(16 days)
The Carotid Coil GE1.5T is a receive-only 2-channel diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Twinspeed HDx 1.5T MRI scanner/system. It is used for obtaining diagnostic images of the carotid arteries in the region of the neck and lower cranium.
The Carotid Coil GE1.5T is a receive-only 2-channel coil for operation at a magnetic field strength of 1.5T with the GE Twinspeed HDx system. The coil is a two-element coil consisting of two independent rectangular loops, each of approximate size 7 cm x 4.5 cm. Coupling of either coil element to the transmitted field is prevented through respective active blocking circuits. The Carotid Coil GE1.5T is specially designed for MR imaging of the carotid arteries in the region of the neck and lower cranium. The coil provides optimum signal to noise ratio and coverage in the area of the carotid arteries, allowing high-resolution imaging, while the sensitive region of the coil covers an approximately 7 cm Field of View.
The provided document is a 510(k) premarket notification for a medical device called "Carotid Coil GE1.5T". This document describes the device, its intended use, and its substantial equivalence to predicate devices, in accordance with FDA regulations.
However, it does not contain information about a study proving the device meets specific acceptance criteria in terms of diagnostic performance or clinical effectiveness. The "Performance Testing & Standards" section and "Safety and Effectiveness" section focus on compliance with electrical, mechanical, flammability, and biocompatibility standards, and a side-by-side comparison for substantial equivalence, rather than a clinical study with outcome-based acceptance criteria regarding diagnostic accuracy.
Therefore, the requested information elements related to diagnostic performance, ground truth, sample sizes for test/training sets, expert involvement, and MRMC studies are not available in this document.
Here's a breakdown of what is available and what is not:
Description of the Acceptance Criteria and Device Performance (Limited to Safety and Equivalence)
The acceptance criteria for the Carotid Coil GE1.5T, as described in this 510(k) summary, are primarily centered around safety and substantial equivalence to legally marketed predicate devices, rather than specific diagnostic accuracy metrics. The device's "performance" in this context refers to its ability to function safely and similarly to existing technology.
Acceptance Criteria for Safety and Effectiveness (as inferred from the document):
- Compliance with Safety Standards: The device must meet international and national safety standards for medical electrical equipment, flammability, and biocompatibility.
- Substantial Equivalence in Performance: The device must demonstrate performance that is substantially equivalent to predicate devices in terms of image quality capabilities (e.g., Signal-to-Noise Ratio (SNR), coverage, allowing high-resolution imaging suitable for the intended use).
- No New Potential Safety Risks: The device should not introduce any new or unacceptable safety risks compared to the predicate devices.
Reported Device Performance (against the inferred criteria):
- Safety Compliance: Tursiop Technologies, LLC states compliance with:
- IEC 60601-1 (1988) with amendments (Medical electrical equipment safety)
- IEC 60601-2-33 (2006) (Safety of magnetic resonance equipment)
- UL 94 (Tests for Flammability of Plastic Materials)
- ISO 10993-1 (2009) (Biological evaluation of medical devices)
- NEMA MS-6 (2008) (Characterization of Special Purpose Coils)
- NEMA MS-9 (2008) (Characterization of Phased Array Coils)
- ISO 13485-certified for design and manufacture.
- Risk assessment (FMEA) procedures utilized to mitigate risks.
- Patient contacting surface material (polycarbonate with biocompatible paint) is safe.
- "The Carotid Coil GE1.5T does not introduce any new potential safety risks."
- Substantial Equivalence (Performance Aspect):
- "Side by side comparison testing was conducted with one of the predicate devices, GE 3-inch General Purpose Coil which demonstrated substantially equivalent performance."
- The Carotid Coil GE1.5T offers "Optimal Signal to Noise Ratio (SNR) and coverage allowing high-resolution imaging, while the sensitive region of the coils covers an approximately 7 cm Field of View." (This is compared to predicate devices also claiming optimal SNR, coverage, and high-resolution imaging, though with slightly different FOV specifications for one predicate).
