(133 days)
No
The device description explicitly states that the device does not contain or consist of software/firmware, and there are no mentions of AI, DNN, or ML in the summary.
Yes.
The device is used for cancer treatment of specific anatomical sites (uterus, cervix, paracervix, endometrium, and vagina) using brachytherapy, which is a therapeutic intervention.
No
Explanation: The device is described as an "Applicator Set" used for cancer treatment via brachytherapy. Its function is to apply radiation, not to diagnose a condition. The sections "Intended Use / Indications for Use" and "Device Description" consistently refer to its role in "cancer treatment" and "performing HDR or PDR brachytherapy," which are therapeutic, not diagnostic, actions.
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 performed directly on the patient.
- Device Description: The device is a physical applicator set used to deliver radiation sources for treatment. It does not involve testing samples taken from the human body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body) for therapeutic purposes.
N/A
Intended Use / 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 Smit Cervical Sleeves are indicated for use where any intrauterine tandem is used for HDR or PDR brachytherapy.
Product codes
JAQ
Device Description
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 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 Titanium Fletcher-Style Applicator Set Defined Geometry includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Titanium Fletcher-Style Applicator Set Defined Geometry is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
This 510(k) submission is also inclusive of the Smit Cervical Sleeve which is an optional component that may be used with the Titanium Fletcher Style Applicator Set Defined Geometry but is not required to successfully perform the intended use. Please note that some of the documentation that is provided in this submission for the Titanium Fletcher Style Applicator Set Defined Geometry is also inclusive of/applicable to the Smit Cervical Sleeve.
The key performance characteristics of this applicator set are as follows:
- The rigid design allows for a reproducible setup.
- The probes and the central clamping mechanism are made from strong, lightweight titanium which are marked with "Ti" for easy identification.
- 3mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort.
- Six different intrauterine tandem lengths available allowing for insertion across a range of anatomical sizes (from 3 to 8 cm past the cervical os).
- Integrated cervical stoppers reduce the risk of perforation.
- Channel marking on the intrauterine tandems and colpostat probes for easy identification.
- Flat-edged ovoids to help prevent tissue protrusion between ovoids.
- Four different ovoid sizes to allow for varying anatomy.
- Optional interstitial ovoids allow the additional use of plastic needles for more complex cases.
- Optional needle collectors allow for the fixation of the needles.
- Optional Smit cervical sleeves with markers allow easy multiple fraction and help provide maximum patient comfort.
- Optional rectal retractor available to help lower rectal doses.
- CT compatible and MR conditional
- HDR and PDR compatible
- Can be manually or machine cleaned, disinfected and is steam sterilizable.
- Can be securely connected to the BRAVOS Afterloader System, GammaMedplus iX and VariSource iX series afterloaders.
- Suitable for patient contact for a period less than 30 days
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus, cervix, paracervix, endometrium and vagina
Indicated Patient Age Range
Not Found
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)
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 Titanium Fletcher-Style Applicator Set Defined Geometry 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
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 conding 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 Titanium Fletcher-Style Applicator Set Defined Geometry has undergone formal 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 Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The seal features a stylized depiction of a human figure, while the text is in a clear, sans-serif font, with "FDA" in a blue square.
November 7, 2024
Varian Medical Systems, Inc. Lynn Allman Sr. Director, Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304
Re: K241853
Trade/Device Name: Titaniuim Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: June 26, 2024 Received: June 27, 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/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.
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"
1
(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 (OS) 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-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 medical devices and radiation-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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
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,
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
510(k) Number (if known) K241853
Device Name Titanium Fletcher Style Applicator Set Defined Geometry Smit Cervical Sleeves
Indications for Use (Describe)
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 Smit Cervical Sleeves are indicated for use where any intrauterine tandem is used for 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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
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4
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K241853
Premarket Notification - 510(k) Summary
Traditional 510(k) Submission for Titanium Fletcher-Style Applicator Set Defined Geometry
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
II. Device Information
Proprietary Name: Titanium Fletcher-Style Applicator Set Defined Geometry, Smit Cervical Sleeve
Classification Name: Remote Controlled Radionucleotide Applicator System Regulation Number: §892.5700 Product Code: JAQ
lll. Predicate Device
Titanium Fletcher-Style Applicator Set Defined Geometry (K120731)
Reference Device
INTRACAVITARY BRACHYTHERAPY APPLICATORS SEGMENTED CERVIX APPLICATOR SET (K033371)
IV. Device Description
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 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 Titanium Fletcher-Style Applicator Set Defined Geometry includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Titanium Fletcher-Style Applicator Set Defined Geometry is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
This 510(k) submission is also inclusive of the Smit Cervical Sleeve which is an optional component that may be used with the Titanium Fletcher Style Applicator Set Defined Geometry but is not required to successfully perform the intended use. Please note that some of the documentation that is provided in this submission for the Titanium Fletcher Style Applicator Set Defined Geometry is also inclusive of/applicable to the Smit Cervical Sleeve.
