(22 days)
No
The summary describes MR coils, which are hardware components for signal reception in MRI. There is no mention of software processing, algorithms, or any AI/ML related terms or concepts. The performance studies focus on hardware characteristics and image quality assessment by a radiologist, not algorithmic performance.
No
The device is intended to produce diagnostic images, not to treat a medical condition.
Yes
Explanation: The device is an MR coil intended to "produce diagnostic images" of the foot, ankle, hand, and wrist anatomy. These images can then be "interpreted by a trained physician," indicating its role in the diagnostic process. The Summary of Performance Studies also mentions that "Acquired Image quality was assessed by a U.S. Board Certified radiologist to confirm images produced on the subject coil are sufficient quality for diagnostic use."
No
The device description explicitly states that the device is a physical coil designed to receive RF signals in conjunction with an MRI system, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these are MR coils used in conjunction with MRI scanners to produce diagnostic images of the foot, ankle, hand, wrist, and small extremities. This is an in vivo imaging technique, meaning it examines the body directly, not through analysis of a specimen outside the body.
- Intended Use: The intended use is to produce diagnostic images that are interpreted by a trained physician. This aligns with the function of an imaging device, not an IVD.
Therefore, the Philips Orthopedic MR Coils are medical devices used for diagnostic imaging, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The dS FootAnkle 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the foot and ankle anatomy that can be interpreted by a trained physician.
The dS HiRes Hand/Wrist 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the hand and wrist anatomy that can be interpreted by a trained physician.
The dS Small Extremity 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the small extremities anatomy on adult and pediatric patients that can be interpreted by a trained physician.
Product codes
MOS
Device Description
The Philips Orthopedic MR Coils are designed for use with Magnetic Resonance Imaging (MRI) systems. The coils are designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei.
The subject devices have 16-elements and are for use with Philips Ingenia 1.5T and 3.0T MR Systems with dStream interface (K193215). The devices are designed for optimum coverage and high-resolution visualization of detailed cartilage structures of the body anatomy (foot/ankle, hand/wrist, small extremity). The coil is used independently and cannot be combined with any other coils. The coils are available in both 1.5T and 3.0T magnetic strengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Foot and ankle, hand and wrist, small extremities
Indicated Patient Age Range
Adult and pediatric patients (for dS Small Extremity 16ch 1.5T and 3.0T MR Coils)
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)
The Philips Orthopedic MR Coils have undergone the following testing in accordance with FDA-recognized consensus standards and as recommended in FDA guidance documents:
- Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016
- Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020:
- Image Signal to Noise and Image Uniformity characterization (NEMA MS 1, 3, 9 and IEC 62464-1)
- Surface heating (ANSI/AAMI ES 60601-1 and NEMA MS 14)
- Acquired Image quality was assessed by a U.S. Board Certified radiologist to confirm images produced on the subject coil are sufficient quality for diagnostic use.
- Presence of decoupling mechanisms
- EMC – Immunity, electrostatic discharge (IEC 60601-1-2)
- General electrical/mechanical safety (IEC 60601-2-33 and AAMI/ANSI ES 60601-1)
- Biocompatibility evaluation (ISO 10993 series)
The performance testing demonstrated that the Philips Orthopedic MR Coils are safe and effective for the intended use(s) and will perform in a manner that demonstrates substantial equivalence to the predicate devices and meets predefined performance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
dS FootAnkle 16Ch Coil for 1.5T, Invivo Corporation, K162177 cleared on 09/14/2016, Hand-Wrist Coil 16Ch Coil for 1.5T, Invivo Corporation, K103149 cleared on 01/03/2010, dS Small Extremity 16Ch 1.5T Coil, Invivo Corporation, K162863 cleared on 11/7/2016
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
December 23, 2021
Invivo Corporation % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K213766
Trade/Device Name: dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: November 30, 2021 Received: December 1, 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.
1
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 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.
