(133 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device, the "Titanium Fletcher-Style Applicator Set Defined Geometry" and "Smit Cervical Sleeves" by Varian Medical Systems, Inc. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that a new AI/software-based device meets specific acceptance criteria through a clinical study.
The acceptance criteria and study information requested in your prompt (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth types for training/test sets) are highly relevant for AI-powered medical devices (software as a medical device - SaMD). However, this 510(k) submission is for a physical medical device used in brachytherapy, not an AI or software device.
Therefore, many of the specific questions in your prompt are not applicable to this non-AI medical device submission. The document details the device's technical specifications, intended use, indications for use, and a comparison to a predicate device to argue for substantial equivalence. The "performance testing" mentioned is primarily non-clinical (biocompatibility, MR compatibility, cleaning/sterilization, human factors, mechanical/acoustic testing), focusing on the device's physical properties and safety, not its diagnostic or therapeutic performance in a statistical sense that would require large clinical studies with ground truth derived from experts or pathology.
Here's a breakdown based on the provided text, addressing the points where information is available and noting where it's not applicable:
Acceptance Criteria and Device Performance (for a non-AI physical device)
The concept of "acceptance criteria" for this type of physical device is framed around demonstrating that its design and performance characteristics are equivalent to or do not raise new questions of safety and effectiveness compared to a legally marketed predicate device. The "performance" is primarily assessed through non-clinical laboratory testing to ensure physical integrity, material compatibility, and functionality within its intended use.
Table of Acceptance Criteria and Reported Device Performance (as inferred for a non-AI device through a 510(k))
| Acceptance Criteria Category (Inferred from 510(k) process for physical devices) | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance/Compliance |
|---|---|---|
| Intended Use & Indications for Use Equivalence | Device's intended use and indications for use are substantially similar to predicate, or differences do not raise new safety/effectiveness questions. Added paracervix. | Claimed: "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." (p. 1 |
| Material Biocompatibility | Materials are biocompatible for patient contact. | Compliance: Meets ISO 10993-1 and applicable parts. |
| MR Compatibility | Device is safe for use in magnetic resonance environments. | Compliance: MR Conditional; complies with ASTM F2503-23. |
| Cleaning, Disinfection, and Sterilization (CDS) | Device can be effectively cleaned, disinfected, and sterilized; maintains integrity over specified cycles. | Demonstrated: Testing conducted to show effective sterilization and durability for specified cycles (e.g., sterilization cycle updated to 250 & 500 times from 100 & 500 times). |
| Human Factors/Usability | Device performs as intended for intended users, uses, and use environments. (Non-clinical validation) | Demonstrated: Human factors validation study conducted per IEC 62366. |
| Mechanical Integrity/Performance | Device maintains structural integrity and performs its mechanical functions as designed. | Demonstrated: Formal design validation testing, design verification testing, and design validation testing confirming performance as intended, in accordance with FDA QSR (21 CFR §820), ISO 13485, and ISO 14971. |
| Compatibility with Afterloaders | Device is compatible with specified brachytherapy afterloaders. | Confirmed: Compatible with GammaMedplus Series, VariSource Series, and addition of BRAVOS Afterloader System. |
| Safety Standards Compliance | Device conforms to relevant safety and performance consensus standards. | Compliance: Utilized FDA-recognized voluntary consensus standards including ISO 13485, ISO 14971, ISO 15223-1, ISO 20417, IEC 62366-1, ISO 11737-2, ISO 17664-1, ISO 11607-1, ISO 17665-1, various ISO 10993 parts, EN 60601-1, and EN 60601-2-17. (p. 10-11) |
Study Information (as applicable to a non-AI physical device 510(k) submission):
-
Sample size used for the test set and the data provenance:
- N/A (for clinical performance data): This is a submission for a physical device, not an AI/software device requiring a clinical test set for performance evaluation (e.g., diagnostic accuracy). The "testing" refers to non-clinical lab tests (biocompatibility, MR, mechanical, sterilization, human factors).
- For the non-clinical tests (e.g., sterilization cycles, human factors study), the sample size would be determined by the specific ISO/ASTM standards referenced, but typically isn't a large "test set" in the sense of clinical cases. The document does not specify these sample sizes.
- Data Provenance: Not applicable in the context of clinical data for a physical device. Testing is conducted in a laboratory environment, not on patient data from specific countries.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: Ground truth established by medical experts is not listed as a component of this non-AI device's performance testing for 510(k) clearance. The device's "performance" is assessed through engineering testing against physical and safety standards and comparison to a predicate.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: Not applicable as there is no clinical test set requiring expert adjudication for accuracy or performance.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No: This is not an AI-powered device, so an MRMC study comparing human performance with and without AI assistance was not conducted.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A: This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A: "Ground truth" in the sense of clinical reference standards (pathology, expert consensus) is not applied to this type of 510(k) submission for a non-AI physical device. The "truth" or reference is established by engineering specifications, material standards, and functional test results (e.g., "does it sterilize correctly?", "is it MR compatible?").
