VARIAN NASOPHARYNX APPLICATOR

K042360 · Varian Medical Systems, Inc. · JAQ · Feb 16, 2005 · Radiology

Device Facts

• Record ID: K042360
• Device Name: VARIAN NASOPHARYNX APPLICATOR
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Feb 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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.

Device Story

Nasopharynx Applicator is an accessory for high dose rate (HDR) afterloaders (VariSource, GM Plus, GM 3/24, MammoSource). Device consists of ENT mould probes, including versions with and without balloons, designed for intracavitary nasopharynx brachytherapy. Used in clinical settings by radiation oncology staff to facilitate precise delivery of prescribed radiation doses to tumors in the upper throat, nasal cavity, and nasopharyngeal regions. Applicator acts as a physical conduit for the radioactive source; ensures correct positioning within the treatment area. Benefits include targeted radiation delivery to cancerous tissue while maintaining applicator stability during the procedure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparison to the predicate device.

Technological Characteristics

Accessory to remote afterloader; consists of ENT mould probes (with/without balloon). Designed for use with Varian HDR afterloaders. Mechanical device for radiation source positioning.

Indications for Use

Indicated for the delivery of therapeutic radiation therapy to treat cancer in the upper throat, nasal cavity, and nasopharyngeal regions.

Regulatory Classification

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.

Predicate Devices

• Nucletron's Rotterdam Nasopharynx Mould Set (K983337)

Submission Summary (Full Text)

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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: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| 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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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 [phone] or [phone] 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.

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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