Table of Acceptance Criteria and Reported Device Performance
| Feature/Criteria | Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance |
|---|---|---|
| Safety - Electrical, Mechanical, Flammability | Compliance with IEC 60601-1 & IEC 60601-2-33, UL 94. | Device complies with IEC 60601-1, IEC 60601-2-33, UL 94. |
| Safety - Biocompatibility | Compliance with ISO 10993-1. Patient contact materials are biocompatible. | Device complies with ISO 10993-1. Patient contacting surface is polycarbonate painted with biocompatible paint. |
| Safety - Risk Management | ISO 13485 certification, risk assessment (FMEA) to minimize hazards. | Tursiop Technologies, LLC is ISO 13485-certified. Risk assessment (FMEA) procedures utilized to assess and mitigate potential risks. |
| Performance - Image Quality (SNR, Resolution) | Optimal SNR, coverage, allowing high-resolution imaging, substantially equivalent to predicate. | Optimal Signal to Noise Ratio (SNR) and coverage allowing high-resolution imaging, with sensitive region covering approximately 7 cm Field of View. Demonstrated "substantially equivalent performance" in side-by-side testing with GE 3-inch General Purpose Coil. |
| Operational Safety | Does not introduce new potential safety risks compared to predicate. | "The Carotid Coil GE1.5T does not introduce any new potential safety risks and operates in a manner similar to the predicate devices." |
| Technical Characteristics (RF Coil Specific) | Compliance with NEMA MS-6, NEMA MS-9. | Device complies with NEMA MS-6, NEMA MS-9. |
| Principle of Operation | Hydrogen nuclei excitation for imaging of the scanned organ. | Uses hydrogen nuclei excitation for imaging, same as predicate devices. |
Information Not Available / Not Applicable for this Device Type and Submission:
This 510(k) submission primarily addresses the substantial equivalence of a medical device accessory (an MRI coil) based on technical, safety, and performance characteristics compared to existing devices. It is not a clinical study to evaluate diagnostic accuracy outcomes of an AI-powered diagnostic algorithm. Therefore, the following requested information is not present or relevant to this document:
- Sample size used for the test set and the data provenance: Not applicable. The "testing" referred to is engineering and side-by-side comparison for equivalence, not a clinical diagnostic performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for diagnostic accuracy was established in this context.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size of human readers improve with AI vs without AI assistance: Not applicable. This is an MRI coil, not an AI diagnostic software.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. No AI model training is described.
- How the ground truth for the training set was established: Not applicable.
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NOV 23 2011
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
A. GENERAL INFORMATION
| Classification Name | Magnetic Resonance Diagnostic Device (21 CFR 892.1000) | |
|---|---|---|
| Device Trade Name: | Carotid Coil GE1.5T | |
| Applicant's Name and Address: | Tursiop Technologies, LLC11000 Cedar Ave. Suite 280Cleveland OH 44106 | |
| Submitter: | Raju ViswanathanChief Technology OfficerTursiop Technologies, LLC11000 Cedar Ave. Suite 280 | |
| Telephone: (216) 658-4521Email: raju@tursiop.com |
B. INTENDED USE
The Carotid Coil GE1.5T is a receive-only 2-channel diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Twinspeed HDx 1.5T MRI scanner/system. It is used for obtaining diagnostic images of the carotid arteries in the neck and lower cranium.
C. DEVICE DESCRIPTION
The Carotid Coil GE1.5T is a receive-only 2-channel coil for operation at a magnetic field strength of 1.5T with the GE Twinspeed HDx system. The coil is a two-element coil consisting of two independent rectangular loops, each of approximate size 7 cm x 4.5 cm. Coupling of either coil element to the transmitted field is prevented through respective active blocking circuits.
The Carotid Coil GE1.5T is specially designed for MR imaging of the carotid arteries in the region of the neck and lower cranium. The coil provides optimum signal to noise ratio and coverage in the area of the carotid arteries, allowing high-resolution imaging, while the sensitive region of the coil covers an approximately 7 cm Field of View.
D. PERFORMANCE TESTING & STANDARDS
- IEC 60601-1 (1988): Medical electrical equipment Part 1: General requirements for safety, . including Amendment 1 (1991) and Amendment 2 (1995).
- . IEC 60601-2-33 (2006): Medical electrical equipment-Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
- . UL 94; Tests for Flammability of Plastic Materials for parts in Devices and Appliance
- . ISO 10993-1 (2009): Biological evaluation of medical devices-Evaluation and testing within a risk management process
- . NEMA: MS-6 (2008) Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images
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- . NEMA: MS-9 (2008) Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
- . NEMA Standardized 510(k) Pre-Market Notification Submission Template for RF Coil Accessories Intended for Use with Magnetic Resonance Diagnostic Imaging Devices
E. PREDICATE DEVICES
The Carotid Coil GE1.5T is substantially equivalent to the predicate devices. The table below identifies similarities between the devices. Although the GE 3-inch General Purpose Coil is in commercial distribution it is not included in the FDA 510(k) database and/or has been purged from the FDA PMA Tursiop Technologies LLC has conducted side by side testing between the Carotid Coil database. GE1.5T and the GE 3-inch General Purpose Coil to verify substantial equivalence.
