(29 days)
No
The description focuses solely on the hardware (coil) and its function in receiving MR signals. There is no mention of software processing or analysis of these signals using AI/ML.
No.
The device is used to produce diagnostic images, not for therapeutic purposes.
No
Explanation: The device is an MR coil, which is a component of an MRI scanner. It receives signals to produce diagnostic images, but it does not independently perform the diagnostic interpretation. The diagnostic interpretation is performed by a trained physician using the images produced by the overall MR system.
No
The device description clearly describes a physical magnetic resonance coil, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The 8ch Wrist Coil is a component of a Magnetic Resonance (MR) scanner. It receives magnetic resonance signals generated within the patient's wrist anatomy. It does not analyze specimens taken from the patient.
- Intended Use: The intended use is to produce diagnostic images of the wrist anatomy, which are then interpreted by a physician. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro diagnostic testing.
Therefore, the 8ch Wrist Coil falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MOS
Device Description
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 sideor 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 bythe 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
wrist anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / Not Found
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)
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/mechanical safety 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 performance criteria and will perform in a manner that demonstrates substantial equivalence to the predicate device (K050622, 04/08/2005).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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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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K222325
510(k) Summary
prepared in accordance with 21 CFR §807.92.
| 510(k) Owner: | Invivo Corporation
(Business Trade Name:
Philips)
3545 SW 47th Ave
Gainesville, FL 32608
Establishment Registration #1056069 |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer Conyac
Regulatory Affairs
Specialist
Phone: +1 (352) 384-8629
E-mail: jennifer.bonacci@philips.com |
| Preparation Date: | July 27, 2022 |
| Name of Device: | 8ch Wrist Coil |
| Classification: | Classification Name: Coil, Magnetic Resonance, Specialty
Classification Regulation: 21 CFR 892.1000
Classification Panel: Radiology
Device Class: Class II
Product code: MOS |
| Primary Predicate
Device Trade
Name: | MRI Devices Corporation Models HRW-63-8 and HRW-127-8 Wrist Array
Coils (K050622 – cleared 08April2005) |
| Primary Predicate
Classification: | Classification Name: Coil, Magnetic Resonance, Specialty
Classification Regulation: 21 CFR 892.1000
Classification Panel: Radiology
Device Class: Class II
Product 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.
| Device
Description: | 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 sideor
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 bythe 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. | |
| Indications for
Use: | 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. | |
| Fundamental
Scientific
Technology: | Both the subject and predicate devices have the same indications for use and
fundamental design and scientific technology:
Prescription use Anatomy of interest is the wrist 8-channel, receive only phased-array coil with decoupling
methodology Designed for use with the same MRI scanner manufacturer (GE) and
magnetic strength (1.5T) Rigid housing design (anterior and posterior coil parts) that are
opened 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 with
biocompatibility 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 subject
coil is designed for compatibility with the SIGNA Prime (K211980). Therefore,
the cable/connector design is different than the predicate K050622 wrist
coils, which were cleared for use with the GE 1.5T Signa Excite I, II, and III
MRI systems. | |
| | Based on the non-clinical performance testing and clinical images reviewed by
a radiologist provided in this submission, this difference in technology does
not raise new issues of safety or effectiveness. The subject coil, when
connected to the compatible MR scanner, performs the intended use with no
user or patient risks identified. | |
| Summary of Non-
Clinical and Clinical
Performance Data: | The 8ch Wrist Coil has undergone the following testing in accordance withFDA-
recognized consensus standards and as recommended in FDA guidance
documents Submission of Premarket Notifications for Magnetic Resonance
Diagnostic Devices, issued November 18, 2016 and Magnetic Resonance (MR)
Receive-only Coil – Performance Criteria for Safety and Performance Based
Pathway, 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/mechanical
safety | |
| | 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). | |
| Substantial
Equivalence
Conclusion: | 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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