Who can help prepare an FDA 510(k) submission like GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER

Q: Who is the manufacturer of GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER?

Varian Medical Systems, Inc. filed the 510(k) submission for GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER (K120993).

Q: What is the FDA product code for GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER?

JAQ. It is classified under 21 CFR 892.5700 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER?

GammaMedplus iX Series HDR Afterloaders (K071381); Nucletron MicroSelectron V3 (K061354).

K120993 · Varian Medical Systems, Inc. · JAQ · Jul 26, 2012 · Radiology

Device Facts

Record ID	K120993
Device Name	GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER
Applicant	Varian Medical Systems, Inc.
Product Code	JAQ · Radiology
Decision Date	Jul 26, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5700
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

GammaMedplus iX Series are computer-controlled remote afterloaders for brachytherapy; place high-activity Ir-192 radioactive source within needles or applicators previously positioned in/on patient. System drives source via transfer guide tubes from afterloader to applicator. Operator uses console to control dwell time and position of source per treatment prescription. Used in clinical settings by trained personnel. Console software manages treatment delivery, source decay calculations, and error reporting. Includes emergency manual retraction and automatic source retraction upon emergency signal. Benefits patients by enabling precise, remote-controlled radiation delivery to tumor sites while minimizing clinician radiation exposure.

Clinical Evidence

No clinical data. Bench testing only; full verification tests performed on all software and hardware aspects to ensure safe functioning.

Technological Characteristics

Remote-controlled radionuclide applicator system; Ir-192 source; tungsten shielding; max activity 555 GBq (15 Ci); 24 channels (iX) or 5 channels (3/24 iX); 60 dwell positions per channel; PC-based console; connectivity via DICOM/Aria; mobile/transportable form factor; battery-powered RAM for data retention; emergency manual/automatic retraction.

Indications for Use

Indicated for treatment of benign and malignant disease, for curative and palliative intent, via remote-controlled HDR and PDR brachytherapy in patients requiring radiation therapy.

Regulatory Classification

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.

Predicate Devices

GammaMedplus iX Series HDR Afterloaders (K071381)
Nucletron MicroSelectron V3 (K061354)

Related Devices

K071467 — VARISOURCE IX HDR AFTERLOADER · Varian Medical Systems, Inc. · Jul 16, 2007
K122236 — VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER · Varian Medical Systems, Inc. · Nov 16, 2012
K031524 — GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER · Varian Medical Systems, Inc. · Nov 26, 2003
K181903 — BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device · Varian Medical Systems, Inc. · Oct 3, 2018
K071381 — GAMMAMEDPLUS IX SERIES HDR AFTERLOADER · Varian Medical Systems · Jul 18, 2007

Submission Summary (Full Text)

