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.

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.

AI/ML Overview

The provided document (K020268) is a 510(k) summary for the ISAAC 1.5 T MR System. Based on the content, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a table with specific thresholds for performance metrics. Instead, it refers to compliance with NEMA performance standards as the basis for demonstrating substantial equivalence. The reported "performance" is that the device was tested to and complies with these standards.

Acceptance Criteria (Implicit)	Reported Device Performance
Compliance with appropriate NEMA performance standards	"Testing to the appropriate NEMA performance standards was carried out and reported in this 510(k)."
Operating in Normal Operating Mode for static field level, dB/dt, and SAR according to proposed revision of IEC 601-2-33 standard	"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."
Acoustic noise within 99 dBA limit specified in IEC standard	"The acoustic noise is well within the 99 dBA limit specified in the IEC standard."

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on a "test set" in the context of clinical image data used for algorithm evaluation. The testing referenced is related to NEMA performance standards, which typically involve phantom studies and hardware performance measurements, not clinical image analysis. Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not available.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable and not provided. The submission focuses on demonstrating substantial equivalence to a predicate MR system based on technological characteristics and NEMA performance testing of the hardware, not on the performance of an AI algorithm or a diagnostic interpretation by experts. The "ground truth" for the NEMA standards is the physical correctness of the MR system's output based on defined metrics. The intended use states that "When interpreted by a trained physician, these images provide information that can be useful in determining an diagnosis," but this refers to the end-user interpretation, not a part of the device's substantial equivalence testing for this 510(k).

4. Adjudication Method for the Test Set

This information is not applicable and not provided. No clinical test set requiring expert adjudication is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done or reported in this 510(k). This submission is for an MR imaging system itself, not an AI-based diagnostic aid that would improve human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done or reported. The device is a Magnetic Resonance Diagnostic Device, an imaging system, not an algorithm, and it explicitly requires interpretation "by a trained physician."

7. The Type of Ground Truth Used

For the NEMA performance standards testing, the "ground truth" is based on physical and engineering specifications and measurements from the MR system, rather than clinical ground truth like pathology or expert consensus. The device's output (images) is evaluated against these engineering and physics-based criteria.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The ISAAC 1.5 T MR System is a hardware imaging device, not an AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as there is no training set for an AI algorithm.

Summary

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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.

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.

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INTENDED USE C.

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.

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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

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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 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

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STATEMENT OF INDICATIONS FOR USE

K020268 510(k) Number (if known):

ISAAC 1.5 T MR System Device Name:

Indications For Use:

(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

000003

Thrist G. Sypor
(Division Sign-Off)

(Division Sign-On)
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number K020268

Regulation Number and Section

N/A