(98 days)
Not Found
Based on the information provided in the "overview," here's an analysis to determine if the device contains an AI model:
To give you a definitive "yes" or "no," I need to see the content of the {{overview}} variable.
However, I can tell you what to look for within the {{overview}} to identify if the device contains an AI model:
Potential indicators of an AI model within the overview:
- Explicit mention of AI, Machine Learning (ML), Deep Learning (DL): Look for terms like "artificial intelligence," "machine learning," "deep learning," "neural networks," "AI-powered," "ML algorithm," etc.
- Specific AI functionalities: Does the overview describe features that typically rely on AI, such as:
- Image recognition: "detects objects," "identifies faces," "categorizes images"
- Natural Language Processing (NLP): "understands spoken commands," "processes text," "translates language"
- Predictive analytics: "predicts user behavior," "forecasts trends"
- Anomalous behavior detection: "identifies unusual patterns"
- Decision making or automation based on data input: "automatically adjusts settings," "optimizes performance," "intelligent recommendations"
- Learning from data: "learns user preferences," "adapts over time"
- References to specialized AI hardware: Mentions of "AI accelerator," "NPU (Neural Processing Unit)," "tensor core," or specific chips designed for AI processing.
- Descriptions of complex data processing that goes beyond simple rules: If the device is analyzing large amounts of data to make decisions or provide insights, it might be using AI.
- Statements about "smart" or "adaptive" behavior that isn't based on predefined rules: While "smart" can be a marketing term, if it's linked to the device learning or making complex decisions, it's a potential indicator.
Things that don't necessarily mean the device has an AI model:
- Basic automation: A device following a fixed set of 'if this, then that' rules isn't necessarily using AI.
- Simple data processing: Calculating averages or performing basic mathematical operations is not AI.
- Connectivity: Being connected to the internet or other devices doesn't automatically mean it has local AI processing. It could be connecting to cloud-based AI.
- Keywords used for marketing: Terms like "intelligent" or "smart" can be used loosely without involving true AI.
How to help me determine:
Please provide the content of the {{overview}} variable. Once you provide the text, I can analyze it and give you a more accurate answer.
Yes
The device is specifically indicated for "cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR Brachytherapy," which is a therapeutic application.
No
The device is an applicator used for treatment (HDR Brachytherapy) by guiding a radioactive source to a specific location for cancer treatment. It does not perform any diagnostic function.
Let's analyze the provided 510(k) summary to determine if the [Device Name], as described in the summary, qualifies as a software-only medical device.
{{overview}}
Now, based on the text above, here's the answer:
To definitively determine if the device is an IVD, I would need a clearer understanding of its intended use and how it operates.
Based solely on the information "overview", it's impossible to say for certain. However, to help you assess if it's likely an IVD, consider the following questions:
- What is the device designed to do? Does it analyze biological specimens (like blood, urine, tissue, or saliva) to provide information about a person's health or condition?
- Does it make a healthcare decision or diagnosis? Is the output of the device used to determine the presence of a disease, infection, deficiency, or physiological state?
- Does it require a specimen to be taken from the human body? IVDs typically work with specimens taken from a person.
- Is it used in vitro (meaning "in glass" or outside of the living body)? Does the analysis happen in a laboratory setting or with a specimen treated and analyzed separately from the individual?
- Is it intended for the purpose of: (as defined by regulatory bodies like the FDA or EU IVDR)
- Diagnosis, monitoring, prognosis, prediction, or determination of physiological or pathological states.
- Providing information for a medical decision.
- Screening for the presence of a condition.
- Assessing eligibility for or response to treatment.
If the answer to several of these questions is "yes", it is highly probable that the device is an In Vitro Diagnostic (IVD).
Examples of common IVDs:
- Home pregnancy tests
- Blood glucose meters
- COVID-19 antigen or PCR tests
- Lab tests for cholesterol, liver function, or thyroid levels
- Devices that analyze biopsy samples for cancer markers
Examples of devices that are typically NOT IVDs (though there can be nuances):
- Medical imaging devices (like X-rays or MRIs) which analyze within the body.
- Therapeutic devices (like pacemakers or ventilators).
- Software that analyzes existing patient data but doesn't analyze new biological specimens.
- Devices for collecting specimens, but not analyzing them (e.g., a simple urine cup).
To give you a better answer, please provide more details about the "overview" information. Specifically, tell me:
- What does the device measure or analyze?
- What kind of specimen does it use (if any)?
- What is the purpose of the analysis?
- Where is the analysis performed?
With more information, I can provide a more accurate assessment of whether the device is an IVD.
