(49 days)
The Shielded Applicator Set is intended for cancer treatment of the vagina, vaginal stump or rectum where partial shielding is required using HDR or PDR Brachytherapy.
The Cervical Stop is indicated for use with Varian metallic intrauterine tandems/probes to provide a physical stop for depth of insertion of these applicators within the uterus during HDR or PDR brachytherapy.
The applicator set in this submission is designed to be used with all Varian afterloaders to deliver high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy treatment for gynecological and rectal applications. The intracavitary applicator will be used for the treatment of cancerous tumors, and are designed to be inserted into a body cavity.
The cervical stop is a stainless steel component that is placed on the applicator probe during HDR and PDR brachytherapy treatment of the uterus. It provides a physical stop for depth of insertion.
The provided text is a 510(k) Premarket Notification summary for medical devices (Shielded Applicator Set and Cervical Stop) used in brachytherapy. It details the device's characteristics, intended use, and comparison to predicate devices, but it does not contain information about an AI/ML-based device.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance for an AI/ML device cannot be extracted from this document.
However, I can extract the general acceptance criteria and the type of non-clinical study performed.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Applicator functions correctly with specified afterloaders. | Bench testing performed; results showed conformance to applicable requirements and specifications. |
| Devices can withstand the number of cycles of use in their lifetime. | Bench testing performed; results showed conformance to applicable requirements and specifications. |
| Applicator enables the radioactive source to be located with required accuracy. | Bench testing performed; results showed conformance to applicable requirements and specifications. The positional accuracy of the source within the applicator is adequate. |
| Devices are constructed of materials not significantly affected by radiation in their lifetime. | Bench testing performed; results showed conformance to applicable requirements and specifications. |
| Device components may be sterilized effectively (as appropriate). | Bench testing performed; results showed conformance to applicable requirements and specifications. (Specifically mentions steam sterilization for certain parts, and no sterilization of PMMA parts, implying use of sterile condom). |
| Devices can be used and sterilized for the specified number of times. | Bench testing performed; results showed conformance to applicable requirements and specifications. |
| Positional accuracy of the source within the applicator is adequate. | Bench testing performed; results showed conformance to applicable requirements and specifications. |
| Usability assessed to requirements of IEC 62366:2007. | Bench testing performed; results showed conformance to applicable requirements and specifications. |
2. Sample size used for the test set and the data provenance:
- Not applicable as this is not an AI/ML device. The document discusses non-clinical bench testing of physical devices. The "test set" would refer to the physical samples of the devices tested. The provenance of the data is from Varian Medical Systems' internal bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device requiring expert ground truth for image or diagnostic data. Ground truth for mechanical and functional performance is established through engineering and physics principles by the manufacturer.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML device. Adjudication methods are typically used for disagreements in human interpretation of diagnostic 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:
- No. This document explicitly states, "No clinical tests have been included in this pre-market submission." An MRMC study is a clinical study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical bench tests, the "ground truth" would be engineering specifications, physical measurements, and compliance with recognized standards (e.g., source positioning accuracy, material properties, sterilization effectiveness, usability per IEC 62366:2007).
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K151657
Trade/Device Name: Shielded Applicator Set-GM11004380. Cervical Stop-GM11000670 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 17, 2015 Received: June 19, 2015
Dear Mr. Coronado:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151657
Device Name
GM11004380 - Shielded Applicator Set GM11000670 - Cervical Stop
Indications for Use (Describe)
The Shielded Applicator Set is intended for cancer treatment of the vaginal stump or rectum where partial shielding is required using HDR or PDR Brachytherapy.
The Cervical Stop is indicated for use with Varian metallic intrauterine tandems/probes to provide a physical stop for depth of insertion of these applicators within the uterus during HDR or PDR brachytherapy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com
Premarket Notification [510(k)] Summary
GM11004380 Shielded Applicator Set GM11000670 Cervical Stop
The following information is provided following the format of 21 CFR 807.92(c).
