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

Q: Who is the manufacturer of 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?

Varian Medical Systems, Inc. filed the 510(k) submission for 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).

Q: What is the FDA product code for 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?

JAQ. It is classified under 21 CFR 892.5700 as a Class 2 device in the Radiology panel.

Q: What is the regulatory pathway for 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?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for 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?

Universal Cylinder Applicator Family (K160516).

Q: Who can help prepare an FDA 510(k) submission like 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?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Indications for 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)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ ### 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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: 650/424.6320 | | | Fax: 650/646.9200 | | | 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 Stump Applicator Set are indicated for use 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 indicated for use for cancer treatment of the vagina, 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 indicated for use for cancer treatment of the vagina, vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy. | {4}------------------------------------------------ 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 Comparison Chart | Predicate Device: Universal Cylinder Applicator Family (K160516) | Subject Device: Universal Cylinder Applicator Family | |-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sets within the Universal Cylinder Applicator Family (UCAF) | • Universal Segmented Cylinder Applicator Set • Universal Stump Applicator Set • Universal Cervix Probe Sets | • Universal Segmented Cylinder Applicator Set • Universal Stump Applicator Set • Universal Cervix Probe Sets • Universal Titanium Cervix Probe Sets | | Compatible Afterloader | All Sets: GammaMed Plus series VariSource 200 and iX | All Sets: GammaMed Plus series VariSource 200 and iX | | Design | Universal Segmented Cylinder Applicator Set: Cylinder Segment Dimension: diameters 20, 25, 30, 35, 40 mm; length 30 mm Front Segment: 1 front segment for vaginal wall and vaginal stump treatment Front Segment Dimension: diameter 20, 25, 30, 35, 40 mm; length 50 – 60 mm Guiding Tube & Applicator Probe: straight rigid $ø$ 3.2 mm; length 200 and 250 mm Universal Stump Applicator Set: Cylinder Dimension: diameters 20, 25, 30, 35 mm; length 140 mm Applicator Probe Dimension: $ø$ 3.2 mm; inner length 200 and 250 mm | Universal Segmented Cylinder Applicator Set: Cylinder Segment Dimension: diameters 20, 25, 30, 35, 40 mm; length 30 mm Front Segment: 1 front segment for vaginal wall and vaginal stump treatment Front Segment Dimension: diameter 20, 25, 30, 35, 40 mm; length 50 – 60 mm Guiding Tube & Applicator Probe: straight rigid $ø$ 3.2 mm; length 200 and 250 mm Universal Stump Applicator Set: Cylinder Dimension: diameters 20, 25, 30, 35 mm; length 140 mm Applicator Probe Dimension: $ø$ 3.2 mm; inner length 200 and 250 mm | | Feature Comparison Chart | Predicate Device: Universal Cylinder Applicator Family (K160516) | Subject Device: Universal Cylinder Applicator Family | | | Universal Cervix Probe Sets: Diameter: 6.3 mm Inner Length: 320 mm Cervix Length: 30, 40, 50, 60, 70, 80 mm Probe Tip Shapes: Straight or Curved with 15°, 30° | Universal Cervix Probe Sets: Diameter: 6.3 mm Inner Length: 320 mm Cervix Length: 30, 40, 50, 60, 70, 80 mm Probe Tip Shapes: Straight or Curved with 15°, 30° | | | | Universal Titanium Cervix Probe Sets: Diameter: 3 mm Inner Length: 320 mm Cervix Length: 30, 40, 50, 60, 70, 80 mm Probe Tip Shapes: 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 Method | All Sets: Steam sterilization 132 °C for 4 min 134 °C for 3 min 134 °C for 5 min | All Sets: Steam sterilization 132 °C for 4 min 134 °C for 3 min 134 °C for 5 min | | Biocompatibility | All Sets: Full biocompatibility | All Sets: Full biocompatibility | | Materials | Universal Segmented Cylinder Applicator Set: Cylinder: PPSU plastic white Guiding Tube & Applicator Probe: PEEK plastic natural, Titanium Universal Stump Applicator Set: Cylinder: PPSU plastic white Applicator Probe: PEEK plastic natural, Titanium Universal Cervix Probe Sets: PEEK plastic natural, FEP, Titanium | Universal Segmented Cylinder Applicator Set: Cylinder: PPSU plastic white Guiding Tube & Applicator Probe: PEEK plastic natural, Titanium Universal Stump Applicator Set: Cylinder: PPSU plastic white Applicator Probe: PEEK plastic natural, Titanium Universal Cervix Probe Sets: PEEK plastic natural, FEP, Titanium Universal Titanium Cervix Applicator | | Feature Comparison Chart | Predicate Device: Universal Cylinder Applicator Family (K160516) | Subject Device: Universal Cylinder Applicator Family | | | | Sets: Titanium | | | | | | Anatomical Sites | Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set: Vagina, vaginal stump and rectum | Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set: Vagina, vaginal stump and rectum | | | Universal Cervix Probe Sets: Vagina, vaginal stump, cervix, uterus and endometrium | Universal Cervix Probe Sets and Universal Titanium Cervix Probe Sets: Vagina, vaginal stump, cervix, uterus and endometrium | | Compatibility w/ Environment & Other Devices | All Sets: CT compatible Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, and Universal Cervix Probe Sets: MR conditional | All Sets: CT compatible Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, and Universal Cervix Probe Sets: MR conditional | | | | Universal Titanium Cervix Probe Sets: MR Unsafe | | Where Used | All Sets: Brachytherapy treatment room | All Sets: Brachytherapy treatment room | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ | 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. Varian considers the devices to be safe and effective and to perform as well or better than the predicate. |

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

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Submission Summary (Full Text)

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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

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Indications for Use

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Technological Characteristics

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Identification

Predicate Devices

Submission Summary (Full Text)

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