(73 days)
Not Found
No
The device description explicitly states that the device does not contain or consist of software/firmware, and there is no mention of AI or ML in the document.
Yes.
The device is intended for cancer treatment using brachytherapy, which is a therapeutic intervention.
No
The device is described as an applicator set intended for cancer treatment using brachytherapy, which is a therapeutic rather than a diagnostic procedure.
No
The device description explicitly states, "The device does not contain or consist of software/firmware."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cancer treatment using brachytherapy, which is a therapeutic procedure, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details a physical applicator set used for delivering radiation, not a device designed to examine specimens from the human body to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose, monitor, or screen for diseases or conditions by analyzing biological samples.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to provide information about a person's health status. This device is a therapeutic tool used in the treatment of cancer.
N/A
Intended Use / Indications for Use
The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vaqina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.
Product codes (comma separated list FDA assigned to the subject device)
JAO
Device Description
The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.
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 intended patient population includes adult female patients whose cancer can be treated using HDR brachytherapy, as determined by the prescribing physician. The subject device is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
The key performance characteristics of this applicator set are as follows:
- The ability to customize the relative depth of the tandem and ovoids, as well as adapt to different anatomies with three tandem angles (15°, 30°, 45°) and a movable cervical stop.
- 3.5 mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort.
- The tandems and the pivot assembly are made from strong, lightweight titanium.
- Four different ovoid sizes to allow for varying anatomy.
- Channel marking on the intrauterine tandems and colpostat tandems for easy identification.
- Ability to image the patient using CT imaging.
- Ability to image the patient using MR imaging.
- Optional interstitial ovoids for more complex cases with guide tubes to allow for the needles to be preloaded outside of the patient and locked into place.
- Compatible with cervical sleeves to allow easy multiple fraction and help provide maximum patient comfort and eliminate the risk of perforation.
- Can be manually or machine cleaned, disinfected and steam sterilizable.
- Can be securely connected to the BRAVOS Afterloader System and GammaMedeplus iX series afterloader.
- Suitable for patient contact for a period of less than 30 days
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT imaging, MR imaging
Anatomical Site
uterus, cervix, paracervix, endometrium and vagina
Indicated Patient Age Range
Adult female patients
Intended User / Care Setting
healthcare or treatment facility 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 subject device is MR Conditional 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
- ASTM F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
- 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 F2119-07 (2013): Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
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 subject device 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.
Key Results: The overall verification and validation testing for the Titanium Flexible Geometry FSD Applicator Set demonstrates that the device requirements and risk control measures perform as intended at a level similar to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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March 3, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Varian Medical Systems, Inc. Lynn Allman Senior Director, Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304
Re: K243939
Trade/Device Name: Titanium Flexible Geometry FSD Applicator Set (GM11013400) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAO Dated: December 19, 2024 Received: December 20, 2024
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/cdrb/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.
1
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 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-reportingcombination-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 Re"). 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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
2
the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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,
Locon Weidner
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
3
Indications for Use
Submission Number (if known)
Device Name
Titanium Flexible Geometry FSD Applicator Set (GM11013400)
Indications for Use (Describe)
The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vaqina, with intracavitary or with a combination of intracavitary and interstitial 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)
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K243939
Premarket Notification - 510(k) Summary
Traditional 510(k) Submission for Titanium Flexible Geometry FSD Applicator Set
l. 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
ll. Device Information
Proprietary Name: Titanium Flexible Geometry FSD Applicator Set Classification Name: Remote Controlled Radionucleotide Applicator System Regulation Number: §892.5700 Product Code: JAQ
lll. Predicate Device
Titanium Fletcher-Style Applicator Set Defined Geometry (K241853)
IV. Device Description
The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.
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 intended patient population includes adult female patients whose cancer can be treated using HDR brachytherapy, as determined by the prescribing physician. The subject device is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
The key performance characteristics of this applicator set are as follows:
- . The ability to customize the relative depth of the tandem and ovoids, as well as adapt to different anatomies with three tandem angles (15°, 30°, 45°) and a movable cervical stop.
- 3.5 mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort.
- The tandems and the pivot assembly are made from strong, lightweight titanium.
- Four different ovoid sizes to allow for varying anatomy.
