(115 days)
Not Found
No
The summary describes a computer-controlled electro/mechanical system for brachytherapy, with no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for "treatment of both benign and malignant disease, for both curative and palliative intent." Treatment indicates a therapeutic purpose.
No
Explanation: The device is described as being "indicated for use in the treatment of both benign and malignant disease" and "for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy." This indicates a therapeutic, not diagnostic, purpose.
No
The device description explicitly states it is a "computer controlled remote electro/mechanical system" and mentions "verification tests were performed on every pertinent aspect of the software and hardware," indicating it includes significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of both benign and malignant disease" through brachytherapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a system for placing a radioactive seed internally or close to a tumor for treatment. This is a physical intervention for therapy.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing information for diagnosis. IVDs are designed to provide information about a patient's health status through the examination of such samples.
Therefore, the GammaMedplus iX Series is a therapeutic device used in the treatment of disease, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GammaMedplus™ iX Series is indicated for use in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of High Dose Rate (HDR) and Pulsed Dose Rate (PDR) remote-controlled brachytherapy. The GammaMedplus iX™ Series is indicated for use in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of High Dose Rate (HDR) and Pulsed Dose Rate (PDR)remotecontrolled brachytherapy.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The GammaMedplus iX Series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anywhere in the body
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)
Non Clinical Tests For each device, in every mode of use, a full set of verification tests were performed on every pertinent aspect of the software and hardware to determine the safe functioning of the device. Clinical Tests No Clinical tests have been included in this pre-market submission. All the tests that were performed met the applied pass criteria. Varian considers the device to be safe and effective and to perform as well or better than the predicate.
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
120993
JUL 26 2012
PREMARKET NOTIFICATION
510(k) Summary
GammaMedplus™ iX and GammaMedplus™ 3/24 iX
As required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems
3100 Hansen Way, m/s E110
Palo Alto CA94304 | | Nucletron
MicroSelectron V3 | GammaMedplus™ iX,
(with Console
Software version 1.1) | GammaMedplus™ iX,
(with Console Software
version 1.2) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Ms Vy Tran,
Vice President, Regulatory Affairs and Quality Systems
Phone: 650/424.5731
Fax: 650/842.5040
vy.tran@varian.com
Date: 23rd March 2012 | Predicate Device
Clearance Number: | K061354 | K071381 | N/A |
| Proprietry Name: | GammaMedplus™ iX and GammaMedplus™ 3/24 iX | Indications for Use | The MicroSelectron V3 is
intended to enable an
operator to apply, by remote
control, a radionuclide source
into the body (including
Interstitial, Intracavitary,
Intraluminal, Bronchial,
Endovascular, and Intra-
operative) or to the surface
of the body for radiation
therapy. | Both the GammaMedplus iX
and GammaMedplus 3/24 iX
are indicated, in the
treatment of both benign
and malignant disease, for
both curative and palliative
intent, in the delivery of
remote controlled high dose
rate brachytherapy for
conditions anywhere in the
body when brachytherapy
treatment is indicated. | The GammaMedplus™ iX
Series is indicated for use in
the treatment of both benign
and malignant disease, for
both curative and palliative
intent, in the delivery of
remote-controlled High Dose
Rate (HDR) and Pulsed Dose
Rate (PDR) brachytherapy. |
| Classification Name: | Remote controlled radionuclide applicator system
21CFR892.5700
Class II | Intended use | The MicroSelectron V3 is
intended to enable an
operator to apply, by remote
control, a radionuclide source
into the body (including
Interstitial, Intracavitary,
Intraluminal, Bronchial,
Endovascular, and Intra-
operative) or to the surface
of the body for radiation.
therapy. | The GammaMedplus iX
Series is 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 GammaMedplus iX™
Series is intended for use in
the treatment of both benign
and malignant disease, for
both curative and palliative
intent, in the delivery of
remote-controlled High Dose
Rate (HDR) and Pulsed Dose
Rate (PDR) brachytherapy. |
| Common/Usual Name: | GammaMedplus™ iX afterloader,
GammaMedplus™ iX,
GammaMedplus™ iX series
GammaMedplus™ iX series afterloader systems,
GammaMedplus™ iX series afterloaders | Base Area | 80 cm x 46 cm | 57,5 cm x 51 cm | 57,5 cm x 51 cm |
| Predicate Devices: | GammaMedplus iX Series HDR Afterloaders (K071381) and
Nucletron MicroSelectron V3 (K061354). | Height | 98 cm - 138 cm | 105 cm-145 cm | 105 cm-145 cm |
| Device Description: | The GammaMedplus iX Series afterloader systems are computer
controlled remote electro/mechanical systems used for medical
purposes, for placing a cable incorporating an irradiated iridium
seed internally or close by a malignant tumor or tumor bed in a
practice known as brachytherapy. | | | | |
| Indications for Use: | The GammaMedplus iX™ Series is indicated for use in the
treatment of both benign and malignant disease, for both curative
and palliative intent, in the delivery of High Dose Rate (HDR) and
Pulsed Dose Rate (PDR) remote-controlled brachytherapy. | | | | |
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Technological Characteristics:
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Carolina Career States
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| | Nucletron
MicroSelectron V3 | GammaMedplus™ iX,
(with Console
Software version 1.1) | GammaMedplus™ iX,
(with Console Software
version 1.2) | |
|-------------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|--|
| Adjustable height
position measured in
the center of the
indexer | 90.8cm- 138.0cm | 90 cm-130 cm | 90 cm-130 cm | |
| Weight | 120 kg | 130 kg | 130 kg | |
| Transportable (USDOT-
7A; Type A) | Yes | Yes | Yes | |
| Power Supply | 90-130V; 60 Hz, or 190-250V;
50 Hz | 230/115/100V
50-60 Hz | 230/115/100V
50-60 Hz | |
| Mobile | Yes | Yes | Yes | |
| HDR | Yes | Yes | Yes | |
| PDR | Yes | No | Yes for GammaMedplus iX
No for GammaMedplus 3/24 iX | |
| Number of Channels | 6, 18, 30 | 24 for GammaMedplus iX
5 for GammaMedplus 3/24
iX | 24 for GammaMedplus iX
5 for GammaMedplus 3/24 iX | |
| Shielding | Tungsten. | Tungsten | Tungsten | |
| Maximum shielding
activity | 518 GBq / 14 Ci | 555 GBq / 15 Ci | 555 GBq / 15 Ci | |
| Maximum treatment
activity | 518 GBq / 14 Ci | 555 GBq / 15 Ci | 555 GBq / 15 Ci | |
| Max. exposure rate at
1m distance containing
the maximum activity |