Kelowna GYN and Crook Prostate Templates

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 31, 2017 Varian Medical Systems, Inc. % Mr. Peter Coronado Director. Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304 Re: K162533 Trade/Device Name: Kelowna Gyn and Crook Prostate Templates Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 14, 2017 Received: August 18, 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 {1}------------------------------------------------ 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. 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/ResourcesforYou/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. Michael D. O'Hara 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) K162533 Device Name Kelowna GYN and Crook Prostate Templates Indications for Use (Describe) The Kelowna GYN Templates are interstitial brachytherapy treatments for gynecological and rectal/anal cancer using HDR or PDR brachytherapy. The Crook Prostate Templates are intended for interstitial brachytherapy treatments for prostate cancer 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) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Corporate Headquarters 3100 Hansen Way Palo Alto, CA 94304-1038 Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com # 510k Summary ## 510(k) Submission for the Kelowna GYN and Crook Prostate Templates As required by 21 CFR 807.92, Reference: FDA's Guidance Document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (June 2014). #### SUBMITTER l. | Submitter's Name: | Varian Medical Systems<br>3100 Hansen Way,<br>Palo Alto CA 94304-1038 | |-------------------|-----------------------------------------------------------------------| | Contact Name: | Peter J. Coronado | | Position: | Director, Regulatory Affairs | | Phone: | 1.650.424.6230 | | Fax: | 1.650.646.9200 | | Email: | submissions.support@varian.com | | Date Prepared: | August 25, 2016 | #### II. DEVICE | Name of Devices: | Kelowna GYN and Crook Prostate Templates | |------------------------------------|--------------------------------------------------------------------| | Common/Usual Name: | System, Applicator, Radionuclide, Remote-Controlled | | Regulation Name: | Remote controlled radionuclide applicator system (21 CFR 892.5700) | | Regulatory Class:<br>Product Code: | Class II<br>JAQ | {4}------------------------------------------------ #### PREDICATE DEVICE lll. GammaMed Plus High Dose Rate Remote Name of Predicate: Afterloading System 510k Number: K983436 #### DEVICE DESCRIPTION IV. The Kelowna GYN and Crook Prostate Templates are applicator accessories for Brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicators act to guide the radioactive source to the correct location or locations for treatment. The devices do not contain or consist of software/firmware. The devices do not contain any biologics or drug components. The devices have patient-contacting materials. The devices are designed for repeated use. No parts of the system are provided sterile. The devices can be steam sterilized with common parameters using pre-vacuum sterilization. These devices are used on both female and male patients. The Kelowna GYN and Crook Prostate Templates are compatible with the following Varian Afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™. The Kelowna GYN and Crook Prostate Templates are CT compatible. The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment. {5}------------------------------------------------ The associated components of the Kelowna GYN and Crook Prostate Templates include: | Product Number | Component List | Associated<br>510(k) | Refer ISD | |----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------------------| | GM11012200 | Kelowna GYN Template for 2.0 mm needles, including<br>locking collets (pack of 25) and needle collet wrench | | | | GM11012210 | Kelowna GYN Template for 16 gauge (1.65 mm) needles,<br>including locking collets (pack of 25) and needle collet<br>wrench | | | | GM11012220 | Kelowna GYN Template for 17 gauge (1.47 mm) needles,<br>including locking collets (pack of 25) and needle collet<br>wrench | | Kelowna<br>GYN and<br>Crook | | GM11012230 | Crook Prostate Template for 2.0 mm needles, B-K labelling,<br>including locking collets (pack of 25) and needle collet<br>wrench | This 510(k) | Prostate<br>Templates | | GM11012240 | Crook Prostate Template for 17 gauge (1.47 mm) needles, B-<br>K labelling, including locking collets (pack of 25)<br>and needle collet wrench | | | | GM11012250 | Crook Prostate Template for 2.0 mm needles, Siemens<br>labelling, including locking collets (pack of 25) and needle<br>collet wrench | | | | GM11012260 | Crook Prostate Template for 17 gauge (1.47 mm) needles,<br>Siemens labelling, including