INTERSTITIAL NEEDLES

K073133 · Varian Medical Systems, Inc. · JAQ · Nov 16, 2007 · Radiology

Device Facts

• Record ID: K073133
• Device Name: INTERSTITIAL NEEDLES
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Nov 16, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Varian Remote High Dose Rate Afterloader system, including the applicators and accessories included in this notification, is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose. Remote operation of the Afterloader eliminates the necessity of hand placement of radioactive sources on or within the body of a patient. The radioactive source is Iridium-192, encapsulated in the end of a wire stored in the Afterloader and mechanically driven from it to a precisely described position for a specified dwell time during treatments the wire is retracted into the Afterloader so that the source end resides in a tungsten-shielded safe to limit personnel exposures to an acceptable, safe level. The Afterloader contains a radiation detector which signals whenever the source is not in the safe.

Device Story

Family of closed-ended interstitial needles and associated obturators; used with high dose rate (HDR) brachytherapy afterloading devices. Needles (17G or 18G; 113mm-320mm lengths) and obturators (113mm-320mm lengths) facilitate implantation of radioactive sources. Obturators provide structural stiffness during implantation and between radiation fractions. Needles and obturators are provided unsterile; require steam sterilization. Needles qualified for 25 uses; obturators for 100 uses. Used by trained medical personnel in clinical settings. Device enables remote delivery of Iridium-192 source to target tissue, reducing clinician radiation exposure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stainless steel interstitial needles and aluminum obturators. Available in 17G and 18G outer diameters; lengths 113mm, 200mm, 250mm, 320mm. Steam sterilization required. Mechanical device; no energy source or software.

Indications for Use

Indicated for use with Varian High Dose Rate Afterloaders for patients requiring radiation brachytherapy.

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

• Applicators for Varian VariSource Remote High Dose Rate Afterloader (K952913)

Submission Summary (Full Text)

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KC73233

#### 510(k) Summary

The following information is provided following the format of 21 CFR 807.92 for the Interstitial Needles.

> Varian Medical Systems 3100 Hansen Wav M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Ms. Vy Tran [phone] Phone: Fax: [phone] Email: [e-mail] Date summary was prepared: October 31st, 2007

NOV 1 6 2007

#### Name of the Device:

Submitter:

Trade/Proprietary Name: Common or Usual Name: Classification Name:

Varian Interstitial Needles Varian Interstitial Needles Varian Interstitial Needles System, Applicator, Radionuclide, Remote - Controlled 21 CFR 892.5700 Class II Product Code: JAQ

#### Predicate Devices to claim substantial equivalence:

K952913 - Applicators for Varian VariSource Remote High Dose Rate Afterloader

AL13103000 18 Gauge Stainless Steel Needle, 100mm AL13103001 18 Gauge Stainless Steel Needle, 150mm AL13103002 18 Gauge Stainless Steel Needle, 200mm AL13104000 20 Gauge Stainless Steel Needle, 100mm AL13104001 20 Gauge Stainless Steel Needle, 150mm AL13104002 20 Gauge Stainless Steel Needle, 200mm AL13105000 21 Gauge Stainless Steel Needle, 100mm AL13105001 21 Gauge Stainless Steel Needle, 150mm AL13105002 21 Gauge Stainless Steel Needle, 200mm AL13107000 Needle Cap Aluminum AL13108000 Obturator Cap Aluminum

#### Description of the Device:

The device is a family of closed-ended, interstitial needles and associated obturators to be used in conjunction with a high dose rate (HDR) brachytherapy afterloading device. The needles are available in either 17 gauge O.D. or 18 gauge O.D. and in lengths of 113mm, 200mm, 250mm, and 320mm. The associated obturators are inserted into needles to stiffen the needles during implantation of the needles into the patient and to stiffen the needles between radiation therapy fractions. The obturators are available in lengths of 113mm, 200mm, 250mm, and 320mm. The needles are provided unsterile with instructions for steam sterilization and have been qualified for 25 uses. The obturators are provided unsterile with instructions for steam sterilization and have been qualified for 100 uses.

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#### Intended Use Statement:

The Varian Remote High Dose Rate Afterloader system, including the applicators and accessories included in this notification, is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose. Remote operation of the Afterloader eliminates the necessity of hand placement of radioactive sources on or within the body of a patient. The radioactive source is Iridium-192, encapsulated in the end of a wire stored in the Afterloader and mechanically driven from it to a precisely described position for a specified dwell time during treatments the wire is retracted into the Afterloader so that the source end resides in a tungsten-shielded safe to limit personnel exposures to an acceptable, safe level. The Afterloader contains a radiation detector which signals whenever the source is not in the safe.

#### Indications for Use Statement:

The Interstitial Needles are used with Varian High Dose Rate Afterloaders.

#### 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 the submission.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three abstract human figures, represented by flowing lines, next to each other.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### NOV 1 6 2007

Ms. Vy Tran Senior Director, Corporate Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304

Re: K073133

Trade/Device Name: Interstitial Needles Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: November 5, 2007 Received: November 7, 2007

#### 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a backed complies with other requirements of the Act that FDA has made a determination administered by other Federal agencies. You must of ally rederal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, moreans, and manufacturing practice requirements as set CrK Fart 807), labeling (21 CFRT art 807), good if applicable, the electronic form in the quality systems (QB) rogalSans (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) This letter will anow you to begin maing of substantial equivalence of your device to a legally prematics notification: "The PDS 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 If you desire specific advisories for your as now in the s (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number 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" Also, prease note the regarding postmarket surveillance, please contact CDRH3 (21GTN Fart 807.97). Tor questions rogans 1 3474. For questions regarding of device adverse events (Medical Device Reporting 5474. For questions regarding me reporting eillance Systems at 240-276-3464. You may obtain (IDN)), prease contact the Drimon on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Mandracturers, international and Octrosa http://www.fda.gov/cdrh/industry/support/index.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

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# Indications for Use

510(k) Number (if known): __KO7 31 33

Device Name: Interstitial Needles

Indications for Use:

The Interstitial Needles are used with Varian High Dose Rate Afterloaders.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Tornin M Wh
(Division Sign-Off)

Division of Reproductive, Abdominal and Radiological Devices 510(k) Number