510(k) Summary
Traditional 510(k) Application Titanium Flexible Geometry FSD Applicator Set
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Image /page/5/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is in black and white.
- . Channel marking on the intrauterine tandems and colpostat tandems for easy identification.
- . Ability to image the patient using CT imaging.
- Ability to image the patient using MR imaging.
- Optional interstitial ovoids for more complex cases with guide tubes to allow for the needles to be preloaded outside of the patient and locked into place.
- . Compatible with cervical sleeves to allow easy multiple fraction and help provide maximum patient comfort and eliminate the risk of perforation.
- Can be manually or machine cleaned, disinfected and steam sterilizable.
- Can be securely connected to the BRAVOS Afterloader System and GammaMedeplus iX series afterloader.
- Suitable for patient contact for a period of less than 30 days
V. Intended Use
The Titanium Flexible Geometry FSD Applicator Set with the optional interstitial ovoids is intended for cancer treatment of the uterus, cervix, paracervix, endometrium and vagina, with intracavitary or with a combination of intracavitary and interstitial HDR brachytherapy.
VI. Comparison of Technological Characteristics with the Predicate Device
| FEATURE AND/OR
SPECIFICATION OF NEW
DEVICE | Predicate Device:
GM11006200 Titanium
Fletcher-Style Applicator Set
Defined Geometry (K241853) | Subject Device: GM11013400
Titanium Flexible Geometry
FSD Applicator 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 Titanium Flexible
Geometry FSD Applicator Set
with the optional interstitial
ovoids is intended for cancer
treatment of the uterus,
cervix, paracervix,
endometrium and vagina, with
intracavitary or with a
combination of intracavitary
and interstitial HDR
brachytherapy. | Similar, as both devices are
intended for brachytherapy
cancer treatment in the same
anatomical areas. The subject
device is not indicated for use
with PDR brachytherapy. |
| 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 Titanium Flexible
Geometry FSD Applicator Set
with the optional interstitial
ovoids is intended for cancer
treatment of the uterus,
cervix, paracervix,
endometrium and vagina, with
intracavitary or with a
combination of intracavitary
and interstitial HDR
brachytherapy. | Similar, as both devices are
intended for brachytherapy
cancer treatment in the same
anatomical areas. The subject
device is not indicated for use
with PDR brachytherapy. |
| Device Classification | Class II, IAQ | Class II, IAQ | Same |
| FEATURE AND/OR
SPECIFICATION OF NEW
DEVICE | Predicate Device:
GM11006200 Titanium
Fletcher-Style Applicator Set
Defined Geometry (K241853) | Subject Device: GM11013400
Titanium Flexible Geometry
FSD Applicator Set | Comparison |
| Intended Patient Population | Adult female patients for
which brachytherapy is
determined to be an
appropriate treatment by a
prescribing physician | Adult female patients for
which brachytherapy is
determined to be an
appropriate treatment by a
prescribing physician | Same |
| Compatible Afterloader | GammaMedplus iX Afterloader
Series
BRAVOS Afterloader System
VariSource Afterloader Series | GammaMedplus iX Afterloader
Series
BRAVOS Afterloader System | Similar, the subject device is
not indicated for use with the
VariSource afterloader series |
| Performance Characteristics | Device is made of
biocompatible, sturdy, and
lightweight components,
which are marked for
identification.
Users can adjust components
of the device and select from a
variety of sizing for a range of
anatomical sizes. | Device is made of
biocompatible, sturdy, and
lightweight components,
which are marked for
identification.
Users can adjust components
of device and select from a
variety of sizing for a range of
anatomical sizes. | Similar, there are differences in
the design and optional
accessories as detailed in
Components and Design (&
Optional Accessories). |
| Components and Design (&
Optional Accessories) | Rigid design / defined
geometry | Adjustable design / flexible
geometry | Similar, the primary difference
is in the type of orientation
angles available and adjustable
design of the subject device.