| Submitter's Name: | Varian Medical Systems, Inc.3100 Hansen Way E-110Palo Alto, CA 94304 |
|---|---|
| Contact Name: Peter J. CoronadoPhone: 650.424.6320Fax: 650.646.9200 | |
| Date: 17 June 2015 | |
| Proprietary Name: | Shielded Applicator Set - GM11004380Cervical Stop- GM11000670 |
| Classification Name: | Remote controlled radionuclide applicator system21 CFR 892.5700, Class IIProduct Code: JAQ |
| Common/Usual Name: | Remote controlled radionuclide applicator system |
| Predicate Devices: | K033371 Intracavitary Brachytherapy Applicators(Primary predicate: GM11004380 – Shielded Applicator SetSecondary predicate: 1100404 – Cervix Applicator Set, Cervical Stopper) |
| Device Description: | The applicator set in this submission is designed to be used with all Varianafterloaders to deliver high dose rate (HDR) and pulsed-dose-rate (PDR)brachytherapy treatment for gynecological and rectal applications. Theintracavitary applicator will be used for the treatment of cancerous tumors, andare designed to be inserted into a body cavity.The cervical stop is a stainless steel component that is placed on the applicatorprobe during HDR and PDR brachytherapy treatment of the uterus. It provides aphysical stop for depth of insertion. |
| Intended Use Statement -Shielded Applicator Set | The Shielded Applicator Set is intended for cancer treatment of the vagina, vaginalstump or rectum where partial shielding is required using HDR or PDRBrachytherapy. |
| Intended Use Statement -Cervical Stop | The Cervical Stop is indicated for use with Varian metallic intrauterinetandems/probes to provide a physical stop for depth of insertion of theseapplicators within the uterus during HDR or PDR brachytherapy. |
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| Indications for UseStatement –Shielded Applicator Set | The Shielded Applicator Set is intended for cancer treatment of the vagina, vaginalstump or rectum where partial shielding is required using HDR or PDRBrachytherapy. |
|---|---|
| Indications for UseStatement– Cervical Stop | The Cervical Stop is indicated for use with Varian metallic intrauterinetandems/probes to provide a physical stop for depth of insertion of theseapplicators within the uterus during HDR or PDR brachytherapy. |
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Technological Characteristics:
| Shielded Applicator Set (K033371) | Modified Shielded Applicator Set | |
|---|---|---|
| CompatibleAfterloaders | VariSource Afterloader Systems | VariSource iX™VariSource 200™GammaMedplus iX™GammaMedplus™ |
| Intended use | Shielded applicator is developed to treatcancer of the vagina or rectum wherepartial shielding is required. The maximplantation time for this applicator is 2days | The Shielded Applicator Set is intended forcancer treatment of the vagina, vaginalstump or rectum where partial shielding isrequired using HDR or PDR Brachytherapy. |
| Indications for Use | The applicator will be used with theVariSource High Dose Rate Afterloaders todeliver brachytherapy treatment forgynecological and rectal applications. Theapplicator will be used in medicalintracavitary for treatment of canceroustumors. | The Shielded Applicator Set is intended forcancer treatment of the vagina, vaginalstump or rectum where partial shielding isrequired using HDR or PDR Brachytherapy. |
| Design | Cylinder:- Ø 20, 23, 26, 30, 35mm- length 140mmApplicator probe:- Ø 3.0mm, straight- Length 320mmTungston Alloy Shielding:- 90°, 180°- Length 122.5mmMarking Screw (shielded)0°, 90°, 2 x 90°, 180°, 270°Clamping Nut for marking screwClamping screw for probe, 3mmPlexiglass Filler Piece, 90°Yellow Cleaning Cap | Cylinder:- Ø 20, 23, 26, 30, 35mm- length 140mmApplicator probe:- Ø 3.0mm, straight- Length 320mmTungston Alloy Shielding:- 90°, 180°- Length 122.5mmMarking Screw (shielded)0°, 90°, 2 x 90°, 180°, 270°Clamping Nut for marking screwClamping screw for probe, 3mmPlexiglass Filler Piece, 90°Blue Cleaning Cap |
| Materials | - Shielding - Tungsten Alloy- Marking Screw, Clamping nut/Screwand applicator probe - Stainless Steel- Cylinders - PMMA- Cleaning cap- Silicone | - Shielding - Tungsten Alloy- Marking Screw, Clamping nut/Screw andapplicator probe - Stainless Steel- Cylinders - PMMA- Cleaning cap- Silicone |
| Guide Tubes | - Source guide tube with lockingmechanism for 320mm applicatorsGM plus- VariSource Transfer Guide Tubes | - Source guide tube with lockingmechanism for 320mm applicators GMplus (K141336)ClickFit transfer guide tube, set of 4 foriVS 200 (K113766) |
