(168 days)
The Universal Segmented Cylinder Set and Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump and rectum using HDR or PDR brachytherapy.
The Universal Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump, cervix, uterus and endometrium 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.
The provided document pertains to a 510(k) premarket notification for the "Universal Cylinder Applicator Family" by Varian Medical Systems. This family of devices is used for brachytherapy and its primary purpose is to deliver radioactive sources for cancer treatment.
The document indicates that this is a 510(k) submission, which means it aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical trials. Therefore, the information provided focuses on engineering and bench testing rather than clinical study results demonstrating performance against acceptance criteria in a clinical context.
Here's an analysis of the requested information based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics in a typical clinical study format. Instead, it lists several non-clinical tests and states that the "Results of Bench Testing showed conformance to applicable requirements and specifications" and "All the tests that were performed met the applied pass criteria."
Here's a summary of the stated performance based on the non-clinical tests:
| Acceptance Criteria (Implied from Test Purpose) | Reported Device Performance |
|---|---|
| Correct function with specified afterloaders. | Devices function correctly with the specified afterloaders (GammaMed Plus, VariSource 200, IX). |
| Withstand specified number of use cycles over lifetime. | Devices can withstand the number of cycles of use they will experience in their lifetime. |
| Accurate radioactive source location. | Devices enable the radioactive source to be located to the accuracy required. |
| Material integrity under radiation exposure over lifetime. | Devices are constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product. |
| Effective sterilization. | Devices may be sterilized effectively. |
| Maintain usage and sterilization integrity for specified number of times. | Devices can be used and sterilized for the specified number of times. |
| Adequate positional accuracy of the source within the devices. | The positional accuracy of the source within the devices is adequate. |
| Biocompatibility according to ISO 10933 standards. | Devices are biocompatible as per ISO10933 standards. |
| Safe and effective use in CT environments. | Devices can be used safely and effectively in CT environments (CT compatible). |
| Safe use in MRI environments under specified conditions. | Testing in MRI environments has demonstrated they are safe to use under the conditions specified in the labeling (MR conditional). |
| Conformance to usability requirements (IEC 62366:2007). | Usability has been assessed to the requirements of IEC 62366:2007, and results showed conformance. |
2. Sample Size for the Test Set and Data Provenance
The document describes non-clinical bench testing. Therefore, there isn't a "test set" in the sense of patient data. The "samples" would be a certain number of the Universal Cylinder Applicator Family devices that underwent various physical and functional tests. The document does not specify the exact number of devices tested for each non-clinical test.
- Data Provenance: The tests are "Bench Testing," implying they were conducted in a laboratory or engineering environment. There is no mention of country of origin for this data or if it's retrospective or prospective, as these terms are generally applicable to human subject studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes non-clinical bench testing of a physical medical device (an applicator for brachytherapy), not an AI or diagnostic device that requires expert-established ground truth from medical images or patient cases.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. Adjudication is relevant for studies involving human interpretation or clinical outcomes, not for engineering bench tests.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests have been included in this pre-market submission." This type of study would compare human readers' performance with and without an AI-assisted device, which is not relevant for this physical brachytherapy applicator.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
A standalone study was not done. This device is a physical applicator system used in conjunction with "afterloaders" and operated by medical professionals. It is not an algorithm or a device that functions independently without human intervention in a diagnostic or interpretive capacity.
7. Type of Ground Truth Used
The concept of "ground truth" as pathology, outcomes data, or expert consensus is not applicable in the context of this 510(k) submission. The "truth" for the bench tests would be defined by engineering specifications, material properties, and functional requirements (e.g., source position accuracy within manufacturing tolerances, sterilization efficacy according to validated protocols, biocompatibility meeting ISO standards).
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" as this device is a physical medical device, not a machine learning or AI model that requires training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8. There is no training set for this type of device.
In summary, the provided document is a 510(k) premarket notification for a physical medical device, not a diagnostic or AI-based system. Therefore, many of the requested items related to clinical studies, AI performance, and ground truth establishment in a diagnostic context are not present or applicable. The submission relies solely on non-clinical bench testing to demonstrate substantial equivalence to a predicate device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust 10, 2016
Varian Medical Systems, Inc % Mr. Peter J. Coronado Director, Regulatory Affairs 911 Hansen Wav PALO ALTO CA 94304
Re: K160516
Trade/Device Name: Universal Cylinder Applicator Family Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 20, 2016 Received: June 27, 2016
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. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K160516 Device Name
Universal Cylinder Applicator Family
Indications for Use (Describe)
The Universal Segmented Cylinder Set and Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump and rectum using HDR or PDR brachytherapy.
