(202 days)
Not Found
No
The summary describes physical applicator sets for brachytherapy and their compatibility with afterloaders. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for cancer treatment using brachytherapy, which is a therapeutic intervention.
No
The provided text states that the device is "intended for cancer treatment" using brachytherapy, and is designed to "deliver high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy treatment". These descriptions indicate a therapeutic, not a diagnostic, function.
No
The device description explicitly states that the applicator sets are physical devices designed to be inserted into a body cavity and used with afterloaders. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "cancer treatment" using brachytherapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description confirms the device is used to "deliver high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy treatment for gynaecological and rectal applications." This is a treatment delivery system.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, tissue, etc.) to provide diagnostic information. IVDs are designed for diagnosis, monitoring, or screening.
The device is a medical device used for delivering radiation therapy, which is a form of treatment.
N/A
Intended Use / Indications for Use
The Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set are intended for cancer treatment of the vagina, vaginal stump and rectum using HDR or PDR brachytherapy.
The Universal Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.
The Universal Titanium Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.
Product codes
JAO
Device Description
The applicator sets in this submission are designed to be used with the GammaMed Plus afterloader series, VariSource 200 and iX afterloaders to deliver high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy treatment for gynaecological and rectal applications. The intracavitary applicators will be used for the treatment of cancerous tumors, and are designed to be inserted into a body cavity.
The Universal Cylinder Applicator Family includes:
- Universal Segmented Cylinder Applicator Set
- Universal Stump Applicator Set
- Universal Cervix Probe Sets
- Universal Titanium Cervix Probe Sets
These sets are compatible with GammaMed Plus series, VariSource 200 and iX afterloaders. They are provided non-sterile and can be steam sterilized at 132 °C for 4 min, 134 °C for 3 min, or 134 °C for 5 min. They are CT compatible and have full biocompatibility.
Design specifications for each set:
- Universal Segmented Cylinder Applicator Set: Cylinder Segment Dimension: diameters 20, 25, 30, 35, 40 mm; length 30 mm. Front Segment: 1 front segment for vaginal wall and vaginal stump treatment. Front Segment Dimension: diameter 20, 25, 30, 35, 40 mm; length 50 – 60 mm. Guiding Tube & Applicator Probe: straight rigid ø 3.2 mm; length 200 and 250 mm. Materials: Cylinder: PPSU plastic white; Guiding Tube & Applicator Probe: PEEK plastic natural, Titanium.
- Universal Stump Applicator Set: Cylinder Dimension: diameters 20, 25, 30, 35 mm; length 140 mm. Applicator Probe Dimension: ø 3.2 mm; inner length 200 and 250 mm. Materials: Cylinder: PPSU plastic white; Applicator Probe: PEEK plastic natural, Titanium.
- Universal Cervix Probe Sets: Diameter: 6.3 mm; Inner Length: 320 mm; Cervix Length: 30, 40, 50, 60, 70, 80 mm. Probe Tip Shapes: Straight or Curved with 15°, 30°. Materials: PEEK plastic natural, FEP, Titanium. MR conditional.
- Universal Titanium Cervix Probe Sets: Diameter: 3 mm; Inner Length: 320 mm; Cervix Length: 30, 40, 50, 60, 70, 80 mm. Probe Tip Shapes: Curved with 15°, 30°, or 45°. Materials: Titanium. MR Unsafe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, vaginal stump, rectum, cervix, uterus, endometrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Brachytherapy treatment room
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)
Non-Clinical Tests:
Bench Testing has been performed to demonstrate that:
- the devices function correctly with the specified afterloaders
- the devices can withstand the number of cycles of use they will experience in its lifetime
- the devices enable the radioactive source to be located to the accuracy required
- the devices are constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product
- the devices may be sterilized effectively
- the devices can be used and sterilized for the specified cycle limits
- the positional accuracy of the source in the devices is adequate
- the devices are biocompatible as per ISO 10933 standards
- the devices can be used safely and effectively in CT environments
Results of Bench Testing showed conformance to applicable requirements and specifications.
Clinical Tests:
No clinical tests have been included in this pre-market submission.
Conclusions:
All the tests that were performed met the applied pass criteria. Varian considers the devices to be safe and effective and to perform as well or better than the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K160516 - Universal Cylinder Applicator Family
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
March 21, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Varian Medical Systems, Inc % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K172611
Trade/Device Name: Universal Cylinder Applicator Family Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: March 6, 2018 Received: March 7, 2018
Dear Mr. Coronado:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172611
Device Name Universal Cylinder Applicator Family
Indications for Use (Describe)
The Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set are intended for cancer treatment of the vagina, vaginal stump and rectum using HDR or PDR brachytherapy.
