinical image quality was seen and images were considered have sufficient quality for diagnostic use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
September 1, 2023
Philips Healthcare (Suzhou) Co., Ltd. % Li Sherry Regulatory Affairs Specialist No. 258, Zhongyuan Road Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA
Re: K232021
Trade/Device Name: Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: June 12, 2023 Received: July 7, 2023
Dear Li Sherry:
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
1
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); 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 (QS) 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 medical devices and radiation-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,
D
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
Indications for Use (Describe)
The Smart Fit TorsoCardiac 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the torso (including chest, abdomen, pelvis), head and neck and heart that can be interpreted by a trained physician.
The Smart Fit Shoulder 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR system to produce diagnostic images of the Shoulder that can be interpreted by a trained physician.
Type of Use (Select one or both, as applicable)
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."
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510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92(c)]
| [As required by 21 CFR 807.92(c)] | ||||
|---|---|---|---|---|
| Date | ||||
| Prepared: | July 04, 2023 | |||
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | |||
| No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou Jiangsu, CHINA, 215024 | ||||
| Establishment Registration Number: 3009529630 | ||||
| Primary | ||||
| Contact | ||||
| Person: | Sherry Li | |||
| Regulatory Affairs Specialist | ||||
| Phone: +86-17849535031 | ||||
| E-mail: sherry.li@philips.com | ||||
| Secondary | ||||
| Contact | ||||
| Person | Erhong Wang | |||
| Senior Manager Regulatory Affairs | ||||
| Phone: +86-512-67336804 | ||||
| E-mail: erhong.wang@philips.com | ||||
| Device Name: | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | |||
| Classification: | Classification name: | Magnetic Resonance Diagnostic Device | ||
| Classification Regulation: | 21CFR 892.1000 | |||
| Classification Panel: | Magnetic Resonance Diagnostic Device | |||
| Device Class: | Class II | |||
| Primary Product Code: | MOS | |||
| Predicate | ||||
| Device for | ||||
| Smart Fit | ||||
| TorsoCardiac | ||||
| 1.5T | Trade name: | dS TorsoCardiac 1.5T | ||
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. | |||
| 510(k) Clearance: | K212864 | |||
| Classification Regulation: | 21CFR 892.1000 | |||
| Classification name: | Magnetic Resonance Diagnostic Device | |||
| Classification Panel: | Radiology | |||
| Device class | ||||
| Product Code: | Class II | |||
| MOS | ||||
| Predicate | ||||
| Device for | ||||
| Smart Fit | ||||
| Shoulder 1.5T | Trade name: | 1.5T 16 CH GE Shoulder Coils | ||
| Manufacturer: | InVivo Corporation | |||
| 510(k) Clearance: | K162001 | |||
| Classification Regulation: | 21CFR 892.1000 | |||
| Classification name: | Magnetic Resonance Diagnostic Device | |||
| Classification Panel: | Radiology | |||
| Device class | ||||
| Product Code: | Class II | |||
| MOS | ||||
| Device | ||||
| Description: | The proposed of Smart Fit Shoulder 1.5T and Smart Fit TorsoCardiac 1.5T are intended to be used | |||
| in conjunction with a Philips MR-system to enable trained physicians to obtain cross-sectional | ||||
| images of the internal structure of the head, body, or extremities, in any orientation. These images, | ||||
| when interpreted by a trained physician, provide information that may assist diagnosis and therapy | ||||
| planning. |
The proposed Smart Fit Torsocardiac 1.5T is a phased array receive-only coil for high resolution
diagnostic imaging of the torso (including chest, abdomen, pelvis), head and neck and heart. The coil
foam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Right
direction for patient body scan. The layers from outside to patient side are: PU foil (outer surface),
EVA30 foam, PCBA of the coil and PU foil (inner surface). The foam looks flat at the top surface. A
few parts, two feed- board boxes, cable housing and a small connector placed across the central
Head-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slots
to fit well to the patient body.
The proposed Smart Fit Shoulder 1.5T is a phased array receive-only coil for high resolution
diagnostic imaging of shoulder. The coil foam is composed of PU foil, flexible PCB and EVA to
provide sufficient flexibility along Anterior-Posterior direction for patient shoulder scan. The layers
from outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil, EVA 30
foam, and PU foil (inner surface). A few parts, feed-board boxes, cable housing and a small connector placed across the Head-Feet axis are also at the outer surface. Inner surface is naturally flat and is bendable along slots to fit well to the patient body. | | | |
| Indications
for Use: | The Smart Fit TorsoCardiac 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR
system to produce diagnostic images of the torso (including chest, abdomen, pelvis), head and neck
and heart that can be interpreted by a trained physician.
The Smart Fit Shoulder 1.5T coil is designed to be used in conjunction with a Philips 1.5T MR
system to produce diagnostic images of the Shoulder that can be interpreted by a trained physician. | | | |
| Substantial
Equivalence: | The 510(k) summary contains a summary of the technological characteristics of the proposed Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T compared to the predicate devices dS TorsoCardiac 1.5T(K212864) and 1.5T 16CH GE Shoulder Coils(K162001). | | | |
| Table 1
Comparison of the primary currently marketed and predicate device, dS TorsoCardiac 1.5T versus the proposed Smart Fit TorsoCardiac 1.5T | | | | |
| Design features | Proposed Smart Fit TorsoCardiac 1.5T | Primary Currently Marketed and Predicate Device, dS TorsoCardiac 1.5T | Conclusion | |
| Appearance | Image: Proposed Smart Fit TorsoCardiac 1.5T | Image: Primary Currently Marketed and Predicate Device, dS TorsoCardiac 1.5T | Similar.