-
The sample size for the training set:
- N/A: This is not a machine learning/AI device, so there is no training set in the AI sense.
-
How the ground truth for the training set was established:
- N/A: Not applicable.
In summary: The provided document is a 510(k) letter for a physical brachytherapy applicator set, demonstrating substantial equivalence to a predicate device. The regulatory pathway for such devices involves rigorous non-clinical testing (e.g., material testing, mechanical testing, sterilization validation) and a comparison of technical characteristics to a predicate, rather than large-scale clinical performance studies or AI-specific validation methods outlined in your prompt.
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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"
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(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
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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
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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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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.
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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.
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VII. Comparison of Technological Characteristics with the Predicate Device
Table 1: Comparison of Subject Device to Predicate Device
| FEATURE ANO/ORSPECIFICATION OFNEW/MODIFIED DEVICE | CLEARED DEVICEFEATURE/SPECIFICATION510(K) ID# K120731GammaMed Titanium Fletcher-Style Applicator Set GM11006200GammaMedTitanium Fletcher-style ApplicatorSet - Definedgeometry | NEW/MODIFIED DEVICE NAMEGM11006200 Titanium Fletcher- StyleApplicator Set - Defined Geometry | COMPARISON |
|---|---|---|---|
| Intended use | The GammaMed Titanium Fletcher-style Applicator Set with definedgeometry was developed to treatcancer of the uterus, cervix,endometrium and vagina. | The Titanium Fletcher-style Applicator Set -Defined Geometry is intended for use forcancer treatment of the uterus, cervix,paracervix, endometrium and vagina whenperforming HDR or PDR brachytherapy. | Added paracervix to intendeduse and clarified product nameto Titanium Fletcher-styleApplicator Set - DefinedGeometry to reflect the broadrange of compatible applicatorsets as opposed to highlightingonly the GammaMed.Although this change adds anadditional anatomical site, themanner in which the device isused is consistent with theanatomical area that wasoriginally cleared and does notintroduce an additional risk ofbeing used in a generalizedtreatment application. |
| Indications for Use | The GammaMed TitaniumFletcher-style Applicator Setwith defined geometry wasdeveloped for brachytherapytreatment of cancer ofthe uterus, cervix,endometrium and vagina. | The Titanium Fletcher-style ApplicatorSet – Defined Geometry is indicatedfor use for cancer treatment of theuterus, cervix, paracervix,endometrium and vagina using HDR orPDR brachytherapy. | Added paracervix to intendeduse and clarified product nameto Titanium Fletcher-styleApplicator Set - DefinedGeometry |
| Labeling | The probes are marked withnumbers at the proximal endso that each probe can beindividually identified. (Centerprobe = 1, left probe (patient'sleft) = 2, right probe (patient'sright) = 3)" (PGM11006200_11EN, dated 2013-07-30) | The probes are marked with numbers atthe proximal end so that each probe canbe individually identified. (Center probe= 1, right probe (patient's left) = 2, leftprobe (patient's right) = 3)"(PGM11006200_12 EN, dated 2014-07-09) | Update made for consistencywith electronic library |
| Compatible After loader | GammaMedp/us SeriesVariSource Series | GammaMedp/us Series VariSourceSeriesBRAVOS Afterloader System | Addition of BRAVOSAfterloader |
| FEATURE ANO/ORSPECIFICATION OFNEW/MODIFIED DEVICE | CLEARED DEVICEFEATURE/SPECIFICATION510(K) ID# K120731GammaMed Titanium Fletcher-Style Applicator Set GM11006200GammaMedTitanium Fletcher-style ApplicatorSet - Definedgeometry | NEW/MODIFIED DEVICE NAMEGM11006200 Titanium Fletcher- StyleApplicator Set - Defined Geometry | COMPARISON |
| Design (OptionalAccessories) | Intrauterine Probe withstopper 30°,length: 40mm, 60mm, 80mm(optional 30mm, 50mm,70mm) | Titanium intrauterine probe withcervical stop 30°,length: 40mm, 60mm, 80mm(optional 30mm, 50mm, 70mm) | Clarified that the material of theintrauterine probe is Titanium |
| Mini-colpostat segment, pairColpostats segment: 20mm,25mm, 30mm spread | Mini-ovoids, pairOvoids for 20, 25, 30 mm spread, pairTitanium central clamping mechanism | Re-named the colpostatsegment pair to "ovoid" ovoids toharmonize the naming comparedto other Varian Applicator sets | |
| Grub Screw Diameter:0.25x45° | Grub Screw Diameter: 0.4x45° | Diameter change was made tocreate a better fit between screws | |
| Central fixation screw for intrauterineprobeFixation screws for colpostat probe | Inclusion of two (2) newoptional components that willbe available if requested foruse 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 gradewas released to enlarge thedelivery availability of the tubefor the colpostat andintrauterine probes |
| Materials | Shallow well of the 4.5mm holder | Shallow well of the 4.5mm holder wasremoved | The shallow well of the 4.5mmholder was redundant for thethree channel applicators;therefore, it was removed. |