The Universal Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.
The Universal Titanium Cervix Probe Sets in combination with the Universal Segmented Cylinder Applicator Set and the Universal Stump Applicator Set are intended for cancer treatment of the vaginal stump, cervix, uterus and endometrium using HDR or PDR brachytherapy.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
PREMARKET NOTIFICATION - 510(k) SUMMARY
Universal Cylinder Applicator Family
As required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems |
|---|---|
| 3100 Hansen Way, m/s E110 | |
| Palo Alto CA 94304 | |
| Contact Name: Peter J. Coronado | |
| Phone: 650/424.6320 | |
| Fax: 650/646.9200 | |
| Date: 30 August 2017 | |
| Proprietary Name: | Universal Cylinder Applicator Family |
| Classification Name: | Remote controlled radionuclide applicator system |
| 21 CFR892.5700 | |
| Class II | |
| Common/Usual Name: | Universal Segmented Cylinder Applicator Set |
| Universal Stump Applicator Set | |
| Universal Cervix Probe Sets | |
| Universal Titanium Cervix Probe Sets | |
| Predicate Devices: | K160516 - Universal Cylinder Applicator Family |
| Indications for Use: | The Universal Segmented Cylinder Applicator Set and Universal |
| Stump Applicator Set are indicated for use for cancer treatment of | |
| the vagina, vaginal stump and rectum using HDR or PDR | |
| brachytherapy. | |
| The Universal Cervix Probe Sets in combination with the Universal | |
| Segmented Cylinder Applicator Set and the Universal Stump | |
| Applicator Set are indicated for use for cancer treatment of the | |
| vagina, vaginal stump, cervix, uterus and endometrium using HDR | |
| or PDR brachytherapy. | |
| The Universal Titanium Cervix Probe Sets in combination with the | |
| Universal Segmented Cylinder Applicator Set and the Universal | |
| Stump Applicator Set are indicated for use for cancer treatment of | |
| the vagina, vaginal stump, cervix, uterus and endometrium using | |
| HDR or PDR brachytherapy. |
4
The applicator sets in this submission are designed to be used with the GammaMed Plus afterloader series, VariSource 200 and iX afterloaders to deliver high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy treatment for gynaecological and rectal applications. The intracavitary applicators will be used for the treatment of cancerous tumors, and are designed to be inserted into a body cavity.
Technological Characteristics:
| Feature
Comparison
Chart | Predicate Device:
Universal Cylinder Applicator Family
(K160516) | Subject Device:
Universal Cylinder Applicator Family |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sets within the
Universal
Cylinder
Applicator
Family (UCAF) | • Universal Segmented Cylinder
Applicator Set
• Universal Stump Applicator Set
• Universal Cervix Probe Sets | • Universal Segmented Cylinder
Applicator Set
• Universal Stump Applicator Set
• Universal Cervix Probe Sets
• Universal Titanium Cervix Probe
Sets |
| Compatible
Afterloader | All Sets:
GammaMed Plus series
VariSource 200 and iX | All Sets:
GammaMed Plus series
VariSource 200 and iX |
| Design | Universal Segmented Cylinder
Applicator Set:
Cylinder Segment Dimension:
diameters 20, 25, 30, 35, 40 mm;
length 30 mm
Front Segment: 1 front segment for
vaginal wall and vaginal stump
treatment
Front Segment Dimension: diameter
20, 25, 30, 35, 40 mm; length 50 –
60 mm
Guiding Tube & Applicator Probe:
straight rigid $ø$ 3.2 mm; length 200
and 250 mm
Universal Stump Applicator Set:
Cylinder Dimension:
diameters 20, 25, 30, 35 mm; length
140 mm
Applicator Probe Dimension:
$ø$ 3.2 mm; inner length 200 and 250
mm | Universal Segmented Cylinder
Applicator Set:
Cylinder Segment Dimension:
diameters 20, 25, 30, 35, 40 mm;
length 30 mm
Front Segment: 1 front segment for
vaginal wall and vaginal stump
treatment
Front Segment Dimension: diameter
20, 25, 30, 35, 40 mm; length 50 –
60 mm
Guiding Tube & Applicator Probe:
straight rigid $ø$ 3.2 mm; length 200
and 250 mm
Universal Stump Applicator Set:
Cylinder Dimension:
diameters 20, 25, 30, 35 mm; length
140 mm
