(49 days)
Not Found
No
The summary describes a physical medical device (applicator set and cervical stop) used in brachytherapy. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies focus on physical characteristics and functionality.
Yes
The device is intended for cancer treatment using brachytherapy, which is a medical therapy.
No
The device is used for cancer treatment (brachytherapy) by delivering radiation, not for diagnosing medical conditions.
No
The device description clearly indicates physical components (applicator set, cervical stop made of stainless steel) used for brachytherapy treatment, which are hardware.
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 involves delivering radiation directly to a tumor. This is a therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an applicator designed to be inserted into body cavities (vagina, rectum, uterus) to deliver radiation from an afterloader. This is a medical device used for treatment delivery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is clearly intended for therapeutic intervention.
N/A
Intended Use / Indications for Use
Device Name
GM11004380 - Shielded Applicator Set GM11000670 - Cervical Stop
Indications for Use (Describe)
The Shielded Applicator Set is intended for cancer treatment of the vaginal stump or rectum where partial shielding is required using HDR or PDR Brachytherapy.
The Cervical Stop is indicated for use with Varian metallic intrauterine tandems/probes to provide a physical stop for depth of insertion of these applicators within the uterus during HDR or PDR brachytherapy.
Intended Use Statement - Shielded Applicator Set
The Shielded Applicator Set is intended for cancer treatment of the vagina, vaginal stump or rectum where partial shielding is required using HDR or PDR Brachytherapy.
Intended Use Statement - Cervical Stop
The Cervical Stop is indicated for use with Varian metallic intrauterine tandems/probes to provide a physical stop for depth of insertion of these applicators within the uterus during HDR or PDR brachytherapy.
Indications for Use Statement – Shielded Applicator Set
The Shielded Applicator Set is intended for cancer treatment of the vagina, vaginal stump or rectum where partial shielding is required using HDR or PDR Brachytherapy.
Indications for Use Statement – Cervical Stop
The Cervical Stop is indicated for use with Varian metallic intrauterine tandems/probes to provide a physical stop for depth of insertion of these applicators within the uterus during HDR or PDR brachytherapy.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The applicator set in this submission is designed to be used with all Varian afterloaders to deliver high dose rate (HDR) and pulsed-dose-rate (PDR) brachytherapy treatment for gynecological and rectal applications. The intracavitary applicator will be used for the treatment of cancerous tumors, and are designed to be inserted into a body cavity.
The cervical stop is a stainless steel component that is placed on the applicator probe during HDR and PDR brachytherapy treatment of the uterus. It provides a physical stop for depth of insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The Shielded Applicator Set is used on female (vaginal and rectal) and male (rectal) patients.
Cervical Stop
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Shielded Applicator Set is intended to be used in a radiation therapy or radiation oncology department in a hospital environment.
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 applicator functions correctly with the specified afterloaders; .
- the devices can withstand the number of cycles of use that it will experience in its lifetime;
- the applicator enables 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 products;
- . the device components may be sterilized effectively (as appropriate)
- . the devices can be used and sterilized for the specified number of times
- the positional accuracy of the source within the applicator is adequate. ●
Usability was assessed to the requirements of IEC 62366:2007.
Results of Bench Testing showed conformance to applicable requirements and specifications
Clinical Tests No clinical tests have been included in this pre-market submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K151657
Trade/Device Name: Shielded Applicator Set-GM11004380. Cervical Stop-GM11000670 Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: June 17, 2015 Received: June 19, 2015
Dear Mr. Coronado:
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 (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 (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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting 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) K151657
Device Name
GM11004380 - Shielded Applicator Set GM11000670 - Cervical Stop
Indications for Use (Describe)
The Shielded Applicator Set is intended for cancer treatment of the vaginal stump or rectum where partial shielding is required using HDR or PDR Brachytherapy.
The Cervical Stop is indicated for use with Varian metallic intrauterine tandems/probes to provide a physical stop for depth of insertion of these applicators within the uterus during 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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3
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com
Premarket Notification [510(k)] Summary
GM11004380 Shielded Applicator Set GM11000670 Cervical Stop
The following information is provided following the format of 21 CFR 807.92(c).
| Submitter's Name: | Varian Medical Systems, Inc.