locking collets (pack of 25) and<br>needle collet wrench | | | #### INDICATIONS FOR USE V. Indications for Use Statement: The Kelowna GYN Templates are intended for interstitial brachytherapy treatments for gynecological and rectal/anal cancer using HDR or PDR brachytherapy. The Crook Prostate Templates are intended for interstitial brachytherapy treatments for prostate cancer using HDR or PDR brachytherapy. {6}------------------------------------------------ ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Both subject and predicate devices are intended for use in the treatment of cancer through interstitial brachytherapy. | | CLEARED DEVICE<br>FEATURE/SPECIFICATION | NEW / MODIFIED DEVICE | NEW / MODIFIED DEVICE | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FEATURE AND/OR<br>SPECIFICATION | 510(K) K983436 GAMMAMED<br>PLUS HIGH DOSE RATE<br>REMOTE AFTERLOADING<br>SYSTEM<br>(GM11004650 PROSTATE AND<br>PERINEAL IMPLANT<br>TEMPLATED<br>SET IS LISTED IN<br>ATTACHMENT B, PAGE 11) | KELOWNA GYN TEMPLATES | CROOK PROSTATE TEMPLATES | | Intended use | The intended use of the<br>GammaMed Plus transportable<br>high-dose-rate remotely<br>controlled afterloading<br>brachytherapy device is for the<br>treatment of cancer by<br>intracavitary, interstitial,<br>intralumenal and intraoperative<br>irradiation. | The Kelowna GYN Templates<br>are intended for interstitial<br>brachytherapy treatments for<br>gynecological and rectal/anal<br>cancer using HDR an PDR<br>brachytherapy. | The Crook Prostate Templates<br>are intended for interstitial<br>prostate cancer using HDR or<br>PDR brachytherapy. | | Indication for<br>use | The intended use of the<br>GammaMed Plus transportable<br>high-dose-rate remotely<br>controlled afterloading<br>brachytherapy device is for the<br>treatment of cancer by<br>intracavitary, interstitial,<br>intralumenal and intraoperative<br>irradiation. | The Kelowna GYN<br>Templates are intended for<br>interstitial brachytherapy<br>treatments for gynecological<br>and rectal/anal cancer using<br>HDR and PDR brachytherapy. | The Crook Prostate Templates<br>are intended for interstitial<br>prostate cancer using HDR or<br>PDR brachytherapy. | | Applicator<br>Design | Various Plates (Templates) with<br>10 x 10mm hole geometry<br>pattern;<br>Cylinder, length 130mm, Ø<br>24.9mm;<br>Needle: length 200mm,<br>Ø1.65mm;<br>Needle stopper/holder for<br>1.65mm needles;<br>Pipe screw driver | Kelowna GYN Templates for<br>16 gauge, 17 gauge and Ø 2<br>mm needles<br>Dosimetry based hole<br>geometry pattern;<br>Locking collets for fixation of<br>needles;<br>Needle collet wrench to<br>securely affix the needles | Crook Prostate Templates<br>for 17 gauge and Ø 2 mm<br>needles<br>5 x 5 mm hole geometry pattern;<br>Locking collets for fixation of<br>needles;<br>Needle collet wrench to securely<br>affix the needles | | Compatible<br>Afterloader | GammaMed Plus Afterloader<br>Series | GammaMed Plus Afterloader<br>Series | GammaMed Plus Afterloader<br>Series | | | GammaMed 12i(t) | VariSource Afterloader Series | VariSource Afterloader Series | | Component List | Base plate for 1.65mm steel needles Cover plate II without cylinder hole, with fixation screws Cover plate III with centered cylinder hole with fixation screws Cover plate IV with de-centered cylinder hole, with fixation screws Cylinder, length 130mm, 24.9mm diameter Base plate filling piece for needles Cover plate filling piece for cylinder with fixation screws Needle stopper for 1.56mm needles Pipe screwdriver Stainless Steel needle, 200mm, 1.65mm diameter Sterilization plugs (pack of 25) Cleaning caps, white (pack of 20) | Kelowna GYN Template for Ø 2.0 mm needles, including locking collets (pack of 25) and needle collet wrench Kelowna GYN Template for 16 gauge (1.65 mm) needles, including locking collets (pack of 25) and needle collet wrench Kelowna GYN Template for 17 gauge (1.47 mm) needles, including locking collets (pack of 25) and needle collet wrench | Crook Prostate Template for Ø 2.0 mm needles, B-K labelling, including locking collets (pack of 25) and needle collet wrench Crook Prostate Template for 17 gauge (1.47 mm) needles, B-K labelling, including locking collets (pack of 25) and needle collet wrench Crook Prostate Template for 2.0 mm needles, Siemens labelling, including locking collets (pack of 25) and needle collet wrench | | | Channel marker clips, code 1-12 Channel marker clips, coded 13-24 Leak stop buttons, non-sterile, pack of 50 | | | | Materials | Template: PPSU<br>Needle stopper: Stainless Steel<br>Screw Driver: Stainless Steel | Template: PEEK<br>Locking collets: Titanium<br>Needle collet wrench: Stainless Steel | Template: PEEK<br>Locking collets: Titanium<br>Needle collet wrench: Stainless Steel | | Packing | Individual | Individual | Individual | | Sterility | Provided in non-sterile condition<br>Sterilized by user prior to use | Provided in non-sterile condition<br>Sterilized by user prior to use | Provided in non-sterile condition<br>Sterilized by user prior to use | | Cleaning<br>Method | Manual cleaning | Manual cleaning<br>Machine cleaning | Manual cleaning<br>Machine cleaning | | Sterilization<br>method | Steam Sterilization | Steam Sterilization | Steam Sterilization | | Biocompatibility | Fully biocompatible | Fully biocompatible | Fully biocompatible | | Anatomical sites | Pelvic, vaginal, female urethral,<br>cervical, prostatic and rectal | Pelvic | Pelvic | | Compatibility<br>with Imaging<br>Environment | CT Compatible | CT compatible | CT compatible | | Supporting<br>Accessories | Required:<br>interstitial accessory kit<br>Optional:<br>screws for cover platesource guide tube support16G stainless steel<br>needle, 113mm trocar | Required:<br>Ø 2.0 mm Plastic Interstitial Needles (K141624) 17G (1.47mm) Titanium and Stainless Steel Interstitial Needles (K160815) 16G (1.65mm) Titanium and Stainless Steel Interstitial Needles (K160815) Optional: 25mm diameter cylinders of the Universal | Required:<br>Ø 2.0 mm Plastic Interstitial Needles (K141624) 17 gauge (1.47mm) Titanium and Stainless Steel Interstitial Needles (K160815) Optional: Bard (Amertek) adapter Blue locking collets for Ø 2.0 mm needles | | | point | Segmented Cylinder Applicator Set and Universal Stump Applicator Set | | | | Source guide tube with locking mechanism for 180mm needles | Blue locking collets for Ø 2.0 mm needles Locking collets for 16 G and 17 G needles Needle collet wrench | Locking collets for 16 G and 17 G needles Needle collet wrench | | Where used | Brachytherapy treatment room | Brachytherapy treatment room | Brachytherapy treatment room | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ #### VI. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ## Non-Clinical Tests: ## Biocompatibility Testing: The biocompatibility evaluation for the subject devices was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. This included the following tests: - Cytotoxicity ● - . Sensitization - Irritation ● - System Toxicity ● - Subacute Toxicity ● - Implantation According to ISO 10993-1 the components of the Kelowna GYN and Crook Prostate Templates are categorized as a medical device, surface device in contact with breached or compromised surfaces and prolonged contact duration (>24h to 30d). (B). {10}------------------------------------------------ ## Sterilization Testing: Sterilization testing for the subiect devices were conducted to assess the effectiveness of the provided cleaning, disinfection, and sterilization procedures for the device. Furthermore, the components of the subject set were subjected to sterilization cycles up to the stated use life and evaluated for performance and any damage that might affect safety or effectiveness. - . Validation/Efficacy Testing of Cleaning, Disinfection, and Sterilization Cycles - Verification of the Suitability of Applicator Design and Material for the Stated Use Life and Reprocessing Cycles ## Electrical Safety and Electromagnetic Compatibility (EMC): This item is not applicable to the subject devices. No electrical safety and electromagnetic compatibility tests have been included in this submission in support of the substantial equivalence determination. ## Software Verification and Validation Testing: This item is not applicable to the subject devices; the devices do not contain or consist of software/firmware. No software verification and validation testing have been included in this submission in support of the substantial equivalence determination. ### Mechanical and Acoustic Testing: - . CT Compatibility Tests and Analysis - Verification and Validation Testing for Applicator Design Specifications . ### Declaration of Conformity: The following list are standards to which the subject devices conformity: - . AAMI TIR-12:2010 - AAMI TIR-30:2011 - ANSI/AAMI ST-79:2010/A2:2011/A3:2012/A4:2013 (R 2014) ● - ANSI/AAMI ST-81:2004/(R)2010 - IEC 62366 ● - ISO 10993-1:2009 ● {11}------------------------------------------------ - ISO 10993-5:2009 ● - ISO 10993-10:2009 - ISO 17664:2004 - ISO 17665-1: 2006 - ISO 14937:2009/(R)2013 . ## Animal Study / Clinical Tests: No animal studies or clinical tests have been included in this submission in support of the substantial equivalence determination. #### VII. CONCLUSIONS The results of the non-clinical tests support the safety and effectiveness of the device under the specified use conditions. Varian believes that the validation and verification testing demonstrates that the subject devices perform comparably to the predicate device, meeting the intended use.