(84 days)
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.
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.
The provided text is a 510(k) summary for Philips Healthcare's MR coils. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and fundamental scientific technology. The document explicitly states that no clinical study was required for this submission.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment concerning clinical data. The document indicates that safety and performance were evaluated through non-clinical testing and compliance with various standards.
Here's a breakdown of what the document does contain regarding performance and equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of specific acceptance criteria in the sense of quantitative performance metrics for a clinical study with corresponding reported device performance values. Instead, it describes compliance with recognized standards and similarity to predicate devices as the basis for substantial equivalence.
The "performance" is demonstrated through compliance with the following non-clinical testing standards:
| Standard/Guidance | Purpose (As implied by Title) |
|---|---|
| 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) | General requirements for basic safety and essential performance of medical electrical equipment. |
| 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 | Specific safety and performance requirements for Magnetic Resonance Equipment. |
| 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 | Requirements and tests for electromagnetic disturbances (EMC). |
| ISO 14971 Ed. 2.0:2007 Medical devices – Application of risk management to medical devices. | Application of risk management to medical devices. The document states: "There are no risks identified in risk management documentation that require clinical data for the purpose of clinical evaluation." |
| 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" | Biological evaluation of medical devices. |
| IEC 62366 Edition 1.1: 2014-01 Medical devices Application of usability engineering to medical devices | Application of usability engineering to medical devices. |
| NEMA MS 1-2008(R2020) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging | Standard for determining Signal-to-Noise Ratio in diagnostic MRI. (Implied performance characteristic: SNR performance is comparable to predicate, though no numerical values are given). |
| NEMA MS 3-2008 (R2020) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images | Standard for determining Image Uniformity in diagnostic MRI. (Implied performance characteristic: Image uniformity is comparable to predicate, though no numerical values are given). |
| NEMA MS 9-2008 (R2020) Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images | Standard for characterizing phased array coils for diagnostic MRI. (Implied performance characteristic: Coil characteristics are comparable to predicate, though no numerical values are given). |
| NEMA MS 14-2019 Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems | Standard for characterizing RF coil heating in MRI systems. (Implied performance characteristic: RF heating is within acceptable limits and comparable to predicate, though no numerical values are given). |
| Magnetic Resonance (MR) Receive only Coil Performance ● Criteria for Safety and Performance Based Pathway - issued on December 11, 2020 | This is a specific FDA guidance document likely outlining acceptable performance metrics or methods for demonstrating substantial equivalence for MR receive-only coils. The document states the device complies with this. While specific metrics aren't detailed in this summary, the compliance indicates the device met FDA's expectations for performance for this type of device based on non-clinical data. |
The document confirms: "The results of these tests demonstrate that dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T met the acceptance criteria and are adequate for this intended use."
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission relies on non-clinical performance testing and substantial equivalence to predicate devices, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. As no clinical testing/test set was required, there was no need for expert ground truth establishment in this context. The document mentions "A trained physician interprets the diagnostic images (of the anatomy of interest) produced" as part of the Indications for Use, which is standard for MR devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set data requiring adjudication was generated for this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an MR coil, which is a hardware component for imaging, not an AI software algorithm. No MRMC study was performed as it's not relevant to this device's function or the nature of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (MR coil), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. As there was no clinical study evaluating diagnostic performance, no "ground truth" of this nature was established for the purpose of this submission. Device performance was assessed via compliance with engineering and safety standards.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
In summary: The K212864 submission for Philips Healthcare's dS TorsoCardiac 1.5T, dS MSK S 1.5T, and dS MSK M 1.5T MR coils was cleared based on demonstrating substantial equivalence to legally marketed predicate devices. This equivalence was supported by extensive non-clinical performance testing and compliance with various international and FDA-recognized consensus standards for medical electrical equipment, magnetic resonance equipment, electromagnetic compatibility, risk management, biological evaluation, usability, and specific MRI performance characteristics (SNR, uniformity, coil characterization, RF heating). The FDA letter and the 510(k) summary explicitly state that no clinical study was required to prove safety and effectiveness for these devices.
