(113 days)
The Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vagina, vaginal stump and rectum using HDR or PDR brachytherapy.
The applicator sets in this submission are designed to be used with the GammaMed Plus afterloader series, Varisource 200 and IX afterloaders to deliver high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy treatment for gynecological and rectal applications. The intracavitary applicators will be used for the treatment of cancerous tumors, and are designed to be inserted into a body cavity.
This document is a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study proving the device meets specific acceptance criteria in a clinical context.
Based on the provided text, the device is the "Universal Segmented Cylinder Applicator Set" and "Universal Stump Applicator Set," used for cancer treatment via brachytherapy. The submission does not contain a clinical study with acceptance criteria and reported device performance in the way typically associated with diagnostic AI systems or new therapeutic treatments.
Instead, the submission relies on non-clinical bench testing to demonstrate the device's functionality and safety. Therefore, many of the requested categories for a study are not applicable in this context.
Here's an attempt to answer your questions based on the available information:
1. Table of acceptance criteria and the reported device performance
Since this is a brachytherapy applicator set and the submission focuses on substantial equivalence to a predicate device through bench testing rather than a clinical performance study with statistical endpoints, the "acceptance criteria" are related to mechanical function, material properties, and compatibility, not diagnostic accuracy or treatment efficacy in patients as would be for an AI algorithm.
| Acceptance Criteria (Bench Testing Objectives) | Reported Device Performance (Conclusion) |
|---|---|
| Device functions correctly with specified afterloaders | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
| Device withstands the number of cycles of use in its lifetime | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
| Device enables radioactive source to be located with required accuracy | "Results of Bench Testing showed conformance to applicable requirements and specifications" "[Positional accuracy] is adequate." |
| Device materials are not significantly affected by radiation over lifetime | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
| Device can be sterilized effectively | "Results of Bench Testing showed conformance to applicable requirements and specifications" "[Device] may be sterilized effectively." |
| Device can be used and sterilized for the specified number of times | "Results of Bench Testing showed conformance to applicable requirements and specifications" "[Device] can be used and sterilized for the specified number of times." |
| Positional accuracy of the source within the applicator is adequate | "Results of Bench Testing showed conformance to applicable requirements and specifications" "[Positional accuracy] is adequate." |
| Usability assessed to requirements of IEC 62366:2007 | "Results of Bench Testing showed conformance to applicable requirements and specifications" |
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set or patient data was used. The evaluation was based on non-clinical bench testing of the device units themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was bench testing against engineering specifications, not expert-adjudicated clinical ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication was performed.
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 is not an AI/software device. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" or reference standard for this submission was based on engineering specifications, design requirements, and international standards (e.g., IEC 62366:2007) for the physical performance, safety, and compatibility of the brachytherapy applicators.
8. The sample size for the training set
Not applicable. No "training set" in the context of machine learning or clinical data was used. Bench testing involves evaluating the physical devices.
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used. The ground truth for the bench testing was established by engineering design specifications and safety/performance standards.
Summary of the Document's Scope:
The provided document is a 510(k) Pre-Market Notification, which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to an already legally marketed device (predicate device). For a device like a brachytherapy applicator set, this typically involves:
- Comparison of Technological Characteristics: As shown in the tables on pages 4 and 5, the new device is compared feature-by-feature (e.g., compatible afterloader, intended use, design, materials, sterility) to its predicate device. This is the primary "study" presented here.
- Non-Clinical Testing (Bench Testing): This demonstrates that the device meets its own design specifications and is safe and performs as intended, often in a laboratory setting. This is explicitly stated in the "Non Clinical Tests" section on page 5.