{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. | | | | | {1}------------------------------------------------ ### Technological Characteristics: ・ : : : . : : . . : : : : . Carolina Career States {2}------------------------------------------------ | | 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 | <0.15 µSv/hr, when containing a 10 Ci source | 0.3 mrem/hr (3 µSv/hr) | 0.3 mrem/hr (3 µSv/hr) | | | Dwell positions per each channel | 48 | 60 | 60 | | | Area radiation monitor (integrated GM counter) | Yes | Yes | Yes | | | Maintained treatment data during power failure (battery powered RAM) | Yes | Yes | Yes | | | Simulator source | Yes | Yes | Yes | | | Verification of channel length | No | Yes | Yes | | and the comments of the comments of the comments of {3}------------------------------------------------ | | Nucletron MicroSelectron V3 | GammaMedplus™ iX, (with Console Software version 1.1) | GammaMedplus™ iX, (with Console Software version 1.2) | |------------------------------------------------------------|--------------------------------|-------------------------------------------------------------|-------------------------------------------------------------| | Verification of applicator connection | No | Yes* | Yes | | Source positioning | Proximal to distal | Distal to proximal | Distal to proximal | | Max. source position error over treatment length | +/- 1mm per position | 0.35 % referring to 600 mm | 0.35 % referring to 600 mm | | Emergency container for the source | Yes | Yes | Yes | | Response to emergency signal | Automatic source retraction | Automatic source retraction | Automatic source retraction | | Emergency manual retraction | Yes | Yes | Yes | | Isotope | Ir-192 | Ir-192 | Ir-192 | | | | | | | Source | | | | | Maximum 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 | | Capsule dimensions (length x Ø) | 4,50 x 0.9 mm | 4,52 x 0.9 mm | 4,52 x 0.9 mm | | Active dimensions (length x Ø) | 3,5 x 0.6 mm | 3,5 x 0.6 mm | 3,5 x 0.6 mm | | Source extension length | 1500 mm | 1300 mm | 1300 mm | | Operator console | | | | | Operating console with Personal Computer and Printer | Yes | Yes | Yes | | | | | | | Keyswitch control | Yes | Yes | Yes | . and the control control control control controllers and : {4}------------------------------------------------ | | Nucletron | GammaMedplus™ iX, | GammaMedplus™ iX, | |-----------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | | MicroSelectron V3 | (with Console Software version 1.1) | (with Console Software version 1.2) | | | | | | | Control Software | microSelectron™ Treatment Control Software | iX Console Software Version 1.1 | iX Console Software Version 1.2 | | Plan Import | Ability to import data from Nucletron brachytherapy treatment planning systems. | Ability to accept treatment plans from any planning system that produces plans complying with the defined format. | Ability to automatically record some treatment status/history with Aria patient management system (Console software version 1.1) | | | | | Ability to export treatment delivery data via a DICOM treatment delivery record. (Console software version 1.2) | | Plan Creation | Available | Available | Available | | Source Decay Calculation | Once daily | Once daily | Once daily | | Error Reporting | Error code or status messages displayed in text, accompanied by an indication of the action required. | Error code or status messages displayed in text, accompanied by an indication of the action required. | Error code or status messages displayed in text, accompanied by an indication of the action required. | | Report Generation | Treatment report includes an overview of all treatment- related information. | Treatment report includes an overview of all treatment- related information. | Treatment report includes an overview of all treatment- related information. | | Plan Editing | Dwell positions may be programmed manually. | Dwell positions may be programmed manually | Dwell positions may be programmed manually | | Full-Screen Operation | No full screen | Disallows access to windows operating system. | Disallows access to windows operating system | | Workflows | Workflow-based treatment delivery | Workflow-based treatment delivery. | Workflow-based treatment delivery | | Security | Key and password protected | Password-based user access. | Password-based user access. | | Physics Test Plans | Support for physics test plans | Support for physics test plans | Support for physics test plans | | Startup Checks | Automatic self-test when Treatment Control System is | Startup checks | Startup checks | . : : . : . · . {5}------------------------------------------------ | | Nucletron MicroSelectron V3 | GammaMedplus™ iX, (with Console Software version 1.1) | GammaMedplus™ iX, (with Console Software version 1.2) | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Service Access | Service-only access mode, with features for adjusting certain parameters on the afterloader directly from the console. | Service-only access mode, with features for adjusting certain parameters on the afterloader directly from the console. | Service-only access mode, with features for adjusting certain parameters on the afterloader directly from the console. | | User Access Rights | System access can be customized for specific authorization. | Privilege-based user access rights, for multiple users. | Privilege-based user access rights, for multiple users | | Patient Privacy | Has several features for protecting patient privacy, including encryption of patient identification information and data disclosure reporting. | Has several features for protecting patient privacy, including encryption of patient identification information and data disclosure reporting. | Has several features for protecting patient privacy, including encryption of patient identification information and data disclosure reporting | | System Data Display | Continuous display of critical system data, including pending errors, remaining wire cycles, days since last source exchange, and most- recently calculated source strength. | Continuous display of critical system data, including pending errors, remaining wire cycles, days since last source exchange, and most- recently calculated source strength. | Continuous display of critical system data, including pending errors, remaining wire cycles, days since last source exchange, and most-recently calculated source strength. | | Error / Event Logging | System logbook can be displayed by date, code, and type. | Log of all recent system errors and events. | Log of all recent system errors and events. | | Partial Treatment Options | Partial treatment options | Partial treatment options | Removed "redistribute undelivered portion" partial treatment option. | | Error Message Annotation | Each system message can be customized to user's requirements. | Error message annotation, for site-specific error recovery actions. | Error message annotation, for site-specific error recovery actions. | | Fraction Editing | Support for fraction adding and modification | Support for fraction adding and modification | Disallowed if the fraction contains dose information. | | Standard Plans | Support for standard plans | Support for standard plans | Support for standard plans | | Console Data Backup | Database backup and retrieval | Manual and automatic console data backup options. | Manual and automatic console data backup options. | | Applicator Definition | Basic applicator definition, including number of channels, channel names, and channel lengths. | Basic applicator definition, including number of channels, channel names, and channel lengths. | Basic applicator definition, including number of channels, channel names, and channel lengths. | .............................................................................................................................................................................. : : : and the country of the country of the country of {6}------------------------------------------------ | | Nucletron MicroSelectron V3 | GammaMedplusTM iX, (with Console Software version 1.1) | GammaMedplusTM iX, (with Console Software version 1.2) | |---------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Source Exchange Record | Source information recorded, including date of last exchange, and number of source transfers. | On-going record of all source exchanges, including date, strength, and number of cycles. | On-going record of all source exchanges, including date, strength, and number of cycles. | | Remote service access | Not available | Not available | Allows Varian service engineers to log into the console remotely. | * Channels 20 to 24 of the GammaMedplus iX and channels 23 and 24 of the GammaMedplus 3/24 iX do not verify the applicator connection. These channels support use of the GammaMedplus 3/24 with applicators that may not withstand the force of the push test. 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 Conclusions and effective and to perform as well or better than the predicate. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. # DEPARTMENT OF HEALTH & HUMAN SERVICES #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 # JUL 26 2012 Ms. Vy Tran Vice President, Regulatory Affairs and Quality Systems Varian Medical Systems, Inc 3100 Hansen Way PALO ALTO CA 94304 Re: K120993 Trade/Device Name: GammaMedplus iX and GammaMedplus 3/24 iX afterloaders (GammaMedplus iX™ Series Brachytherapy Afterloaders). Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 18, 2012 Received: June 20, 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or any Federal statutes and regulations administered by other Federal agencies. You must i comply with all the Act's requirements, including, but not limited to: registration and listing (21 ። CFR Parts 807); labeling'(21-CFR Parts 801 and 809); medical device reporting (reporting-of ዓፖሊ ነች። {8}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. 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 Diagnostic Device Evaluation and Safety 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, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ### Indications for Use Form 510(k) Number (if known): Device Name: GammaMedplus iX and GammaMedplus 3/24 iX afterloaders (GammaMedplus iX™ Series Brachytherapy Afterloaders). 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)remotecontrolled brachytherapy. Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Division Sign Off Sign-Off Office of In Vitro Diagnostic Device Page 1 of 1

GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Welcome

Check your email

Welcome!