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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
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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
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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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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, 215024Establishment Registration Number: 3009529630 |
| PrimaryContact Person: | Seaman ShaoAssociate Regulatory Affairs ManagerPhone: +86-13913116320E-mail: seaman.shao@philips.com |
| SecondaryContact Person | Erhong WangSenior Regulatory Affairs ManagerPhone: +86-13021019589E-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 |
| ClassificationRegulation: 21CFR §892.1000 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Primary Product code: MOS | |
| PrimaryPredicateDevice: | Trade Name: (1) SENSE Torso 16(2) SENSE MSK S 8CH 1.5T(3) 1.5T 8-CHANNEL MEDIUM GENERALPURPOSE FLEX COIL |
| Manufacturer: Invivo Corporation | |
| 510(k) Clearance: (1) K122897, 21-12-2012(2) K120122, 10-02-2012(3) K111673, 23-12-2011 |
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| 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
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| 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 Receiveonly coil | Identical |
| MagneticFieldOrientation(B0) | Head-Feet oriented | Identical |
| Frequencyrange | 63.87MHz+/-0.75MHz | Identical |
| HousingMaterial | PC and PU | Identical |
| Decouplingmethod | Overlap, pre-ampdecouple, Active/PassivePIN diode decoupling | Identical |
| Energysource | Derived from MRscanner, no internalenergy source | Identical |
| Workflow tosupport theconnectionand signaltransmissionbetween thecoil and MRsystem | The coil cable connectsto MR system tabletopvia coaxial and DC pinsmixed analogueconnector to fit anyintended coil position ontabletop according to theneeds of MR scan. | The coil cable connects todS Interface S 1.5T or dSInterface L 1.5T, which isconnected into DCI of MRsystem tabletop, via a DCIconnector with coaxialpins to fit any intendedcoil position on tabletopaccording to the needs ofMR scan.No impact to device safetyand effectiveness since itonly provides a betterworkflow. |
| Flexibility ofcoil to ensurewell fit topatient body | The coil foam iscomposed of PU foil,flexible PCBA and EVAto provide sufficientflexibility along the Left-Right direction forpatient body scan,whereas it is rigid inHead-Feet direction dueto the existing of longrigid PCBAs and balunsalong this direction. | The coil foam is composedof PU foil, flexible PCBAand EVA to providesufficient flexibility alongthe Left-Right directionfor patient body scan, andthe coil offers a degree offlexibility along the Head-Feet direction since thebaluns are moved to thecoil cable and the size ofrigid PCBAs aredecreased.No impact to device safetyand effectiveness since it |
| only provides a betterflexibility and workflow. | ||
| Easilyremoveablestructure tosupport theserviceabilityof coil | The baluns and one ofrigid PCBA arecentralized in the middleof coil, and a removeableplastic cover is designedto cover them, whereasthe other rigid PCBAscan be repaired orreplaced only after theentire coil foam isdisassembled. | All rigid PCBAs areplaced at the left and rightside of coil, and tworemoveable plastic coversare designed to coverthem, meanwhile thebaluns are covered byplastic housings in the coilcable, and they can be alsorepaired or replaced byremoving housings.No impact to device safetyand effectiveness since itonly provides a betterserviceability. |
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| Attribute | Predicate Device,SENSE MSK S 8CH 1.5T | Proposed dS MSK S 1.5T |
|---|---|---|
| Fundamental Scientific Technology | ||
| Type of coil | Phased-array Receiveonly coil | Identical |
| MagneticFieldOrientation(B0) | Head-Feet oriented | Identical |
| Frequencyrange | 63.87MHz+/-0.75MHz | Identical |
| HousingMaterial | PC and PU | Identical |
| Decouplingmethod | Overlap, pre-ampdecouple, Active/PassivePIN diode decoupling | Identical |
| Energysource | Derived from MRscanner, no internalenergy source | Identical |
| Workflow tosupport theconnectionand signaltransmissionbetween thecoil and MRsystem | The coil cable connectsto MR system tabletopvia coaxial and DC pinsmixed analogueconnector to fit anyintended coil position ontabletop according to theneeds of MR scan. | The coil cable connects todS Interface S 1.5T or dSInterface L 1.5T, which isconnected into DCI of MRsystem tabletop, via a DCIconnector with coaxialpins to fit any intendedcoil position on tabletopaccording to the needs ofMR scan.No impact to device safetyand effectiveness since itonly provides a betterworkflow. |