5
Image /page/5/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written 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 black and white.
The key performance characteristics of this applicator set are as follows:
- The rigid design allows for a reproducible setup.
- . The probes and the central clamping mechanism are made from strong, lightweight titanium which are marked with "Ti" for easy identification.
- 3mm diameter intrauterine tandems allow for easy insertion into the cervical channel helping provide maximum patient comfort.
- . Six different intrauterine tandem lengths available allowing for insertion across a range of anatomical sizes (from 3 to 8 cm past the cervical os).
- . Integrated cervical stoppers reduce the risk of perforation.
- . Channel marking on the intrauterine tandems and colpostat probes for easy identification.
- Flat-edged ovoids to help prevent tissue protrusion between ovoids.
- Four different ovoid sizes to allow for varying anatomy.
- . Optional interstitial ovoids allow the additional use of plastic needles for more complex cases.
- . Optional needle collectors allow for the fixation of the needles.
- Optional Smit cervical sleeves with markers allow easy multiple fraction and help provide maximum patient comfort.
- Optional rectal retractor available to help lower rectal doses.
- CT compatible and MR conditional
- HDR and PDR compatible
- Can be manually or machine cleaned, disinfected and is steam sterilizable.
- Can be securely connected to the BRAVOS Afterloader System, GammaMedplus iX and VariSource iX series afterloaders.
- Suitable for patient contact for a period less than 30 days
V. 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 Smit Cervical Sleeves are intended for use when performing HDR or PDR brachytherapy.
VI. 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 Smit Cervical Sleeves are indicated for use where any intrauterine tandem is used for HDR or PDR brachytherapy.
6
VII. Comparison of Technological Characteristics with the Predicate Device
Table 1: Comparison of Subject Device to Predicate Device
| FEATURE ANO/OR
SPECIFICATION OF
NEW/MODIFIED DEVICE | CLEARED DEVICE
FEATURE/SPECIFICATION
510(K) ID# K120731
GammaMed Titanium Fletcher-
Style Applicator Set GM11006200
GammaMed
Titanium Fletcher-style Applicator
Set - Defined
geometry | NEW/MODIFIED DEVICE NAME
GM11006200 Titanium Fletcher- Style
Applicator Set - Defined Geometry | COMPARISON |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The GammaMed Titanium Fletcher-
style Applicator Set with defined
geometry was developed to treat
cancer of the uterus, cervix,
endometrium and vagina. | 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. | Added paracervix to intended
use and clarified product name
to Titanium Fletcher-style
Applicator Set - Defined
Geometry to reflect the broad
range of compatible applicator
sets as opposed to highlighting
only the GammaMed.
