(27 days)
Not Found
No
The device description focuses on the physical components and operational modes of MRI coils, with no mention of AI, ML, or advanced image processing beyond standard MRI signal detection and processing.
No
The device is used to produce diagnostic images, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to produce diagnostic images" which can be "interpreted by a trained physician."
No
The device description explicitly details physical hardware components (coils, base plate, latches) and their mechanical and electrical functions in generating MRI images. It also mentions performance testing related to hardware safety and image quality.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices 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 described devices are MRI coils. They are external components used in conjunction with an MRI scanner to generate and receive radiofrequency signals. These signals are used to create images of the internal structures of the body.
- Intended Use: The intended use clearly states that the coils are used to "produce diagnostic images of the lower extremities" and "diagnostic images of the knee." This involves imaging the body directly, not analyzing specimens taken from the body.
- Device Description: The description details the physical components and how they interact with the MRI system to create images. There is no mention of analyzing biological samples.
- Input Imaging Modality: The input modality is "Magnetic Resonance," which is an in-vivo imaging technique.
Therefore, the 1.5T T/R Quad Extremity Coil and the 1.5T 8CH T/R Knee Coil are medical devices used for in-vivo diagnostic imaging, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The 1.5T T/R Quad Extremity Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the lower extremities that can be interpreted by a trained physician.
The 1.5T 8CH T/R Knee Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The 1.5T T/R Quad Extremity Coil is quadrature Transmit and Receive coils. At 1.5T the coil can be used in 3 different operational modes: QuadKnee, QuadFoot and QuadAnkle. The coil is designed to image the Knee, Foot and Ankle, but can also be used for other parts of the lower extremities. The base of the coil is attached to a base plate and can be moved to scan either the Left or Right extremity. The coil is moved into position (Left to Right) and locked into place, the patient is then positioned in the base, the top section of the coil is placed over the patient and the latched closed. The fixed position of the coil and helps prevent the patient form moving, reducing artifact. This coil is used independently and can't be combined with any other coils. The 1.5T T/R Quad Extremity Coil is compatible with SIGNA Prime MRI Systems with P-Port Connector. It consists of a birdcage quadrature coil. During transmit phase, the coil is resonated by the RF power source of MR system, to excite hydrogen nuclei (protons) in the anatomy. The quadrature coil detects the magnetic resonance signals generated by hydrogen nuclei (protons) in the knee during the receive phase. The coil is tuned to transmit and receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
The 1.5T 8CH T/R Knee Coil is an 8 element phase array coil with a T/R quadrature birdcage shell, designed to image the knee. The base of the coil is attached to a base plate and can be moved to scan either the Left or Right Knee. The patient is positioned in the base, the top section of the coil is placed over the patient and the latched closed, which locks the position of the coil and helps prevent the patient form moving, reducing artifact. The transmit shell consist of a twist birdcage quadrature coil, resonated by the RF power source of MR system, to excite hydrogen nuclei (protons) in the anatomy. The coil receivers consist of 8 phased array elements that detect the magnetic resonance signals generated by hydrogen nuclei (protons) in the knee while blocking the high-frequency B1 field applied by the coil transmit shell at specified timings. The coil is tuned to transmit and receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. This coil is used independently and cannot be combined with any other coils.
The 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil are compatible with SIGNA Prime MRI systems with a P-Port connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Scanner
Anatomical Site
lower extremities, knee, foot, ankle
Indicated Patient Age Range
The target population for the devices are any patient scheduled for MRI exam of the knee, lower limb and extremities.
Intended User / Care Setting
trained physician / Hospital MRIs across all departments; imaging centers; specialty offices; primary and secondary care centers
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:
- ANSI/AAMI ES 60601-1 and NEMA MS 14 Surface heating
- IEC 60601-1-2 EMC Immunity, electrostatic discharge testing
- IEC 60601-2-33, AAMI/ANSI ES 60601-1 General electrical/mechanical safety
- NEMA MS-1, NEMA MS-3, NEMA MS-9 and IEC 62464-1 Image Signal to Noise and Image Uniformity characterization
- IEC 60601-2-33 and NEMA MS-8 Specific Absorption Rate
- ISO 10993-1 Biological safety evaluation
- ISO 17664 Cleaning and disinfection validations to support reprocessing instructions
Performance Testing - Clinical:
- per NEMA PS 3.1 - 3.20, Sample clinical images for the target anatomical locations were provided in DICOM format to demonstrate the images produced are of sufficient quality for diagnostic use. (Section 20 of 510k Submission)
- There was no adverse event reported during clinical performance testing.