3100 Hansen Way E-110
Palo Alto, CA 94304 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | Contact Name: Peter J. Coronado
Phone: 650.424.6320
Fax: 650.646.9200 |
| | |
| | Date: 17 June 2015 |
| Proprietary Name: | Shielded Applicator Set - GM11004380
Cervical Stop- GM11000670 |
| Classification Name: | Remote controlled radionuclide applicator system
21 CFR 892.5700, Class II
Product Code: JAQ |
| | |
| Common/Usual Name: | Remote controlled radionuclide applicator system |
| | |
| Predicate Devices: | K033371 Intracavitary Brachytherapy Applicators
(Primary predicate: GM11004380 – Shielded Applicator Set
Secondary predicate: 1100404 – Cervix Applicator Set, Cervical Stopper) |
| Device Description: | The applicator set in this submission is designed to be used with all Varian
afterloaders to deliver high dose rate (HDR) and pulsed-dose-rate (PDR)
brachytherapy treatment for gynecological and rectal applications. The
intracavitary applicator will be used for the treatment of cancerous tumors, and
are designed to be inserted into a body cavity.
The cervical stop is a stainless steel component that is placed on the applicator
probe during HDR and PDR brachytherapy treatment of the uterus. It provides a
physical stop for depth of insertion. |
| Intended Use Statement -
Shielded Applicator Set | The Shielded Applicator Set is intended for cancer treatment of the vagina, vaginal
stump or rectum where partial shielding is required using HDR or PDR
Brachytherapy. |
| | |
| Intended Use Statement -
Cervical Stop | The Cervical Stop is indicated for use with Varian metallic intrauterine
tandems/probes to provide a physical stop for depth of insertion of these
applicators within the uterus during HDR or PDR brachytherapy. |
| | |
| | |
4
| Indications for Use
Statement –
Shielded Applicator Set | The Shielded Applicator Set is intended for cancer treatment of the vagina, vaginal
stump or rectum where partial shielding is required using HDR or PDR
Brachytherapy. |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
Statement
– Cervical Stop | The Cervical Stop is indicated for use with Varian metallic intrauterine
tandems/probes to provide a physical stop for depth of insertion of these
applicators within the uterus during HDR or PDR brachytherapy. |
5
Technological Characteristics:
| Shielded Applicator Set (K033371) | Modified Shielded Applicator Set | |
|---|---|---|
| Compatible | ||
| Afterloaders | VariSource Afterloader Systems | VariSource iX™ |
| VariSource 200™ | ||
| GammaMedplus iX™ | ||
| GammaMedplus™ | ||
| Intended use | Shielded applicator is developed to treat | |
| cancer of the vagina or rectum where | ||
| partial shielding is required. The max | ||
| implantation time for this applicator is 2 | ||
| days | The Shielded Applicator Set is intended for | |
| cancer treatment of the vagina, vaginal | ||
| stump or rectum where partial shielding is | ||
| required using HDR or PDR Brachytherapy. | ||
| Indications for Use | The applicator will be used with the | |
| VariSource High Dose Rate Afterloaders to | ||
| deliver brachytherapy treatment for | ||
| gynecological and rectal applications. The | ||
| applicator will be used in medical | ||
| intracavitary for treatment of cancerous | ||
| tumors. | The Shielded Applicator Set is intended for | |
| cancer treatment of the vagina, vaginal | ||
| stump or rectum where partial shielding is | ||
| required using HDR or PDR Brachytherapy. | ||
| Design | Cylinder: |
- Ø 20, 23, 26, 30, 35mm
- length 140mm
Applicator probe: - Ø 3.0mm, straight
- Length 320mm
Tungston Alloy Shielding: - 90°, 180°
- Length 122.5mm
Marking Screw (shielded)
0°, 90°, 2 x 90°, 180°, 270°
Clamping Nut for marking screw
Clamping screw for probe, 3mm
Plexiglass Filler Piece, 90°
Yellow Cleaning Cap | Cylinder: - Ø 20, 23, 26, 30, 35mm
- length 140mm
Applicator probe: - Ø 3.0mm, straight
- Length 320mm
Tungston Alloy Shielding: - 90°, 180°
- Length 122.5mm
Marking Screw (shielded)
0°, 90°, 2 x 90°, 180°, 270°
Clamping Nut for marking screw
Clamping screw for probe, 3mm
Plexiglass Filler Piece, 90°
Blue Cleaning Cap |
| Materials | - Shielding - Tungsten Alloy - Marking Screw, Clamping nut/Screw
and applicator probe - Stainless Steel - Cylinders - PMMA
- Cleaning cap- Silicone | - Shielding - Tungsten Alloy
- Marking Screw, Clamping nut/Screw and
applicator probe - Stainless Steel - Cylinders - PMMA
- Cleaning cap- Silicone |
| Guide Tubes | - Source guide tube with locking
mechanism for 320mm applicators