| Optional accessories | - X-ray marker for 320mm applicators, 0.9mm, uncoded, GammaMedPlus- X-ray marker probe, for 320mm applicators, uncoded, GammaMed 12i(t)- VariSource X-ray marker wire- Leak stop button- VariSource Ruler- Flexible fixation device for gynecological applicators- Universal applicator clamping device (third party product)- Source guide tube support, GammaMed units only | - X-ray marker BV, up to 320 mm applicators, uncoded, GammaMedPlus- Leak stop button- Measurement Ruler- Measurement Marker Wire VS Measurement- Measurement Marker Clip- Flexible fixation device for gynecological applicators- Universal applicator clamping device (third party product)- Source guide tube support, GammaMed units only- Length gauge, GM plus- Cervical Stop- Allen Wrench |
| Packing | Individual | Individual |
| Sterility | Non sterile | Non sterile |
| Sterilization method | Steam sterilization (applicator probe, tungsten shielding and marking screws)EO Sterilization for PMMA parts | Steam sterilization (applicator probe and marking screws)No sterilization of PMMA parts (use sterile medical condom) |
| Use of yellow Cleaning CAP (GM110003260) | Use of dark blue Cleaning CAP (GM11010770) | |
| Biocompatibility | Fully biocompatible only when used in combination with a sterile medical condom. | Fully biocompatible only when used in combination with a sterile medical condom. |
| Anatomical sites | The Shielded Applicator Set is used on female (vaginal and rectal) and male (rectal) patients. | The Shielded Applicator Set is used on female (vaginal and rectal) and male (rectal) patients.Cervical Stop |
| Compatibility with the environment and other devices | N/A | Cervical Stop |
| Where used | The Shielded Applicator Set is intended to be used in a radiation therapy or radiation oncology department in a hospital environment. | The Shielded Applicator Set is intended to be used in a radiation therapy or radiation oncology department in a hospital environment. |
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Cervical Stop – GM11000670
| Cervical Stopper(part of K033371 – Cervix Applicator Set) | Cervical Stop | |
|---|---|---|
| Compatible Applicators | Cervix Applicator Set | All Varian metallic intrauterine |
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| tandems/probes | ||
|---|---|---|
| Intended Use | The Cervical Stopper is indicated for usewith the Cervix Applicator Set to provide aphysical stop for depth of insertion ofthese applicators within the uterus duringHDR or PDR brachytherapy. | The Cervical Stop is indicated for use withVarian metallic intrauterinetandems/probes to provide a physicalstop for depth of insertion of theseapplicators within the uterus during HDRor PDR brachytherapy. |
| Indications for Use | The Cervical Stopper is indicated for usewith the Cervix Applicator to provide aphysical stop for depth of insertion ofthese applicators within the uterus duringHDR or PDR brachytherapy. | The Cervical Stop is indicated for use withVarian metallic intrauterinetandems/probes to provide a physicalstop for depth of insertion of theseapplicators within the uterus during HDRor PDR brachytherapy. |
| Material | PEEK/Titanium | PEEK/Titanium |
| Sterility | Non sterile | Non sterile |
| Reusable | Yes | Yes |
| Design | Ø 16mm flattened to 10mmThickness 5.8mm | Ø 16mm flattened to 10mmThickness 5.8mm |
Non Clinical Tests
Bench Testing has been performed to demonstrate that
- the applicator functions correctly with the specified afterloaders; .
- the devices can withstand the number of cycles of use that it will experience in its lifetime;
- the applicator enables the radioactive source to be located to the accuracy required
- the devices are constructed of materials that are not significantly affected by the radiation to which they • are exposed in the lifetime of the products;
- . the device components may be sterilized effectively (as appropriate)
- . the devices can be used and sterilized for the specified number of times
- the positional accuracy of the source within the applicator is adequate. ●
Usability was assessed to the requirements of IEC 62366:2007.
Results of Bench Testing showed conformance to applicable requirements and specifications
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 to be safe and effective and to perform as well or better than the predicate.
§ 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.