(213 days)
Not Found
No
The summary describes a remote-controlled brachytherapy system and its applicators, focusing on the mechanical and functional aspects of delivering radiation. There is no mention of AI, ML, image processing, or any data-driven decision-making processes typically associated with AI/ML in medical devices. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is used to provide radiation brachytherapy to reduce exposure times to achieve a prescribed dose, which is a therapeutic intervention.
No
The device is described as a system for providing radiation brachytherapy using a radioisotope source, which is a treatment, not a diagnostic procedure. Its function is to apply a radionuclide source for therapeutic purposes ("to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose"), not to diagnose a condition.
No
The device description clearly states it includes "an electromechanical device" and "applicators," which are hardware components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide radiation brachytherapy to the body using a radioisotope source. This is a therapeutic procedure performed directly on a patient.
- Device Description: The device is described as a system for applying a radionuclide source to internal or surface body locations for radiation brachytherapy. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is therapeutic, delivering radiation for treatment.
N/A
Intended Use / Indications for Use
The Varian VariSource Remote High Dose Rate Afterloader system, including the applicators included in this notification, is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose. Remote operation of the Afterloader eliminates the necessity of exposing medical personnel to radiation during hand loading or hand placement of radioactive sources on or within the body of a patient. The radioactive source is iridium-192, encapsulated in the end of a wire stored in the Afterloader and mechanically driven from it to a precisely described position for a specified dwell time during treatment. Between treatments the wire is retracted into the Afterloader and the source resides in a tungstenshielded safe to limit personnel exposures to an acceptable, safe level. The Afterloader contains a radiation detector which signals whenever the source is not in the safe.
Product codes
Not Found
Device Description
The applicators for the Varian VariSource Remote High Dose Rate Afterloader are part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity to be placed at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be located for treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
various internal or surface body locations
Indicated Patient Age Range
Not Found
Intended User / Care Setting
properly trained and licensed medical personnel
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
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
JUL 26 1996
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
.
| 1. Submitter: | Varian Oncology Systems
3045 Hanover Street
Palo Alto, CA 94304 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Charles H. Will, Manager
Regulatory Compliance & Safety
Phone: (415) 424-5036
FAX: (415) 424-4830 |
| Prepared: | December 20, 1995 |
| 2. Device Name: | Applicators and Accessories for Varian VariSource
Remote High Dose Rate Afterloader |
| 3. Predicate Device: | Omnitron PulmoCath
K901615/F
Cleared on November 27, 1992 |
| | Omnitron GYN Applicator System
K913908/B
Cleared on March 6, 1992 |
| | Applicators for Varian VariSource Remote High Dose
Rate Afterloader
K952913
Cleared on November 22, 1995 |
| 4. Description: | The applicators for the Varian VariSource Remote
High Dose Rate Afterloader are part of a remote
controlled radionuclide applicator system, including
an electromechanical device to enable an operator
to apply, by remote control, a radionuclide source of
high activity to be placed at various internal or surface
body locations for radiation brachytherapy. The
shape and materials of the applicator determine
where it will be located for treatment. |
| 5. Intended Use: | The Varian VariSource Remote High Dose Rate
Afterloader system, including the applicators included
in this notification, is a device intended to be used by |
1
properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose. Remote operation of the Afterloader eliminates the necessity of exposing medical personnel to radiation during hand loading or hand placement of radioactive sources on or within the body of a patient. The radioactive source is iridium-192, encapsulated in the end of a wire stored in the Afterloader and mechanically driven from it to a precisely described position for a specified dwell time during treatment. Between treatments the wire is retracted into the Afterloader and the source resides in a tungstenshielded safe to limit personnel exposures to an acceptable, safe level. The Afterloader contains a radiation detector which signals whenever the source is not in the safe.
-
- Technological Considerations:
The applicators for the Varian VariSource Remote High Dose Rate Afterloader are identical or equivalent to the predicate devices in materials. Where a certain predicate device applicator contains low density polyethylene, the equivalent Varian applicator also contains low density polyethylene. Where a certain predicate device applicator contains PTFE and stainless steel, the equivalent Varian applicator contains PTFE and stainless steel.
- Technological Considerations: