SCEPTRE-VS

• K Number: K021314
• Device Name: SCEPTRE-VS
• Manufacturer: HITACHI MEDICAL SYSTEMS AMERICA, INC.
• Date Cleared: 2002-07-02 ( 68 days)
• Product Code: LLZ
• Regulation Number: 892.2050
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: N/A
• Predicate For: K042428

Intended Use

The intended use of the SCEPTRE-VS is to review, process, film and store multi-modality images acquired from other diagnostic imaging systems or workstations.

Device Description

The SCEPTRE-VS is a workstation/server consisting of a computer, keyboard, mouse, monitor, network interface ;optional storage device(s) such as magneto-optical disk ,compact disk amd magnetic tape; and optional film digitizer. The computer workstation is PC based utilizing the latest Intel Pentium technology. The operating system is Windows 2000/XP. The Sceptre-VS workstation is used to store, process, view and print diagnostic medical images from diagnostic imaging systems conforming to DICOM 3.0 including x-ray, MRI, CT, PET, Nuclear Medicine and Ultrasound. Several proprietary image formats can also be accomodated. The optional Fusion 7D fusion module can be used for fusion of 2 modalities such as CT/PET, MRI/PET to provide crossmodality comparison.

AI/ML Overview

This 510(k) summary (K021314) describes the SCEPTRE-VS, a PACS workstation/server intended for reviewing, processing, filming, and storing multi-modality images. The provided document does not contain the detailed study information typically found in acceptance criteria and performance evaluation sections of a modern medical device submission.

Here's an analysis based on the provided text, highlighting the absence of crucial information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated: No specific quantitative or qualitative performance criteria (e.g., accuracy, speed, image quality metrics) are provided in the document.	Not reported: The document states "The device operates in a manner substantially equivalent to other cleared devices in this category, and performs as well as the predicate Hermes." This is a general statement of equivalence and not a report of specific performance metrics against defined criteria.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not specified.
• Data Provenance: Not specified. The document mentions accommodating DICOM 3.0 images from various modalities (x-ray, MRI, CT, PET, Nuclear Medicine, Ultrasound) and "several proprietary image formats," implying a variety of sources but no specific origin or type of study (retrospective/prospective) for a test set.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method

• Adjudication Method: Not specified.

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

• MRMC Study: No mention of an MRMC study. This type of study is typically used for AI-assisted diagnostic devices to quantify the improvement in human reader performance. The SCEPTRE-VS, being a PACS workstation, is focused on image management and display rather than AI-driven diagnosis.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study is mentioned.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No mention of a standalone performance study. The device is described as a "workstation/server" for image review and processing, not as a standalone diagnostic algorithm. While it has an "optional Fusion 7D fusion module," no performance study specific to this module or the overall system as an algorithm is detailed.

7. Type of Ground Truth Used

• Type of Ground Truth: Not specified. Given the device's function as a PACS, the "ground truth" would likely relate to the accurate display, storage, and manipulation of images, rather than a diagnostic 'truth' in the clinical sense. However, no specific method for verifying this is provided.

8. Sample Size for the Training Set

• Sample Size: Not applicable/Not specified. The SCEPTRE-VS, as described, is a PACS workstation, not a machine learning model that would require a "training set." Its function is to display, process, and store images.

9. How Ground Truth for the Training Set Was Established

• Method: Not applicable/Not specified, as no training set is relevant for this type of device.

Summary of Device and Context:

The SCEPTRE-VS, submitted in 2002, is a Picture Archiving and Communication System (PACS). At the time of this submission, the regulatory requirements and expectations for demonstrating "acceptance criteria" and "study results" were different from those applied to modern AI/ML medical devices. This document primarily focuses on establishing substantial equivalence to a predicate device (Nuclear-Diagnostics HERMES Workstation) by comparing technological characteristics, materials, and functional methodology, rather than providing detailed performance metrics from a specific study against a pre-defined ground truth. The FDA's letter confirms the determination of substantial equivalence based on the provided information, allowing the device to be marketed.

Summary

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510(k) Summary

Submitter Information: 1.

1/02/3/4

1.1. Submitter: Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, OH 44087 Phone: [phone] FAX: [phone]

1.2. Manufacturing Facility: Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, OH 44087 Phone: [phone] FAX: [phone]

1.3. Contact: Robert H. McCarthy

• Date: April 19, 2002 1.4.

2. Device Name

2.1.	Classification Name:	PACS (21CFR Section 892.2050)
	Classification Number:	90LLZ
2.2.	Trade/Proprietary Name:	SCEPTRE-VS
2.3.	Predicate Device:	Nuclear-Diagnostics HERMES

3. Device Description

3.1. Function

The SCEPTRE-VS is a workstation/server consisting of a computer, keyboard, mouse, monitor, network interface ;optional storage device(s) such as magneto-optical disk ,compact disk amd magnetic tape; and optional film digitizer.

workstation, K 002782

The computer workstation is PC based utilizing the latest Intel Pentium technology. The operating system is Windows 2000/XP.

The Sceptre-VS workstation is used to store, process, view and print diagnostic medical images from diagnostic imaging systems conforming to DICOM 3.0 including x-ray, MRI, CT, PET, Nuclear Medicine and

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Ultrasound. Several proprietary image formats can also be accomodated. The optional Fusion 7D fusion module can be used for fusion of 2 modalities such as CT/PET, MRI/PET to provide crossmodality comparison.

Device Intended Use: 4.

• 4.1. The intended use of the SCEPTRE-VS is to review, process, film and store multi-modality images acquired from other diagnostic imaging systems or workstations.

5. Device Technological Characteristics:

• 5.1. The characteristics of the Sceptre-VS workstation compare substantially with the Nuclear-Diagnostics Hermes Workstation predicate device, in both materials used, technology applied, and functional methodology, Differences of note do not affect safety and effectiveness of the device. intended use, or application methods. The device operates in a manner substantially equivalent to other cleared devices in this category, and performs as well as the predicate Hermes.

5.2. Safetv

The SCEPTRE-VS is a non-invasive device. It has been designed to comply with applicable safety standards and the applicable sections of 21CFR.

The results of the hazard analysis indicate that the device is of minor level of concern as defined in the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, with flowing lines beneath them.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL = 2 2002

Mr. Robert H. MºCarthy Technical Director Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087

Re: K021314

Trade/Device Name: Sceptre-VS Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: April 24, 2002 Received: April 25, 2002

Dear Mr. M&Carthy:

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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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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K02 1314 . 510(k) Number (if known): Sceptre-VS Device Name:

Indications for Use:

The intended use of the Sceptre-VS is to review, process, film and store multi-modality images acquired from other diagnostic imaging systems or workstations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lippman
(Division Sign-Off)
Division of Reproductive, Abdominal,

Division of Reproduc and Radiological De 510(k) Nun

Prescription Use

Over-the-Counter Use

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).