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 for
Enclosure
2
Indications for Use
510(k) Number (if known) K213766
Device Name dS FootAnkle 16ch 1.5T and 3.0T
Indications for Use (Describe)
The dS FootAnkle 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the foot and ankle anatomy 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K21xxxx
Device Name dS HiRes Hand/Wrist 16ch 1.5T and 3.0T
Indications for Use (Describe)
The dS HiRes Hand/Wrist 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.577.0T Magnetic Resonance Scanners to produce diagnostic images of the hand and wrist anatomy 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K21xxxx
Device Name dS Small Extremity 16ch 1.5T and 3.0T
Indications for Use (Describe)
The dS Small Extremity 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the small extremities anatomy on adult and pediatric patients 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
Image /page/5/Picture/0 description: The image contains the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The letters are large and take up most of the image space.
510(k) Summary Philips Orthopedic MR Coils: dS FootAnkle, dS HiRes HandWrist, dS Small Extremity 16Ch Coils for 1.5T and 3.0T
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: | Ann Lebar
Head of Regulatory
Phone: 1 (414) 217-6244
E-mail: ann.lebar@philips.com |
| Preparation Date: | October 29, 2021 |
| Name of Device: | Philips Orthopedic MR Coils:
dS FootAnkle 16Ch Coils for 1.5T and 3.0T
dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T
dS Small Extremity 16Ch Coils for 1.5T and 3.0T |
| 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 Devices: | dS FootAnkle 16Ch Coil for 1.5T, Invivo Corporation, K162177 cleared on 09/14/2016
Hand-Wrist Coil 16Ch Coil for 1.5T, Invivo Corporation, K103149 cleared on 01/03/2010 |
| Device Description: | The Philips Orthopedic MR Coils are designed for use with
Magnetic Resonance Imaging (MRI) systems. The coils are
designed to work in unison with the Body Coil of the MRI system,
which will transmit the radio frequency (RF) signals, so that the
coil may receive the resultant RF signal from the excited nuclei.
The subject devices have 16-elements and are for use with
Philips Ingenia 1.5T and 3.0T MR Systems with dStream interface
(K193215). The devices are designed for optimum coverage and
high-resolution visualization of detailed cartilage structures of the
body anatomy (foot/ankle, hand/wrist, small extremity). The coil is
used independently and cannot be combined with any other coils.
The coils are available in both 1.5T and 3.0T magnetic strengths. |
| Indications for Use: | The dS FootAnkle 16ch 1.5T and 3.0T MR Coils are intended to
be used in conjunction with Philips 1.5T/3.0T Magnetic
Resonance Scanners to produce diagnostic images of the foot
and ankle anatomy that can be interpreted by a trained physician.
The dS HiRes Hand/Wrist 16ch 1.5T and 3.0T MR Coils are
intended to be used in conjunction with Philips 1.5T/3.0T
Magnetic Resonance Scanners to produce diagnostic images of
the hand and wrist anatomy that can be interpreted by a trained
physician.
The dS Small Extremity 16ch 1.5T and 3.0T MR Coils are
intended to be used in conjunction with Philips 1.5T/3.0T
Magnetic Resonance Scanners to produce diagnostic images of
the small extremities anatomy on adult and pediatric patients that
can be interpreted by a trained physician. |
| Fundamental Scientific Technology: | The subject Philips Orthopedic MR Coils are considered
substantially equivalent to the primary currently marketed
predicate devices (dS FootAnkle 16Ch Coil for 1.5T, Invivo
Corporation, K162177 cleared on 09/14/2016; Hand-Wrist Coil
16Ch Coil for 1.5T, Invivo Corporation, K103149 cleared on
01/03/2010; and dS Small Extremity 16Ch 1.5T Coil, Invivo
Corporation, K162863 cleared on 11/7/2016) in terms of
fundamental scientific technology.
