(56 days)
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.
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.
The provided document is a 510(k) Summary of Safety and Effectiveness for Philips Healthcare's Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T MRI coils. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI/ML-driven device through a multi-reader, multi-case study.
Therefore, many of the requested details regarding acceptance criteria for an AI/ML device, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC studies are not applicable or explicitly mentioned in this document as it pertains to traditional medical device clearance rather than AI/ML software. The document asserts that "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."
However, I can extract the information that is present and indicate what is not applicable.
Acceptance Criteria and Device Performance (based on provided text, primarily regarding equivalence to predicate devices and general performance, not AI/ML specific metrics)
| Acceptance Criteria (Implied / General) | Reported Device Performance |
|---|---|
| Safety and Essential Performance | Complies with: - ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) - IEC60601-2-33 Ed. 3.2:2015 - IEC60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION - IEC60601-1-6 Edition 3.1:2013 - ISO 14971 Ed. 3:2019 - IEC 62366 Edition 1.1: 2020-06 CONSOLIDATED VERSION - ANSI AAMI ISO10993-1:2018 |
| Signal-to-Noise Ratio (SNR) | Meets acceptance criteria (implied by compliance with NEMA MS 1-2008(R2020)) |
| Image Uniformity | Meets acceptance criteria (implied by compliance with NEMA MS 3-2008 (R2020)) |
| Phased Array Coils Characterization | Meets acceptance criteria (implied by compliance with NEMA MS 9-2008 (R2020)) |
| RF Coil Heating | Meets acceptance criteria (implied by compliance with NEMA MS 14-2019) |
| Clinical Image Quality for Diagnostic Use | "No issues with the clinical image quality was seen and images were considered have sufficient quality for diagnostic use." |
| Biocompatibility | Biocompatibility testing against internal specifications and ISO10993-1 performed. "The safety of PC and PU has been proved in the biocompatibility report." |
| Risk Management | "all risks are sufficiently mitigated, that no new risks are" (sentence incomplete in document, but implies compliance/mitigation) |
| Substantial Equivalence | "considered substantially equivalent to the currently marketed and predicate devices" |
Study Information (based on provided text):
-
Sample sizes used for the test set and the data provenance:
- Test set sample size: Not explicitly stated as a distinct "test set" for performance evaluation in the context of an AI/ML algorithm (which is not this device). However, the document mentions "All clinical images on the proposed coils Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T were evaluated by qualified radiologists." This implies a set of clinical images used for evaluation. The number of images or patients is not provided.
- Data Provenance: Not specified (e.g., country of origin). The study is descriptive, focusing on demonstrating equivalence to predicates via technical characteristics, standards compliance, and subjective review of image quality rather than analyzing data from a specific patient cohort. The clinical image evaluation mentioned is a retrospective review of images generated by the new coils.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified beyond "qualified radiologists".
- Qualifications: "qualified radiologists". No specific years of experience or board certifications are detailed in this summary.
- Note: This is not an AI/ML device that generates a "ground truth" for classification or detection. The radiologists are evaluating the diagnostic quality of the images produced by the new coils.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. The document only states that images "were evaluated by qualified radiologists." It does not detail any consensus or adjudication process for image quality assessment.
-
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was NOT done. The document explicitly states: "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." MRMC studies are typically performed for AI/ML devices to assess reader performance with and without AI assistance; this device is an MRI coil, not an AI/ML algorithm.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no AI assistance is involved with these MRI coils, and no such study was performed.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is an MRI coil, which is a hardware component, not a standalone algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of an AI/ML algorithm generating diagnostic output. For this device (an MRI coil), the "ground truth" is implicitly tied to the expectation that the images produced are of sufficient diagnostic quality as determined by "qualified radiologists" (expert opinion on image quality) and meet established technical performance standards (NEMA, IEC, AAMI). There's no disease pathology ground truth being established/compared for an AI model.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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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
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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
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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)
< Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame.
