(48 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on electro/mechanical control and a computer system, which are standard for medical devices and do not inherently imply AI/ML.
Yes
The device is used to treat lesions, tumors, and conditions where radiation is indicated, directly improving health.
No
The device, a high dose rate brachytherapy afterloader, is described as being used to treat lesions, tumors, and conditions by placing an irradiated iridium seed. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is an "electro/mechanical system," indicating the presence of hardware components beyond just software.
Based on the provided information, the VariSource 200 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat lesions, tumors and conditions in the body where radiation is indicated." This describes a therapeutic device used directly on or in the patient's body for treatment.
- Device Description: The description details a system for placing a radioactive source internally or close to a tumor for treatment (brachytherapy). This is a therapeutic procedure.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health. IVDs are designed for this purpose.
While the device mentions "Radiological Image Processing System," this is likely for guiding the placement of the radioactive source during the therapeutic procedure, not for diagnostic analysis of biological samples.
Therefore, the VariSource 200 System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VariSource 200 System is a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specified clinical purpose in a patient.
The radioactive source (enclosed within the wire/cable) is driven via coupling catheters (Transfer Guide Tubes) from the Afterloader into needles or applicators within or on the patient.
The length of time and position that the High Dose Rate source spends within the needle or applicator is controlled in accordance with an Irradiation Treatment Prescription.
The VariSource 200 System is a High Dose Rate Brachytherapy Afterloader used to treat lesions, tumors and conditions in the body where radiation is indicated.
Product codes (comma separated list FDA assigned to the subject device)
90 JAQ
Device Description
The VariSource 200 Series High Dose Rate Afterloader system is a computer controlled remote electro/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy.
The console control application runs on standard Intel PCs under a DOS operating systems. The firmware controlling the High Dose Rate Afterloader runs on an embedded Intel 188 processor.
The 200 Series control console provides real time information of wire position and system status and interfaces with a printer in order to provide a hard copies of a treatment prescriptions and delivery records. In addition the 200 Series control console can receive treatment plans from a treatment planning application (not part of this submission), this information is transferred via a floppy disk.
Mentions image processing
Radiological Image Processing System
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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): 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
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
K061582 510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the VariSource 200 HDR Brachytherapy Afterloader.
- Varian Medical Systems 1. Submitter: 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 (650) 842-5040 Fax: Email: vy.tran@varian.com Date summary was prepared: June 1, 2006
| 2. Name of the Device: | VariSource 200 HDR Afterloader |
|---|---|
| Trade/Proprietary Name: | VariSource 200 HDR Afterloader |
| Common or Usual Name: | |
| Classification Name: | Radiological Image Processing System |
| 21 CFR §892.5700 | |
| Class II | |
| Product Code: 90 JAQ |
-
- Predicate Devices to claim substantial equivalence: a. VariSource K(945383)
-
- Description of the Device: The VariSource 200 Series High Dose Rate Afterloader system is a computer controlled remote electro/mechanical system used for medical purposes, for placing a NiTiNol wire incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy.
Hardware Platform and Operating System
The console control application runs on standard Intel PCs under a DOS operating systems. The firmware controlling the High Dose Rate Afterloader runs on an embedded Intel 188 processor.
Peripherals and Accessories
The 200 Series control console provides real time information of wire position and system status and interfaces with a printer in order to provide a hard copies of a treatment prescriptions and delivery records. In addition the 200 Series control
1
console can receive treatment plans from a treatment planning application (not part of this submission), this information is transferred via a floppy disk.
- Intended Use Statement: The VariSource 200 System is a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specified clinical purpose in a patient.
The radioactive source (enclosed within the wire/cable) is driven via coupling catheters ( Transfer Guide Tubes ) from the Afterloader into needles or applicators within or on the patient.
The length of time and position that the High Dose Rate source spends within the needle or applicator is controlled in accordance with an Irradiation Treatment Prescription.
Summary of the Technological Characteristics: The Substantial Equivalence 6. Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. This chart is located in Tab 9 of the submission.
2
Image /page/2/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in bold, uppercase letters. The "I" in "VARIAN" is stylized with a curved line extending above the letter. Below the word "VARIAN" are the words "medical systems" in a smaller font.
61582
Varian Brachytherapy
HDR Product Comparison Chart
The following table represents information as known to Varian from a review of published information available about competing products and the predicate device.
| Description | Varian VariSource
Remote High Dose Rate
Afterloader
(Predicate Device) | VariSource 200 |
|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K945383 | |
| Intended Use | High Dose Rate
Brachytherapy | High Dose Rate
Brachytherapy |
| Safe
(Maximum source strength) | Tungsten Alloy
370GBq | Tungsten Alloy
407GBq. Safe and Unit
tested to meet Surface
Dose Requirement |
| Maximum Surface Dose
(IEC 601-2-17: 1µGy/h @ 1m) |