Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths

K172611 · Varian Medical Systems, Inc. · JAQ · Mar 21, 2018 · Radiology

Device Facts

• Record ID: K172611
• Device Name: Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Mar 21, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set are intended for cancer treatment of the vagina, 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 intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy. The Universal Titanium Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.

Device Story

Intracavitary applicator set for high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy; used with GammaMed Plus, VariSource 200, and iX afterloaders. Device consists of segmented cylinders, stump applicators, and cervix probes (including new titanium variants). Inserted into body cavities (vagina, rectum, uterus) by clinicians in brachytherapy treatment rooms to guide radioactive sources to tumor sites. Provides precise positioning of radiation source; enables localized tumor treatment while sparing surrounding healthy tissue. Titanium probes offer alternative material properties; MR unsafe status for titanium variants noted. Bench testing confirms positional accuracy, material radiation resistance, and biocompatibility.

Clinical Evidence

No clinical data included. Bench testing only: verified functional compatibility with afterloaders, mechanical durability over lifetime cycles, source positioning accuracy, radiation resistance of materials, sterilization efficacy, and biocompatibility per ISO 10933.

Technological Characteristics

Materials: PPSU plastic, PEEK plastic, FEP, Titanium. Sensing/Actuation: Passive mechanical guidance for radioactive source. Dimensions: Cylinder diameters 20-40mm; probe diameters 3mm (titanium) or 6.3mm. Connectivity: None (mechanical). Sterilization: Steam (132°C/4min, 134°C/3-5min). Compatibility: CT compatible; MR conditional (standard sets) or MR unsafe (titanium sets).

Indications for Use

Indicated for cancer treatment of the vagina, vaginal stump, rectum, cervix, uterus, and endometrium using HDR or PDR brachytherapy in patients requiring intracavitary 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

• Universal Cylinder Applicator Family (K160516)

Submission Summary (Full Text)

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March 21, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Varian Medical Systems, Inc % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304

Re: K172611

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: JAO Dated: March 6, 2018 Received: March 7, 2018

Dear Mr. Coronado:

We have reviewed vour 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 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'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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### Indications for Use

510(k) Number (if known) K172611

Device Name Universal Cylinder Applicator Family

#### Indications for Use (Describe)

The Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set are intended for cancer treatment of the vagina, 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 intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.

The Universal Titanium Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.

X 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 Systems |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 3100 Hansen Way, m/s E110 |
| | Palo Alto CA 94304 |
| | Contact Name: Peter J. Coronado |
| | Phone: [phone] |
| | Fax: [phone] |
| | Date: 30 August 2017 |
| Proprietary Name: | Universal Cylinder Applicator Family |
| Classification Name: | Remote controlled radionuclide applicator system |
| | 21 CFR892.5700 |
| | Class II |
| Common/Usual Name: | Universal Segmented Cylinder Applicator Set |
| | Universal Stump Applicator Set |
| | Universal Cervix Probe Sets |
| | Universal Titanium Cervix Probe Sets |
| Predicate Devices: | K160516 - Universal Cylinder Applicator Family |
| Indications for Use: | The Universal Segmented Cylinder Applicator Set and Universal<br>Stump Applicator Set are indicated for use for cancer treatment of<br>the vagina, vaginal stump and rectum using HDR or PDR<br>brachytherapy. |
| | The Universal Cervix Probe Sets in combination with the Universal<br>Segmented Cylinder Applicator Set and the Universal Stump<br>Applicator Set are indicated for use for cancer treatment of the<br>vagina, vaginal stump, cervix, uterus and endometrium using HDR<br>or PDR brachytherapy. |
| | The Universal Titanium Cervix Probe Sets in combination with the<br>Universal Segmented Cylinder Applicator Set and the Universal<br>Stump Applicator Set are indicated for use for cancer treatment of<br>the vagina, vaginal stump, cervix, uterus and endometrium using<br>HDR or PDR brachytherapy. |

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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 gynaecological 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.

