(508 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard CT imaging and simulation functionalities.
No
The device is described as providing "therapeutic quality CT images at simulation," implying it is used in the planning phase of therapy rather than directly delivering therapy. Its intended uses (to obtain images, determine contours, locate structures, and provide tissue density) are diagnostic and planning functions. The device is referred to as a "Treatment Planning Simulator" in its predicate devices.
No
This device is used to obtain CT images for treatment planning in radiation therapy, focusing on contouring, internal structure identification, isocenter localization, and tissue density for dose calculation. While it provides imaging data, its primary function as described is simulation and planning for therapy, not diagnosing a medical condition.
No
The device description explicitly states it includes hardware components such as "microprocessor controlled solid state electronics, rotating gantry, patient support couch and accessories."
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly indicate that this device is used to obtain CT images of the patient's body directly for radiation therapy planning. It does not involve the analysis of blood, tissue, or other bodily fluids or substances.
- The intended uses are focused on imaging and planning for radiation therapy. The listed uses all relate to obtaining anatomical information and tissue density data for the purpose of accurately delivering radiation treatment. This is a diagnostic imaging and treatment planning function, not an in vitro diagnostic function.
Therefore, the SIMPLI C.T. Option for the SIMVIEW™ 3000 is a medical imaging device used for radiation therapy simulation and planning, not an IVD.
N/A
Intended Use / Indications for Use
The SIMPLI C.T. Option for the SIMVIEW™ 3000 radiation therapy is used for the following:
- To obtain CT images in the same position as the treatment.
- To provide CT images to determine the contour of the patient.
- To provide CT images to determine the size and location of internal structures.
- To provide CT images to be used by the dosimetrist to determine the location of isocenter.
- To provide tissue density information via Hounsfield numbers, which allows for more accurate calculations of the dose by accounting for variations in tissue densities. The intended use is the same as the predicate devices.
Product codes
RA 90 KPQ
Device Description
The SIMPLI C.T. Option for the SIMVIEW™ 3000 provides therapeutic quality CT images at simulation for use by the trained medical practitioner. It is similar in design to other such radiation therapy CT imaging simulation devices. The SIMVIEW™ 3000 has microprocessor controlled solid state electronics, rotating gantry, patient support couch and accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioner
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)
Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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.
0
STEMENS
NOV 2 9 1996
ATTACHMENT E
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 based on the format in the interim rule for 21 CFR § 807.92 as published in the Federal Register, April 28, 1992.
1
SIEMENS
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | Submitter's Information: | Dated: June 22, 1995
Siemens Medical Systems
Oncology Care Systems Group
4040 Nelson Avenue
Concord, CA 94520 |
|----|--------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Kenneth R. Michael, Pharm.D.
Vice President Regulatory Affairs and Quality Assurance |
| 2. | Common or Usual Name: | CT Option for Radiation Therapy Simulation System |
| | Proprietary Name: | SIMPLI C.T. |
| | Classification Names: | Radiation Therapy Simulation System - 21 CFR § 892.5840
Class II, Product Code: RA 90 KPQ |
| 3. | Predicate Devices: | • SIMULIX-MC-CT-EXTENSION Oldelft Corporation of
America
Treatment Planning Simulator, K912466 |
· XIMATRON /CT, Varian Associates Treatment Planning Simulator, K 853349, 82K0274
4. Description of Device:
The SIMPLI C.T. Option for the SIMVIEW™ 3000 provides therapeutic quality CT images at simulation for use by the trained medical practitioner. It is similar in design to other such radiation therapy CT imaging simulation devices. The SIMVIEW™ 3000 has microprocessor controlled solid state electronics, rotating gantry, patient support couch and accessories.
ર્ડ Statement of intended use:
The SIMPLI C.T. Option for the SIMVIEW™ 3000 radiation therapy is used for the following:
-
To obtain CT images in the same position as the treatment.
-
To provide CT images to determine the contour of the patient.
-
- To provide CT images to determine the size and location of internal structures.
-
- To provide CT images to be used by the dosimetrist to determine the location of isocenter.
-
- To provide tissue density information via Hounsfield numbers, which allows for more accurate calculations of the dose by accounting for variations in tissue densities. The intended use is the same as the predicate devices.
6. Statement of technological characteristics:
The SIMPLI C.T. for the SIMVIEW™ 3000 radiation therapy simulation system has no significant change in design, materials, energy source or other technological characteristics compared to the predicate devices.
The intended use and the technological characteristics are the predicate devices and therefore we believe it is substantially equivalent to them.
7. Differences:
The minor configuration differences between the SIMPLI C.T. for the SIMVIEW" 3000 and the predicate devices do not alter the intended use or affect the safety and effectiveness of the SIMPLI C.T. when used as labeled.
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2
Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in bold, black letters. The letters are slightly distressed, giving them a textured appearance. The background is plain white, which makes the word stand out.
Special Controls:
Although there are no performance standards established by the FDA for these devices, the SIMPLI C.T. Option for the SIMVIEW™ 3000 has been designed, and manufactured to meet the following standards:
| IEC 601-1 | Medical electrical equipment - General requirements for safety |
|---|---|
| IEC 601-1.1 | Safety requirements for medical electrical systems |
| IEC 601-2-29 | Particular requirements for the safety of radiotherapy simulators |
| IEC 1168 | Radiotherapy simulators - Functional performance characteristics |
| IEC 878 | Graphical symbols for electrical equipment in medical practice |
Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate devices.