510(k) Summary of Safety and Effectiveness
[As required by 21 CFR 807.92(c)]
| [As required by 21 CFR 807.92(c)] | ||||
|---|---|---|---|---|
| DatePrepared: | July 04, 2023 | |||
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd.No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou Jiangsu, CHINA, 215024Establishment Registration Number: 3009529630 | |||
| PrimaryContactPerson: | Sherry LiRegulatory Affairs SpecialistPhone: +86-17849535031E-mail: sherry.li@philips.com | |||
| SecondaryContactPerson | Erhong WangSenior Manager Regulatory AffairsPhone: +86-512-67336804E-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 | |||
| PredicateDevice forSmart FitTorsoCardiac1.5T | 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 classProduct Code: | Class IIMOS | |||
| PredicateDevice forSmart FitShoulder 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 classProduct Code: | Class IIMOS | |||
| DeviceDescription: | The proposed of Smart Fit Shoulder 1.5T and Smart Fit TorsoCardiac 1.5T are intended to be usedin conjunction with a Philips MR-system to enable trained physicians to obtain cross-sectionalimages 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 therapyplanning.The proposed Smart Fit Torsocardiac 1.5T is a phased array receive-only coil for high resolutiondiagnostic imaging of the torso (including chest, abdomen, pelvis), head and neck and heart. The coilfoam is composed of PU foil, flexible PCB and EVA to provide sufficient flexibility along Left-Rightdirection 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. Afew parts, two feed- board boxes, cable housing and a small connector placed across the centralHead-Feet axis are also at the top surface. Inner surface is naturally flat and is bendable along slotsto fit well to the patient body.The proposed Smart Fit Shoulder 1.5T is a phased array receive-only coil for high resolutiondiagnostic imaging of shoulder. The coil foam is composed of PU foil, flexible PCB and EVA toprovide sufficient flexibility along Anterior-Posterior direction for patient shoulder scan. The layersfrom outside to patient side are: PU foil (outer surface), EVA30 foam, PCBA of the coil, EVA 30foam, 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. | |||
| Indicationsfor Use: | The Smart Fit TorsoCardiac 1.5T coil is designed to be used in conjunction with a Philips 1.5T MRsystem to produce diagnostic images of the torso (including chest, abdomen, pelvis), head and neckand 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 MRsystem to produce diagnostic images of the Shoulder that can be interpreted by a trained physician. | |||
| SubstantialEquivalence: | 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 1Comparison 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 differencesin appearancebetweenproducts are notexpected totrigger a clinicallysignificantdifference inclinicalperformance orsafety of thedevice. | |
| CoilDimensionsLength XWidth XHeight | LXWXH = 602 X 554 X 25mm | LXWXH = 586 X 503 X 40mm | Similar.The differencesin appearancebetweenproducts are notexpected totrigger a clinicallysignificantdifference inclinicalperformance orsafety of thedevice. | |
| Type of coil | Phased-array Receive only coil | Phased-array Receive only coil | Same. | |
| Number ofChannels /Preamplifiers | Sixteen preamplifiers along thecable and sixteen elementsdistributed in four rows and fourcolumns | Eight preamplifiers inside thecoil foam and distributed intwo rows and four columns. | Similar.The differencesin number ofchannels and | |
| distribution ofelementsbetweenproducts are notexpected totrigger a clinicallysignificantdifference inclinicalperformance orsafety of thedevice. | ||||
| Coil Geometry/ HousingDesign | Image: Coil Geometry Housing Design | Image: Coil Geometry Housing Design | Similar.The differencesin distribution ofelementsbetweenproducts are notexpected totrigger a clinicallysignificantdifference inclinicalperformance orsafety of thedevice. | |
| SystemConnector /Compatibilityand coilconnector | Analogue connector mating facewith dS Interface S 1.5T or dSInterface L 1.5T, which has a DCIconnector mating face with theMR system. | Analogue connector matingface with 16ch dS InterfaceBox (dS Interface S 1.5T or dSInterface L 1.5T) which has aDCI connector mating facewith the MR system. | Same | |
| Applicationsite / bodypart | Torso (incl. chest, abdomen,pelvis), head and neck, andheart | Thorax, abdomen, pelvis,cardiac imaging, peripheralvascular imaging, long bones. | Same.Anatomies thatcan be imagedwith the SmartFit TorsoCardiaccan also beimaged with theequivalentdevice. | |
| Patientpopulation | Philips Rx coils are intended forany patient who requires an MRexamination, and for whom theuse of the coil provides anadditional diagnostic benefit (interms of Field of View or Signal- | Philips MR systems aredesigned to create images ofthe head, body or extremitiesof any patient (prenatal togeriatric) referred to an MRstudy by a trained physician. | Same.Although thewording isslightly different,the meaning is | |
