(113 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electro/mechanical systems and computer control without mentioning AI/ML functionalities.
Yes
The device is indicated for use in the "treatment of both benign and malignant disease," fulfilling the definition of a therapeutic device.
No
Explanation: The device description states that the VariSource iX Series is used for treatment (brachytherapy), not for diagnosis.
No
The device description explicitly states it is a "computer controlled remote electro/mechanical system" and mentions placing a "cable incorporating an irradiated iridium seed," indicating significant hardware components beyond just software.
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 "delivery of remote-controlled High Dose Rate (HDR) brachytherapy." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a system for placing a radioactive source near a tumor for treatment. This aligns with a therapeutic device, not a device used to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
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 to deliver radiation for treatment.
N/A
Intended Use / Indications for Use
The VariSource iX and VariSource iX(t) are 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) brachytherapy.
Product codes
JAQ
Device Description
The VariSource 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 turnor 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
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
Non Clinical Tests
Results of Verification and Validation Testing showed conformance to applicable requirements and specifications and assured hazard safeguards functioned properly.
Clinical Tests
No Clinical Tests have been included in this pre-market submission
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
PREMARKET 'NOTIFICATION
510(k) Summary
VariSource iX and VariSource iX(t) Afterloaders
As required by 21 CFR 807.92
Submitter's Name:
Varian Medical Systems 911 Hansen Way, M/S C-255 Palo Alto CA94304
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: 30 April 2012
Proprietry Name:
VariSource iX VariSource iX(t)
Classification Name:
Common/Usual Name:
Predicate Device:
Device Description:
Indications for Use:
Remote controlled radionuclide applicator system 21CFR892.5700 Class II
VariSource iX afterloader, VariSource iX Series afterloaders, VariSource IX series afterloader systems, VariSource iX Series
VariSource iX HDR Afterloader (K071467)
The VariSource 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 turnor bed in a practice known as brachytherapy.
The VariSource 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) brachytherapy.
1
Substantial Equivalence Discussion
Intended Use
The VariSource 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) brachytherapy ..
Differences
The differences with respect to the predicate are listed in the substantial equivalence chart.
With respect to the previous version of this device, which contained Console software Version 1.1, the changes are to Plan Importing, Partial treatment Options, Fraction Editing and Remote Service Access.
Technological Characteristics
Both the current device and the predicate are remote-controlled afterloading devices for brachytherapy. The systems both utilize a small, high activity Iridium-192 source that is fixed to a flexible metal cable and driven via one or more source guide tubes into an applicator(s) or needle(s) inserted for a specified clinical purpose into a patient.
Argument for Substantial Equivalence to the Predicate Device
There are few differences between the VariSource IX Series afterioaders and the predicate. Varian therefore believes that the VariSource iX Series afterloaders are substantially equivalent to the predicate.
Non Clinical Tests
Results of Verification and Validation Testing showed conformance to applicable requirements and specifications and assured hazard safeguards functioned properly.
Clinical Tests
No Clinical Tests have been included in this pre-market submission
Conclusions
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
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
NOV 1 6 2012
Ms. Vy Tran Vice President, Regulatory Affairs and Quality Systems Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304
Re: K122236
Trade/Device Name: VariSource iX and VariSource iX(t) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: September 26, 2012 Received: October 4, 2012
Dear Ms. Tran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be . found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
3
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Machal D. Offair 11:55:20 -05'00'
Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K122236
Device Name: VariSource iX and VariSource iX(t)
Indications for Use:
The VariSource iX and VariSource iX(t) are 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) brachytherapy.
Yes Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara 2012.11.16
11:56:44 -05'00'
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K122236
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