(158 days)
No
The summary describes image manipulation and contouring software, which are standard image processing techniques, and does not mention AI, ML, or related concepts.
No
The device is described as image manipulation and contouring software for surgical and treatment planning, but it does not directly treat a disease or condition. Its function is to aid in planning, not to provide therapy itself.
No.
The "Intended Use / Indications for Use" states that the software is for "image manipulation and contouring... for use in surgical and treatment planning." It is an image editing tool for planning, not for diagnosing medical conditions.
Yes
The device is described as a "software package" and "utility" for image manipulation and contouring, with no mention of accompanying hardware components. Its function is purely software-based image processing for surgical and treatment planning.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "surgical and treatment planning" and "contouring anatomies." This is a direct application in the clinical setting for patient care, not for examining specimens in vitro (outside the body) to diagnose or monitor a condition.
- Device Description: The description reinforces its use with "surgical and treatment planning systems" and as "image editing software" for creating and modifying anatomical structures. This aligns with clinical imaging and planning tools.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
The device is clearly intended as a tool for manipulating medical images for the purpose of planning surgical procedures and treatments, which falls under the category of medical device software used in clinical practice, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
90 IYE
Device Description
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anatomical structures / anatomes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical and treatment planning systems
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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.
1
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:
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.
(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)
OR
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