(84 days)
Not Found
No
The summary describes passive MR coils and their physical characteristics, with no mention of software, algorithms, or data processing that would indicate AI/ML. The interpretation of images is explicitly stated to be done by a trained physician.
No.
The device is used to produce diagnostic images, meaning its purpose is diagnosis rather than therapy.
Yes
The device is described as "designed to be used in conjunction with MR Scanner to produce diagnostic images," and a "trained physician interprets the diagnostic images." This indicates its role in the diagnostic process.
No
The device description explicitly details the physical components of the MR coils, including foam, flexible PCB, EVA, feed-board boxes, cable housing, and connectors. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a Magnetic Resonance (MR) coil. Its function is to be used with an MR scanner to produce diagnostic images of the anatomy. It does not perform tests on samples taken from the body.
- Intended Use: The intended use is to produce diagnostic images that are interpreted by a physician. This is a function of an imaging device, not an IVD.
Therefore, the device described is an imaging accessory used in conjunction with an MR scanner, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Magnetic Resonance (MR) coil is used with a Philips 1.5T MR scanner. A trained physician interprets the diagnostic images (of the anatomy of interest) produced.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T are designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
The proposed dS TorsoCardiac 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of torso, cardiac, and neck. 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 dS MSK S 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of wrist, foot-ankle, and elbow. 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, EVA 30 foam, and PU foil (inner surface). A few parts, 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 dS MSK M 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of shoulder, knee, hip, foot, and elbow. 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, EVA30 foam, and PU foil (inner surface). A few parts, 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 dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T are designed to be used with the Philips 1.5T MRI Scanners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Torso, cardiac, neck, wrist, foot-ankle, elbow, shoulder, knee, hip, foot.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician interprets the diagnostic images. Prescription Use (Part 21 CFR 801 Subpart D).
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)
Non-clinical performance testing was conducted. The devices comply with international and FDA-recognized consensus standards including AAMI / ANSI ES60601-1, IEC60601-2-33, IEC60601-1-2, ISO 14971, IEC 62366, NEMA MS 1, NEMA MS 3, NEMA MS 9, and NEMA MS 14. These tests demonstrated that the devices met acceptance criteria and are adequate for their intended use. No clinical data was required.
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
December 1, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Philips Healthcare (Suzhou) Co., Ltd. % Seaman Shao Associate Regulatory Affairs Manager No.258, ZhongYuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA
Re: K212864
Trade/Device Name: dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: August 26, 2021 Received: September 8, 2021
Dear Seaman Shao:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212864
Device Name
dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T
Indications for Use (Describe)
The Magnetic Resonance (MR) coil is used with a Philips 1.5T MR scanner. A trained physician interprets the diagnostic images (of the anatomy of interest) produced.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | August 26, 2021 |
|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. |
| No. 258, ZhongYuan Road, Suzhou Industrial Park, | |
| Suzhou Jiangsu, CHINA, 215024 | |
| Establishment Registration Number: 3009529630 | |
| Primary | |
| Contact Person: | Seaman Shao |
| Associate Regulatory Affairs Manager | |
| Phone: +86-13913116320 | |
| E-mail: seaman.shao@philips.com | |
| Secondary | |
| Contact Person | Erhong Wang |
| Senior Regulatory Affairs Manager | |
| Phone: +86-13021019589 | |
| E-mail: erhong.wang@philips.com | |
| Device Name: | dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T |
| Classification: | Classification Name: Magnetic resonance diagnostic device |
| Classification | |
| Regulation: 21CFR §892.1000 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Primary Product code: MOS | |
| Primary | |
| Predicate | |
| Device: | Trade Name: (1) SENSE Torso 16 |
| (2) SENSE MSK S 8CH 1.5T | |
| (3) 1.5T 8-CHANNEL MEDIUM GENERAL | |
| PURPOSE FLEX COIL | |
| Manufacturer: Invivo Corporation | |
| 510(k) Clearance: (1) K122897, 21-12-2012 | |
| (2) K120122, 10-02-2012 | |
| (3) K111673, 23-12-2011 |
4
| Classification Regulation: | 21CFR §892.1000 |
|---|---|
| Classification Name: | Magnetic resonance diagnostic device |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Product Code: | MOS |
Device The proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T description: are designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
The proposed dS TorsoCardiac 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of torso, cardiac, and neck. 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 dS MSK S 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of wrist, foot-ankle, and elbow. 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, EVA 30 foam, and PU foil (inner surface). A few parts, 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 dS MSK M 1.5T is a phased array receive-only coil for high resolution diagnostic imaging of shoulder, knee, hip, foot, and elbow. 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, EVA30 foam, and PU foil (inner surface). A few parts, feed-board boxes, cable housing and a small connector placed across
5
| 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 dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T are designed to be used with the Philips 1.5T MRI Scanners. | |
| Indications for Use: | The indications for use for the proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T are as follows: |
| The Magnetic Resonance (MR) coil is used with a Philips 1.5T MR scanner. A trained physician interprets the diagnostic images (of the anatomy of interest) produced. | |
| Fundamental Scientific Technology: | The 510(k) summary contains a summary of the technological characteristics of the proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T compared to the predicate devices |
| Attribute | Predicate Device,
SENSE Torso 16 | Proposed dS TorsoCardiac 1.5T |
|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental Scientific Technology | | |
| Type of coil | Phased-array Receive
only coil | Identical |
| Magnetic
Field
Orientation
(B0) | Head-Feet oriented | Identical |
| Frequency
range | 63.87MHz+/-0.75MHz | Identical |
| Housing
Material | PC and PU | Identical |
| Decoupling
method | Overlap, pre-amp
decouple, Active/Passive
PIN diode decoupling | Identical |
| Energy
source | Derived from MR
scanner, no internal
energy source | Identical |
| Workflow to
support the
connection
and signal
transmission
between the
coil and MR
system | The coil cable connects
to MR system tabletop
via coaxial and DC pins
mixed analogue
connector to fit any
intended coil position on
tabletop according to the
needs of MR scan. | The coil cable connects to
dS Interface S 1.5T or dS
Interface L 1.5T, which is
connected into DCI of MR
system tabletop, via a DCI
connector with coaxial
pins to fit any intended
coil position on tabletop
according to the needs of
MR scan.