| Flexibility ofcoil to ensurewell fit topatient body | The coil foam iscomposed of PU foil,flexible PCBA and EVAto provide sufficientflexibility along the Left-Right direction forpatient body scan,whereas it is rigid inHead-Feet direction dueto the existing of longrigid PCBAs and balunsalong this direction. | The coil foam is composedof PU foil, flexible PCBAand EVA to providesufficient flexibility alongthe Left-Right directionfor patient body scan, andthe coil offers a degree offlexibility along the Head-Feet direction since thebaluns are moved to thecoil cable and the size ofrigid PCBAs are decreasedsignificantly. |
| No impact to device safetyand effectiveness since itonly provides a betterflexibility and workflow. |
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| Attribute | Predicate Device,1.5T 8-CHANNEL MEDIUMGENERAL PURPOSE FLEX COIL | Proposed dS MSK M 1.5T |
|---|---|---|
| Fundamental Scientific Technology | ||
| Type of coil | Phased-array Receiveonly coil | Identical |
| MagneticFieldOrientation(B0) | Head-Feet oriented | Identical |
| Frequencyrange | 63.87MHz+/-0.75MHz | Identical |
| HousingMaterial | PC and PU | Identical |
| Decouplingmethod | Overlap, pre-ampdecouple, Active/PassivePIN diode decoupling | Identical |
| Energysource | Derived from MRscanner, no internalenergy source | Identical |
| Workflow tosupport theconnectionand signaltransmissionbetween thecoil and MRsystem | The coil cable connectsto MR system tabletopvia coaxial and DC pinsmixed analogueconnector to fit anyintended coil position ontabletop according to theneeds of MR scan. | The coil cable connects todS Interface S 1.5T or dSInterface L 1.5T, which isconnected into DCI of MRsystem tabletop, via a DCIconnector with coaxialpins to fit any intendedcoil position on tabletopaccording to the needs ofMR scan.No impact to device safetyand effectiveness since itonly provides a betterworkflow. |
| Flexibility ofcoil to ensurewell fit topatient body | The coil foam iscomposed of PU foil,flexible PCBA and EVAto provide sufficientflexibility along the Left-Right direction forpatient body scan,whereas it is rigid inHead-Feet direction dueto the existing of longrigid PCBAs and balunsalong this direction. | The coil foam is composedof PU foil, flexible PCBAand EVA to providesufficient flexibility alongthe Left-Right directionfor patient body scan, andthe coil offers a degree offlexibility along the Head-Feet direction since thebaluns are moved to thecoil cable and the size ofrigid PCBAs are decreasedsignificantly.No impact to device safetyand effectiveness since it |
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| only provides a betterflexibility and workflow. | |||
|---|---|---|---|
| Based on the information provided above, dS TorsoCardiac 1.5T isconsidered substantially equivalent to the primary currently marketed andpredicate device SENSE Torso 16 (K122897, 21-12-2012) in terms offundamental scientific technologyBased on the information provided above, dS MSK S 1.5T is consideredsubstantially equivalent to the primary currently marketed and predicatedevice SENSE MSK S 8CH 1.5T (K120122, 10-02-2012) in terms offundamental scientific technologyBased on the information provided above, dS MSK M 1.5T is consideredsubstantially equivalent to the primary currently marketed and predicatedevice 1.5T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL(K111673, 23-12-2011) in terms of fundamental scientific technology | |||
| Summary ofNon-ClinicalPerformanceData: | The proposed dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5Tcomplies with the following international and FDA-recognized consensusstandards: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. ForBasic 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 essentialperformance of magnetic resonance equipment for medicaldiagnosisFDA/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 - Requirementsand testsFDA/CDRH recognition number 19-8 ISO 14971 Ed. 2.0:2007 Medical devices – Application of riskmanagement to medical devices.FDA/CDRH recognition number 5-40. |
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- 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.
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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; .
Substantial The 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 Equivalence device SENSE Torso 16, SENSE MSK S 8CH 1.5T, 1.5T 8-CHANNEL Conclusion: MEDIUM GENERAL PURPOSE FLEX COIL in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance tests, which complied with the requirements specified in the international and FDA-recognized consensus standards. The results of these tests demonstrate that dS TorsoCardiac 1.5T, dS MSK S 1.5T and dS MSK M 1.5T met the acceptance criteria and are adequate for this intended 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.