Although this change adds an
additional anatomical site, the
manner in which the device is
used is consistent with the
anatomical area that was
originally cleared and does not
introduce an additional risk of
being used in a generalized
treatment application. |
| Indications for Use | The GammaMed Titanium
Fletcher-style Applicator Set
with defined geometry was
developed for brachytherapy
treatment of cancer of
the uterus, cervix,
endometrium and vagina. | 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. | Added paracervix to intended
use and clarified product name
to Titanium Fletcher-style
Applicator Set - Defined
Geometry |
| Labeling | The probes are marked with
numbers at the proximal end
so that each probe can be
individually identified. (Center
probe = 1, left probe (patient's
left) = 2, right probe (patient's
right) = 3)" (PGM11006200_11
EN, dated 2013-07-30) | 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) | Update made for consistency
with electronic library |
| Compatible After loader | GammaMedp/us Series
VariSource Series | GammaMedp/us Series VariSource
Series
BRAVOS Afterloader System | Addition of BRAVOS
Afterloader |
| FEATURE ANO/OR
SPECIFICATION OF
NEW/MODIFIED DEVICE | CLEARED DEVICE
FEATURE/SPECIFICATION
510(K) ID# K120731
GammaMed Titanium Fletcher-
Style Applicator Set GM11006200
GammaMed
Titanium Fletcher-style Applicator
Set - Defined
geometry | NEW/MODIFIED DEVICE NAME
GM11006200 Titanium Fletcher- Style
Applicator Set - Defined Geometry | COMPARISON |
| Design (Optional
Accessories) | Intrauterine Probe with
stopper 30°,
length: 40mm, 60mm, 80mm
(optional 30mm, 50mm,
70mm) | Titanium intrauterine probe with
cervical stop 30°,
length: 40mm, 60mm, 80mm
(optional 30mm, 50mm, 70mm) | Clarified that the material of the
intrauterine probe is Titanium |
| | Mini-colpostat segment, pair
Colpostats segment: 20mm,
25mm, 30mm spread | Mini-ovoids, pair
Ovoids for 20, 25, 30 mm spread, pair
Titanium central clamping mechanism | Re-named the colpostat
segment pair to "ovoid" ovoids to
harmonize the naming compared
to other Varian Applicator sets |
| | Grub Screw Diameter:
0.25x45° | Grub Screw Diameter: 0.4x45° | Diameter change was made to
create a better fit between screws |
| | | Central fixation screw for intrauterine
probe
Fixation screws for colpostat probe | Inclusion of two (2) new
optional components that will
be available if requested for
use with the colpostat probe |
| Materials | Stainless Steel, PPSU, PEEK,
Titanium 3.7025 (Grade 1) | Stainless Steel, PPSU, PEEK, Titanium 3.7035
(Grade 2) | An additional Titanium grade
was released to enlarge the
delivery availability of the tube
for the colpostat and
intrauterine probes |
| Materials | Shallow well of the 4.5mm holder | Shallow well of the 4.5mm holder was
removed | The shallow well of the 4.5mm
holder was redundant for the
three channel applicators;
therefore, it was removed. |
| Materials | Rectal retractor connection rod
tube | Rectal retractor connection rod solid
material (stainless steel) | Increased improved availability
of semi-finished goods |
| FEATURE ANO/OR
SPECIFICATION OF
NEW/MODIFIED DEVICE | CLEARED DEVICE
FEATURE/SPECIFICATION
5I0(K) ID# K120731
GammaMed Titanium Fletcher-
Style Applicator Set GM11006200
GammaMed
Titanium Fletcher-style Applicator
Set - Defined
geometry | NEW/MODIFIED DEVICE NAME
GM11006200 Titanium Fletcher- Style
Applicator Set - Defined Geometry | COMPARISON |
| Packing | Individual | Individual | No change |
| Sterility | Delivered in non-sterile
condition. To be sterilized
at customer site.
Number of sterilization cycle:
100 & 500 times | Delivered in non-sterile condition. To
be sterilized at customer site.
Number of sterilization cycle: 250 times &
500 times | Updated number of sterilization
cycles to 250 & 500 |
| Sterilization method | Manual and machine cleaning
Steam sterilization | Manual and machine cleaning Steam
sterilization | No change |
| Biocompatibility | Fully biocompatible | Fully biocompatible | No change |
| Anatomical sites | Uterus, cervix, endometrium, and
vagina | Uterus, cervix, paracervix, endometrium and
vagina | Addition of paracervix
anatomical site |
| Compatibility with the
environment and other
devices | CT Compatible, MR Conditional | CT Compatible, MR Conditional | No change |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room | No change |
| FEATURE AND/OR | CLEARED DEVICE FEATURE/SPECIFICATION | | |
| SPECIFICATION OF | 510(K) ID# K033371 INTRACAVITARY | NEW/ MODIFIED DEVICE NAME | Comparison |
| NEW/MODIFIED DEVICE | BRACHYTHERAPY APPLICATORS | APPLICATORS FOR | |
| | SEGMENTED CERVIX APPLICATOR SET | SMIT CERVICAL SLEEVES | |
| | | | |
| Intended use | Segmented Cervix Applicator Set is
developed to irradiate the cervix, the vagina
and the vaginal stump. The applicator set is
MR and CT compatible. The cylinder
segments can be used with cervical sleeves
(Smit), flexible intra-uterine probes or
without intra-uterine probes. The segmented
construction of the applicator allows an
individual adaptation to the patient's
anatomy. The maximum implantation time
for the Segmented Cervix Applicator is 7 days | The Smit Cervical Sleeves are
intended for use when performing
HDR or PDR brachy- therapy. | Creation of intended use
