(115 days)
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 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.
The provided text is a 510(k) Summary for the GammaMedplus™ iX and GammaMedplus™ 3/24 iX afterloaders. This document focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and non-clinical testing. It does not contain information about acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, nor does it describe a study proving the device meets such criteria in a clinical sense.
Medical devices like brachytherapy afterloaders are evaluated for safety and effectiveness through different types of assessments than, for example, diagnostic AI algorithms. Their "performance" is typically related to precise mechanical operation, safety mechanisms, and adherence to dose delivery protocols.
Here's an analysis based on the information provided and what is intentionally absent from this type of regulatory submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of sensitivity, specificity, or similar performance metrics typically seen for diagnostic AI. Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting safety and functional specifications. The "reported device performance" is a comparative analysis of its technological characteristics against the predicate devices (Nucletron MicroSelectron V3 and GammaMedplus iX Series HDR Afterloaders (K071381)).
Below is a table summarizing key characteristics that would be considered "performance" in the context of this device, comparing the proposed device (GammaMedplus™ iX, Console Software version 1.2) against its predicate (Nucletron MicroSelectron V3). The "acceptance criteria" are implied to be that the proposed device performs at least as well as or is equivalent to the predicate.
| Feature / Characteristic | Acceptance Criteria (Implied: Comparator = Nucletron MicroSelectron V3) | Reported Device Performance (GammaMedplus™ iX (Console SW v1.2)) |
|---|---|---|
| PDR (Pulsed Dose Rate) | Yes (Present in predicate) | Yes for GammaMedplus iX (No for GammaMedplus 3/24 iX) |
| Max. exposure rate at 1m distance (containing max activity) | <0.15 µSv/hr (with 10 Ci source) | 0.3 mrem/hr (3 µSv/hr) (with 15 Ci source - higher activity) |
| Dwell positions per each channel | 48 | 60 |
| Verification of channel length | No (Not present in predicate) | Yes |
| Verification of applicator connection | No (Not present in predicate) | Yes (with noted exceptions for certain channels/applicators) |
| Max. source position error | +/- 1mm per position | 0.35 % referring to 600 mm |
| Maximum activity (source) | 518 GBq / 14 Ci | 555 GBq / 15 Ci |
| Remote service access | Not available (Not present in predicate) | Allows Varian service engineers to log in remotely |
| Partial Treatment Options | Partial treatment options (including "redistribute undelivered portion") | Removed "redistribute undelivered portion" partial treatment option |
| Fraction Editing | Support for fraction adding and modification | Disallowed if the fraction contains dose information |
Note on "Max. exposure rate": The proposed device has a higher maximum activity (15 Ci vs 10 Ci in the predicate), which inherently allows for a higher exposure rate. The specified value of 0.3 mrem/hr (3 µSv/hr) for the higher activity would need to be considered acceptable from a safety perspective, likely meeting some regulatory threshold for leakage radiation. The document implicitly claims "performa as well or better than the predicate."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No Clinical tests have been included in this pre-market submission."
Therefore, there is no "test set" in the context of patient data, no sample size, and no data provenance from clinical sources for performance evaluation. The "tests" mentioned are non-clinical, focusing on software and hardware functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical tests or human-in-the-loop evaluations were performed or submitted, there was no need for experts to establish ground truth for a test set. Ground truth, in this context, would be based on engineering specifications, physical measurements, and regulatory standards for safety and performance of medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set or expert ground truth was established for performance evaluation with patient data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an afterloader for brachytherapy, not a diagnostic AI tool that assists human readers in interpreting medical images. There are no human readers or AI assistance in that context for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the "Non Clinical Tests" section. The document states:
"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."
This constitutes a standalone evaluation of the device's functional performance against engineering and safety specifications, without human intervention in the "performance" as one might see in an AI algorithm. The device's performance here relates to its mechanical accuracy, software control, shielding, dose delivery capabilities (though not clinical dose), and safety features.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be the engineering specifications, design requirements, and established industry standards for brachytherapy devices. For example:
- Mechanical Accuracy: Measured distances and positions verified against design specifications.