| to-noise ratio) according to theclinical user.Exceptions to admissiblepatients relate to their physicalcharacteristics (circumference,mass) in relation to coildimensions. | Exceptions to admissiblepatients relate to theirphysical characteristics(circumference, mass) inrelation to system capabilities(magnet bore size: 60 cm or70 cm; mechanical strength ofthe patient support, allowing150 kg or 250 kg) and takinginto account pre-screeningresults and contraindications. | the same. Thewording for theSmart Fit coils isadapted suchthat it is morespecific to coils.No difference incharacteristicsbetweenproducts. | ||
| Intended Use | ||||
| Intended use | Philips Magnetic Resonance(MR) Receive-only (Rx) coils areintended to be used inconjunction with a Philips MR-system to enable trainedphysicians to obtain cross-sectional images of the internalstructure of the head, body, orextremities, in any orientation.These images, when interpretedby a trained physician, provideinformation that may assistdiagnosis and therapy planning. | The Magnetic Resonance (MR)coil is used with an MRscanner. A trained physicianinterprets the diagnosticimages (of the anatomy ofinterest) produced. | Same.Although thewording isslightly differentthe meaning isthe same. Nodifference incharacteristicsbetweenproducts. | |
| Fundamental Scientific Technology | ||||
| Type of coil | Phased-array Receive only coil | Phased-array Receive only coil | Same. | |
| MagneticFieldOrientation(BO) | Head-Feet oriented | Head-Feet oriented | Same. | |
| Frequencyrange | 63.87MHz+/-0.75MHz | 63.87MHz+/-0.75MHz | Same. | |
| MagneticFieldOrientation(BO) | Head-Feet oriented | Head-Feet oriented | Same. | |
| Decouplingmethod | Overlap, pre-amp decouple,Active/Passive PIN diodedecoupling | Overlap, pre-amp decouple,Active/Passive PIN diodedecoupling | Same. | |
| Energy source | Derived from MR scanner, nointernal energy source | Derived from MR scanner, nointernal energy source | Same. | |
| Base Pad | PCB | PCB | Same. | |
| Principle ofoperation | The coil receives magneticresonance signals generated inhydrogen nuclei (protons) in thehuman body while blocking theradio frequency magnetic fieldapplied by the MRI system atspecified timings. The receivedsignal is amplified andtransmitted to the MRI system,where it is processed intotomographic images by thecomputer. | The coil receives magneticresonance signals generatedin hydrogen nuclei (protons)in the human body whileblocking the radio frequencymagnetic field applied by theMRI system at specifiedtimings. The received signal isamplified and transmitted tothe MRI system, where it isprocessed into tomographicimages by the computer. | Same. | |
| Criticalperformancerequirements | Philips MR coils fulfill allapplicable IEC60601 andIEC60601-2-33 requirements,describing the safety andessential performancerequirements for medicaldevices in general and MR coilspecifically. | Philips MR coils fulfill allapplicable IEC60601 andIEC60601-2-33 requirements,describing the safety andessential performancerequirements for medicaldevices in general and MR coilspecifically. | Same. | |
| Biological characteristics | Philips MR RF Rx coils are non-invasive surface devices that are only in contact with covered and/orintact patient skin with limited exposure (<24h). Biocompatibility testing against internal specificationsand requirements of the ISO10993-1 has been performed. Further details can be found in theBiocompatibility Report. | |||
| Materials orsubstances incontact withwhich humantissues orbody fluids* | Intact skin | Intact skin | Same | |
| Kind andduration ofcontact withwhich humantissues orbody fluids | coils are only in contact withcovered and/or intact skin withlimited exposure < 24h | coils are only in contact withcovered and/or intact skinwith limited exposure < 24h | Same | |
| Releasecharacteristicsof substances,includingdegradationproducts andleachables | Due to the nature of bodycontact of Rx coils, degradationis not considered arecommended endpoint forconsideration ofbiocompatibility. | Due to the nature of bodycontact of Rx coils,degradation is not considereda recommended endpoint forconsideration ofbiocompatibility. | Same | |
| Table 2 | ||||
| Comparison of the primary currently marketed and predicate device, 1.5T 16CH GE Shoulder Coils versus the proposed Smart Fit Shoulder 1.5T | ||||
| Design features | Proposed Smart Fit TorsoCardiac 1.5T | Primary Currently Marketed and Predicate Device, 1.5T 16CH GE Shoulder Coils | Conclusion | |
| Appearance | Image: Proposed Smart Fit TorsoCardiac 1.5T | Image: Primary Currently Marketed and Predicate Device, 1.5T 16CH GE Shoulder Coils | Similar.The differences in appearance between products are not expected to trigger a clinically significant difference in clinical performance or safety of the device. | |
