(247 days)
No
The summary describes a mechanical applicator for brachytherapy and does not mention any AI or ML components or functions.
Yes
The device is described as providing radiation brachytherapy, which is a medical treatment.
No
The device is described as a system for providing radiation brachytherapy, which is a treatment modality, not a diagnostic one. Its function is to apply a radionuclide source for treatment, not to diagnose a condition.
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 a "shape and materials," indicating it is a physical hardware component.
No, 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 is a treatment delivery system.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
This device is clearly a therapeutic medical device used for delivering radiation treatment.
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 Henschke Type GYN 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
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
Not Found
Key Metrics
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 2 1998
Attachment 2 Page 1 of 2
Image /page/0/Picture/2 description: The image shows the logo for Varian Oncology Systems. The word "varian" is in bold, black letters on the top line, with a circled "VA" symbol to the right. Below that, the words "oncology systems" are in a smaller, non-bold font.
510K SUMMARY AS REQUIRED BY 21 CFR 807.92
Kg80590
- Varian Oncology Systems 1. Submitter: 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
| Prepared: | February 12, 1998 |
|---|---|
| Revised: | July 23, 1998 |
- VariSource Henschke Type GYN Applicator for Varian 2. Device Name: VariSource™ Remote High Dose Rate Afterloader.
-
- Predicate Device: Mick Radio-Nuclear Instruments, Inc., Henschke Afterloading Applicator, K871217.
- 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 Henschke Type GYN Applicator which is the subject of this 510(k) is a component of the VariSource system.
- 6.Technological See attached comparison sheet. Characteristics
Image /page/0/Picture/13 description: The image shows a logo for "Partners for Life". The word "Partners" is stacked on top of the word "For", and the word "Life" is written in cursive to the right of the other two words. The logo is in black and white.
Varian Associates, Inc. 3045 Hanover Street Palo Alto, California 94304-1129 U.S.A. 415.493.4000 FAX: 415.424.4830
1
Comparison to Predicate Device
ﺰ
| # | Feature | MRNI Henschke
Afterloading Applicator
K871217 | VariSource Henschke
Type GYN Applicator
K980590 |
|---|-------------------------------|-----------------------------------------------------|-------------------------------------------------------|
| 1 | Afterloading Method | Manual | Remote HDR |
| 2 | Coupling Catheter
Fittings | No | Yes |
| 3 | Tandem | | |
| | Diameter and material | 6 mm, Stainless steel | 6/3 mm, Stainless Steel |
| | Configuration | Straight, Medium Curved,
& Maximum Curved | Straight, Medium Curved,
& Maximum Curved |
| | Cervical Stop | Yes | Yes |
| 4 | Colpostat | | |
| | Diameter and material | 6 mm, Stainless steel | 6/3 mm, Stainless Steel |
| | Configuration | 1 left, 1 right | 1 left, 1 right |
| 5 | Spacing/locking Bracket | Aluminum | Aluminum |
| 6 | Hemispherical Ovoids | | |
| | Diameter and material | 2 cm, Delrin | 2cm, Polysulfone |
| 7 | Ovoid Caps | | |
| | Diameter and material | 2.5 cm & 3.0 cm, Delrin | 2.5 cm & 3.0 cm,
Polysulfone |
| 8 | Ovoid Inserts | Tungsten shields and
Delrin fillers | Tungsten shields and
Polysulfone fillers |
2
Image /page/2/Picture/0 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 1998
Linda Nash Regulatory Compliance and Radiation Safety Manager Varian Associates, Inc. 3045 Hanover Street Palo Alto, CA 94304
Re:
VariSource Henschke Type GYN Applicator for VariSource HDR Afterloader Dated: July 24, 1998 Received: July 28, 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 (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 disgnostic 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 finternet address "http://www.fda.gov/cdrf/dsma/dsmamain.html".
Sincerely yours,
William Yi, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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 Henschke Type GYN applicator which is the subject of this 510(k) is a component of the VariSource system.
Charles Seibel
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).
Daniel h. Symm
Division Sign-off Office of Device Evaluation
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use