(57 days)
No
The summary describes hardware components (coils, monitor) and their function in aiding real-time MR guidance. There is no mention of AI, ML, or any software features that would suggest the use of such technologies.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device aids in the performance of "therapeutic" procedures.
Yes
The device is used for obtaining "diagnostic images of the head and body regions" and is an "enhancement designed for use with the Hitachi Model Altaire Magnetic Resonance Diagnostic Device."
No
The device description explicitly states that the package consists of hardware components: an open head coil, an open body coil, and an MR compatible in room color monitor.
Based on the provided information, the Hitachi Model Altaire MR Interventional Package is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the Hitachi Model Altaire MR Interventional Package clearly states its purpose is to aid in surgical procedures performed on the head, body, and extremities, facilitated by real-time MR guidance. It's used for imaging and guiding interventions within the body, not for analyzing samples taken from the body.
- The device description focuses on imaging and guidance during procedures. The components are coils for obtaining images and a monitor for viewing those images during the procedure. This aligns with an imaging and interventional guidance system, not an IVD.
- The intended use is for surgical procedures. The description explicitly mentions "minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures." This is the domain of surgical and imaging devices, not IVDs.
Therefore, the Hitachi Model Altaire MR Interventional Package is a medical device used for imaging and guiding surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hitachi Model Altaire MR Interventional Package aids in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user.
Product codes
LNH
Device Description
The Hitachi Model Altaire Interventional MR Package is an optional enhancement designed for use with the Hitachi Model Altaire Magnetic Resonance Diagnostic Device (K050620). It's intended function and use is to aid to aid in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. (Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user).
The package consists of an open head coil, an open body coil and an MR compatible in room color monitor. The head and body coils are used for obtaining diagnostic images of the head and body regions, while the display monitor is used for in room review of the images during the interventional procedure(s). The head and body coils are compatible with existing Altaire hardware and software. Therefore no hardware or software modifications are needed to use these coils.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR guidance
Anatomical Site
head, body, and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical user
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 2 4 2006
510(k) SUMMARY
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44087-2371 Phone: (330) 425-1313 Fax: (330) 425-1410
- Contact Person: Doug Thistlethwaitc Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44087-2371 Phone: (330) 425-1313 Fax: (330) 425-1410
Date Prepared:November 15, 2005
Name of Device
Altaire MR Interventional Package
Common or Usual Name
MRI System
Classification Name
Magnetic Resonance Diagnostic Device
Predicate Device
Hitachi AIRIS II Magnetic Resonance Diagnostic Device Interventional MR Package (K984280)
(2005 Hitachi Medical Systems America, Inc.
Altaire Interventional MR Package
· ----
1
Intended Use
The Hitachi Model Altaire MR Interventional Package aids in the performance of minimally invasive, diagnostic, therapeutie, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. Such procedures mast be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user.
Device Description
The Hitachi Model Altaire Interventional MR Package is an optional enhancement designed for use with the Hitachi Model Altaire Magnetic Resonance Diagnostic Device (K050620). It's intended function and use is to aid to aid in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. (Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user).
The package consists of an open head coil, an open body coil and an MR compatible in room color monitor. The head and body coils are used for obtaining diagnostic images of the head and body regions, while the display monitor is used for in room review of the images during the interventional procedure(s). The head and body coils are compatible with existing Altaire hardware and software. Therefore no hardware or software modifications are needed to use these coils.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2006
Mr. Doug Thistlewaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087-2371
Re: K053309 Trade/Device Name: Hitachi Model Altaire MR Interventional Package Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 23, 2005 Received: November 28, 2005
Dear Mr. Thistlewaite:
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, listing 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 (Premarket Approval), 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.
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 oystams (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control organisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115 |
|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ 野 大 053307
Device Name: Hitachi Model Altaire MR Interventional Package
Indications for Use:
The Hitachi Model Altaire MR Interventional Package aids in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user.
Prescription Use 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Sayum
(Division Sign. Ora
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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