No impact to device safety
and effectiveness since it
only provides a better
workflow. |
| Flexibility of
coil to ensure
well fit to
patient body | The coil foam is
composed of PU foil,
flexible PCBA and EVA
to provide sufficient
flexibility along the Left-
Right direction for
patient body scan,
whereas it is rigid in
Head-Feet direction due
to the existing of long
rigid PCBAs and baluns
along this direction. | The coil foam is composed
of PU foil, flexible PCBA
and EVA to provide
sufficient flexibility along
the Left-Right direction
for patient body scan, and
the coil offers a degree of
flexibility along the Head-
Feet direction since the
baluns are moved to the
coil cable and the size of
rigid PCBAs are
decreased.
No impact to device safety
and effectiveness since it |
| | | only provides a better
flexibility and workflow. |
| | | |
| Easily
removeable
structure to
support the
serviceability
of coil | The baluns and one of
rigid PCBA are
centralized in the middle
of coil, and a removeable
plastic cover is designed
to cover them, whereas
the other rigid PCBAs
can be repaired or
replaced only after the
entire coil foam is
disassembled. | All rigid PCBAs are
placed at the left and right
side of coil, and two
removeable plastic covers
are designed to cover
them, meanwhile the
baluns are covered by
plastic housings in the coil
cable, and they can be also
repaired or replaced by
removing housings.
No impact to device safety
and effectiveness since it
only provides a better
serviceability. |
6
7
| Attribute | Predicate Device,
SENSE MSK S 8CH 1.5T | Proposed dS MSK S 1.5T |
|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental Scientific Technology | | |
| Type of coil | Phased-array Receive
only coil | Identical |
| Magnetic
Field
Orientation
(B0) | Head-Feet oriented | Identical |
| Frequency
range | 63.87MHz+/-0.75MHz | Identical |
| Housing
Material | PC and PU | Identical |
| Decoupling
method | Overlap, pre-amp
decouple, Active/Passive
PIN diode decoupling | Identical |
| Energy
source | Derived from MR
scanner, no internal
energy source | Identical |
| Workflow to
support the
connection
and signal
transmission
between the
coil and MR
system | The coil cable connects
to MR system tabletop
via coaxial and DC pins
mixed analogue
connector to fit any
intended coil position on
tabletop according to the
needs of MR scan. | The coil cable connects to
dS Interface S 1.5T or dS
Interface L 1.5T, which is
connected into DCI of MR
system tabletop, via a DCI
connector with coaxial
pins to fit any intended
coil position on tabletop
according to the needs of
MR scan.
No impact to device safety
and effectiveness since it
only provides a better
workflow. |
| Flexibility of
coil to ensure
well fit to
patient body | The coil foam is
composed of PU foil,
flexible PCBA and EVA
to provide sufficient
flexibility along the Left-
Right direction for
patient body scan,
whereas it is rigid in
Head-Feet direction due
to the existing of long
rigid PCBAs and baluns
along this direction. | The coil foam is composed
of PU foil, flexible PCBA
and EVA to provide
sufficient flexibility along
the Left-Right direction
for patient body scan, and
the coil offers a degree of
flexibility along the Head-
Feet direction since the
baluns are moved to the
coil cable and the size of
rigid PCBAs are decreased
significantly. |
| | | |
| No impact to device safety
and effectiveness since it
only provides a better
flexibility and workflow. | | |
8
9
| Attribute | Predicate Device,
1.5T 8-CHANNEL MEDIUM
GENERAL PURPOSE FLEX COIL | Proposed dS MSK M 1.5T |
|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental Scientific Technology | | |
| Type of coil | Phased-array Receive
only coil | Identical |
| Magnetic
Field
Orientation
(B0) | Head-Feet oriented | Identical |
| Frequency
range | 63.87MHz+/-0.75MHz | Identical |
| Housing
Material | PC and PU | Identical |
| Decoupling
method | Overlap, pre-amp
decouple, Active/Passive
PIN diode decoupling | Identical |
| Energy
source | Derived from MR
scanner, no internal
energy source | Identical |
| Workflow to
support the
connection
and signal
transmission
between the
coil and MR
system | The coil cable connects
to MR system tabletop
via coaxial and DC pins
mixed analogue
connector to fit any
intended coil position on
tabletop according to the
needs of MR scan. | The coil cable connects to
dS Interface S 1.5T or dS
Interface L 1.5T, which is
connected into DCI of MR
system tabletop, via a DCI
connector with coaxial
pins to fit any intended
coil position on tabletop
according to the needs of
MR scan.
