(33 days)
The TT1 General Purpose Coil is a receive-only diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Signa® 1.5T system. It is used for obtaining diagnostic images of a variety of small-to-medium sized anatomical regions, such as jaw, spine, neck, shoulder, thigh, foot, ankle and joints.
The TT1 General Purpose Coil is a linear receive-only coil for operation at a magnetic field strength of 1.5T with the GE Signa® 1.5T system. The coil is a single element coil consisting of a 3-inch diameter loop. Coupling of the coil to the transmitted field is prevented through an active blocking circuit.
The TT1 General Purpose Coil is specially designed for MR imaging of small-to-medium sized anatomical regions, such as jaw, spine, neck, shoulder, thigh, foot, ankle and joints. The coil provides optimum signal to noise ratio and coverage, allowing high-resolution imaging, while the sensitive region of the coil covers an approximately a 10 cm Field of View.
The TT1 General Purpose Coil is a magnetic resonance diagnostic device (a receive-only MR imaging coil) intended for use at 1.5T with the GE Signa® 1.5T system. It is used for obtaining diagnostic images of small-to-medium sized anatomical regions.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | The TT1 General Purpose Coil is a receive-only diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Signa® 1.5T system. It is used for obtaining diagnostic images of a variety of small-to-medium sized anatomical regions, such as jaw, spine, neck, shoulder, thigh, foot, ankle and joints. |
| Dimensions | Coil length - 3 inches, Coil width - 3 inches. Similar in weight to the predicate GE 3-inch General Purpose Coil. |
| Coil Architecture | Linear/Single channel receive-only for 1.5T operation. Housing Type - ABS plastic. Primary Decoupling - Active/PIN diode-enabled blocking circuitry. |
| Performance (SNR & Coverage) | Optimal Signal to Noise Ratio (SNR) and coverage allowing high-resolution imaging, while the sensitive region of the coil covers an approximately 10 cm Field of View. This is stated to be substantially equivalent to the predicate GE 3-inch General Purpose Coil which also has "Optimal Signal to Noise Ratio (SNR) and coverage and high resolution imaging". The other predicate, MRgFUS, has a 15 cm Field of View. |
| Safety | Compliance with IEC 60601-1 (medical electrical equipment safety), UL 94 (flammability of plastic materials), and NEMA MS-6 (characterization of special purpose coils for diagnostic MR images). A risk assessment (FMEA) was conducted. |
| Principles of Operation | Hydrogen nuclei excitation for imaging of the scanned organ. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Side by side comparison testing was conducted with the predicate device, GE 3-inch General Purpose Coil which demonstrated substantially equivalent performance." However, the exact sample size used for the test set (number of images, patients, or anatomical regions) is not specified.
The data provenance is also not explicitly stated. It is implied that the testing was conducted by the applicant, Tursiop Technologies, L.L.C., using their device and a commercially available predicate. Whether this involved human subjects, phantoms, or retrospective data is not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The study appears to be a technical comparison of coil performance (e.g., SNR, image quality) rather than a clinical study requiring expert interpretation of medical images for ground truth.
4. Adjudication Method for the Test Set:
This information is not provided. Given the nature of the device (an MR coil), an adjudication method for establishing ground truth in a diagnostic context is not directly applicable to the described performance testing. The comparison is focused on technical equivalence.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not conducted and is not relevant for this type of device submission. This submission focuses on the technical equivalence of an MR coil to existing predicate devices, not on the improvement of human reader performance with AI assistance.
6. Standalone Performance:
The "standalone performance" of the device, in terms of its ability to acquire images, is inherently what was tested. The document states that the TT1 General Purpose Coil demonstrated "substantially equivalent performance" in side-by-side comparison testing with a predicate device. This implies that the device, on its own (as a coil), met the expected performance characteristics for an MR imaging coil. There isn't a separate "algorithm only" component for this hardware device.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is established by comparison to a predicate device (the GE 3-inch General Purpose Coil) through "side by side comparison testing." This implies that the performance metrics (e.g., SNR, image quality, coverage) achieved by the TT1 coil were directly compared to those of the predicate. This is a form of technical equivalence ground truth rather than a clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set:
This information is not applicable as the TT1 General Purpose Coil is a hardware device (an MR coil) and does not involve AI or machine learning algorithms that require training sets.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this hardware device.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
A. GENERAL INFORMATION
| Classification Name | Magnetic Resonance Diagnostic Device (21 CFR 892.1000) | |
|---|---|---|
| Device Trade Name: | TTI General Purpose Coil | |
| Applicant's Name and Address: | Tursiop Technologies, LLC11000 Cedar Ave. Suite 280Cleveland OH 44106 | DEC 23 2008 |
| Submitter: | Raju ViswanathanChief Technology OfficerTursiop Technologies, LLC11000 Cedar Ave. Suite 280Telephone: (216) 658-4521Email: raju@tursiop.com |
B. INTENDED USE
The TT1 General Purpose Coil is a receive-only diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Signa® 1.5T system. It is used for obtaining diagnostic images of a variety of small-to-medium sized anatomical regions, such as jaw, spine, neck, shoulder, thigh, foot, ankle and joints.
