The NSM-S15 product is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by MRI system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, 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 diagnosis determination.

The indications for use are as follows:
Anatomical Region: Head, Shoulder, Breast, Wrist, Body, Spine, Knee, Extremities
Nucleus excited: Proton
Diagnostic uses: T1, T2, proton density weighted imaging, Diffusion weighted imaging, MR Angiography, Imaging processing
Imaging capabilities: Spin Echo (SE and 3D SE), Fast Field Echo (FFE and 3D FFE), Inversion Recovery (IRFFE, IRSE), T1-FFE, T2-FFE, N-FFE (2D and 3D), IR prepared T1-FFE3D, Dual Echo (DE) and Dual Spin Echo (DSE), Dual Fast Field Echo (DFFE), Turbo Spin Echo (TSE, 2D and 3D), Single-shot TSE, Dual Contrast Turbo Spin Echo (DTSE), Driven Equilibrium Turbo Spin Echo, IR TSE T2, Balance Fast Field Echo (B-FFE and 3D B-FFE), Diffusion-Weighted Imaging with DWISE and Fast DWISE, Echo Planar Imaging (EPI)

Device Description

The NSM-S15 product is a 1.5T superconducting magnet MRI system. The operating software based on Windows XP. The system software is an interactive program with user-friendly interface. Its functions cover scanning control, image reconstruction and image/archive management and maintenance.

AI/ML Overview

The provided text describes a 510(k) submission for the Neusoft NSM-S15 MRI System. The key information regarding acceptance criteria and supporting studies is:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" typically associated with clinical performance metrics of an AI/software device (e.g., sensitivity, specificity, AUC). Instead, the submission focuses on establishing substantial equivalence to predicate devices. The "acceptance criteria" can be inferred as meeting the safety and effectiveness requirements of the predicate devices.

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Summary of Findings)
Performance equivalent to predicate devices	Evaluated for performance and found substantially equivalent to MAGNETOM ESSENZA (K071925) and Superstar 0.35T (K071154).
Biocompatibility equivalent to predicate devices	Evaluated for biocompatibility and found substantially equivalent to MAGNETOM ESSENZA (K071925) and Superstar 0.35T (K071154).
Electrical, mechanical, chemical safety equivalent to predicate devices	Evaluated for electrical, mechanical, chemical safety and found substantially equivalent to MAGNETOM ESSENZA (K071925) and Superstar 0.35T (K071154).
Intended uses align with predicate devices	Intended uses for providing physiological and clinical information, producing transverse, coronal, sagittal, oblique, and curved cross-sectional images of various anatomical regions, reflecting NMR properties, and being useful in diagnosis determination by a trained physician, were found comparable to predicate devices.
Technology similar to predicate devices	A 1.5T superconducting magnet MRI system, similar to predicate devices in technology (e.g., Gradient Subsystem, RF Subsystem, image reconstruction, 2D/3D imaging, traditional MRI unit).

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

Sample Size for Test Set: Not applicable/Not specified.
Data Provenance: Not applicable.

The submission states, "b. Clinical test: No clinical test conducted." This means no human subjects or patient data (retrospective or prospective) were used for a specific clinical test to evaluate the device's diagnostic performance against a ground truth. The evaluation was primarily non-clinical, focusing on substantial equivalence to existing MRI systems.

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

Not applicable, as no clinical test was conducted with a test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test was conducted.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was conducted. The document explicitly states "No clinical test conducted."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is an MRI system (hardware and software), not an AI algorithm that provides standalone diagnostic assessments. Its performance is inherent to its imaging capabilities, which were compared to predicate MRI systems.

7. Type of Ground Truth Used:

Not applicable, as no clinical test was conducted to evaluate diagnostic performance against a specified ground truth. The "ground truth" for this submission would be the established safety and performance characteristics of the predicate MRI devices.

8. Sample Size for the Training Set:

Not applicable. This is an MRI system, not a machine learning algorithm requiring a 'training set' in the typical sense. Its operating software is based on Windows XP and is described as an interactive program for scanning control, image reconstruction, and image/archive management. The "training" in this context refers to the engineering and development of the system to meet its specifications, rather than a data-driven machine learning training process.

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

Not applicable, for the same reasons as above. The system's functionality is developed and validated through engineering standards and comparison to established MRI technology.

Summary

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Neusoft

SEP O Y 2009

K092237 1/2
510(k)

Attachment 1

Summary of Safety and Effectiveness

Page 1 of 2

. . .

............................................................................................................................................................................