| Materials | Rectal retractor connection rodtube | Rectal retractor connection rod solidmaterial (stainless steel) | Increased improved availabilityof semi-finished goods |
| FEATURE ANO/ORSPECIFICATION OFNEW/MODIFIED DEVICE | CLEARED DEVICEFEATURE/SPECIFICATION5I0(K) ID# K120731GammaMed Titanium Fletcher-Style Applicator Set GM11006200GammaMedTitanium Fletcher-style ApplicatorSet - Definedgeometry | NEW/MODIFIED DEVICE NAMEGM11006200 Titanium Fletcher- StyleApplicator Set - Defined Geometry | COMPARISON |
| Packing | Individual | Individual | No change |
| Sterility | Delivered in non-sterilecondition. To be sterilizedat customer site.Number of sterilization cycle:100 & 500 times | Delivered in non-sterile condition. Tobe sterilized at customer site.Number of sterilization cycle: 250 times &500 times | Updated number of sterilizationcycles to 250 & 500 |
| Sterilization method | Manual and machine cleaningSteam sterilization | Manual and machine cleaning Steamsterilization | No change |
| Biocompatibility | Fully biocompatible | Fully biocompatible | No change |
| Anatomical sites | Uterus, cervix, endometrium, andvagina | Uterus, cervix, paracervix, endometrium andvagina | Addition of paracervixanatomical site |
| Compatibility with theenvironment and otherdevices | 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 isdeveloped to irradiate the cervix, the vaginaand the vaginal stump. The applicator set isMR and CT compatible. The cylindersegments can be used with cervical sleeves(Smit), flexible intra-uterine probes orwithout intra-uterine probes. The segmentedconstruction of the applicator allows anindividual adaptation to the patient'sanatomy. The maximum implantation timefor the Segmented Cervix Applicator is 7 days | The Smit Cervical Sleeves areintended for use when performingHDR or PDR brachy- therapy. | Creation of intended useto be consistent withTitanium Fletcher StyleApplicator Set DefinedGeometry |
| Indications for Use | Segmented Cervix Applicator Set isdeveloped to irradiate the cervix, the vaginaand the vaginal stump. The applicator set isMR and CT compatible. The cylindersegments can be used with cervical sleeves(Smit), flexible intra-uterine probes orwithout intra-uterine probes. The segmentedconstruction of the applicator allows anindividual adaptation to the patient'sanatomy. The maximum implantation timefor the Segmented Cervix Applicator is 7 days | The Smit Cervical Sleeves areindicated for use where anyintrauterine tandem is used for HDRor PDR brachytherapy. | Creation of intended useto be consistent withTitanium Fletcher StyleApplicator Set DefinedGeometry |
| Compatible After- loader | GammaMedplus Series VariSource Series | GammaMedplus SeriesVariSource SeriesBRAVOS Afterloader System | Addition of BRAVOSafterloader system |
| Design | Cervical SleevesSmit cervical sleeve diameter 6 mm, lengths30, 40, 50, 60, 70, 80 mm | Smit cervical sleeves: Diameter 6 mm,lengths 30, 40, 50, 60, 70, 80 mm | No change |
| Materials | Cervical SleevesPPSU, Titanium (marking screw) | PPSU, Titanium | No change |
| Packing | Individual | Individual | No change |
| Sterility | Delivered in non-sterile condition. To besterilized at customer site. | Delivered in non-sterile condition. Tobe 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, andendometrium |
| Compatibility with the environmentand 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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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 (ISO14971:2019) |
| EN ISO 15223-1:2021 | Medical devices - Symbols to be used with medical device labels, labellingand 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 ofsterility performed in the definition, validation and maintenance of asterilization process |
| EN ISO 17664-1:2021 | Processing of health care products-Information to be provided by themedical device manufacturer for the processing of medical devices. |
| EN ISO 11607-1:2020 | Packaging for terminally sterilized medical devices - Part 1: Requirements formaterials, sterile barrier systems and packaging systems |
| EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements forthe development, validation and routine control of a sterilization process formedical devices |
| EN ISO 10993-1:2020 | Biological evaluation of medical devices -- Part 1: Evaluation and testing withina 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 afterimplantation |
| EN ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for irritation and skinsensitization |
| 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 andreference materials |
| EN ISO 10993-17:2023 | Biological evaluation of medical devices - Part 17: Establishment of allowablelimits for leachable substances |
| Standard/ CS | Standard/ CS Title |
| EN ISO 10993-18:2020 | Biological evaluation of medical devices - Part 18: Chemical characterization ofmedical 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 andessential performance |
| EN 60601-2-17:2015 | Medical electrical equipment - Part 2-17: Particular requirements for the basicsafety and essential performance of automatically-controlled brachytherapyafter 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.
§ 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.