(29 days)
The 8ch Wrist Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance scanner to produce diagnostic images of the wrist anatomy that can be interpreted by a trained physician.
The 8ch Wrist Coil magnetic resonance (MR) coil is a receive only phased array coil with 8 channels for wrist imaging. This Wrist Coil is designed for use with the SIGNA Prime (K211980). The 8ch Wrist Coil is designed to be used vertically at the patient's side or horizontally overhead. The wrist array comes with two rigid base plates (for flat or curved tabletops) for fixation to reduce patient motion. The coil receives magnetic resonance signals generated in hydrogen nuclei (protons) in the wrist while blocking the high-frequency B1 field applied by the MRI scanner at specified timing. The 8ch Wrist Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the wrist anatomy.
The provided document is a 510(k) summary for the Philips 8ch Wrist Coil, a magnetic resonance (MR) coil. It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it lists the types of performance testing conducted and generally states that the device "meets predefined performance criteria."
However, based on the non-clinical and clinical performance data summary, we can infer the areas of acceptance:
| Acceptance Criteria Category | Specific Acceptance Criteria/Test | Reported Device Performance |
|---|---|---|
| Image Quality | Signal to Noise Ratio (SNR) (based on NEMA MS-1, NEMA MS-9, IEC 62464-1) | Demonstrated satisfactory performance/meets criteria |
| Image Uniformity (based on NEMA MS-3) | Demonstrated satisfactory performance/meets criteria | |
| Safety - Thermal | Surface Heating (based on NEMA MS 14) | Demonstrated satisfactory performance/meets criteria |
| Safety - Electrical/EMC | Decoupling circuit performance | Demonstrated satisfactory performance/meets criteria |
| EMC Immunity, electrostatic discharge testing (IEC 60601-1-2) | Demonstrated satisfactory performance/meets criteria | |
| General electrical/mechanical safety (IEC 60601-2-33, AAMI/ANSI ES 60601-1) | Demonstrated satisfactory performance/meets criteria | |
| Safety - Biocompatibility | Biological safety evaluation (ISO 10993-1) | Compliance with biocompatibility standards |
| Reprocessing | Cleaning and disinfection validations (ISO 17664) | Validated reprocessing instructions |
| Clinical Efficacy | Diagnostic image quality suitable for interpretation by a trained physician | Clinical images reviewed by a radiologist were found adequate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the clinical test set. It mentions "clinical images" were reviewed by a radiologist. It does not indicate the number of images or cases.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It simply refers to "clinical images reviewed by a radiologist provided in this submission."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: One expert was used.
- Qualifications of Expert: "US Board Certified radiologist." No specific information on years of experience is provided.
4. Adjudication Method for the Test Set
The document states that a "US Board Certified radiologist's review of clinical images" was conducted. This suggests that a single expert provided the assessment, implying no formal adjudication method (like 2+1 or 3+1 consensus) was used for establishing ground truth from multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the performance of the device itself, rather than comparing human reader performance with and without AI assistance. The device is an MRI coil, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, a "standalone" performance evaluation of the device itself was conducted through the non-clinical and clinical image review. This device is an MRI coil, which is a component of an imaging system, not an AI algorithm. The performance being evaluated is its ability to acquire diagnostic-quality images. The "standalone" aspect here refers to the intrinsic performance of the coil (e.g., SNR, uniformity, safety) and the quality of the images it produces, which are then interpreted by a human.
7. The Type of Ground Truth Used
The ground truth for the clinical performance assessment was primarily based on expert assessment/consensus (from a single US Board Certified radiologist) of the diagnostic quality of the images produced by the device. Pathology or outcomes data are not mentioned as being used for ground truth in this context.
8. The Sample Size for the Training Set
The document does not mention a training set because the device is a physical MRI coil, not an AI algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as the device is not an AI algorithm and therefore does not have a training set or associated ground truth for training purposes.
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August 31, 2022
Invivo Corporation (Business Trade Name: Philips) % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114
Re: K222325
Trade/Device Name: 8ch Wrist Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: August 1, 2021 Received: August 2, 2021
Dear Prithul Bom:
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
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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 (OS) 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,
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of 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) K222325
Device Name 8ch Wrist Coil
Indications for Use (Describe)
The 8ch Wrist Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance scanner to produce diagnostic images of the wrist anatomy that can be interpreted by a trained physician.
| 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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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 background is white, which makes the blue letters stand out.