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

General Information:Product Name:	NSM-S15 MRI System
Product Model:	NSM-S15
CFR Section:	21 CFR Part 892.1000Magnetic resonance diagnostic device
Classification Name:	System, Magnetic Resonance Imaging
Product Code:	LNH
Device Class:	Class II
Applicable Standard:	IEC60601-1, Medical electrical equipment - Part 1: GeneralRequirements for SafetyIEC60601-2-33, Medical electrical equipment - Part 2-33: Particularrequirements for the safety of magnetic resonance equipment formedical diagnosis21 CFR Subchapter J, Radiological HealthIEC60825-1, Safety of laser products-PartI :Equipment classification,requirement and user's guideDICOM 3.0NEMA MS Series (MS1 - MS9)
Manufacturer:	PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD.Neusoft Park, Hun Nan Industrial Area, Shenyang 110179,P.R.China
Distributor:	NEUSOFT MEDICAL SYSTEMS CO., LTD.No. 16, Shiji Road, Hunnan Industrial Area,Shenyang,Liaoning,China, 110179
Submitter:	Contact : TianyuehuiTitle : Manager of Quality Management DepartmentTel : 86-24-83660646Fax : 86-24-83660563E-Mail : Tianyh@neusoft.comSummary prepared : June 17, 2009

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2/2

510(k)

Page 2 of 2

Safety and Effectiveness information

Intended Uses:

Device Description:

Predicated Device:

K071925: MAGNETOM ESSENZA K071154: Superstar 0.35T

Statement of Substantial Equivalence:

The NSM-S15 product is a 1.5T superconducting magnet MRI system. It is comparable and substantially equivalent to the MAGNETOM ESSENZA (K071925) and Superstar 0.35T (K071154) in that they are similar in technology and intended uses. Both of these systems use Gradient Subsystem to provide controlled and uniform gradient magnet fields in the X, Y and Z planes, and use RF Subsystem to complete the function of RF signal transmitting/receiving and processing. Image reconstruction is controlled by console' s computer that has an interactive user interface, and the system produces 2D and 3D image that can be filmed or electronically stored for future review. Both of these systems have the traditional MRI unit.

a. Non-clinical test: The device has been evaluated for performance, biocompatibility and effectiveness as well as electrical, mechanical, chemical , biocompatibility safety and has been found to substantially equivalent to MAGNETOM ESSENZA and Superstar 0.35T.
b. Clinical test: No clinical test conducted.
c. Conclusion: The device was evaluated against MAGNETOM ESSENZA (K071925) and Superstar 0.35T(K071154) for all performance, safety & effectiveness requirements. According to the comparison based on the requirements of 21.CFR 807.87, we state that these devices are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

SEP 0 4 2009

Neusoft Medical Systems Co., Ltd. % Mr. Tamas Borsai TUV Rheinland of North America, Inc. 12 Commerce Road NEWTON CT 06470

Re: K092237

Trade/Device Name: NSM-S15 MRI System Regulation Number: 21 CFR 892:1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 20, 2009 Received: August 25, 2009

Dear Mr. Borsai:

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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 100-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHODRHOPfices/ucm1118800.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, Jease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Paca 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrb/indr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 the (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Neusoft

Attachment 2

Indications for Use

510(k) Number:

Page 1 of 1

Device Name: NSM-S15 MRI System

The NSM-S15 product is an imaging device, and is intended to provide the physician with physiological and clinical information obtained non-invasively and without the use of ionizing radiation. The MRI system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by MRI system reflect the spatial i distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T) ), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The indications for use are as follows:

Anatomical Region:	Head, Shoulder, Breast, Wrist, Body, Spine, Knee, Extremities
Nucleus excited:	Proton
Diagnostic uses:	T1, T2, proton density weighted imagingDiffusion weighted imagingMR AngiographyImaging processing
Imaging capabilities:	Spin Echo (SE and 3D SE)Fast Field Echo (FFE and 3D FFE)Inversion Recovery (IRFFE, IRSE)T1-FFE, T2-FFE, N-FFE (2D and 3D)IR prepared T1-FFE3DDual Echo (DE) and Dual Spin Echo (DSE)Dual Fast Field Echo (DFFE)Turbo Spin Echo (TSE, 2D and 3D)Single-shot TSEDual Contrast Turbo Spin Echo (DTSE)Driven Equilibrium Turbo Spin EchoIR TSE T2Balance Fast Field Echo (B-FFE and 3D B-FFE)Diffusion-Weighted Imaging with DWISE and Fast DWISEEcho Planar Imaging (EPI)

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Prescription Use: YES

Neusoft

ー

(Part 21 CFR 80! Subpart D)

Over-The-Counter Use: NO

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF DEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aom Mitz

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K092237 510(k) Number --

Regulation Number and Section

§ 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.