RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY by RADIONICS, INC.

The Slice Editor Imaging Software Utility is an image manipulation and eontouring software package for use in surgical and treatment planning. The Slice Editor can replace the IMEX contouring utility as the component for contouring anatomes in all applications in which IMEX is currently utilized.

Device Description

The "Slice Editor" utility. It is an upgraded version of software intended for use in with surgical and treatment planning svstems where a graphical editing facility is used to create and modify anatomical structures. The common name is image editing software and its classification name is Stereotaxic instrument (accessory/utility).

AI/ML Overview

The provided text is a 510(k) summary and related FDA correspondence for the "Slice Editor" imaging software utility. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

Specifically, the document states:

Device Name: Slice Editor utility
Intended Use: An upgraded version of software intended for use with surgical and treatment planning systems where a graphical editing facility is used to create and modify anatomical structures. It serves as an image manipulation and contouring package for use with existing and new RSA applications.
Predicate Devices: IMEX software used in Radionics' XPlan-1 (K972905) and StereoPlan (K946252).
Technological Characteristics: "The technological characteristics are the same or similar to those found with the predicate devices where contouring sessions generate anatomical data to assist in the treatment planning process."

The 510(k) process for this device relies on substantial equivalence to previously cleared predicate devices. This means the manufacturer demonstrated that the Slice Editor is as safe and effective as the predicate devices, often by showing it has the same or similar technological characteristics and indications for use. This typically does not involve presenting a new study with specific acceptance criteria, as would be expected for a novel device or a device making new claims.

Therefore, I cannot provide the requested information from the provided text for the following reasons:

Acceptance Criteria and Reported Device Performance: The document does not define any specific acceptance criteria for performance metrics, nor does it report any performance data (e.g., accuracy, precision, speed of contouring) for the Slice Editor.
Study Information (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): As there is no study described that establishes performance against defined acceptance criteria, none of these details are present in the provided text. The submission focuses on demonstrating substantial equivalence based on the device's functional similarity to existing cleared devices.

Summary

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OCT = 9 1998

K981/597

5.0 510(k) Summary

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. § 807.92.

The submitter of this premarket notification is:

Lisa Misterka Benati Senior Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803 Tel: (781) 272 - 1233 Fax: (781) 272 - 2428

This summary was prepared on April 30, 1998.

The name of this device is the "Slice Editor" utility. It is an upgraded version of software intended for use in with surgical and treatment planning svstems where a graphical editing facility is used to create and modify anatomical structures. The common name is image editing software and its classification name is Stereotaxic instrument (accessory/utility).
The Slice Editor software is substantially equivalent to the IMEX software used in Radionics' XPlan-1 for radiology applications (K972905) and its StereoPlan used for neurology applications (K946252).
The Slice Editor software is totally compatible with IMEX in its applications. When installed, Slice Editor provides the same anatomical data to the workstation as previously supplied with IMEX.
The Slice Editor is intended to serve as an image manipulation and contouring package for use with existing and new RSA applications. There is no change to indications for use.
The technological characteristics are the same or similar to those found with the predicate devices where contouring sessions generate anatomical data to assist in the treatment planning process.

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DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - a 1998

Lisa Misterka Benati Senior Regulatory Engineer Radionics® Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803

Re:

K981597 Slice Editor Imaging Software Utility Dated: August 14, 1998 Received: August 17, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Ms. Benati:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 povisions of the Federal Pood. Drug, and Cosmetic Act (Act). 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, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Prematict 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions, Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 ourslabeling regulation (21 CFR Part additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmaldsmamain.html".

Sincerely yours,
Kilian Yi

Lillian Yin, Ph Director, Division of Reprodu Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): n 9815-97

Device Name: Slice Editor Imaging Software Utility

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_V (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Tami C. Segon

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number

Regulation Number and Section

N/A