(28 days)
Not Found
No
The summary describes a mechanical device for delivering radiation and does not mention any AI/ML components or capabilities.
Yes
The device is explicitly described as being used "for the treatment of cancer," indicating a therapeutic purpose.
No
The device is described as a "transportable high-dose-rate remotely controlled afterloading brachytherapy device" used "for the treatment of cancer." This indicates a therapeutic, not diagnostic, purpose.
No
The device description clearly states it uses a radioactive source, wire/cable, and coupling catheters/tubes, indicating significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation." This describes a therapeutic device that delivers radiation directly to the patient's body.
- Device Description: The description details a system that uses a radioactive source and delivery mechanisms to treat cancer within the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a therapeutic device used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The intended use of the Varian transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.
Product codes
JAQ
Device Description
Varian's High Dose Rate BrachyTherapy Afterloaders use a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites.
The radioactive source is enclosed within a wire/cable which is driven via coupling catheters /Transfer Guide Tubes / Source Guide Tubes from the Applicator in to the patient.
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
Not Found
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 1 0 2008
510(k) Summary
The information below is provided for the Modifications to the Centering Intraluminal Applicators, following the format of 21 CFR 807.92 ..
Submitter:
Varian Medical Systems 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Ms. Vy Tran Phone: (650) 424-5731 Fax: (650) 842-5040 Email: vy.tran@varian.com Date summary was prepared: September 11, 2008
Name of the Device:
Trade/Proprietary Name: Common or Usual Name: Classification Name:
Centering Intraluminal Applicator Centering Intraluminal Applicator Centering Intraluminal Applicator System, Applicator, Radionuclide, Remote - Controlled 21 CFR 892.5700 Class II Product Code: JAQ
Predicate Device to claim substantial equivalence:
K983436 - GammaMed Plus High Does Rate Remote Afterloading System
Description of the Device:
Varian's High Dose Rate BrachyTherapy Afterloaders use a single radioactive source of Iridium-192 to treat cancer in a wide range of body sites.
The radioactive source is enclosed within a wire/cable which is driven via coupling catheters /Transfer Guide Tubes / Source Guide Tubes from the Applicator in to the patient.
Intended Use Statement:
The intended use of the Varian transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.
Summary of the Technological Characteristics:
The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate device. The chart is located in Tab 7 of this submission.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract representation of a human form or a caduceus, rendered in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2008
Ms. Vy Tran Senior Director, Corporate Regulatory Affairs Varian Medical Systems, Incorporated 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K082653
Trade/Device Name: Centering Intraluminal Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: September 11, 2008 Received: September 12, 2008
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 either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 | |
|---|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 | |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
logu M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PAGE 1 of 1
510(k) Number (if known): K082653
Device Name: Centering Intraluminal Applicator
Indications For Use:
The indications for use of the Varian transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Optional Format 3-10-98)
Armi'th Khan
(Division Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number