N/A
Intended Use / Indications for Use
The CT/MR Tandem and Ovoid Set is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR Brachytherapy.
Product codes
JAQ
Device Description
The CT/MR Tandem and Ovoid Set is a gynecological brachytherapy applicator intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR brachytherapy.
The CT/MR Tandem and Ovoid Set is an applicator for intracavitary and interstitial 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 applicator acts to guide the radioactive source to the correct location or locations for treatment. The radioactive source is provided by an afterloader.
The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.
The applicator is inserted into the patient and connected to an afterloader. This combination places the remote-controlled radioisotope treatment source nearby the target tissue. The applicator guides the radioactive source to the correct location or locations for treatment. The CT/MR Tandem and Ovoid Set is MR safe and CT compatible.
This applicator set includes several parts, such as intrauterine tandems, interstitial ovoids, guide tubes, and optional rectal retractors. It is designed to be used with MR and CT imaging, and the components come in different sizes and angles to suit different patient anatomies. It also includes a needle tandem for specific situations and can be used for up to 30 days in some cases.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
uterus, cervix, paracervix, endometrium, and vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The CT/MR Tandem and Ovoid Set is intended to be used in a radiation therapy or radiation oncology department in a hospital environment by trained and qualified personnel.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility Testing: The compatibility of the skin-contact component material in the finished product meets the biocompatibility requirements. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1 and its applicable parts, "Biological Evaluation of Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process".
Magnetic Resonance Testing (MR): MR Compatibility testing was completed. The CT/MR Tandem Ovoid Set is MR Safe and complies with ASTM F2503-23 (2023 ED): Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. No testing was performed according to ASTM F2052-21, ASTM F2213-17, and ASTM F2182-19 as the device is made from non-metallic, non-magnetic material.
Cleaning, Disinfection and Sterilization Testing: Cleaning, disinfection and sterilization testing was conducted to demonstrate the device components may be sterilized effectively (as appropriate) and the device can be used and sterilized for the specified number of times.
Human Factors Validation Study: A human factors validation study was conducted according to the standard IEC 62366 to verify that the device performs well as intended for the intended users, uses, and use environments.
Mechanical and Acoustic Testing: The CT/MR Tandem Ovoid Set has undergone formal design verification and design validation testing. Design verification and design validation testing demonstrates that the device performs as intended. This testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
FDA Clearance Letter for CT/MR Tandem and Ovoid Set
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
May 9, 2025
Varian Medical Systems, Inc.
Lynn Allman
Sr. Director, Regulatory Affairs
3100 Hansen Way
Palo Alto, California 94304
Re: K250299
Trade/Device Name: CT/ MR Tandem and Ovoid Set
Regulation Number: 21 CFR 892.5700
Regulation Name: Remote Controlled Radionuclide Applicator System
Regulatory Class: Class II
Product Code: JAQ
Dated: April 14, 2025
Received: April 14, 2025
Dear Lynn Allman:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lora D. Weidner, Ph.D.
Assistant Director
Radiation Therapy Team
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known):
Device Name:
CT/ MR Tandem and Ovoid Set
Indications for Use (Describe):
The CT/MR Tandem and Ovoid Set is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR 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.
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
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Office of Chief Information Officer
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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.
Page 5
510(k) Summary
Traditional 510(k) Application
CT/MR Tandem and Ovoid Set
Page 1 of 6
Premarket Notification – 510(k) Summary
Traditional 510(k) Submission for CT/MR Tandem and Ovoid Set.
I. Submitter's Name
Varian Medical Systems
3100 Hansen Way
Palo Alto, CA 94304
Contact Name: Lynn, Allman, PhD., Senior Director Regulatory Affairs
Phone: (650) 424-5369
E-mail: submissions.support@varian.com
II. Device Information
Proprietary Name: CT/MR Tandem and Ovoid Set
Classification Name: Remote Controlled Radionucleotide Applicator System
Regulation Number: §892.5700
Product Code: JAQ
III. Predicate Device
Titanium Fletcher-Style Applicator Set Defined Geometry (K241853)
IV. Device Description
The CT/MR Tandem and Ovoid Set is a gynecological brachytherapy applicator intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR brachytherapy.
The CT/MR Tandem and Ovoid Set is an applicator for intracavitary and interstitial 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 applicator acts to guide the radioactive source to the correct location or locations for treatment. The radioactive source is provided by an afterloader.
The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.
The applicator is inserted into the patient and connected to an afterloader. This combination places the remote-controlled radioisotope treatment source nearby the target tissue. The applicator guides the radioactive source to the correct location or locations for treatment. The CT/MR Tandem and Ovoid Set is MR safe and CT compatible.