C. DEVICE DESCRIPTION
The TT1 General Purpose Coil is a linear receive-only coil for operation at a magnetic field strength of 1.5T with the GE Signa® 1.5T system. The coil is a single element coil consisting of a 3-inch diameter loop. Coupling of the coil to the transmitted field is prevented through an active blocking circuit.
The TT1 General Purpose Coil is specially designed for MR imaging of small-to-medium sized anatomical regions, such as jaw, spine, neck, shoulder, thigh, foot, ankle and joints. The coil provides optimum signal to noise ratio and coverage, allowing high-resolution imaging, while the sensitive region of the coil covers an approximately a 10 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).
- UL 94; Tests for Flammability of Plastic Materials for parts in Devices and Appliance .
- . NEMA: MS-6 (2008) Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images
- NEMA Standardized 510(k) Pre-Market Notification Submission Template for RF Coil t Accessories Intended for Use with Magnetic Resonance Diagnostic Imaging Devices
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E. PREDICATE DEVICES
The TT1 General Purpose Coil 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 database. Tursiop Technologies LLC has conducted side by side testing between the TT1 General Purpose Coil and the GE 3-inch General Purpose Coil to verify substantial equivalence.
| Parameter | TT1 General Purpose Coil | Predicate Coil: GE 3-inch GeneralPurpose Coil | Predicate Coil: MRgFUS GeneralPurpose and Breast Coil (K061715) |
|---|---|---|---|
| Intended/Indications forUse | The TT1 General Purpose Coil isa receive-only diagnostic MRimaging coil designed for use at astatic magnetic field strength of1.5T with the GE Signa® 1.5Tsystem. It is used for obtainingdiagnostic images of a variety ofsmall-to-medium sizedanatomical regions, such as jaw,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. | The MRgFUS General Purpose andBreast Coil is a receive-only RF coildesigned for MR imaging of breastand auxiliary tissue and variousmedium sized anatomical regions suchas spine, neck, shoulder, thigh, foot,ankle and joints. MRgFUS is designedfor use with GE Signa (1.5T or 3.0T)MR Systems |
| Dimens | Coil length - 3 inchesCoil width - 3 inchesSimilar in weight | Coil length - 3 inchesCoil width - 3 inchesSimilar in weight | Coil length - 6.5 inchSimilar in size and weight |
| Coil Architecture | Linear/Single channel receive-only for 1.5T operation | Linear/Single channel receive-only for1.5T operation | Single channel receive-only for 1.5Tor 3.0T operation |
| Housing Type - ABS plastic | Housing Type - Fiberglass | n/a | |
| Primary Decoupling - Active/PINdiode-enabled blocking circuitry | Primary Decoupling - Active/PINdiode-enabled blocking circuitry | Active and Passive RF Decouplingcircuits | |
| Performance& Safety | IEC 60601-1Flammability UL 94NEMA MS6 | IEC 60601-1Flammability UL 94NEMA MS6 | IEC 60601-1Flammability UL 94NEMA MS6 |
| Principles 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 |
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fechnologic
haracteristic
Optimal Signal to Noise Ratio (SNR) and coverage allowing high-resolution imaging, while the sensitive region of the coil covers an approximately 10 cm Field of View.
Optimal Signal to Noise Ratio (SNR) and coverage and high resolution imaging
Optimal Signal to Noise Ratio (SNR) and coverage, allowing highresolution imaging, while the sensitive region of the coil covers an approximately 15 cm Field of View.
F. SAFETY AND EFFECTIVENESS
Tursiop Technologies, L.L.C will comply with FDA's GMPs and the TT1 General Purpose Coil does comply with voluntary standards for safety/effectiveness (IEC 60601, UL 94) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and flammability). A risk assessment (FMEA) has been conducted. Risk management practices will be utilized to assess potential risks throughout the device life cycle and mitigate unacceptable levels of risk.
Tursiop Technologies, L.L.C. has conducted testing to establish the safety and effectiveness concerning the TT1 General Purpose Coil. Side by side comparison testing was conducted with the predicate device, GE 3-inch General Purpose Coil which demonstrated substantially equivalent performance. The TT1 General Purpose Coil does not introduce any new potential safety risks and operates in a manner similar to the predicate devices.
G. SUBSTANTIAL EQUIVALENCE STATEMENT
The TT1 General Purpose Coil is substantially equivalent to the GE 3-inch General Purpose Coil and the MRgFUS General Purpose and Breast Coil (K061715).
This opinion is based on the fact that comparing the TT1 General Purpose Coil 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Bonlevard Rockville MD 20850
DEC 2 3 2008
Tursion Technologies LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 53313
Re: K083434
Trade/Device Name: TT1 General Purpose Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: December 6, 2008
Received: December 8, 2008
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
hoque In Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Koog 3434
Device Name: TT1 General Purpose Coil
Indications for Use: The TT1 General Purpose Coil is a receive-only diagnostic MR imaging coil designed for use at a static magnetic field strength of 1.5T with the GE Signa® 1.5T system. It is used for obtaining diagnostic images of a variety of small-to-medium sized anatomical regions, such as jaw, spine, neck, shoulder, thigh, foot, ankle and joints.
PrescriptionUse X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
§ 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.