Mould Applicator Set

K162615 · Varian Medical Systems, Inc. · JAQ · Mar 24, 2017 · Radiology

Device Facts

• Record ID: K162615
• Device Name: Mould Applicator Set
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Mar 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy.

Device Story

Mould Applicator Set functions as a guide for radioactive sources in brachytherapy; used in conjunction with GammaMedplus HDR afterloading system. Device consists of mould probes (1.8mm or 2.8mm diameter) that guide radioactive source to predefined treatment locations within or near tumors. Operated by clinicians in brachytherapy treatment rooms. Probes are inserted into patient; mandrins removed for MR conditional use (1.5T and 3T). Device is CT compatible. Probes constructed from Polyamide or FEP with titanium connectors and stainless steel mandrins. Steam sterilization required; 1.8mm probes are single-use if steam sterilized, or reusable up to 10 times if only disinfected. 2.8mm probes reusable up to 25 times. Output is physical guidance of radiation source to ensure accurate dose delivery per treatment plan. Benefits include precise, localized radiation delivery for cancer treatment.

Clinical Evidence

No clinical data. Bench testing only. Testing confirmed device functionality with afterloader, structural integrity over lifetime, positional accuracy of radioactive source, radiation resistance of materials, sterilization effectiveness, biocompatibility per ISO 10993, and safety in CT and MRI environments (1.5T/3T). Usability assessed per IEC 62366:2007.

Technological Characteristics

Materials: Polyamide (PA), Fluorinated ethylene propylene (FEP), Titanium connectors, Stainless steel mandrins. Sensing/Actuation: Mechanical guide for radioactive source. Energy: Passive (guides HDR/PDR radiation). Dimensions: 320mm length, 1.8mm or 2.8mm diameter. Connectivity: None (mechanical accessory). Sterilization: Steam sterilization. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for patients requiring IORT, interstitial, intraluminal, or superficial brachytherapy for cancer or other superficial disease using HDR or PDR radiation sources.

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

• GammamedPlus HDR Afterloading System (K983436)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

March 24, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K162615 Trade/Device Name: Mould Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: February 22, 2017 Received: February 23, 2017

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

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)

K162615

Device Name Mould Applicator Set

Indications for Use (Describe)

The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease 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)

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)

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 [e-mail]

"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."

FORM FDA 3881 (1/14)

{3}------------------------------------------------

# PREMARKET NOTIFICATION

## 510(k) Summary

# Mould Applicator Set

## As required by 21 CFR 807.92

| Submitter's Name: | Varian Medical Systems<br>3100 Hansen Way, m/s E110<br>Palo Alto CA94304 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado<br>Phone: [phone]<br>Fax: [phone]<br>Date: 9th Sep 2016 |
| Proprietary Name: | Mould Applicator Set |
| Classification Name: | Remote controlled radionuclide applicator system<br>21CFR892.5700<br>Class II |
| Common/Usual Name: | Mould Applicator Set |
| Predicate Devices: | GammamedPlus HDR Afterloading System (K983436). |
| Device Description: | The Mould Applicator Set is an applicator for intraoperative,<br>interstitial, intraluminal or surface brachytherapy. Brachytherapy<br>is a form of radiotherapy using Gamma rays from a radioactive<br>source placed at locations close to or within a tumor or other<br>treatment area to a predefined treatment plan. The treatment<br>plan defines the positions and times for the source to ensure the<br>correct dose for the treatment area. The applicator acts to guide<br>the radioactive source to the correct location or locations for<br>treatment. |
| | The Mould Applicator Set can be steam sterilized with common<br>parameters using Pre-vacuum sterilization. |
| | The mould probes Ø 2.8mm (GM11002280), which are part of the<br>set, have a maximum implantation time of up to 24 hours.<br>According to ISO 10993-1 they are categorised as medical devices,<br>external communicating with tissue/bone communicating and a<br>limited contact duration (A). They can be steam sterilized and<br>used 25 times. |
| | The mould probes Ø 1.8mm (GM11002290) have a maximum<br>implantation time of up to 7 days. According to ISO 10993-1 they |

{4}------------------------------------------------

are categorised as a medical device, external communicating with tissue/bone communicating and prolonged contact duration (B). When steam sterilised, they are a single use product and can be used for IORT, interstitial and intraluminal treatments. If only disinfected the probe can be used up to 10 times for treatment of superficial diseases. The Mould Applicator Set is CT compatible. The Mould Applicator Set is MR conditional for 1.5 and 3 Tesla when the mandrins have been removed from the mould probes after insertion in the patient. Indications for Use: The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or

other superficial disease using HDR or PDR brachytherapy.

| | 1.5 and 2.8mm Catheters as part of<br>GammaMedplus HDR Afterloading | Mould Applicator set |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | System K983436. | |
| Intended use | Covered by intended use of complete<br>afterloader system in original submission:<br>The intended use of the GammaMed Plus<br>transportable high-dose-rate remotely<br>controlled afterloading brachytherapy<br>device is for the treatment of cancer by<br>intracavitary, interstitial, intraluminal and<br>intraoperative irradiation. | The Mould Applicator Set is intended for<br>IORT, interstitial and intraluminal<br>treatments of cancer and treatments of<br>cancer or other superficial disease using<br>HDR or PDR brachytherapy. |
| Indications for Use | Covered by indication for use of complete<br>afterloader system in original submission:<br>The intended use of the GammaMed Plus<br>transportable high-dose-rate remotely<br>controlled afterloading brachytherapy<br>device is for the treatment of cancer by<br>intracavitary, interstitial, intraluminal and<br>intraoperative irradiation. | The Mould Applicator Set is indicated for<br>IORT, interstitial and intraluminal<br>treatments of cancer and treatments of<br>cancer or other superficial disease using<br>HDR or PDR brachytherapy. |
| Compatible Afterloader | GammaMedplus | GammaMedplus |
| Design | Catheters:<br>• Diameter: 1.5 or 2.8mm<br>• Length: 130cm | Mould Probe Diameter: 1.8 or 2.8mm<br>Length: 320 mm<br>1.8mm Mould Probe supplied with mandrin |
| Materials | 1.5mm Catheter: Polyamide<br>2.8mm Catheter: Fluorinated ethylene<br>propylene (FEP)<br>Probe connectors: Stainless steel | 1.8mm Mould Probe: Polyamide (PA)<br>2.8mm Mould Probe: Fluorinated ethylene<br>propylene (FEP)<br>Probe connectors: Titanium<br>Mandrin: Stainless steel |
| Packing | individual | Individual |
| Sterility | Provided non sterile | Provided non sterile |

#### Technological Characteristics:

{5}------------------------------------------------

| Sterilization method | Steam sterilization | 1.8mm and 2.8mm Mould Probes:<br>Manual Cleaning, Steam sterilization.<br>1.8mm Mould Probe is a single use product<br>when steam sterilized. |
|------------------------------------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Full biocompatibility | Full biocompatibility<br>Max 24 hours contact for the 2.8mm Mould<br>Probe.<br>Max7 days contact for 1.8mm Mould Probe |
| Compatibility with the<br>environment and other<br>devices | No CT or MR claims | CT compatible, MR conditional 1.5 and 3 T |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |

Non Clinical Tests Bench Testing has been performed to demonstrate that

- the devices function correctly with the specified afterloader;
- . 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 number of times
- the positional accuracy of the source within the devices is adequate.
- . the devices are biocompatible as per ISO10993 standards
- the devices can be used safely and effectively in CT environments
- testing of the Mould Applicator in MRI environments has demonstrated it is 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