(258 days)
Not Found
No
The summary describes a mechanical applicator for brachytherapy and does not mention any AI/ML terms or functionalities.
Yes
The device is described as "a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy," which is a medical treatment.
No
Explanation: The device is described as a "Remote High Dose Rate Afterloader" used to "provide radiation brachytherapy" and apply a "radionuclide source for radiation brachytherapy." This indicates a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a component of a "remote controlled radionuclide applicator system, including an electromechanical device" and describes the applicator itself as having "shape and materials," indicating it is a physical hardware component.
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, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system for applying a radionuclide source for radiation therapy. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed 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 Endometrial applicator which is the subject of this 510(k) is a component of the VariSource system.
Product codes (comma separated list FDA assigned to the subject device)
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
Not Found
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): 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
Attachment 3 Page 1 of 2
NOV 2 1998
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: Requlatory 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
February 12, 1998 Prepared: Revised: July 24, 1998
- VariSource Endometrial Applicator for Varian VariSource™ 2. Device Name: Remote High Dose Rate Afterloader.
-
- Predicate Device: Mick Radio-Nuclear Instruments, Inc., Hilaris-Nori Endometrial Applicator, K871216.
- 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.
-
- Intended 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 Endometrial Applicator which is the subject of this 510(k) is a component of the VariSource system.
-
- Technological See attached comparison chart. Characteristics
1
Comparison to Predicate Device
| # | Feature | MRNI Hilaris-Nori Endometrial
Applicator, K871216 | VariSource Endometrial
Applicator
K980576 |
|---|-------------------------------|----------------------------------------------------------------|--------------------------------------------------|
| 1 | Afterloading Method | Manual | Remote HDR |
| 2 | Coupling Catheter
Fittings | No | Yes |
| 3 | Vaginal Cylinder | Yes | Yes |
| | Diameter and Length | 2.5 cm X 6, 7, 8, 10, & 12 cm
3.0 cm X 6, 7, 8, 10, & 12 cm | 3.1 cm X 10.2 cm |
| | Material | Delrin | Polysulfone |
| 4 | Irradiation Tubes | 3: 1 straight, 2curved | 3: 1 straight, 2curved |
| | Material | Stainless steel | Stainless Steel |
| | Diameter and Length | 6 mm X 24 cm | Straight: 3 mm X 38.1 cm
Curved: 3 mm X 36 cm |
| | Fixation | Snap Lock | Pivot Assembly Lock |
ਿਵ
2
Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles, stacked on top of each other. The profiles are facing to the right and are connected by a flowing line.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1998
Linda Nash Regulatory Compliance and Radiation Safety Manager Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304
Re:
VariSource Endometrial Appliator for VariSource HDR Afterloader Dated: August 13, 1998 Received: August 14, 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 (OS) 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 801 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/cdr/dsmaldsmamain.html".
Sincerely yours,
Kilian Yi
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 Endometrial applicator which is the subject of this 510(k) is a component of the VariSource system.
Charles Seuil
Charles H. Will, Manager Requlatory Compliance & Safety
February 12, 1998 Date
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 800.92(a)(5).
K980576
510(k) Number
510(k) Number
Elvin A. Segner
Division Sign-off Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use _