#### Technological Characteristics:

| Feature<br>Comparison<br>Chart | Predicate Device:<br>Universal Cylinder Applicator Family<br>(K160516) | Subject Device:<br>Universal Cylinder Applicator Family |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sets within the<br>Universal<br>Cylinder<br>Applicator<br>Family (UCAF) | • Universal Segmented Cylinder<br>Applicator Set<br>• Universal Stump Applicator Set<br>• Universal Cervix Probe Sets | • Universal Segmented Cylinder<br>Applicator Set<br>• Universal Stump Applicator Set<br>• Universal Cervix Probe Sets<br>• Universal Titanium Cervix Probe<br>Sets |
| Compatible<br>Afterloader | All Sets:<br>GammaMed Plus series<br>VariSource 200 and iX | All Sets:<br>GammaMed Plus series<br>VariSource 200 and iX |
| Design | Universal Segmented Cylinder<br>Applicator Set:<br>Cylinder Segment Dimension:<br>diameters 20, 25, 30, 35, 40 mm;<br>length 30 mm<br>Front Segment: 1 front segment for<br>vaginal wall and vaginal stump<br>treatment<br>Front Segment Dimension: diameter<br>20, 25, 30, 35, 40 mm; length 50 –<br>60 mm<br>Guiding Tube & Applicator Probe:<br>straight rigid $ø$ 3.2 mm; length 200<br>and 250 mm<br><br>Universal Stump Applicator Set:<br>Cylinder Dimension:<br>diameters 20, 25, 30, 35 mm; length<br>140 mm<br>Applicator Probe Dimension:<br>$ø$ 3.2 mm; inner length 200 and 250<br>mm | Universal Segmented Cylinder<br>Applicator Set:<br>Cylinder Segment Dimension:<br>diameters 20, 25, 30, 35, 40 mm;<br>length 30 mm<br>Front Segment: 1 front segment for<br>vaginal wall and vaginal stump<br>treatment<br>Front Segment Dimension: diameter<br>20, 25, 30, 35, 40 mm; length 50 –<br>60 mm<br>Guiding Tube & Applicator Probe:<br>straight rigid $ø$ 3.2 mm; length 200<br>and 250 mm<br><br>Universal Stump Applicator Set:<br>Cylinder Dimension:<br>diameters 20, 25, 30, 35 mm; length<br>140 mm<br>Applicator Probe Dimension:<br>$ø$ 3.2 mm; inner length 200 and 250<br>mm |
| Feature<br>Comparison<br>Chart | Predicate Device:<br>Universal Cylinder Applicator Family<br>(K160516) | Subject Device:<br>Universal Cylinder Applicator Family |
| | Universal Cervix Probe Sets:<br>Diameter: 6.3 mm<br>Inner Length: 320 mm<br>Cervix Length:<br>30, 40, 50, 60, 70, 80 mm<br>Probe Tip Shapes: Straight or Curved<br>with 15°, 30° | Universal Cervix Probe Sets:<br>Diameter: 6.3 mm<br>Inner Length: 320 mm<br>Cervix Length:<br>30, 40, 50, 60, 70, 80 mm<br>Probe Tip Shapes: Straight or Curved<br>with 15°, 30° |
| | | Universal Titanium Cervix Probe<br>Sets:<br>Diameter: 3 mm<br>Inner Length: 320 mm<br>Cervix Length:<br>30, 40, 50, 60, 70, 80 mm<br>Probe Tip Shapes:<br>Curved with 15°, 30°, or 45° |
| Packing | All Sets: Individual | All Sets: Individual |
| Sterility | All Sets: Provided non-sterile | All Sets: Provided non-sterile |
| Sterilization<br>Method | All Sets: Steam sterilization<br>132 °C for 4 min<br>134 °C for 3 min<br>134 °C for 5 min | All Sets: Steam sterilization<br>132 °C for 4 min<br>134 °C for 3 min<br>134 °C for 5 min |
| Biocompatibility | All Sets: Full biocompatibility | All Sets: Full biocompatibility |
| Materials | Universal Segmented Cylinder<br>Applicator Set:<br>Cylinder: PPSU plastic white<br>Guiding Tube & Applicator Probe:<br>PEEK plastic natural, Titanium<br>Universal Stump Applicator Set:<br>Cylinder: PPSU plastic white<br>Applicator Probe: PEEK plastic<br>natural, Titanium<br>Universal Cervix Probe Sets:<br>PEEK plastic natural, FEP, Titanium | Universal Segmented Cylinder<br>Applicator Set:<br>Cylinder: PPSU plastic white<br>Guiding Tube & Applicator Probe:<br>PEEK plastic natural, Titanium<br>Universal Stump Applicator Set:<br>Cylinder: PPSU plastic white<br>Applicator Probe: PEEK plastic<br>natural, Titanium<br>Universal Cervix Probe Sets:<br>PEEK plastic natural, FEP, Titanium<br>Universal Titanium Cervix Applicator |
| Feature<br>Comparison<br>Chart | Predicate Device:<br>Universal Cylinder Applicator Family<br>(K160516) | Subject Device:<br>Universal Cylinder Applicator Family |
| | | Sets:<br>Titanium |
| | | |
| Anatomical Sites | Universal Segmented Cylinder<br>Applicator Set and Universal Stump<br>Applicator Set:<br>Vagina, vaginal stump and rectum | Universal Segmented Cylinder<br>Applicator Set and Universal Stump<br>Applicator Set:<br>Vagina, vaginal stump and rectum |
| | Universal Cervix Probe Sets:<br>Vagina, vaginal stump, cervix, uterus<br>and endometrium | Universal Cervix Probe Sets and<br>Universal Titanium Cervix Probe<br>Sets:<br>Vagina, vaginal stump, cervix, uterus<br>and endometrium |
| Compatibility w/<br>Environment &<br>Other Devices | All Sets:<br>CT compatible<br><br>Universal Segmented Cylinder<br>Applicator Set, Universal Stump<br>Applicator Set, and Universal Cervix<br>Probe Sets: MR conditional | All Sets:<br>CT compatible<br><br>Universal Segmented Cylinder<br>Applicator Set, Universal Stump<br>Applicator Set, and Universal Cervix<br>Probe Sets: MR conditional |
| | | Universal Titanium Cervix Probe<br>Sets:<br>MR Unsafe |
| Where Used | All Sets:<br>Brachytherapy treatment room | All Sets:<br>Brachytherapy treatment room |

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| Non-Clinical Tests: | Bench Testing has been performed to demonstrate that... |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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 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 cycle limits the positional accuracy of the source in the devices is adequate the devices are biocompatible as per ISO 10933 standards the devices can be used safely and effectively in CT environments |
| | 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.<br>Varian considers the devices to be safe and effective and to perform as well or better than the predicate. |