GM plus - VariSource Transfer Guide Tubes | - Source guide tube with locking
mechanism for 320mm applicators GM
plus (K141336)
ClickFit transfer guide tube, set of 4 for
i
VS 200 (K113766) |
| Optional accessories | - X-ray marker for 320mm applicators, 0.9mm, uncoded, GammaMedPlus - X-ray marker probe, for 320mm applicators, uncoded, GammaMed 12i(t)
- VariSource X-ray marker wire
- Leak stop button
- VariSource Ruler
- Flexible fixation device for gynecological applicators
- Universal applicator clamping device (third party product)
- Source guide tube support, GammaMed units only | - X-ray marker BV, up to 320 mm applicators, uncoded, GammaMedPlus
- Leak stop button
- Measurement Ruler
- Measurement Marker Wire VS Measurement
- Measurement Marker Clip
- Flexible fixation device for gynecological applicators
- Universal applicator clamping device (third party product)
- Source guide tube support, GammaMed units only
- Length gauge, GM plus
- Cervical Stop
- Allen Wrench |
| Packing | Individual | Individual |
| Sterility | Non sterile | Non sterile |
| Sterilization method | Steam sterilization (applicator probe, tungsten shielding and marking screws)
EO Sterilization for PMMA parts | Steam sterilization (applicator probe and marking screws)
No sterilization of PMMA parts (use sterile medical condom) |
| | Use of yellow Cleaning CAP (GM110003260) | Use of dark blue Cleaning CAP (GM11010770) |
| Biocompatibility | Fully biocompatible only when used in combination with a sterile medical condom. | Fully biocompatible only when used in combination with a sterile medical condom. |
| Anatomical sites | The Shielded Applicator Set is used on female (vaginal and rectal) and male (rectal) patients. | The Shielded Applicator Set is used on female (vaginal and rectal) and male (rectal) patients.
Cervical Stop |
| Compatibility with the environment and other devices | N/A | Cervical Stop |
| Where used | The Shielded Applicator Set is intended to be used in a radiation therapy or radiation oncology department in a hospital environment. | The Shielded Applicator Set is intended to be used in a radiation therapy or radiation oncology department in a hospital environment. |
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Cervical Stop – GM11000670
| | Cervical Stopper
(part of K033371 – Cervix Applicator Set) | Cervical Stop |
|------------------------|---------------------------------------------------------------|----------------------------------|
| Compatible Applicators | Cervix Applicator Set | All Varian metallic intrauterine |
7
| tandems/probes | ||
|---|---|---|
| Intended Use | The Cervical Stopper is indicated for use | |
| with the Cervix Applicator Set to provide a | ||
| physical stop for depth of insertion of | ||
| these applicators within the uterus during | ||
| HDR or PDR brachytherapy. | The Cervical Stop is indicated for use with | |
| Varian metallic intrauterine | ||
| tandems/probes to provide a physical | ||
| stop for depth of insertion of these | ||
| applicators within the uterus during HDR | ||
| or PDR brachytherapy. | ||
| Indications for Use | The Cervical Stopper is indicated for use | |
| with the Cervix Applicator to provide a | ||
| physical stop for depth of insertion of | ||
| these applicators within the uterus during | ||
| HDR or PDR brachytherapy. | The Cervical Stop is indicated for use with | |
| Varian metallic intrauterine | ||
| tandems/probes to provide a physical | ||
| stop for depth of insertion of these | ||
| applicators within the uterus during HDR | ||
| or PDR brachytherapy. | ||
| Material | PEEK/Titanium | PEEK/Titanium |
| Sterility | Non sterile | Non sterile |
| Reusable | Yes | Yes |
| Design | Ø 16mm flattened to 10mm | |
| Thickness 5.8mm | Ø 16mm flattened to 10mm | |
| Thickness 5.8mm |
Non Clinical Tests
Bench Testing has been performed to demonstrate that
- the applicator functions correctly with the specified afterloaders; .
- the devices can withstand the number of cycles of use that it will experience in its lifetime;
- the applicator enables 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 products;
- . the device components may be sterilized effectively (as appropriate)
- . the devices can be used and sterilized for the specified number of times
- the positional accuracy of the source within the applicator is adequate. ●
Usability was assessed to the requirements of IEC 62366:2007.
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 to be safe and effective and to perform as well or better than the predicate.