- No Clinical Testing: The document explicitly states: "No clinical tests have been included in this pre-market submission." This means there was no in-human study to evaluate patient outcomes, diagnostic accuracy, or treatment efficacy when the device is used clinically. The focus is on the device's functional integrity and safety.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2014
Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K141490
Trade/Device Name: Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 15, 2014 Received: August 18, 2014
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
Janine M. Morris 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) K141490
Device Name
GM11011100 - Universal Segmented Cylinder Applicator Set GM11011160 - Universal Stump Applicator Set
Indications for Use (Describe)
The Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump and rectum using HDR or PDR brachytherapy.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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
GM11011100 Universal Segmented Cylinder Applicator Set GM11011160 Universal Stump Applicator Set
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: 04 June 2014 | |
| Proprietary Name: | Universal Segmented Cylinder Applicator SetUniversal Stump Applicator Set |
| Classification Name: | Remote controlled radionuclide applicator system21 CFR 892.5700, Class IIProduct Code: JAQ |
| Common/UsualName: | Remote controlled radionuclide applicator system |
| Predicate Devices: | K033371 Intracavitary Brachytherapy Applicators(11-00415 Segmented Cylinder Set, 11-00416 Stump Applicator Set) |
| Device Description: | The applicator sets in this submission are designed to be used with the GammaMed Plusafterloader series, Varisource 200 and IX afterloaders to deliver high dose rate (HDR) andpulsed-dose-rate (PDR) brachytherapy treatment for gynecological and rectalapplications. The intracavitary applicators will be used for the treatment of canceroustumors, and are designed to be inserted into a body cavity. |
| Intended UseStatement | The Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Setare indicated for use for cancer treatment of the vagina, vaginal stump and rectum usingHDR or PDR brachytherapy. |
| Indications for UseStatement | The Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Setare indicated for use for cancer treatment of the vagina, vaginal stump and rectum usingHDR or PDR brachytherapy. |
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Technological Characteristics:
| Segmented Applicator Cylinder Set andStump Applicator Set (K033371) | Universal Segmented Cylinder ApplicatorSet and Universal Stump Applicator Set | |
|---|---|---|
| Compatible Afterloader | Varian Afterloader (GammaMed andVariSource) | GammaMed Plus afterloader seriesVarisource 200 and IX afterloader |
| Intended use | 11-00415 Segmented Cylinder SetSegmented Cylinder Set is developed totreat cancer of the vagina and the vaginalstump. It is also suitable to treat rectalcancer. The applicator set is MR and CTcompatible. The maximum implantationtime for this applicator is 2 days. | The Universal Segmented CylinderApplicator Set and the Universal StumpApplicator Set are indicated for use forcancer treatment of the vagina, vaginalstump and rectum using HDR or PDRBrachytherapy. |
| 11-00416 Stump Applicator SetStump Applicator Set is developed forpost-operative irradiation of the vaginalstump. The flexible applicator probe has aconnector made of titanium, so thatposition checks can be made using CT orMRI. The maximum implantation time forthis applicator is 30 days. | ||
| Indications for Use | The applicators will be used with theVariSource High Dose Rate Afterloaders todeliver brachytherapy treatment forgynecological and rectal applications. Theapplicators will be used in medicalintracavitary for treatment of canceroustumors. | The Universal Segmented CylinderApplicator Set and the Universal StumpApplicator Set are indicated for use forcancer treatment of the vagina, vaginalstump and rectum using HDR or PDRBrachytherapy. |
| Design | Segmented Cylinder:Cylinder segment dimension: diameters20, 25, 30, 35 mm; length 30 mmFront segment: 2 front segments forvaginal wall and vaginal stump treatmentFront segment dimension: diameters 20,25, 30, 35 mm; length 20 – 27.5 mmGuiding tube: straight ø 6.4 mm; length228 mmApplicator probe: ø 3.2 mm; inner length320 mm; flexible with blocking washer | Segmented Cylinder:Cylinder segment dimension: diameters20, 25, 30, 35, 40 mm; length 30 mmFront segment: 1 front segment for vaginalwall and vaginal stump treatmentFront segment dimension: diameter 20,25, 30, 35, 40 mm; length 50 – 60 mmGuiding tube & applicator probe: straightrigid ø 3.2 mm; length 200 and 250 mm |
| Stump Applicator:Cylinder dimension: diameters 20, 23, 26,30, 35 mm; length 140 mmApplicator probe dimension:ø 3.2 mm;inner length 320 mm | Stump Applicator:Cylinder dimension: diameters 20, 25, 30,35 mm; length 140 mmApplicator probe dimension: ø 3.2 mm;inner length 200 and 250 mm |
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| Materials | Segmented Cylinder:Cylinder: PPSU plastic whiteGuiding tube: PEEK plastic naturalApplicator probe: FEP, Titanium | Segmented Cylinder:Cylinder: PPSU plastic whiteGuiding tube & applicator probe: PEEKplastic natural, Titanium |
|---|---|---|
| Stump Applicator:Cylinder: PPSU plastic whiteApplicator probe: PVDF, Titanium | Stump Applicator: Cylinder: PPSU plasticwhiteApplicator probe: PEEK plastic natural,Titanium | |
| Packing | Individual | Individual |
| Sterility | Provided non-sterile | Provided non-sterile |
| Sterilization method | Steam sterilization134 °C for 5 minutes121 °C for 15 minutes | Steam sterilization132 °C for 4 min134 °C for 3 min134 °C for 5 min |
| Biocompatibility | Full biocompatibility | Full biocompatibility |
| Anatomical sites | Segmented Cylinder:Vaginal, rectum | Segmented Cylinder:Vaginal, rectum |
| Stump Applicator: Vaginal | Stump Applicator: Vaginal, rectum | |
| Compatibility with theenvironment and otherdevices | Segmented Cylinder:CT compatibleMR conditional | Segmented Cylinder:CT compatibleMR conditional |
| Stump Applicator:CT compatibleMR conditional | Stump Applicator:CT compatibleMR conditional | |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |
Non Clinical Tests
Bench Testing has been performed to demonstrate that
- the device functions correctly with the specified afterloaders; ●
- . the device can withstand the number of cycles of use that it will experience in its lifetime;
- the device enables the radioactive source to be located to the accuracy required,
- the device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- . the device may be sterilized effectively
- . the device 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.