(55 days)
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.
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.
The document provided describes a 510(k) premarket notification for the Illuminator™ Automatic Tune Box and Interface Cable (ATIB). The focus of the submission is on demonstrating substantial equivalence to a predicate device, rather than proving novel efficacy through extensive clinical studies and acceptance criteria in the way a new drug or high-risk medical device might.
Based on the provided text, here's a breakdown of the requested information, with limitations noted due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in the format typically seen for algorithm performance (e.g., target specificity, sensitivity, or AUC). Instead, the performance testing focuses on demonstrating equivalency of the new automatic tuning box to the previously cleared manual tune box.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Imaging Performance | Equivalent to manual tune box | Comparable to manual tune box |
| Signal to Noise | Equivalent to manual tune box | Comparable to manual tune box |
| Temperature | Safe operation | Data collected (implied safe) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the testing or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Magna-Lab has performed testing and/or analysis of the Interface Box." This suggests internal testing without a explicitly defined "test set" in the context of a large-scale clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The concept of "ground truth" and expert consensus in the clinical interpretation sense (e.g., radiologists reviewing images) is not applicable or discussed for this device. The performance testing appears to be technical in nature, comparing physical characteristics like imaging quality, signal-to-noise ratio, and temperature, which would likely be evaluated by engineers or physicists.
4. Adjudication Method for the Test Set
Not applicable. The testing described is technical comparison, not a diagnostic assessment requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The device is an automatic tuning interface box, not a diagnostic algorithm that assists human readers in interpreting medical images. Therefore, an effect size of human improvement with or without AI assistance is not relevant or measurable in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is an "automatic tune box," implying its operation is standalone in tuning the probe. However, the performance testing described is not an "algorithm-only" study in the sense of an AI model's diagnostic accuracy. It's about the physical and electrical performance of the new automatic mechanism compared to the old manual one.
7. Type of Ground Truth Used
The "ground truth" for the performance testing would be objective technical measurements related to MRI image quality (e.g., contrast, resolution, artifacts) and signal characteristics (e.g., SNR values) and temperature readings, all compared against baseline measurements from the manual tune box. It is not expert consensus, pathology, or outcomes data in a clinical diagnostic sense.
8. Sample Size for the Training Set
No training set is mentioned or applicable. The device is a hardware interface, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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
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- 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
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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.
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- 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 ●
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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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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
§ 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.