(90 days)
Not Found
No
The summary describes a standard MRI system and does not mention any AI or ML capabilities in the intended use, device description, or specific sections for AI/ML mentions.
No.
The device is described as an imaging system intended for diagnostic use and provides information to aid in determining a diagnosis, rather than treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for general diagnostic use" and that the images produced "provide information that can be useful in determining a diagnosis."
No
The device description explicitly states it is a "whole-body MR system, utilizing a superconducting magnet operating at 1.5 T" and includes hardware components like coils and a gradient coil. This is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "general diagnostic use" and produces images that are "useful in determining an diagnosis" when interpreted by a trained physician. This describes an in vivo diagnostic process (examining the body directly), not an in vitro process (examining samples outside the body).
- Device Description: The description details a whole-body MRI system, which is used to image the inside of a living patient.
- Input Imaging Modality: Magnetic Resonance Imaging (MRI) is an in vivo imaging technique.
- Anatomical Site: Whole-body imaging is an in vivo process.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ISAAC 1.5 T MR System is a 1.5 T whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique planes may be imaged. MRI images produced by the ISAAC system reflect the spatial distribution of the density of hydrogen nuclei (protons), spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in determining an diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The ISAAC 1.5 T MR System is a new clinical whole-body MR system, utilizing a superconducting magnet operating at 1.5 T. A variety of pulse sequences are available as described in Section II. The system is provided with transmit/receive head and body coils, along with several receive-only specialty coils. The system utilizes an actively shielded gradient coil.
In regard to saffety, the system always operates in the Normal Operating Mode for static field level, dB/dt and SAR, according to the proposed revision of the IEC 601-2-33 standard. The acoustic noise is well within the 99 dBA limit specified in the IEC standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
whole-body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician
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)
Testing to the appropriate NEMA performance standards was carried out and reported in this 510(k). These data do, in fact, demonstrate equivalence.
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.
K971684, K971246, K010946, K964531, K972205, K982340, K980157
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
K020268
APR 2 5 2002
510(k) Summary
ISAAC 1.5 T MR System
Common/Classification Name: Magnetic Resonance Diagnostic Device 21 CFR 892.1170
CHI. Inc. 104-10, Mun-Ji-Dong Yu-Seong-Gu, TaeJon KOREA
Telephone: +82-42-863-6341 FAX No.: +82-42-863-6343
Contact: Henry Jang, Prepared: January 16, 2002
LEGALLY MARKETED PREDICATE DEVICES A.
The CHI 1.5 T MR System is substantially equivalent to the Siemens Magnetom Symphony. The applicant believes that the device now called the Symphony is the same as the Siemens Magnetom Project 047, cleared by FDA as K971684 on August 5, 1997.
In regard to the six receive-only specialty coils, they are substantially equivalent to the similar coils manufactured by USA Instruments. These were cleared for marketing under the following 510(k)s: K971246 (knee coil), K010946 (shoulder coil), K964531 (neck coil), K972205 (wrist coil), K982340, and K980157 (CTL coil).
DEVICE DESCRIPTION B.
The ISAAC 1.5 T MR System is a new clinical whole-body MR system, utilizing a superconducting magnet operating at 1.5 T. A variety of pulse sequences are available as described in Section II. The system is provided with transmit/receive head and body coils, along with several receive-only specialty coils. The system utilizes an actively shielded gradient coil.
In regard to saffety, the system always operates in the Normal Operating Mode for static field level, dB/dt and SAR, according to the proposed revision of the IEC 601-2-33 standard. The acoustic noise is well within the 99 dBA limit specified in the IEC standard.
1
INTENDED USE C.
The ISAAC 1.5 T MR System is a 1.5 T whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique planes may be imaged. MRI images produced by the ISAAC system reflect the spatial distribution of the density of hydrogen nuclei (protons), spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in determining an diagnosis.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The ISAAC 1.5 T MR System is a medical device, and it has the same indications for use and target population as the legally marketed predicate device. The ISAAC 1.5 T MR System has the same technological characteristics as the predicate devices. A comparison of the descriptive characteristics may not be sufficiently precise to assure substantial equivalence, so for those characteristics, performance data are provided to assure equivalence. These data do, in fact, demonstrate equivalence.
E. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the ISAAC 1.5 T MR System are the same as for the predicate device.
F. TESTING
Testing to the appropriate NEMA performance standards was carried out and reported in this 510(k).
G. CONCLUSIONS
This pre-market notification has demonstrated Substantial Equivalence as defined and understood in Sections 513(f)(1) and 513(i)(1) of the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2002
Chi. Inc. % T. Whit Athey, Ph.D. CL McIntosh & Associates 12300 Twinbrook Parkway Suite 230 ROCKVILLE MD 20852
Re: K020268
Trade/Device Name: ISAAC 1.5 T MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: 90 LNH Dated: January 25, 2002 Received: January 25, 2002
Dear Dr. Athey:
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 (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.
મહુર
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 vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
K020268 510(k) Number (if known):
ISAAC 1.5 T MR System Device Name:
Indications For Use:
The ISAAC 1.5 T MR System is a 1.5 T whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique planes may be imaged. MRI images produced by the ISAAC system reflect the spatial distribution of the density of hydrogen nuclei (protons), spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in determining an diagnosis.
(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)
OR
Over-The-Counter Use
000003
Thrist G. Sypor
(Division Sign-Off)
(Division Sign-On)
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number K020268