Applicator Probe Dimension:
$ø$ 3.2 mm; inner length 200 and 250
mm |
| Feature
Comparison
Chart | Predicate Device:
Universal Cylinder Applicator Family
(K160516) | Subject Device:
Universal Cylinder Applicator Family |
| | Universal Cervix Probe Sets:
Diameter: 6.3 mm
Inner Length: 320 mm
Cervix Length:
30, 40, 50, 60, 70, 80 mm
Probe Tip Shapes: Straight or Curved
with 15°, 30° | Universal Cervix Probe Sets:
Diameter: 6.3 mm
Inner Length: 320 mm
Cervix Length:
30, 40, 50, 60, 70, 80 mm
Probe Tip Shapes: Straight or Curved
with 15°, 30° |
| | | Universal Titanium Cervix Probe
Sets:
Diameter: 3 mm
Inner Length: 320 mm
Cervix Length:
30, 40, 50, 60, 70, 80 mm
Probe Tip Shapes:
Curved with 15°, 30°, or 45° |
| Packing | All Sets: Individual | All Sets: Individual |
| Sterility | All Sets: Provided non-sterile | All Sets: Provided non-sterile |
| Sterilization
Method | All Sets: Steam sterilization
132 °C for 4 min
134 °C for 3 min
134 °C for 5 min | All Sets: Steam sterilization
132 °C for 4 min
134 °C for 3 min
134 °C for 5 min |
| Biocompatibility | All Sets: Full biocompatibility | All Sets: Full biocompatibility |
| Materials | Universal Segmented Cylinder
Applicator Set:
Cylinder: PPSU plastic white
Guiding Tube & Applicator Probe:
PEEK plastic natural, Titanium
Universal Stump Applicator Set:
Cylinder: PPSU plastic white
Applicator Probe: PEEK plastic
natural, Titanium
Universal Cervix Probe Sets:
PEEK plastic natural, FEP, Titanium | Universal Segmented Cylinder
Applicator Set:
Cylinder: PPSU plastic white
Guiding Tube & Applicator Probe:
PEEK plastic natural, Titanium
Universal Stump Applicator Set:
Cylinder: PPSU plastic white
Applicator Probe: PEEK plastic
natural, Titanium
Universal Cervix Probe Sets:
PEEK plastic natural, FEP, Titanium
Universal Titanium Cervix Applicator |
| Feature
Comparison
Chart | Predicate Device:
Universal Cylinder Applicator Family
(K160516) | Subject Device:
Universal Cylinder Applicator Family |
| | | Sets:
Titanium |
| | | |
| Anatomical Sites | Universal Segmented Cylinder
Applicator Set and Universal Stump
Applicator Set:
Vagina, vaginal stump and rectum | Universal Segmented Cylinder
Applicator Set and Universal Stump
Applicator Set:
Vagina, vaginal stump and rectum |
| | Universal Cervix Probe Sets:
Vagina, vaginal stump, cervix, uterus
and endometrium | Universal Cervix Probe Sets and
Universal Titanium Cervix Probe
Sets:
Vagina, vaginal stump, cervix, uterus
and endometrium |
| Compatibility w/
Environment &
Other Devices | All Sets:
CT compatible
Universal Segmented Cylinder
Applicator Set, Universal Stump
Applicator Set, and Universal Cervix
Probe Sets: MR conditional | All Sets:
CT compatible
Universal Segmented Cylinder
Applicator Set, Universal Stump
Applicator Set, and Universal Cervix
Probe Sets: MR conditional |
| | | Universal Titanium Cervix Probe
Sets:
MR Unsafe |
| Where Used | All Sets:
Brachytherapy treatment room | All Sets:
Brachytherapy treatment room |
5
6
7
| Non-Clinical Tests: | Bench Testing has been performed to demonstrate that... |
|---|---|
| the devices function correctly with the specified afterloaders the devices can withstand the number of cycles of use they will experience in its lifetime the devices enable the radioactive source to be located to the accuracy required the devices are constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product the devices may be sterilized effectively the devices can be used and sterilized for the specified cycle limits the positional accuracy of the source in the devices is adequate the devices are biocompatible as per ISO 10933 standards the devices can be used safely and effectively in CT environments | |
| Results of Bench Testing showed conformance to applicable requirements and specifications. | |
| Clinical Tests: | No clinical tests have been included in this pre-market submission. |
| Conclusions: | All the tests that were performed met the applied pass criteria. |
| Varian considers the devices to be safe and effective and to perform as well or better than the predicate. |