- The clinical performance testing plan and report is provided with a statement from a US Board Certified radiologist that can support the ability of the device to generate diagnostic quality images. (Section 20 of 510k Submission)
The performance testing demonstrated that the 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil are safe and effective for the intended use(s) and meets predefined performance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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August 23, 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: K222257
Trade/Device Name: 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: July 26, 2022 Received: July 27, 2022
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
1
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
2
Indications for Use
510(k) Number (if known) K222257
Device Name
1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil
Indications for Use (Describe)
The 1.5T T/R Quad Extremity Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the lower extremities that can be interpreted by a trained physician.
The 1.5T 8CH T/R Knee Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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. The image is simple and clean, with a focus on the brand name.
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 Bonacci |
| Regulatory Affairs Specialist | |
| Phone: +1-352-384-8629 | |
| E-mail: jennifer.bonacci@philips.com | |
| Preparation Date: | July 25, 2022 |
| Name of Device(s): | 1.5T T/R Quad Extremity Coil |
| 1.5T 8CH T/R Knee Coil | |
| Device Classification: | Classification Name - Coil, Magnetic Resonance, Specialty |
| Classification Regulation - 21 CFR 892.1000 | |
| Classification Panel - Radiology | |
| Device Class - Class II | |
| Product Code - MOS | |
| Predicate Device: | Quadrature Lower Extremity Coil, K934396, cleared November 24, 1993 |
| Predicate Device | |
| Classification: | Classification Name - Coil, Magnetic Resonance, Specialty |
| Classification Regulation - 21 CFR 892.1000 | |
| Classification Panel - Radiology | |
| Device Class - Class II | |
| Product Code - MOS | |
| Predicate Device: | HRK-63-8 Knee Array Coil, K032633, cleared September 25, 2003 |
| Predicate Device | |
| Classification: | Classification Name - Coil, Magnetic Resonance, Specialty |
| Classification Regulation - 21 CFR 892.1000 | |
| Classification Panel - Radiology | |
| Device Class - Class II | |
| Product Code - MOS | |
| Device Description: | The 1.5T T/R Quad Extremity Coil is quadrature Transmit and Receive |
| coils. At 1.5T the coil can be used in 3 different operational modes: | |
| QuadKnee, QuadFoot and QuadAnkle. The coil is designed to image the | |
| Knee, Foot and Ankle, but can also be used for other parts of the lower | |
| extremities. |
4
The base of the coil is attached to a base plate and can be moved to scan either the Left or Right extremity. The coil is moved into position (Left to Right) and locked into place, the patient is then positioned in the base, the top section of the coil is placed over the patient and the latched closed. The fixed position of the coil and helps prevent the patient form moving, reducing artifact.
This coil is used independently and can't be combined with any other coils.
The 1.5T T/R Quad Extremity Coil is compatible with SIGNA Prime MRI Systems with P-Port Connector. It consists of a birdcage quadrature coil. During transmit phase, the coil is resonated by the RF power source of MR system, to excite hydrogen nuclei (protons) in the anatomy. The quadrature coil detects the magnetic resonance signals generated by hydrogen nuclei (protons) in the knee during the receive phase.
The coil is tuned to transmit and receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
The 1.5T 8CH T/R Knee Coil is an 8 element phase array coil with a T/R quadrature birdcage shell, designed to image the knee. The base of the coil is attached to a base plate and can be moved to scan either the Left or Right Knee. The patient is positioned in the base, the top section of the coil is placed over the patient and the latched closed, which locks the position of the coil and helps prevent the patient form moving, reducing artifact.
The transmit shell consist of a twist birdcage quadrature coil, resonated by the RF power source of MR system, to excite hydrogen nuclei (protons) in the anatomy.
The coil receivers consist of 8 phased array elements that detect the magnetic resonance signals generated by hydrogen nuclei (protons) in the knee while blocking the high-frequency B1 field applied by the coil transmit shell at specified timings.
The coil is tuned to transmit and receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.
This coil is used independently and cannot be combined with any other coils.