Both sets provide applicators
for brachytherapy treatment
for the same anatomical
region. |
| | Pair of titanium colpostat
probes (left and right): | Pair of titanium colpostat
tandems (left and right): | |
| | Titanium intrauterine probe
with cervical stop 30°,
Length: 40mm, 60mm, 80mm
(optional 30mm, 50mm,
70mm)
Diameter: 3mm | Titanium intrauterine tandems
with cervical stop with 15°, 30°
and 45° curved;
Length: Adjustable
Diameter: 3.5mm | |
| | Ovoids and mini-ovoids:
Dimensions: 16, 20, 25, 30 mm | Ovoids and mini-ovoids:
Dimensions: 16, 20, 25 and
30mm; | |
| | Titanium central clamping
mechanism
Allen Key | Titanium Tandem Pivot
Assembly, Locking Nut,
Cervical Stop; | |
| | Cleaning Caps | Cleaning Caps | |
| | Optional Components:
Fixation for 3-channel
applicators
Titanium rectal retractor | Optional Components:
Ovoid/cervical stop set screw
Interstitial ovoids with fixation
for guide tubes | |
Table 1: Comparison of Subject Device to Predicate Device
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Image /page/7/Picture/0 description: This image is a table comparing the features and specifications of a new device to a predicate device. The predicate device is the GM11006200 Titanium Fletcher-Style Applicator Set Defined Geometry (K241853), and the subject device is the GM11013400 Titanium Flexible Geometry FSD Applicator Set. The table compares the materials, packing, sterility, sterilization method, biocompatibility, anatomical sites, compatibility with the environment and other devices, and where the devices are used.
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VII. 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 subject device is MR Conditional 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
- ASTM F2182-19e2 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
- . 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 F2119-07 (2013): Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
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 subject device 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.
9
| 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 ISO 62366-1:2015+Al:2020 | Application of Usability Engineering to Medical Devices |
| EN ISO 11737-2:2020 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of |
| sterility performed in the definition, validation and maintenance of a | |
| sterilization process | |
| 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 11607-1:2020 | Packaging for terminally sterilized medical devices - Part 1: Requirements for |
| materials, sterile barrier systems and packaging systems | |
| 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 | |
| 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 ISO 60601-1:2006/A1:2013 | Medical Electrical Equipment Part 1- General Requirements For Safety and |
| essential performance | |
| EN ISO 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 |
VIII. Determination of Substantial Equivalence to the Predicate
Subject Device: Titanium Flexible Geometry FSD Applicator Set Predicate device: Titanium Fletcher-Style Applicator Set Defined Geometry (K241853)
1. Is the predicate device legally marketed?
510(k) Summary Traditional 510(k) Application Titanium Flexible Geometry FSD Applicator Set
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Yes, the predicate device received 510(k) Clearance under K241853 and since then has been legally marketed in the United States.
2. Do the devices have the same intended use?
Yes, with both devices, users are able to perform brachytherapy cancer treatment where indicated under the direction of clinical professionals. Both devices can be used with HDR brachytherapy.
3. Do the devices have the same technological characteristics?
No, There are differences in the flexibility and configurability that the subject device provides relative to the predicate that addresses varying patient anatomy. However, they are both patient-contacting applicator sets that are intended for use in the same anatomical region. The material composition, general design (Fletcher-Style), and device/environment compatibility is similar between the devices.
4. Do the different technological characteristics of the devices raise different questions of safety and effectiveness?
No, these differences do not raise different questions of safety and effectiveness. As demonstrated within this 510(k) submission, these differences raise similar questions relating to usability and performance. These considerations of safety and effectiveness were also applicable to the predicate device, as there are similar configurable elements which can be used to accommodate varying patient anatomy.
5a. Are the methods acceptable?
Yes, these verification and validation methods are similar to those applied to the predicate device and are well established and acceptable for the purpose of evaluation, either through the use of voluntary consensus or having been utilized in other 510(k) clearances. Test results demonstrate conformance to applicable requirements specifications and assure hazard safeguards function properly.
5b. Do the data demonstrate substantial equivalence?
Yes, the overall verification and validation testing for the Titanium Flexible Geometry FSD Applicator Set demonstrates that the device requirements and risk control measures perform as intended at a level similar to the predicate.
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 compared to the predicate.
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 Titanium Flexible Geometry FSD Applicator Set to be as safe and effective as the predicate and therefore substantially equivalent to the predicate device.