(89 days)
Not Found
No
The summary describes a physical medical device (applicator set) for brachytherapy and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as being developed for brachytherapy treatment of cancer, and designed for intracavitary radiotherapy treatments, which are therapeutic medical procedures.
No
The device is described as an applicator set for brachytherapy treatment, which is a form of therapy, not diagnosis. Its function is to deliver radiation, not to identify or characterize a disease.
No
The device description clearly states it is a "Titanium Fletcher-Style Applicator Set," which are physical medical devices used in brachytherapy. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a "Titanium Fletcher-style Applicator Set" used for "brachytherapy treatment of cancer." Brachytherapy is a type of radiation therapy where a radioactive source is placed inside or next to the area requiring treatment.
- Intended Use: The intended use is for delivering radiation treatment directly to the affected anatomical sites (uterus, cervix, endometrium, vagina). This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is a therapeutic medical device used in the treatment of cancer, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for 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 with defined geometry was developed for brachytherapy treatment of cancer of the uterus, cervix, endometrium and vagina.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The GM11006200 Titanium Fletcher-Style Applicator Sets are designed for intracavitary radiotherapy treatments in the uterus, cervix, endometrium and vagina. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus, cervix, endometrium, vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers 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)
Not Found
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
PREMARKET NOTIFICATION
510(k) Summary
Titanium Fletcher-Style Applicator Set
As required by 21 CFR 807.92
Submitter's Name:
Varian Medical Systems 3100 Hansen Way, m/s E110 Palo Alto CA94304
Contact Name: Vy Tran Phone: 650/424.5731 Fax:650/842.5040 Date: 07 October 2011
Proprietary Name:
Classification Name:
Common/Usual Name:
Predicate Devices:
Device Description:
Indications for Use:
GM11006200 Titanium Fletcher-Style Applicator Set-Defined Geometry
Remote controlled radionuclide applicator system 21CFR892.5700 Class H
GM11006200 Titanium Fletcher-Style Applicator Set
K980590Henschke Type GYN Applicator Set
The GM11006200 Titanium Fletcher-Style Applicator Sets are designed for intracavitary radiotherapy treatments in the uterus, cervix, endometrium and vagina. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories.
The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
The Fletcher Style Applicator Sets (defined geometry) are intended to treat cancer of the uterus, cervix, endometrium and vagina.
Technological Characteristics:
| FEATURE AND/OR | CLEARED DEVICE | NEW DEVICE |
|---|---|---|
| SPECIFICATION OF | FEATURE/SPECIFICATION | |
| NEW/MODIFIED DEVICE | ||
| Predicate Device | ||
| Clearance Number: | Henschke Type GYN Applicator | |
| Set K980590 | N/A | |
| Compatible Afterloader | VariSource | GammaMed plus |
| GammaMed 12i(t) | ||
| VariSource | ||
| Intended use | The Varian VariSource Remote | |
| High Dose Rate Afterloader | ||
| (system including applicators | ||
| and accessories) is a device | ||
| intended to be used by trained | ||
| and licensed medical personnel | ||
| to provide radiation | ||
| brachytherapy. The VariSource | ||
| Henschke Type GYN applicator | ||
| which is the subject of this | ||
| 510(k) is a component of the | ||
| VariSource system. | The GammaMed Titanium | |
| Fletcher-style Applicator Set | ||
| with defined geometry was | ||
| developed to treat cancer of the | ||
| uterus, cervix, endometrium | ||
| and vagina. | ||
| Indications for Use | The Henschke Type Applicator | |
| is indicated for use in any case | ||
| where High Dose Rate (HDR) | ||
| radiation treatment of the | ||
| cervix and uterus is accepted | ||
| clinical practice. | The GammaMed Titanium | |
| Fletcher-style Applicator Set | ||
| with defined geometry was | ||
| developed to treat cancer of the | ||
| uterus, cervix, endometrium | ||
| and vagina. | ||
| Design | Rigid intra-uterine tandem and | |
| a pair of interlocking colpostats | ||
| with Henschke type ovoids. The | ||
| hemispsherical ovoids are | ||
| segemented and will accept | ||
| either tungsten or plastic | ||
| inserts so that shielding is | ||
| optional. Distance between | ||
| ovoids is adjustable. Three | ||
| tandems are provided: one | ||
| straight and two with a | ||
| minimum and maximum | ||
| curvature of the distal end to | ||
| accommodate intrauterine tilt. | Intrauterine Probe with stopper | |
| 30 °, length: 40mm, 60mm, | ||
| 80mm (optional 30mm, 50mm, | ||
| 70mm | ||
| Colpostats: 20mm, 25mm, | ||
| 30mm spread | ||
| Materials | Stainless Steel, Polysulphone, | |
| Tungsten | PEEK Titanium, stainless steel, | |
| PPSU. | ||
| Packing | individual | individual |
| Sterility | Provided Non sterile | Provided Non sterile |
| Sterilization method | EtO Gas sterilization or Steam | |
| sterilization | Steam sterilization | |
| Sterilization conditions | 30minutes ±2 minutes at | |
| 250°F±5°F (121°C±1°C). | 15minutes @121°C | |
| 5 minutes @134°C | ||
| 18 minutes @134°C | ||
| Biocompatibility | Biocompatibility not | |
| mentioned. | Full biocompatibility | |
| Anatomical sites | uterus, cervix, | uterus, cervix, endometrium, |
| vagina | ||
| Compatibility with the | ||
| environment and other | ||
| devices | Not stated to be CT compatible | |
| or MR Conditional for 3 Tesla | CT compatible | |
| MR Conditional for 3 Tesla | ||
| Rectal Retractor | Rectal Retractor not included as | |
| optional accessory | Rectal Retractor included as | |
| optional accessory |
JUN - 6 2012
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2
and the control control control control controlled in the consideration of the consistential
- Sales of the same of the same
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem. The emblem is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
- 6 2012
Ms. Vy Tran Vice President, Regulatory Affairs and Quality Systems Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304
Re: K120731
Trade/Device Name: Titanium Fletcher-style Applicator Set-Defined Geometry Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: March 7, 2012 Received: March 9, 2012
Dear Ms. Tran:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known):
Device Name: Titanium Fletcher-style Applicator Set-Defined Geometry
Indications for Use:
The Titanium Fletcher-style Applicator Set with defined geometry was developed for brachytherapy treatment of cancer of the uterus, cervix, endometrium and vagina.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safe 510(k)
Page 1 of _ 1