The 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil are compatible with SIGNA Prime MRI systems with a P-Port connector.
Indications for Use: The 1.5T T/R Quad Extremity Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic
5
images of the lower extremities that can be interpreted by a trained physician.
The 1.5T 8CH T/R Knee Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.
Fundamental Scientific Technology:
The subject 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil are similar in design, material, chemical composition and energy source to the legally marketed and predicate devices (Quadrature Lower Extremity Coil: K934396, November 24, 1993; and HRK-63-8 Knee Array Coil: K032633, September 25, 2003). At a high level, the 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil and the predicate devices are based on the following same characteristics:
- Clinical
- Technical
- . Biological
The detailed comparisons are:
| Item | Quadrature Lower
Extremity Coil
(Predicate Device,
K934396) | 1.5T T/R Quad
Extremity Coil
(Subject Device) |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cable assembly /
system connector | Image: Cable assembly / system connector | Image: 1.5T T/R Quad Extremity Coil |
| Intended Use
population | Adult | The target population
for the devices are any
patient scheduled for
MRI exam of the knee,
lower limb and
extremities. |
| Clinical application site | Musculoskeletal
structures, soft tissue
and vascular structure
of the lower extremities | Knee / Foot / Lower
Extremity |
| Type of device contact
to body | Body surface | Body surface |
| Indications for Use | Magnetic resonance
imaging (MRI) and
magnetic resonance
angiography (MRA) of
the musculoskeletal
structures, soft tissue
and vascular structures
of the lower
extremities. | The 1.5T T/R Quad
Extremity Coil is
intended to be used in
conjunction with a GE
1.5T Magnetic
Resonance Scanner to
produce diagnostic
images of the lower
extremities that can be
interpreted by a trained
physician. |
| Illness stage and degree
for use | Across all stages and
degree of illness | Across all stages and
degree of illness |
| Operating Environment | Hospital MRIs across all
departments; imaging | Hospital MRIs across all
departments; imaging |
6
| | centers; specialty
offices; primary and
secondary care centers | centers, specialty
offices, primary and
secondary care centers |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Frequency range | 63.86 MHz | 63.86 MHz |
| Coil Design | Quadrature transmit-
receive coil | Quadrature transmit-
receive coil |
| Magnetic Field
Orientation (BO) | Horizontal | Horizontal |
| Decoupling method | System body coil does
not transmit when this
device is connected, no
decoupling necessary | System body coil does
not transmit when this
device is connected, no
decoupling necessary |
| Number of Channels /
Preamplifiers | Quadrature combined
single channel | Quadrature combined
single channel (QLE) |
| Housing Material | Hylex P1010FR and
Lexan 925
polycarbonate | Hylex P1010FR and
Lexan 925
polycarbonate |
| Base Pad | Polyether foam with
vinyl-based spray-on
coating | Polyether foam with
vinyl-based spray-on
coating |
| System Connector /
Compatibility | GE legacy "A-Port"
connector | GE "P-Port connector |
| Patient Contact
materials | - Hylex P1010FR and
Lexan 925
polycarbonate
- Polyether foam with
vinyl-based spray-on
coating | - Hylex P1010FR and
Lexan 925
polycarbonate - Polyether foam with
vinyl-based spray-on
coating |
| Components | No incorporation of any
medicinal substances. | No incorporation of any
medicinal substances. |
| Item | HRK-63-8 Knee Array
Coil
(Predicate Device,
K032633) | 1.5T 8CH T/R Knee Coil
(Subject Device) |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cable assembly /
system connector | Image: Cable assembly | Image: Cable assembly |
| Intended Use
population | Adult | The target population
for the devices are any
patient scheduled for
MRI exam of the knee,
lower limb and
extremities. |
| Clinical application site | Knee | Knee |
| Type of device contact
to body | Body surface | Body surface |
| Indications for Use | To be used in
conjunction with a
Magnetic Resonance
Scanner to produce
diagnostic images of the
knee that can be | The 1.5T 8CH T/R Knee
Coil is intended to be
used in conjunction
with a GE 1.5T Magnetic
Resonance Scanner to
produce diagnostic
images of the knee that |
7
| interpreted by a trained | can be interpreted by a | |
|---|---|---|
| physician. | trained physician. | |
| Illness stage and degree | Across all stages and | Across all stages and |