No impact to device safety
and effectiveness since it
only provides a better
workflow. |
| Flexibility of
coil to ensure
well fit to
patient body | The coil foam is
composed of PU foil,
flexible PCBA and EVA
to provide sufficient
flexibility along the Left-
Right direction for
patient body scan,
whereas it is rigid in
Head-Feet direction due
to the existing of long
rigid PCBAs and baluns
along this direction. | The coil foam is composed
of PU foil, flexible PCBA
and EVA to provide
sufficient flexibility along
the Left-Right direction
for patient body scan, and
the coil offers a degree of
flexibility along the Head-
Feet direction since the
baluns are moved to the
coil cable and the size of
rigid PCBAs are decreased
significantly.
No impact to device safety
and effectiveness since it |
10
11
| | | | only provides a better
flexibility and workflow. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------|
| Based on the information provided above, dS TorsoCardiac 1.5T is
considered substantially equivalent to the primary currently marketed and
predicate device SENSE Torso 16 (K122897, 21-12-2012) in terms of
fundamental scientific technology
Based on the information provided above, dS MSK S 1.5T is considered
substantially equivalent to the primary currently marketed and predicate
device SENSE MSK S 8CH 1.5T (K120122, 10-02-2012) in terms of
fundamental scientific technology
Based on the information provided above, dS MSK M 1.5T is considered
substantially equivalent to the primary currently marketed and predicate
device 1.5T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
(K111673, 23-12-2011) in terms of fundamental scientific technology | | | |
| Summary of
Non-Clinical
Performance
Data: | The proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T
complies with the following international and FDA-recognized consensus
standards:
AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,
C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated Text)
Medical Electrical Equipment - Part 1: General Requirements. For
Basic Safety And Essential Performance (IEC 60601-1:2012,
MOD)
FDA/CDRH recognition number 19-4 IEC60601-2-33 Ed. 3.2:2015 Medical electrical equipment - Part 2-
33: Particular requirements for the basic safety and essential
performance of magnetic resonance equipment for medical
diagnosis
FDA/CDRH recognition number 12-295 IEC60601-1-2 Ed. 4.0:2014 Medical electrical equipment - Part 1-
2: General requirements for basic safety and essential performance
- Collateral standard: Electromagnetic disturbances - Requirements
and tests
FDA/CDRH recognition number 19-8 ISO 14971 Ed. 2.0:2007 Medical devices – Application of risk
management to medical devices.
FDA/CDRH recognition number 5-40. | | |
12
- Magnetic Resonance (MR) Receive only Coil Performance ● Criteria for Safety and Performance Based Pathway - issued on December 11, 2020
- . Guidance for Industry and FDA Staff - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" (issued June 16, 2016 - document number 1811)
- IEC 62366 Edition 1.1: 2014-01 Medical devices Application of . usability engineering to medical devices FDA/CDRH recognition number 5-87
- NEMA MS 1-2008(R2020) ● Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
- NEMA MS 3-2008 (R2020) ● Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- . NEMA MS 9-2008 (R2020) Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
- NEMA MS 14-2019 Characterization of Radiofrequency (RF) Coil . Heating in Magnetic Resonance Imaging Systems
There are no risks identified in risk management documentation that require clinical data for the purpose of clinical evaluation: Risk Management Plan as Appendix 001, Risk Management Report as Appendix 002, and Risk Management Matrix as Appendix 003 of dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T.
Sufficient evidence is available to demonstrate the ability of dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T achieve the intended performances during normal condition of use;
Full consistency exists between the state-of-the-art, the evaluated data, the risk management documentation and the information materials supplied.
Therefore, the proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T are substantially equivalent to the primary currently marketed and predicate device SENSE Torso 16 (K122897, 21-12-2012), SENSE MSK S 8CH 1.5T (K120122, 10-02-2012) and 1.5T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL (K111673, 23-12-2011) in terms of safety and effectiveness.
13
The proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T Summary of Clinical Data: do not require clinical study since substantial equivalence to the predicate device was demonstrated with the following attributes:
- . Design features.
- . Fundamental scientific technology
- Indications for use; ●
- Safetv and effectiveness ●
- Non-clinical performance testing; .