Page 6
The CT/MR Tandem and Ovoid Set includes patients whose cancer can be treated using HDR brachytherapy, as determined by the prescribing physician. The CT/MR Tandem and Ovoid Set is intended to be used in a radiation therapy or radiation oncology department in a hospital environment by trained and qualified personnel.
This applicator set includes several parts, such as intrauterine tandems, interstitial ovoids, guide tubes, and optional rectal retractors. It is designed to be used with MR and CT imaging, and the components come in different sizes and angles to suit different patient anatomies. It also includes a needle tandem for specific situations and can be used for up to 30 days in some cases.
V. Intended Use
The CT/MR Tandem and Ovoid Set is a gynecological brachytherapy applicator intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR brachytherapy.
VI. Indications for Use
The CT/MR Tandem and Ovoid Set is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR brachytherapy
VII. Comparison of Technological Characteristics with the Predicate Device
The following comparison table below demonstrates the substantial equivalence of the subject CT/MR Tandem and Ovoid Set to the predicate device Titanium Fletcher-Style Applicator Set Defined Geometry [K241853].
The differences between the subject and predicate are indicated in blue fill. Please refer to the Substantial Equivalence Discussion attached with this submission for a more in depth comparison between the devices.
| FEATURE AND/OR SPECIFICATION OF NEW/MODIFIED DEVICE | CLEARED DEVICE FEATURE/SPECIFICATION Titanium Fletcher-Style Applicator Set Defined Geometry [510(k) ID# K241853] Titanium Fletcher-style Applicator Set - Defined geometry | SUBJECT DEVICE CT/MR Tandem and Ovoid Set | Comparison |
|---|---|---|---|
| Intended use | The Titanium Fletcher-style Applicator Set - Defined Geometry is intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina when performing HDR or PDR brachytherapy. | The CT/MR Tandem and Ovoid Set is intended for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR brachytherapy. | Substantially Equivalent PDR not supported for new applicators |
Page 7
| Indications for Use | The Titanium Fletcher-style Applicator Set - Defined Geometry is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina using HDR or PDR brachytherapy. | The CT/MR Tandem and Ovoid Set is indicated for use for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using HDR brachytherapy | Substantially Equivalent PDR not supported for new applicators |
|---|---|---|---|
| Labeling | The probes are marked with numbers at the proximal end so that each probe can be individually identified. (Center probe = 1, right probe (patient's left) = 2, left probe (patient's right) = 3)" (PGM11006200_12 EN, dated 2014- 07-09) | The probes are marked with numbers at the proximal end so that each probe can be individually identified Center tandem (one marking) = Channel 1 Left colpostat/patient's left (two markings) = Channel 2 Right colpostat/patient's right (three markings) = Channel 3 (P1057168-003-C, OCTOBER 2024) | Substantially Equivalent PDR not supported for new applicators |
| Compatible After loader | GammaMedplus Series VariSource Series BRAVOS Afterloader System | GammaMedplus Afterloader series BRAVOS Afterloader System | Substantially Equivalent The VariSource Afterloader series was obsolete on Dec 25, 2024, and will not be supported anymore. |
| Design (Optional Accessories) | Titanium intrauterine probe with cervical stop 30°, length: 40mm, 60mm, 80mm (optional: 30mm, 50mm, 70mm) Mini-ovoids (colpostat), pair Ovoids for 20, 25, 30 mm spread, pair Titanium central clamping mechanism Grub Screw: 0,4x45° Diameter Colpost probe and fastening screw made of Stainless Steel Central fixation screw for intrauterine probe Fixation screws for colpostat probe | Colpostat probes: left and right Intrauterine tandem dimension: 15°, 30° and 45°, each with 2, 4, 6 cm Intrauterine needle tandem 30° Ovoid pairs for 13, 20, 25, 30 and 40 mm spread Interstitial ovoids pairs for 14.5, 20, 25, 30 and 40 mm Assembly Module CT/MR Guide tube Collector CT/MR Clamping Unit CT/MR Retraction Nut CT/MR Disassembly Pin CT/MR Leak Stop Channel markers Cleaning caps | Different The new device has several new and redesigned sub-items |
Page 8
| Materials | Stainless Steel, PPSU, PEEK, Titanium 3.7035 (Grade 2) | PEEK, PAEK | Different Subject device is comprised of different materials (PEEK and PAEK) |
|---|---|---|---|
| Packing | Individual | Individual | Equivalent |
| Sterility | Delivered in non-sterile condition. To be sterilized at customer site. Number of sterilization cycle: 250 times & 500 times | Delivered in non-sterile condition. To be sterilized at customer site. Number of sterilization cycle: 100 times | Different Number of sterilization cycles limited by material characteristics |
| Sterilization method | Manual and machine cleaning Steam sterilization | Manual and machine cleaning Steam sterilization | Equivalent |
| Biocompatibility | Fully biocompatible | Fully biocompatible | Equivalent |
| Anatomical sites | Uterus, cervix, paracervix, endometrium and vagina | Uterus, cervix, paracervix, endometrium and vagina | Equivalent |
| Compatibility with the environment and other devices | CT compatible MR conditional | CT compatible MR safe | Different Subject device is MR safe |
| Where used | Brachytherapy treatment room | Radiation therapy or radiation oncology department | Equivalent Brachytherapy can only be used in a dedicated environment for radiation therapy. |
VIII. Summary of Performance Testing (Non-Clinical Testing)
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing:
The compatibility of the skin-contact component material in the finished product meets the biocompatibility requirements. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1 and its applicable parts, "Biological Evaluation of Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process".