- Radiation Leakage: Measured radiation levels compared against regulatory limits.
- Software Functionality: Software outputs and control actions verified against expected behavior and safety interlocks.
- Source Activity: Measurements verified against manufacturer specifications.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set of patient data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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 Systems3100 Hansen Way, m/s E110Palo Alto CA94304 | NucletronMicroSelectron V3 | GammaMedplus™ iX,(with ConsoleSoftware version 1.1) | GammaMedplus™ iX,(with Console Softwareversion 1.2) | |
|---|---|---|---|---|---|
| Contact Name: Ms Vy Tran,Vice President, Regulatory Affairs and Quality SystemsPhone: 650/424.5731Fax: 650/842.5040vy.tran@varian.comDate: 23rd March 2012 | Predicate DeviceClearance Number: | K061354 | K071381 | N/A | |
| Proprietry Name: | GammaMedplus™ iX and GammaMedplus™ 3/24 iX | Indications for Use | The MicroSelectron V3 isintended to enable anoperator to apply, by remotecontrol, a radionuclide sourceinto the body (includingInterstitial, Intracavitary,Intraluminal, Bronchial,Endovascular, and Intra-operative) or to the surfaceof the body for radiationtherapy. | Both the GammaMedplus iXand GammaMedplus 3/24 iXare indicated, in thetreatment of both benignand malignant disease, forboth curative and palliativeintent, in the delivery ofremote controlled high doserate brachytherapy forconditions anywhere in thebody when brachytherapytreatment is indicated. | The GammaMedplus™ iXSeries is indicated for use inthe treatment of both benignand malignant disease, forboth curative and palliativeintent, in the delivery ofremote-controlled High DoseRate (HDR) and Pulsed DoseRate (PDR) brachytherapy. |
| Classification Name: | Remote controlled radionuclide applicator system21CFR892.5700Class II | Intended use | The MicroSelectron V3 isintended to enable anoperator to apply, by remotecontrol, a radionuclide sourceinto the body (includingInterstitial, Intracavitary,Intraluminal, Bronchial,Endovascular, and Intra-operative) or to the surfaceof the body for radiation.therapy. | The GammaMedplus iXSeries is computer controlledremote HDR Afterloaderused to place a high activityradioactive source within aneedle(s) or applicator(s)which have previously beenplaced for a specified clinicalpurpose in a patient.The radioactive source(enclosed within thewire/cable) is driven viacoupling catheters (TransferGuide Tubes ) from theAfterloader into needles orapplicators within or on thepatient.The length of time andposition that the High DoseRate source spends withinthe needle or applicator iscontrolled in accordancewith an IrradiationTreatment Prescription. | The GammaMedplus iX™Series is intended for use inthe treatment of both benignand malignant disease, forboth curative and palliativeintent, in the delivery ofremote-controlled High DoseRate (HDR) and Pulsed DoseRate (PDR) brachytherapy. |
| Common/Usual Name: | GammaMedplus™ iX afterloader,GammaMedplus™ iX,GammaMedplus™ iX seriesGammaMedplus™ 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) andNucletron 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 computercontrolled remote electro/mechanical systems used for medicalpurposes, for placing a cable incorporating an irradiated iridiumseed internally or close by a malignant tumor or tumor bed in apractice known as brachytherapy. | ||||
| Indications for Use: | The GammaMedplus iX™ Series is indicated for use in thetreatment of both benign and malignant disease, for both curativeand palliative intent, in the delivery of High Dose Rate (HDR) andPulsed Dose Rate (PDR) remote-controlled brachytherapy. |
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Technological Characteristics:
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| NucletronMicroSelectron V3 | GammaMedplus™ iX,(with ConsoleSoftware version 1.1) | GammaMedplus™ iX,(with Console Softwareversion 1.2) | ||
|---|---|---|---|---|
| Adjustable heightposition measured inthe center of theindexer | 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 | 230/115/100V50-60 Hz | 230/115/100V50-60 Hz | |
| Mobile | Yes | Yes | Yes | |
| HDR | Yes | Yes | Yes | |