| Parameter | Carotid Coil GE1.5T | TT1 General Purpose Coil(K083434) | Predicate Coil: GE 3-inch GeneralPurpose Coil |
|---|---|---|---|
| d/Indications forUseInt. | The Carotid Coil GE1.5T is areceive-only 2-channel diagnosticMR imaging coil designed for useat a static magnetic field strength of1.5T with the GE Twinspeed HDx1.5T MRI scanner/system. It is usedfor obtaining diagnostic images ofthe carotid arteries in the region ofthe neck and lower cranium. | The TT1 General Purpose Coil is areceive-only diagnostic MR imagingcoil designed for use at a staticmagnetic field strength of 1.5T withthe GE Signa® 1.5T system. It isused for obtaining diagnostic imagesof a variety of small-to-mediumsized anatomical regions, such asjaw, spine, neck, shoulder, thigh,foot, ankle and joints. | The GE 3-inch General Purpose Coilis a receive-only RF coil designed for1.5T MR imaging of variousanatomical regions, such as jaw, spine,neck, shoulder, thigh, foot, ankle andjoints. |
| Dimensions | Dimensions of each channelelement:Coil length - 7 cmCoil width - 4.5 cmSimilar in weight | Coil length - 7.5 cmCoil width - 7.5 cmSimilar in weight | Coil length - 7.5 cmCoil width – 7.5 cmSimilar in weight |
| Coil Architecture | Two channel receive-only for 1.5ToperationHousing Type - Polycarbonate | Single channel receive-only for 1.5ToperationHousing Type - ABS plastic | Single channel receive-only for 1.5ToperationHousing Type - Fiberglass |
| Primary Decoupling - Active/PINdiode-enabled blocking circuitry foreach channel | Primary Decoupling - Active/PINdiode-enabled blocking circuitry | Primary Decoupling - Active/PINdiode-enabled blocking circuitry | |
| Performance& Safety | IEC 60601-1, IEC60601-2-33Flammability UL 94, ISO 10993-1,NEMA MS6, NEMA MS9 | IEC 60601-1, IEC60601-2-33Flammability UL 94, ISO 10993-1,NEMA MS6 | IEC 60601-1, IEC60601-2-33Flammability UL 94, ISO 10993-1,NEMA MS6 |
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| Principle ofOperation | Hydrogen nuclei excitation forimaging of the scanned organ | Hydrogen nuclei excitation forimaging of the scanned organ | Hydrogen nuclei excitation forimaging of the scanned organ |
|---|---|---|---|
| TechnologicalCharacteristics | Optimal Signal to Noise Ratio(SNR) and coverageallowing high-resolution imaging,while the sensitive region of thecoil covers an approximately 7 cmField of View. | Optimal Signal to Noise Ratio(SNR) and coverageallowing high-resolution imaging,while the sensitive region of the coilcovers an approximately 10 cm Fieldof View. | Optimal Signal to Noise Ratio(SNR) and coverage and highresolution imaging |
F. SAFETY AND EFFECTIVENESS
Tursiop Technologies, LLC complies with FDA's GMPs and is ISO 13485-certified for the design and manufacture of magnetic resonance imaging coils. The Carotid Coil GE1.5T complies with voluntary standards for safety/effectiveness (IEC 60601, UL 94, ISO 10993-1) all of which mandate that relevant components are tested to minimize hazards (electrical, mechanical, flammability, biocompatibility). The patient contacting surface is polycarbonate painted with biocompatible paint. ISO-mandated risk management practices have been utilized to assess potential risks throughout the device life cycle to mitigate unacceptable levels of risk by conducting risk assessment (FMEA) procedures.
Tursiop Technologies, LLC has conducted testing to establish the safety and effectiveness concerning the Carotid Coil GE1.5T. Side by side comparison testing was conducted with one of the predicate devices, GE 3-inch General Purpose Coil which demonstrated substantially equivalent performance. The Carotid Coll GE1.5T does not introduce any new potential safety risks and operates in a manner similar to the predicate devices.
G. SUBSTANTIAL EQUIVALENCE STATEMENT
The Carotid Coil GE1.5T is substantially equivalent to the GE 3-inch General Purpose Coil and the TT1 General Purpose Coil (K083434).
This opinion is based on the fact that comparing the Carotid Coil GE1.5T technological characteristics, coil architecture and operating principles with that of the predicate devices reveals that the devices comply with the same or equivalent standards and have the same or equivalent intended uses.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Tursiop Technologies LLC. Mr. Mark Job Responsible Third Party Official % Regulatory Technology Services, LLC. 1394 25th Street NW BUFFALO MN 55313
NOV 2 3 2011
Re: K113280
Trade/Device Name: Carotid Coil GE 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 4, 2011 Received: November 7, 2011
Dear Mr. Job:
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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): K113280
Device Name: Carotid Coil GE1.5T
Indications for Use:
The Carotid Coil GE1.5T is a receive-only 2-channel diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Twinspeed HDx 1.5T MRI scanner/system. It is used for obtaining diagnostic images of the carotid arteries in the region of the neck and lower cranium.
Prescription Use x x AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Markel D'Oyle
sion Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) 113280
§ 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.