| CoilDimensionsLength XWidth XHeight | LR direction: 160mmHF direction: 240mmAP direction: 260mm | LR direction: 160mmHF direction: 240mmAP direction: 230mm | 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 ofChannels /Preamplifiers | Sixteen preamplifiers inside the coil foam and symmetrical structure of both wings. There are 6 elements in each wing, and 4 elements arrayed in the middle of the coil. | Sixteen preamplifiers inside the coil foam and 16 elements distributed in top and bottom. | Similar.The differences in distribution of preamplifiers and 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 | Location of elementsAnterior Feed: | Similar.The differences in | |
| Image: Posterior Feed, top view | Image: Posterior Feed, bottom view | distribution of elementsbetween products arenot expected to triggera clinically significantdifference in clinicalperformance or safetyof the device. | ||
| SystemConnector /Compatibilityand coilconnector | Analogue connector mating facewith dS Interface S 1.5T or dSInterface L 1.5T, which has a DCIconnector mating face with theMR system. | Connector mating face with dStreaminterface 1.5T which has a DCIconnector mating with the MRsystem. | Similar.To be compatible withdifferent MRI systems.The difference insystemconnector/compatibilityand coil connectorbetween products arenot expected to triggera clinically significantdifference in clinicalperformance or safetyof the device. | |
| Applicationsite / bodypart | Shoulder | Shoulder | Same. | |
| Patientpopulation | Philips Rx coils are intended forany patient who requires an MRexamination, and for whom theuse of the coil provides anadditional diagnostic benefit (interms of Field of View or Signal-to-noise ratio) according to theclinical user.Exceptions to admissible patientsrelate to their physicalcharacteristics (circumference,mass) in relation to coildimensions. | Philips MR systems are designed tocreate images of the head, body orextremities of any patient (prenatalto geriatric) referred to an MR studyby a trained physician.Exceptions to admissible patientsrelate to their physical characteristics(circumference, mass) in relation tosystem capabilities (magnet bore size:60 cm or 70 cm; mechanical strengthof the patient support, allowing 150kg or 250 kg) and taking into accountpre-screening results andcontraindications. | Same.Although the wording isslightly different, themeaning is the same.The wording for theSmart Fit coils isadapted such that it ismore specific to coils.No difference incharacteristics betweenproducts. | |
| Intended Use | ||||
| Intended use | Philips Magnetic Resonance (MR)Receive-only (Rx) coils areintended to be used in conjunctionwith a Philips MR-system to enabletrained physicians to obtain cross-sectional images of the internalstructure of the head, body, orextremities, in any orientation.These images, when interpretedby a trained physician, provideinformation that may assistdiagnosis and therapy planning. | The 16 Channel Shoulder Coil is to beused in conjunction with MagneticResonance Scanners to producediagnostic images of the shoulderthat can be interpreted by a trainedphysician. | Same.Although the scope ofintended use ofproposed device lookslarger than predicatedevice, the specificanatomical location isonly the shoulder.Details can be found inthe Indications for Useof proposed device. | |
| (Indications for Use:The Smart Fit Shoulder 1.5T coil isdesigned to be used in conjunctionwith a Philips 1.5T MR system toproduce diagnostic images of theShoulder that can be interpretedby a trained physician.) | ||||
| Fundamental Scientific Technology | ||||
| Type of coil | Phased-array Receive only coil | Phased-array Receive only coil | Same. | |
| MagneticFieldOrientation(BO) | Head-Feet oriented | Head-Feet oriented | Same. | |
| Frequencyrange | $63.87MHz+/-0.75MHz$ | $63.87MHz+/-0.75MHz$ | Same. | |
| MagneticFieldOrientation(B0) | Head-Feet oriented | Head-Feet oriented | Same. | |
| Decouplingmethod | Overlap, pre-amp decouple,Active/Passive PIN diodedecoupling | Overlap, pre-amp decouple,Active/Passive PIN diode decoupling | Same. | |
| Energy source | Derived from MR scanner, nointernal energy source | Derived from MR scanner, nointernal energy source | Same. | |
| HousingMaterial | PC and PU for Smart Fit Shoulder1.5T | PC only for 1.5T 16CH GE ShoulderCoils | Similar.The difference inmaterials betweenproducts are notexpected to trigger aclinically significantdifference in clinicalperformance or safety | |
| of the device. Thesafety of PC and PU hasbeen proved in thebiocompatibility report. | ||||
| Base Pad | PCB | PCB | Same. | |
| Principle ofoperation | The coil receives magneticresonance signals generated inhydrogen nuclei (protons) in thehuman body while blocking theradio frequency magnetic fieldapplied by the MRI system atspecified timings. The receivedsignal is amplified and transmittedto the MRI system, where it isprocessed into tomographicimages by the computer. | The coil receives magnetic resonancesignals generated in hydrogen nuclei(protons) in the human body whileblocking the radio frequencymagnetic field applied by the MRIsystem at specified timings. Thereceived signal is amplified andtransmitted to the MRI system,where it is processed intotomographic images by thecomputer. | Same. | |