to be consistent with
Titanium Fletcher Style
Applicator Set Defined
Geometry |
| Indications for Use | Segmented Cervix Applicator Set is
developed to irradiate the cervix, the vagina
and the vaginal stump. The applicator set is
MR and CT compatible. The cylinder
segments can be used with cervical sleeves
(Smit), flexible intra-uterine probes or
without intra-uterine probes. The segmented
construction of the applicator allows an
individual adaptation to the patient's
anatomy. The maximum implantation time
for the Segmented Cervix Applicator is 7 days | The Smit Cervical Sleeves are
indicated for use where any
intrauterine tandem is used for HDR
or PDR brachytherapy. | Creation of intended use
to be consistent with
Titanium Fletcher Style
Applicator Set Defined
Geometry |
| Compatible After- loader | GammaMedplus Series VariSource Series | GammaMedplus Series
VariSource Series
BRAVOS Afterloader System | Addition of BRAVOS
afterloader system |
| Design | Cervical Sleeves
Smit cervical sleeve diameter 6 mm, lengths
30, 40, 50, 60, 70, 80 mm | Smit cervical sleeves: Diameter 6 mm,
lengths 30, 40, 50, 60, 70, 80 mm | No change |
| Materials | Cervical Sleeves
PPSU, Titanium (marking screw) | PPSU, Titanium | No change |
| Packing | Individual | Individual | No change |
| Sterility | Delivered in non-sterile condition. To be
sterilized at customer site. | Delivered in non-sterile condition. To
be sterilized at customer site. | No change |
| Sterilization method | Steam sterilization | Steam sterilization | No change |
| Biocompatibility | Fully biocompatible | Fully biocompatible | No change |
| Anatomical sites | Cervix, Vagina, and Vaginal Stump | Uterus, cervix, paracervix,
endometrium, and vagina | Addition of uterus,
paracervix, and
endometrium |
| Compatibility with the environment
and other devices | CT Compatible, MR Conditional | CT Compatible, MR Conditional | No change |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room | No change |
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Image /page/7/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern.
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Image /page/8/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is in bold, sans-serif font. Below the logo is the text "A Siemens Healthineers Company" in a smaller font size.
9
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Table 2: Comparison of Subject Device to Reference Device
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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 Titanium Fletcher-Style Applicator Set Defined Geometry 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
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 conding 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 Titanium Fletcher-Style Applicator Set Defined Geometry has undergone formal 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 | |
| Standard/ CS | Standard/ CS Title |
| 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 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 | |
| Standard/ CS | Standard/ CS Title |
| 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 |
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VIII. Determination of Substantial Equivalence to the Predicate
Major Changes included:
●
Changes to Intended Use and Indications for Use Statements
- Addition of wording "HDR and PDR brachytherapy" O
- O In comparison to the previous 510(k) submission there is an expansion of the indications for use to include a new anatomical site "paracervix".
lt is important to note that although this change adds an additional anatomical site, the manner in which the device is used is consistent with the anatomical area that was originally cleared and does not introduce an additional risk of being used in a generalized treatment application. The overall intended use to treat cancer with brachytherapy is unchanged. While there are changes to the wording of the statements, overall intended use is not changed.
- O Clarified product name to: The Titanium Fletcher-style Applicator Set – Defined Geometry
- Number of sterilization cycle changed from 100 & 500 times to 250 times & 500 times. ●
- Deletion of warning regarding the use of plastic needles. Due to implementation of new plastic needles that are MR Safe (ISD 14) are tested for 25 reuses as opposed to single use.
- . Added compatibility to the BRAVOS Afterloader System
- Added optional accessories to complete the list
Cumulative changes since the most recent 510(k) filing in 2012 are also included and detailed within the submission.
In addition, we are requesting clearance for the cervical sleeves were previously cleared for use in K03371. The device itself is unchanged however we are adding a separate indication for the Cervical sleeves with this submission.
There are no changes in the design or principle of operation of the devices.
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Varian believes the major technological characteristics are substantially equivalent to 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 Fletcher Set Defined Geometry to be as safe and effective as the predicate and therefore substantially equivalent to the predicate device.