The Universal Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are indicated for use for cancer treatment of the vaginal stump, cervix, uterus and endometrium using 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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PREMARKET NOTIFICATION
510(k) Summary
Universal Cylinder Applicator Family
As required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems3100 Hansen Way, m/s E110Palo Alto CA94304 |
|---|---|
| Contact Name: Peter J. CoronadoPhone: 650/424.6320Fax: 650/646.9200Date: 5th February 2016 | |
| Proprietary Name: | Universal Cylinder Applicator Family |
| Classification Name: | Remote controlled radionuclide applicator system21CFR892.5700Class II |
| Common/Usual Name: | Universal Segmented Cylinder Applicator SetUniversal Stump Applicator SetUniversal Cervix Probe Sets |
| Predicate Devices: | K141490 Universal Cylinder Set. |
| Device Description: | The applicator sets in this submission are designed to be used withthe GammaMed Plus afterloader series, Varisource 200 and IXafterloaders to deliver high dose rate (HDR) and pulsed-dose-rate(PDR) brachytherapy treatment for gynecological and rectalapplications. The intracavitary applicators will be used for thetreatment of cancerous tumors, and are designed to be insertedinto a body cavity. |
| Indications for Use: | The Universal Segmented Cylinder Applicator Set and UniversalStump Applicator Set are indicated for use for cancer treatment ofthe vagina, vaginal stump and rectum using HDR or PDRbrachytherapy. |
| The Universal Cervix Probe Sets in combination with the UniversalSegmented Cylinder Applicator Set and the Universal StumpApplicator Set are indicated for use for cancer treatment of thevagina, vaginal stump, cervix, uterus and endometrium using HDRor PDR brachytherapy. |
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Technological Characteristics:
| FEATURE AND/ORSPECIFICATION OFNEW/MODIFIED DEVICE | DEVICE FEATURE/SPECIFICATION510(K) ID #K141490 UNIVERSAL SEGMENTEDCYLINDER APPLICATOR SET AND | NAME AND VERSIONUNIVERSAL SEGMENTED CYLINDERAPPLICATOR SET AND UNIVERSAL STUMPAPPLICATOR SET AND IN COMBINATION WITH |
|---|---|---|
| UNIVERSAL STUMP APPLICATOR SET | UNIVERSAL CERVIX PROBE SETS | |
| Compatible Afterloader | GammaMed Plus afterloader seriesVariSource 200 and iX afterloader | GammaMed Plus afterloader seriesVariSource 200 and iX afterloader |
| Intended use | 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 | The Universal Segmented CylinderApplicator Set and the Universal StumpApplicator Set are intended for use forcancer treatment of the vagina, vaginalstump and rectum using HDR or PDRBrachytherapy |
| The Universal Cervix Probe Sets incombination with the UniversalSegmented Cylinder Applicator Set andthe Universal Stump Applicator Set areintended for use for cancer treatment ofthe vagina, vaginal stump, cervix, uterusand endometrium using HDR or PDRBrachytherapy | ||
| Indications for use | 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 | 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 |
| The Universal Cervix Probe Sets incombination with the UniversalSegmented Cylinder Applicator Set andthe Universal Stump Applicator Set areindicated for use for cancer treatment ofthe vagina, vaginal stump, cervix, uterusand endometrium using HDR or PDRBrachytherapy | ||
| Design | Segmented Cylinder:Cylinder segment dimension: diameters20, 25, 30, 35, 40 mm; length 30 mmFront segment: 1 front segment forvaginal wall and vaginal stumptreatmentFront 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 | Segmented Cylinder.Cylinder segment dimension: diameters20, 25, 30, 35, 40 mm; length 30 mmFront segment: 1 front segment forvaginal wall 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 |
| Universal Cervix Probe Sets:6.3 mm diameter; inner length 320 mm;cervix length 30, 40, 50, 60, 70, 80 mm;straight, curved with 15° or 30°. | ||
| Stump Applicator: | Stump Applicator: | |
| Cylinder dimension: diameters 20, 25, 30, 35 mm; length 140 mm | ||
| Cylinder dimension: diameters 20, 25, 30, 35 mm; length 140 mm | ||
| Applicator probe dimension: Ø 3.2 mm; inner length 200 and 250 mm | ||
| Applicator probe dimension: Ø 3.2 mm; inner length 200 and 250 mm | ||
| Universal Cervix Probe Sets: | ||
| 6.3 mm diameter; inner length 320 mm; | ||
| cervix length 30, 40, 50, 60, 70, 80 mm; | ||
| straight, curved with 15° or 30°. | ||
| Materials | Segmented Cylinder: | |
| Cylinder: PPSU plastic white | ||
| Guiding tube & applicator probe: PEEK plastic natural, Titanium | ||
| Universal Cervix Probe Sets: | ||
| PEEK plastic natural, Titanium, FEP | ||
| Stump Applicator: | ||
| Cylinder: PPSU plastic white | ||
| Applicator probe: PEEK plastic natural, Titanium | ||
| Universal Cervix Probe Sets: | ||
| PEEK plastic natural, Titanium, FEP | ||
| Packing | Individual | |
| Sterility | Provided non-sterile | |
| Sterilization method | Steam sterilization | |
| 132 °C for 4 min | ||
| 134 °C for 3 min | ||
| 134 °C for 5 min | ||
| Biocompatibility | Full biocompatibility | |
| Anatomical sites | Segmented Cylinder & Cervix Probe Sets: | |
| Vaginal, vaginal stump, rectum, endometrium, cervix, uterus | ||
| Stump Applicator / Cervix Probe Sets: | ||
| Vaginal, rectum, vaginal stump, endometrium, cervix, uterus | ||
| Compatibility with the environment and other devices | Segmented Cylinder & Cervix Probe Sets: | |
| CT compatible | ||
| MR conditional | ||
| Stump Applicator & Cervix Probe Sets: | ||
| CT compatible | ||
| MR conditional | ||
| Where used | Brachytherapy treatment room |
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Non Clinical Tests Bench Testing has been performed to demonstrate that
- o the devices function correctly with the specified afterloaders;
- the devices can withstand the number of cycles of use they will experience in its lifetime;
- . the devices enable the radioactive source to be located to the accuracy required,
- o the devices are constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- . the devices may be sterilized effectively
- . the devices can be used and sterilized for the specified number of times
- the positional accuracy of the source within the devices is adequate.
- the devices are biocompatible as per ISO10933 standards
- the devices can be used safely and effectively in CT environments
- testing of the Universal Cylinder Applicator Family in MRI environments has demonstrated they are safe to use under the conditions specified in the labelling.
Usability has been 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.