| PDR | Yes | No | Yes for GammaMedplus iXNo for GammaMedplus 3/24 iX | |
| Number of Channels | 6, 18, 30 | 24 for GammaMedplus iX5 for GammaMedplus 3/24iX | 24 for GammaMedplus iX5 for GammaMedplus 3/24 iX | |
| Shielding | Tungsten. | Tungsten | Tungsten | |
| Maximum shieldingactivity | 518 GBq / 14 Ci | 555 GBq / 15 Ci | 555 GBq / 15 Ci | |
| Maximum treatmentactivity | 518 GBq / 14 Ci | 555 GBq / 15 Ci | 555 GBq / 15 Ci | |
| Max. exposure rate at1m distance containingthe maximum activity | <0.15 µSv/hr, whencontaining a 10 Ci source | 0.3 mrem/hr(3 µSv/hr) | 0.3 mrem/hr(3 µSv/hr) | |
| Dwell positions pereach channel | 48 | 60 | 60 | |
| Area radiation monitor(integrated GMcounter) | Yes | Yes | Yes | |
| Maintained treatmentdata during powerfailure (batterypowered RAM) | Yes | Yes | Yes | |
| Simulator source | Yes | Yes | Yes | |
| Verification of channellength | No | Yes | Yes |
and the comments of the comments of the comments of
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| NucletronMicroSelectron V3 | GammaMedplus™ iX,(with ConsoleSoftware version 1.1) | GammaMedplus™ iX,(with Console Softwareversion 1.2) | |
|---|---|---|---|
| Verification ofapplicator connection | No | Yes* | Yes |
| Source positioning | Proximal to distal | Distal to proximal | Distal to proximal |
| Max. source positionerror over treatmentlength | +/- 1mm per position | 0.35 % referring to 600 mm | 0.35 % referring to 600 mm |
| Emergency containerfor the source | Yes | Yes | Yes |
| Response toemergency signal | Automatic source retraction | Automatic source retraction | Automatic source retraction |
| Emergency manualretraction | 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 treatmentactivity | 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 extensionlength | 1500 mm | 1300 mm | 1300 mm |
| Operator console | |||
| Operating console withPersonal Computer andPrinter | Yes | Yes | Yes |
| Keyswitch control | Yes | Yes | Yes |
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and the control control control control controllers and
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| Nucletron | GammaMedplus™ iX, | GammaMedplus™ iX, | |
|---|---|---|---|
| MicroSelectron V3 | (with ConsoleSoftware version 1.1) | (with Console Softwareversion 1.2) | |
| Control Software | microSelectron™Treatment ControlSoftware | iX Console SoftwareVersion 1.1 | iX Console SoftwareVersion 1.2 |
| Plan Import | Ability to import data fromNucletron brachytherapytreatment planning systems. | Ability to accept treatmentplans from any planningsystem that produces planscomplying with the definedformat. | Ability to automatically recordsome treatment status/historywith Aria patient managementsystem (Console softwareversion 1.1) |
| Ability to export treatmentdelivery data via a DICOMtreatment delivery record.(Console software version 1.2) | |||
| Plan Creation | Available | Available | Available |
| Source DecayCalculation | Once daily | Once daily | Once daily |
| Error Reporting | Error code or status messagesdisplayed in text,accompanied by an indicationof the action required. | Error code or statusmessages displayed in text,accompanied by anindication of the actionrequired. | Error code or status messagesdisplayed in text, accompaniedby an indication of the actionrequired. |
| Report Generation | Treatment report includes anoverview of all treatment-related information. | Treatment report includes anoverview of all treatment-related information. | Treatment report includes anoverview of all treatment-related information. |
| Plan Editing | Dwell positions may beprogrammed manually. | Dwell positions may beprogrammed manually | Dwell positions may beprogrammed manually |
| Full-Screen Operation | No full screen | Disallows access to windowsoperating system. | Disallows access to windowsoperating system |
| Workflows | Workflow-based treatmentdelivery | Workflow-based treatmentdelivery. | Workflow-based treatmentdelivery |
| Security | Key and password protected | Password-based user access. | Password-based user access. |
| Physics Test Plans | Support for physics test plans | Support for physics testplans | Support for physics test plans |