Magnetic Resonance Testing (MR)
MR Compatibility testing was completed, and documentation was provided to FDA in support of the substantial equivalence determination. The CT/MR Tandem Ovoid Set is MR Safe and complies with the following MR standard:
- ASTM F2503-23 (2023 ED): Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Since CT/MR Tandem and Ovoid Set is made from non-metallic, non-magnetic material, no testing is performed according to the following standards.
Page 9
- ASTM F2052-21: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- ASTM F2182-19: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Cleaning, Disinfection and Sterilization Testing:
Cleaning, disinfection and sterilization testing was conducted to demonstrate the device components may be sterilized effectively (as appropriate) and the device can be used and sterilized for the specified number of times.
A human factors validation study was conducted according to the standard IEC 62366 to verify that the device performs well as intended for the intended users, uses, and use environments.
Mechanical and Acoustic Testing:
The CT/MR Tandem Ovoid Set has undergone formal design verification and design validation testing. Design verification and design validation testing demonstrates that the device performs as intended.
Design verification and design validation testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard.
Use of Consensus Standards:
The following list of FDA-recognized, voluntary consensus standards were utilized in the design and evaluation of the subject device's safety and efficacy.
| Standard/ CS | Standard/ CS Title |
|---|---|
| EN ISO 13485:2016 | Quality management systems. Requirements for regulatory purposes |
| EN ISO 14971:2019+All:2021 | Medical devices - Application of risk management to medical devices (ISO 14971:2019) |
| EN ISO 15223-1:2021 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements |
| EN ISO 20417:2021 | Information supplied by the manufacturer of medical devices |
| EN 62366-1:2015+Al:2020 | Application of Usability Engineering to Medical Devices |
| EN ISO 17664-1:2021 | Processing of health care products-Information to be provided by the medical device manufacturer for the processing of medical devices. |
| EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
Page 10
| EN ISO 10993-1:2020 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. |
|---|---|
| EN ISO 10993-2:2022 | Biological evaluation of medical devices. - Part 2: Animal welfare requirements |
| EN ISO 10993-5:2009 | Biological evaluation of medical devices - part 5: Tests for in vitro cytotoxicity |
| EN ISO 10993-6:2016 | Biological evaluation of medical devices - Part 6: Tests for local effects after implantation |
| EN ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization |
| EN ISO 10993-11:2018 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
| EN ISO 10993-12:2021 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials |
| EN ISO 10993-17:2023 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances |
| EN ISO 10993-18:2020 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process |
| EN ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation |
| EN 60601-1:2006/Al:2013 | Medical Electrical Equipment Part 1- General Requirements For Safety and essential performance |
| EN 60601-2-17:2015 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically- controlled brachytherapy after loading equipment |
IX. Determination of Substantial Equivalence to the Predicate
The intended use and indications for use for the subject are substantially equivalent to the predicate device. The subject device does not cover PDR Brachytherapy, whereas the predicate is intended for use in both HDR and PDR brachytherapy. The subject device has several new components as a part of its design, which were also added to the labeling for completeness.
Varian believes the major technological characteristics are substantially equivalent to the predicate device and the differences do not raise new questions of safety and effectiveness. While the predicate device is MR compatible due to its carefully designed metallic components, the subject device is deemed MR safe as it is fully non-metallic and nonconductive.
The results of verification and validation as well as conformance to relevant safety standards demonstrate that the device meets the safety and performance criteria.
Varian considers the CT/MR Tandem and Ovoid Set to be as safe and effective as the predicate and to perform at least as well as the predicate device (K241853)