K222325
510(k) Summary
prepared in accordance with 21 CFR §807.92.
| 510(k) Owner: | Invivo Corporation(Business Trade Name:Philips)3545 SW 47th AveGainesville, FL 32608Establishment Registration #1056069 |
|---|---|
| Contact: | Jennifer ConyacRegulatory AffairsSpecialistPhone: +1 (352) 384-8629E-mail: jennifer.bonacci@philips.com |
| Preparation Date: | July 27, 2022 |
| Name of Device: | 8ch Wrist Coil |
| Classification: | Classification Name: Coil, Magnetic Resonance, SpecialtyClassification Regulation: 21 CFR 892.1000Classification Panel: RadiologyDevice Class: Class IIProduct code: MOS |
| Primary PredicateDevice TradeName: | MRI Devices Corporation Models HRW-63-8 and HRW-127-8 Wrist ArrayCoils (K050622 – cleared 08April2005) |
| Primary PredicateClassification: | Classification Name: Coil, Magnetic Resonance, SpecialtyClassification Regulation: 21 CFR 892.1000Classification Panel: RadiologyDevice Class: Class IIProduct code: MOS |
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Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are spaced closely together, creating a strong visual impact. The font is sans-serif and appears to be a custom design or a proprietary typeface used by the Philips brand.
| DeviceDescription: | The 8ch Wrist Coil magnetic resonance (MR) coil is a receive only phasedarray coil with 8 channels for wrist imaging. This Wrist Coil is designed foruse with the SIGNA Prime (K211980). | |
|---|---|---|
| The 8ch Wrist Coil is designed to be used vertically at the patient's sideorhorizontally overhead. The wrist array comes with two rigid base plates(for flat or curved tabletops) for fixation to reduce patient motion.The coil receives magnetic resonance signals generated in hydrogennuclei(protons) in the wrist while blocking the high-frequency B1 fieldapplied bythe MRI scanner at specified timing. | ||
| The 8ch Wrist Coil is tuned to receive RF frequency corresponding to theproton precession in a 1.5 tesla magnetic field, which is governed by theLarmor equation. | ||
| Images are typically generated as axial, sagittal, coronal oblique slices andinclude coverage of the wrist anatomy. | ||
| Indications forUse: | The 8ch Wrist Coil is intended to be used in conjunction with a SIGNAPrime Magnetic Resonance Scanner to produce diagnostic images ofthe wrist anatomy that can be interpreted by a trained physician. | |
| FundamentalScientificTechnology: | Both the subject and predicate devices have the same indications for use andfundamental design and scientific technology:Prescription use Anatomy of interest is the wrist 8-channel, receive only phased-array coil with decouplingmethodology Designed for use with the same MRI scanner manufacturer (GE) andmagnetic strength (1.5T) Rigid housing design (anterior and posterior coil parts) that areopened and closed to facilitate wrist examinations Connected to the MR system with cable/connectors Energy source is the same Patient contacting materials have been assessed for compliance withbiocompatibility standards Non-sterile and reusable Cleaned and disinfected by the user prior to use | |
| Compared to the predicate (K050622), the main difference is that the subjectcoil is designed for compatibility with the SIGNA Prime (K211980). Therefore,the cable/connector design is different than the predicate K050622 wristcoils, which were cleared for use with the GE 1.5T Signa Excite I, II, and IIIMRI systems. | ||
| Based on the non-clinical performance testing and clinical images reviewed bya radiologist provided in this submission, this difference in technology doesnot raise new issues of safety or effectiveness. The subject coil, whenconnected to the compatible MR scanner, performs the intended use with nouser or patient risks identified. | ||
| Summary of Non-Clinical and ClinicalPerformance Data: | The 8ch Wrist Coil has undergone the following testing in accordance withFDA-recognized consensus standards and as recommended in FDA guidancedocuments Submission of Premarket Notifications for Magnetic ResonanceDiagnostic Devices, issued November 18, 2016 and Magnetic Resonance (MR)Receive-only Coil – Performance Criteria for Safety and Performance BasedPathway, issued December 11, 2020: | |
| Performance Testing – Non-Clinical:NEMA MS-1, NEMA MS-9, IEC 62464-1 - Image Signal to Noise (SNR) NEMA MS-3 - Image uniformity NEMA MS 14 - Surface heating Decoupling circuit IEC 60601-1-2 - EMC Immunity, electrostatic discharge testing IEC 60601-2-33, AAMI/ANSI ES 60601-1 - General electrical/mechanicalsafety | ||
| ISO 10993-1 Biological safety evaluation ISO 17664 Cleaning and disinfection validations to support reprocessing instructions Performance Testing - Clinical: US Board Certified radiologist's review of clinical images The performance testing demonstrated that the 8ch Wrist Coil are safe and effective for the intended use(s), meets predefined performancecriteria and will perform in a manner that demonstrates substantial equivalence to the predicate device (K050622, 04/08/2005). | ||
| SubstantialEquivalenceConclusion: | The 8ch Wrist Coil is substantially equivalent to the primary currently marketed and predicate device (K050622, 04/08/2005) in terms of design features, fundamental scientific technology, indicationsfor use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical and clinical performance tests, which complied with the requirements specified in FDA-recognized consensus standards and guidance documents. The summary includes the conclusions drawn from the nonclinical and clinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device according to 807.92(b)(3). |
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PHILIPS
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§ 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.