The subject coils are similar in design, material, chemical
composition and energy source to the legally marketed predicate
devices. |
| | At a high level, the subject coils as part of this submission and the predicate devices are based on the following same technological elements: Prescription use Coil designs are receive-only phased array coils Decoupling methodology Patient contacting materials and chemical composition are known materials that have been assessed for compliance with recognized biocompatibility standards Energy source for the coils is the MRI scanner No energy is supplied by the coils Coils designs are targeted for imaging the anatomy of interest Mechanical designs are contoured for the patient anatomy The following technological differences exist between the subject and predicate devices: |
| | Coil geometry housing design: Housing with similar design. Subject housing design is slightly different design to more closely mimic subject patient anatomy and provide additional patient comfort. System compatibility: New coil compatible with 3.0T MR scanner. |
| | The intended use for subject coils is the same as for the predicate device, specifically the coils are intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images that can be interpreted by a trained physician; only differing in name of the coil and the reference to the specific body part (e.g., foot and ankle vs anatomy of interest). For the dS Small Extremity 16Ch Coils for 1.5T and 3.0T , it was also determined that the coils can be used to assess both adult and pediatric patients which has been added to the indications for use. |
| | Clinical and non-clinical testing demonstrates that the safety and effectiveness requirements as outlined in FDA guidance Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway , issued December 11, 2020 were met. |
| Summary of
Non-Clinical and
Clinical | The Philips Orthopedic MR Coils have undergone the following testing in accordance with FDA-recognized consensus standards and as recommended in FDA guidance documents Submission of |
| Performance
Data: | 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: |
| | • Image Signal to Noise and Image Uniformity characterization
(NEMA MS 1, 3, 9 and IEC 62464-1) |
| | • Surface heating (ANSI/AAMI ES 60601-1 and NEMA MS 14) |
| | • Acquired Image quality was assessed by a U.S. Board
Certified radiologist to confirm images produced on the subject
coil are sufficient quality for diagnostic use. |
| | • Presence of decoupling mechanisms |
| | • EMC – Immunity, electrostatic discharge (IEC 60601-1-2) |
| | • General electrical/mechanical safety (IEC 60601-2-33 and
AAMI/ANSI ES 60601-1) |
| | • Biocompatibility evaluation (ISO 10993 series) |
| | The performance testing demonstrated that the Philips
Orthopedic MR Coils are safe and effective for the intended
use(s) and will perform in a manner that demonstrates substantial
equivalence to the predicate devices and meets predefined
performance criteria. |
6
Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast to the blue text.
510(k) Summary Philips Orthopedic MR Coils:
dS FootAnkle, dS HiRes HandWrist, dS Small Extremity 16Ch Coils for 1.5T and 3.0T prepared in accordance with 21 CFR §807.92.
7
Image /page/7/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 Philips Orthopedic MR Coils:
dS FootAnkle, dS HiRes HandWrist, dS Small Extremity 16Ch Coils for 1.5T and 3.0T prepared in accordance with 21 CFR §807.92.
8
Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are all capitalized and evenly spaced. The font is sans-serif and the overall impression is clean and modern.
510(k) Summary
Philips Orthopedic MR Coils:
dS FootAnkle, dS HiRes HandWrist, dS Small Extremity 16Ch Coils for 1.5T and 3.0T prepared in accordance with 21 CFR §807.92.
9
Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in a bright blue color. The letters are evenly spaced and appear to be slightly italicized.
510(k) Summary
Philips Orthopedic MR Coils: dS FootAnkle, dS HiRes HandWrist, dS Small Extremity 16Ch Coils for 1.5T and 3.0T prepared in accordance with 21 CFR §807.92.
| Substantial
Equivalence
Conclusion: | The Philips Orthopedic MR Coils (dS FootAnkle 16Ch Coils
for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T
and 3.0T, and dS Small Extremity 16Ch Coils for 1.5T and
3.0T) are substantially equivalent to the predicate devices (dS
FootAnkle 16Ch Coil for 1.5T, Invivo Corporation, K162177
cleared on 09/14/2016; Hand-Wrist Coil 16Ch Coil for 1.5T, Invivo
Corporation, K103149 cleared on 01/03/2010; and dS Small
Extremity 16Ch 1.5T Coil, Invivo Corporation, K162863 cleared
on 11/7/2016) in terms of design features, fundamental scientific
technology, indications for 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 results of these tests demonstrate
that Philips Orthopedic MR Coils (dS FootAnkle 16Ch Coils
for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T
and 3.0T, and dS Small Extremity 16Ch Coils for 1.5T and
3.0T) meet the acceptance criteria and are adequate for this
intended use. |