(55 days)
Not Found
No
The description focuses on automatic tuning and impedance matching, which are typically achieved through conventional control systems and algorithms, not AI/ML. There is no mention of AI, ML, or related concepts in the text.
No
The device is described as an interface box that automatically tunes and matches the impedance of an MRI probe to an MRI system for imaging purposes, not for treating a disease or condition.
No
This device is described as an "interface box" that "automatically tunes the Transesophageal (TE) Probe and matches the impedance of the probe to the interface of the MRI system." Its function is to facilitate the operation of an MRI system and its probes/coils, not to directly diagnose medical conditions or provide diagnostic information itself.
No
The device description explicitly mentions "Interface Box" and "interface cable," which are hardware components. The device's function is to interface and tune hardware (TE Probe and Surface Coil) to an MRI system, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly stated as "for high resolution Magnetic Resonance Imaging (MRI)." This is an imaging modality used for diagnostic purposes, but the device itself is a component of the imaging system, not a test performed on biological samples in vitro.
- Device Description: The description details how the device interfaces with an MRI system and tunes/matches the impedance of probes/coils. This is a technical function related to the operation of the MRI machine, not a diagnostic test performed on a patient's sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components associated with in vitro diagnostics.
The device is a component of an MRI system, which is a diagnostic imaging tool, but the device itself does not perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The intended use of the Illuminator™ Automatic Tune Interface Box and Interface Cable is for high resolution Magnetic Resonance Imaging (MRI). It is used in conjunction with the Magna-Lab TE Probe and Surface Coil.
Product codes (comma separated list FDA assigned to the subject device)
90 MOS
Device Description
The Illuminator™ Automatic Tuning Interface Box (ATIB) provides an interface for the Illuminator™ Transesophageal Probe, the Illuminator ™ Surface Coil and the General Electric 1.5 T Signa® Magnetic Resonance Imaging (MRI) Systems. The device automatically tunes the Transesophageal (TE) Probe and matches the impedance of the probe to the interface of the MRI system. The Auto Tune Interface Box will be used in clinical MRI rooms. The interface box interfaces with the GE MRI machine through a cable bundle with a 30 pin connector box attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical MRI rooms
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)
Magna-Lab has performed testing and/or analysis of the Interface Box. This testing includes the following: Imaging performance comparisons between the manual tune and auto tune interface units. Signal to Noise Comparisons Temperature Measurements
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
MAY 21 2002 Ko 20993
Premarket Notification - Illuminator™ Automatic Tune Interface Box
Page 1 of 2
510(k) Summary of Safety and Effectiveness
1. Sponsor Name
Magna-Lab, Inc. Six Kimball Lane, Suite 210 Lynnfield, MA 01940 Telephone: 781-246-4774 Contact Individual: John Geisel
-
- Device Name
Illuminator™ Automatic Tune Box and Interface Cable (ATIB)
- Device Name
Identification of Predicate or Legally Marketed Device 3.
The Automatic Tune Interface Box (ATIB) is substantially equivalent to the manual tune interface unit cleared under K010513 for the Transesophageal Probe and K010802 for the Surface Coil.
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Device Description 4.
The Illuminator™ Automatic Tuning Interface Box (ATIB) provides an interface for the Illuminator™ Transesophageal Probe, the Illuminator ™ Surface Coil and the General Electric 1.5 T Signa® Magnetic Resonance Imaging (MRI) Systems. The device automatically tunes the Transesophageal (TE) Probe and matches the impedance of the probe to the interface of the MRI system. The Auto Tune Interface Box will be used in clinical MRI rooms. The interface box interfaces with the GE MRI machine through a cable bundle with a 30 pin connector box attached. -
Intended Use 5.
The intended use of the Illuminator™ Automatic Tune Interface Box and Interface Cable is for high resolution Magnetic Resonance Imaging (MRI). It is used in conjunction with the Magna-Lab TE Probe and Surface Coil. -
Comparison of Technological Characteristics 6.
The manual tune box is replaced by the auto tune box and cable, and the design and materials have not changed in any substantial way.
Confidential
1
Kozorq93
Razeloff
Integrating the ATIB into the Illuminator™ Transesophageal Probe system does not alter or change its intended use. It is substantially equivalent to its predecessor, Transesophageal Probe (with manual tune box), the only difference being that the auto tune box automatically matches and simplifies the electrical impedance tuning process.
-
- Performance Testing
Magna-Lab has performed testing and/or analysis of the Interface Box. This testing includes the following:
- Performance Testing
-
Imaging performance comparisons between the manual tune and . auto tune interface units.
-
Signal to Noise Comparisons ●
-
Temperature Measurements ●
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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ood and Drug Administ 0 Corporate Boulevard Rockville MD 20850
Mr. John R. Geisel Chief Executive Officer Magna-Lab, Inc. Six Kimball Lane, Suite 210 LYNNFIELD MA 01940
Re: K020993 Trade/Device Name: Illuminator™ Automatic Tune Box and Interface Cable (ATIB) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: March 22, 2002 Received: March 27, 2002
Dear Mr. Geisel:
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 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 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.
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3
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2 。
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510(k) Number (if known):
Device Name:
Illuminator™ Automatic Tune Box and Interface Cable (ATIB)
Indications For Use:
The intended use of the Illuminator™ Automatic Tune Interface Box and Interface Cable is for high resolution Magnetic Resonance Imaging (MRI). It is used in conjunction with the Magna-Lab TE Probe and Surface Coil.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
David A. Nyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
OR
Confidential