| Criticalperformancerequirements | Philips MR coils fulfill all applicableIEC60601 and IEC60601-2-33requirements, describing thesafety and essential performancerequirements for medical devicesin general and MR coil specifically. | Philips MR coils fulfill all applicableIEC60601 and IEC60601-2-33requirements, describing the safetyand essential performancerequirements for medical devices ingeneral and MR coil specifically. | Same. | |
| Biological characteristicsPhilips MR RF Rx coils are non-invasive surface devices that are only in contact with covered and/or intact patient skinwith limited exposure (<24h). Biocompatibility testing against internal specifications and requirements of theISO10993-1 has been performed. Further details can be found in the Biocompatibility Report. | ||||
| Materials orsubstances incontact withwhich humantissues orbody fluids* | Intact skin | Intact skin | Same | |
| Kind andduration ofcontact withwhich humantissues orbody fluids | coils are only in contact withcovered and/or intact skin withlimited exposure < 24h | coils are only in contact with coveredand/or intact skin with limitedexposure < 24h | Same | |
| Releasecharacteristicsof substances,includingdegradationproducts andleachables | Due to the nature of body contactof Rx coils, degradation is notconsidered a recommendedendpoint for consideration ofbiocompatibility. | Due to the nature of body contact ofRx coils, degradation is notconsidered a recommended endpointfor consideration of biocompatibility. | Same | |
| * The characteristic must be the same for the demonstration of equivalence |
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Based on the information provided above, Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T are considered substantiall equivalent to the primary currently marketed and predicate device dS TorsoCardiac 1.5T(K212864) and 1.5T 16CH GE Shoulder Coils(K162001). Summary of The proposed Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T complies with the following international and FDA-recognized consensus standards: Non-Clinical Performance Data: ● ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021|Medical electrical equipment - Part 1: General requirements for basic safety and essential performance FDA/CDRH recognition number 19-46 ● 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 IEC0601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION 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 19-36 ● IEC60601-1-6 Edition 3.1:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability FDA/CDRH recognition number 5-89 ISO 14971 Ed. 3:2019 Medical devices – Application of risk management to ● medical devices. FDA/CDRH recognition number 5-125. . IEC 62366 Edition 1.1: 2020-06 CONSOLIDATED VERSION–Medical devices Part 1: Application of usability engineering to medical devices FDA/CDRH recognition number 5-129 ● ANSI AAMI ISO10993-1:2018 – Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process FDA/CDRH recognition number 2-258
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| NEMA MS 1-2008(R2020)Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance ImagingFDA/CDRH recognition number 12-188 NEMA MS 3-2008 (R2020)Determination of Image Uniformity in Diagnostic Magnetic Resonance ImagesFDA/CDRH recognition number 12-187 NEMA MS 9-2008 (R2020) Characterization of Phased Array Coils for Diagnostic Magnetic ResonanceImagesFDA/CDRH recognition number 12-288 NEMA MS 14-2019 Characterization of Radiofrequency (RF) Coil Heating in Magnetic ResonanceImaging SystemsFDA/CDRH recognition number 12-331 | |
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| The performance test results demonstrate that the proposed Smart Fit TorsoCardiac 1.5T and SmartFit Shoulder 1.5T meets the acceptance criteria and adequate for its intended use. Additionally, therisk management activities show that all risks are sufficiently mitigated, that no new risks are | |
| Based on the supporting data provided in this 510(k) submission, the proposed Smart FitTorsoCardiac 1.5T and Smart Fit Shoulder 1.5T are considered substantially equivalent to thecurrently marketed and predicate device dS TorsoCardiac 1.5T(K212864) and 1.5T 16CH GEShoulder Coils(K162001) in terms of safety and effectiveness. | |
| Summary ofClinical Data: | The proposed Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T did not require clinical studysince substantial equivalence to the legally marketed predicate device was proven in the comparisonin terms of safety and effectiveness. |
| All clinical images on the proposed coils Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5Twere evaluated by qualified radiologists. No issues with the clinical image quality was seen andimages were considered have sufficient quality for diagnostic use. |
§ 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.