(246 days)
Not Found
No
The summary describes a mechanical applicator for a brachytherapy system and does not mention any AI or ML components or functionalities.
Yes
The device is described as providing "radiation brachytherapy" and applying "a radionuclide source of high activity at various internal or surface body locations for radiation brachytherapy," which is a form of medical treatment.
No
This device is described as a "Remote High Dose Rate Afterloader" used for radiation brachytherapy, which is a treatment modality, not a diagnostic one. Its purpose is to deliver radiation for therapeutic purposes, specifically mentioned to "provide radiation brachytherapy" and "apply...a radionuclide source...for radiation brachytherapy."
No
The device description explicitly states it is an "electromechanical device" and a "component of the VariSource system," which includes hardware like applicators and accessories.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to provide radiation brachytherapy." This is a therapeutic procedure performed on the patient's body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system for applying a radionuclide source at various internal or surface body locations for radiation brachytherapy. This confirms its therapeutic nature.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Wright Vaginal Cuff applicator which is the subject of this 510(k) is a component of the VariSource system.
Product codes
90 JAQ
Device Description
Applicators for the Varian VariSource Remote High Dose Rate Afterloader are a part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be utilized for treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vaginal Cuff
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Properly trained and licensed medical personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
OCT 2 | 1998
Attachment 3 Page 1 of 2
varian@ oncology systems
510(k) SUMMARY AS REQUIRED BY 21 CFR 807.92
-
- Submitter: Varian Oncology Systems 3045 Hanover Street Palo Alto, CA 94304
Linda S. Nash. Manager Contact: Regulatory Compliance & Radiation Safety Phone (650) 424-6990 FAX (650) 424-4830 linda.nash@os.varian.com
- Submitter: Varian Oncology Systems 3045 Hanover Street Palo Alto, CA 94304
Prepared: February 12, 1998 July 23, 1998 Revised:
- VariSource Wright Vaginal Cuff Applicator for Varian 2. Device Name: VariSource™ Remote High Dose Rate Afterloader.
-
- Predicate Device: Mick Radio-Nuclear Instruments, Inc., Wang Front Loading Applicator, K890485.
- Applicators for the Varian VariSource Remote High Dose Rate 4. Description: Afterloader are a part of a remote controlled radionuclide applicator system, including an electromechanical device to enable an operator to apply, by remote control, a radionuclide source of high activity at various internal or surface body locations for radiation brachytherapy. The shape and materials of the applicator determine where it will be utilized for treatment.
- The Varian VariSource Remote High Dose Rate 5. Intended Use: Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy The VariSource Wright Vaginal Cuff Applicator which is the subject of this 510(k) is a component of the VariSource system.
-
- Technological See attached comparison chart. Characteristics
Image /page/0/Picture/13 description: The image shows the logo for "Partners for Life". The word "Partners" is stacked on top of the word "For", which is stacked on top of the word "Life". The word "Life" is written in a cursive font.
1
Comparison to Predicate Device
| # | Feature | MRNI Wang Front
Loading Applicator,
K89045 | VariSource Wright
Vaginal Cuff Applicator
K980601 |
|---|-------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 1 | Afterloading Method | Manual | Remote HDR |
| 2 | Coupling Catheter
Fittings | No | Yes |
| 3 | Vaginal Cylinder | | |
| | Diameter and Length | 3.0 cm X 7.0cm | 3.4 cm X 12.0 cm |
| | Material | Polysulfone | Solid Water inside
Polysulfone Shell |
| 4 | Irradiation Tubes | 2 | 4 |
| | Material | Stainless steel | Stainless Steel |
| | Configuration | 1 central and 1 lateral
with source positioned
perpendicular to
central. | 4 central at 0, 90, 180,
and 270 degrees. Ends
come together to form
dome (eggbeater) shape. |
| | | | |
2
Image /page/2/Picture/16 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 1998
Linda Nash Regulatory Compliance and Radiation Safety Manager Varian Associates, Inc. 3045 Hanover Street Palo Alto. CA 94304
Re:
K980601 VariSource Wright Cuff Applicator for VariSource HDR Afterloader Dated: June 24, 1998 Received: August 4, 1998 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAQ
Dear Ms. Nash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 Part 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmadsmam.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
varian@
STATEMENT of INDICATIONS for USE*
I state in my capacity as Manager, Regulatory Compliance and Safety, of Varian Oncology Systems that the Product which is the subject of this premarket notification, is intended to be used for the following:
The Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Wright Vaginal Cuff applicator which is the subject of this 510(k) is a component of the VariSource system.
Charles Howell
Charles H. Will, Manager Regulatory Compliance & Safety
February 12, 1998
Date
*Suggested language and format to meet the requirements of section 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and 21 CFR sections 801.4 and 809.92(a)(5).
K98060/
510(k) Number
William Yin
Division Sign-off Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use