| for use | degree of illness | degree of illness |
| Operating environment | Hospital MRIs across all | Hospital MRI s across all |
| departments; imaging | departments; imaging | |
| centers; specialty | centers, specialty | |
| offices, primary and | offices, primary and | |
| secondary care centers | secondary care centers | |
| Frequency range | 63.86 MHz | 63.86 MHz |
| Coil Design | Volume phased-array, | Volume phased-array, |
| transmit-receive coil | transmit-receive coil | |
| Magnetic Field | Horizontal | Horizontal |
| Orientation (B0) | ||
| Decoupling method | System body coil does | System body coil does |
| not transmit when this | not transmit when this | |
| device is connected, no | device is connected, no | |
| decoupling necessary | decoupling necessary | |
| Number of Channels / | 8 channels / | 8 channels / |
| Preamplifiers | preamplifiers | preamplifiers |
| Housing Material | Lexan 925 | Lexan 925 |
| polycarbonate | polycarbonate | |
| Base Pad | Polyether foam with | Polyether foam with |
| vinyl-based spray-on | vinyl-based spray-on | |
| coating | coating | |
| System Connector / | GE legacy "A-Port" | GE "P-Port" connector |
| Compatibility | connector | |
| Patient contact | - Lexan 925 | - Lexan 925 |
| materials | polycarbonate | polycarbonate |
| - Polyether foam with | - Polyether foam with | |
| vinyl-based spray-on | vinyl-based spray-on | |
| coating | coating | |
| Components | No incorporation of any | No incorporation of any |
| medicinal substances. | medicinal substances. |
Based on the information provided above, the difference between 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil, and predicate devices, is the connector design, as the predicate device connects to legacy GE Signa 1.5T system. 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil connects to SIGNA Prime (K211980). The subject devices are considered substantially equivalent to the primary currently marketed and predicate device (Quadrature Lower Extremity Coil: K934396, November 24, 1993; and HRK-63-8 Knee Array Coil: K032633, September 25, 2003) in terms of fundamental scientific technology.
Summary of Non-The 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil has Clinical and Clinical undergone the following testing in accordance with FDA-recognized Performance Data: consensus standards and as recommended in FDA guidance documents Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, issued November 18, 2016.
Performance Testing - Non-Clinical:
- ANSI/AAMI ES 60601-1 and NEMA MS 14 Surface heating
- IEC 60601-1-2 EMC Immunity, electrostatic discharge testing ●
8
| | IEC 60601-2-33, AAMI/ANSI ES 60601-1 General
● |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | electrical/mechanical safety |
| | ●
NEMA MS-1, NEMA MS-3, NEMA MS-9 and IEC 62464-1 Image |
| | Signal to Noise and Image Uniformity characterization |
| | IEC 60601-2-33 and NEMA MS-8 Specific Absorption Rate
● |
| | ISO 10993-1 Biological safety evaluation
● |
| | ISO 17664 Cleaning and disinfection validations to support
● |
| | reprocessing instructions |
| | Performance Testing - Clinical: |
| | per NEMA PS 3.1 - 3.20, Sample clinical images for the target
● |
| | anatomical locations were provided in DICOM format to |
| | demonstrate the images produced are of sufficient quality for |
| | diagnostic use. (Section 20 of 510k Submission) |
| | There was no adverse event reported during clinical performance
●
testing. |
| | The clinical performance testing plan and report is provided with |
| | a statement from a US Board Certified radiologist that can |
| | support the ability of the device to generate diagnostic quality |
| | images. (Section 20 of 510k Submission) |
| | |
| | The performance testing demonstrated that the 1.5T T/R Quad Extremity
Coil and 1.5T 8CH T/R Knee Coil are safe and effective for the intended
use(s) and meets predefined performance criteria. |
| | |
| Substantial | The 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil are |
| Equivalence | substantially equivalent to the primary currently marketed and predicate |
| Conclusion: | device (Quadrature Lower Extremity Coil: K934396, November 24, 1993; |
| | and HRK- 63-8 Knee Array Coil: K032633, September 25, 2003) in terms of |
| | indications for use, design characteristics, fundamental scientific |
| | technology, materials, sterilization, shelf life, 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 1.5T |
| | T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil met the acceptance |
| | criteria and is adequate for this intended use. |