The differences
in appearance
between
products are not
expected to
trigger a clinically
significant
difference in
clinical
performance or
safety of the
device. | |
| Coil
Dimensions
Length X
Width X
Height | LXWXH = 602 X 554 X 25mm | LXWXH = 586 X 503 X 40mm | Similar.
The differences
in appearance
between
products are not
expected to
trigger a clinically
significant
difference in
clinical
performance or
safety of the
device. | |
| Type of coil | Phased-array Receive only coil | Phased-array Receive only coil | Same. | |
| Number of
Channels /
Preamplifiers | Sixteen preamplifiers along the
cable and sixteen elements
distributed in four rows and four
columns | Eight preamplifiers inside the
coil foam and distributed in
two rows and four columns. | Similar.
The differences
in number of
channels and | |
| | | | | |
| | | distribution of
elements
between
products are not
expected to
trigger a clinically
significant
difference in
clinical
performance or
safety of the
device. | | |
| Coil Geometry
/ Housing
Design | Image: Coil Geometry Housing Design | Image: Coil Geometry Housing Design | Similar.
The differences
in distribution of
elements
between
products are not
expected to
trigger a clinically
significant
difference in
clinical
performance or
safety of the
device. | |
| System
Connector /
Compatibility
and coil
connector | Analogue connector mating face
with dS Interface S 1.5T or dS
Interface L 1.5T, which has a DCI
connector mating face with the
MR system. | Analogue connector mating
face with 16ch dS Interface
Box (dS Interface S 1.5T or dS
Interface L 1.5T) which has a
DCI connector mating face
with the MR system. | Same | |
| Application
site / body
part | Torso (incl. chest, abdomen,
pelvis), head and neck, and
heart | Thorax, abdomen, pelvis,
cardiac imaging, peripheral
vascular imaging, long bones. | Same.
Anatomies that
can be imaged
with the Smart
Fit TorsoCardiac
can also be
imaged with the
equivalent
device. | |
| Patient
population | Philips Rx coils are intended for
any patient who requires an MR
examination, and for whom the
use of the coil provides an
additional diagnostic benefit (in
terms of Field of View or Signal- | Philips MR systems are
designed to create images of
the head, body or extremities
of any patient (prenatal to
geriatric) referred to an MR
study by a trained physician. | Same.
Although the
wording is
slightly different,
the meaning is | |
| | to-noise ratio) according to the
clinical user.
Exceptions to admissible
patients relate to their physical
characteristics (circumference,
mass) in relation to coil
dimensions. | Exceptions to admissible
patients relate to their
physical characteristics
(circumference, mass) in
relation to system capabilities
(magnet bore size: 60 cm or
70 cm; mechanical strength of
the patient support, allowing
150 kg or 250 kg) and taking
into account pre-screening
results and contraindications. | the same. The
wording for the
Smart Fit coils is
adapted such
that it is more
specific to coils.
No difference in
characteristics
between
products. | |
| Intended Use | | | | |
| Intended use | Philips Magnetic Resonance
(MR) Receive-only (Rx) coils are
intended to be used in
conjunction with a Philips MR-
system to enable trained
physicians to obtain cross-
sectional images of the internal
structure of the head, body, or
extremities, in any orientation.
These images, when interpreted
by a trained physician, provide
information that may assist
diagnosis and therapy planning. | The Magnetic Resonance (MR)
coil is used with an MR
scanner. A trained physician
interprets the diagnostic
images (of the anatomy of
interest) produced. | Same.
Although the
wording is
slightly different
the meaning is
the same. No
difference in
characteristics
between
products. | |
| | Fundamental Scientific Technology | | | |
| Type of coil | Phased-array Receive only coil | Phased-array Receive only coil | Same. | |
| Magnetic
Field
Orientation
(BO) | Head-Feet oriented | Head-Feet oriented | Same. | |
| Frequency
range | 63.87MHz+/-0.75MHz | 63.87MHz+/-0.75MHz | Same. | |
| Magnetic
Field
Orientation
(BO) | Head-Feet oriented | Head-Feet oriented | Same. | |
| Decoupling
method | Overlap, pre-amp decouple,
Active/Passive PIN diode
decoupling | Overlap, pre-amp decouple,
Active/Passive PIN diode
decoupling | Same. | |
| Energy source | Derived from MR scanner, no
internal energy source | Derived from MR scanner, no
internal energy source | Same. | |
| Base Pad | PCB | PCB | Same. | |
| Principle of
operation | The coil receives magnetic
resonance signals generated in
hydrogen nuclei (protons) in the
human body while blocking the
radio frequency magnetic field
applied by the MRI system at
specified timings. The received
signal is amplified and
transmitted to the MRI system,
where it is processed into
tomographic images by the
computer. | The coil receives magnetic
resonance signals generated
in hydrogen nuclei (protons)
in the human body while
blocking the radio frequency
magnetic field applied by the
MRI system at specified
timings. The received signal is
amplified and transmitted to
the MRI system, where it is
processed into tomographic
images by the computer. | Same. | |
| Critical
performance
requirements | Philips MR coils fulfill all
applicable IEC60601 and
IEC60601-2-33 requirements,
describing the safety and
essential performance
requirements for medical
devices in general and MR coil
specifically. | Philips MR coils fulfill all
applicable IEC60601 and
IEC60601-2-33 requirements,
describing the safety and
essential performance
requirements for medical
devices in general and MR coil
specifically. | Same. | |
| Biological characteristics | Philips MR RF Rx coils are non-invasive surface devices that are only in contact with covered and/or
intact patient skin with limited exposure (