| Startup Checks | Automatic self-test whenTreatment Control System is | Startup checks | Startup checks |
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| NucletronMicroSelectron V3 | GammaMedplus™ iX,(with ConsoleSoftware version 1.1) | GammaMedplus™ iX,(with Console Softwareversion 1.2) | |
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| Service Access | Service-only access mode,with features for adjustingcertain parameters on theafterloader directly from theconsole. | Service-only access mode,with features for adjustingcertain parameters on theafterloader directly from theconsole. | Service-only access mode, withfeatures for adjusting certainparameters on the afterloaderdirectly from the console. |
| User Access Rights | System access can becustomized for specificauthorization. | Privilege-based user accessrights, for multiple users. | Privilege-based user accessrights, for multiple users |
| Patient Privacy | Has several features forprotecting patient privacy,including encryption ofpatient identificationinformation and datadisclosure reporting. | Has several features forprotecting patient privacy,including encryption ofpatient identificationinformation and datadisclosure reporting. | Has several features forprotecting patient privacy,including encryption of patientidentification information anddata disclosure reporting |
| System Data Display | Continuous display of criticalsystem data, includingpending errors, remainingwire cycles, days since lastsource exchange, and most-recently calculated sourcestrength. | Continuous display of criticalsystem data, includingpending errors, remainingwire cycles, days since lastsource exchange, and most-recently calculated sourcestrength. | Continuous display of criticalsystem data, including pendingerrors, remaining wire cycles,days since last sourceexchange, and most-recentlycalculated source strength. |
| Error / Event Logging | System logbook can bedisplayed by date, code, andtype. | Log of all recent systemerrors and events. | Log of all recent system errorsand events. |
| Partial TreatmentOptions | Partial treatment options | Partial treatment options | Removed "redistributeundelivered portion" partialtreatment option. |
| Error MessageAnnotation | Each system message can becustomized to user'srequirements. | Error message annotation,for site-specific errorrecovery actions. | Error message annotation, forsite-specific error recoveryactions. |
| Fraction Editing | Support for fraction addingand modification | Support for fraction addingand modification | Disallowed if the fractioncontains dose information. |
| Standard Plans | Support for standard plans | Support for standard plans | Support for standard plans |
| Console Data Backup | Database backup andretrieval | Manual and automaticconsole data backup options. | Manual and automatic consoledata backup options. |
| Applicator Definition | Basic applicator definition,including number ofchannels, channel names,and channel lengths. | Basic applicator definition,including number ofchannels, channel names,and channel lengths. | Basic applicator definition,including number of channels,channel names, and channellengths. |
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| NucletronMicroSelectron V3 | GammaMedplusTM iX,(with ConsoleSoftware version 1.1) | GammaMedplusTM iX,(with Console Softwareversion 1.2) | |
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| Source ExchangeRecord | Source information recorded,including date of lastexchange, and number ofsource transfers. | On-going record of all sourceexchanges, including date,strength, and number ofcycles. | On-going record of all sourceexchanges, including date,strength, and number ofcycles. |
| Remote service access | Not available | Not available | Allows Varian serviceengineers to log into theconsole 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.
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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።
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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
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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
§ 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.