(169 days)
Varian's Nasopharynx Applicator is a device used to facilitate the delivery of a therapeutic dose of radiation therapy to treat cancer in the upper throat, nasal cavity and nasopharengeal regions.
The Nasopharynx Applicator Set has been designed for the treatment in the upper throat space. The design of the ENT mould probe permits an application in the nasopharyngeal to oropharyngeal area (ENT = Ear Nose Throat). The set contains two different ENT mould probes, one with and one without balloon.
The provided text is a 510(k) Premarket Notification summary for the Nasopharynx Applicator. This document is a regulatory submission to the FDA demonstrating that a device is substantially equivalent to a legally marketed predicate device.
It does not contain any information about acceptance criteria, device performance, a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The 510(k) summary focuses on:
- Predicate Device: Nucletron's Rotterdam Nasopharynx Mould Set (K983337).
- Product Description: A set of two ENT mould probes (one with and one without a balloon) for treatment in the upper throat space.
- Intended Use: For use with Varian high-dose rate afterloaders for intracavitary nasopharynx brachytherapy to deliver a prescribed radiation dose.
- Technological Characteristics: Stated to be "substantially equivalent" to the predicate device.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study that proves the device meets those criteria, as such details are not present in the provided text. The 510(k) process primarily relies on demonstrating substantial equivalence to an already approved device rather than presenting detailed performance studies against specific acceptance criteria for a new device.
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Premarket Notification [510K] Summary
1042360
| Submitter's Name: | Varian Medical Systems |
|---|---|
| 3100 Hansen Way M/S E-110 | |
| Palo Alto, CA 94304 | |
| Contact Name: | Vy Tran |
| Phone: | (650) 424-5731 |
| Fax: | (650) 842-5040 |
| Email: | vy.tran@varian.com |
| Date: | August 25, 2004 |
Proprietary Name: Nasopharynx Applicator
Classification Name: Accessory to remote afterloader, 21 CFR 892.5700, Class II Common/Usual Name: Nasopharynx Applicator
Predicate Device: Nucletron's Rotterdam Nasopharynx Mould Set, K983337
Product Description: The Nasopharynx Applicator Set has been designed for the treatment in the upper throat space. The design of the ENT mould probe permits an application in the nasopharyngeal to oropharyngeal area (ENT = Ear Nose Throat). The set contains two different ENT mould probes, one with and one without balloon.
Statement of Intended Use: Varian's Nasopharynx Applicator set is designed for use with Varian high dose rate afterloaders: VariSource, GM Plus, GM 3/24, and MammoSource for intracavitary nasopharynx brachytherapy. The applicator provides a means of delivering a prescribed radiation dose to the intended treatment area.
Technological Characteristics: The Nasopharynx Applicator is substantially equivalent to Nucletron's Rotterdam Nasopharynx Mould Set. Refer to the "Substantial Equivalence Comparison Chart", Tab F.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with text around the perimeter. Inside the circle is an abstract image of an eagle.
FEB 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K042360 Trade/Device Name: Nasopharynx Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: January 28, 2005 Received: February 2, 2005
Dear Ms. Tran:
We have reviewed your Scction 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 street 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 tave 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 provisions of the Albert 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 affer inning 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.
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 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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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 prumber at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ KOY ZZ GO
Device Name: Nasopharynx Applicator
Indications For Use:
Varian's Nasopharynx Applicator is a device used to facilitate the delivery of a therapeutic dose of radiation therapy to treat cancer in the upper throat, nasal cavity and nasopharengeal regions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Nancy Brogdon
(Division Sign-Off) / Division of Reproductive, Abe fominal, and Radiological Devices 510(k) Number
§ 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.