PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM

K120341 · Varian Medical Systems, Inc. · JAQ · Apr 27, 2012 · Radiology

Device Facts

• Record ID: K120341
• Device Name: PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Apr 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GM11006200 Titanium Fletcher-Style Applicator Sets are designed for intracavitary radiotherapy treatments in the uterus, cervix, endometrium and vagina. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories. The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment. The Fletcher Style Applicator Sets (defined geometry) are intended to treat cancer of the uterus, cervix, endometrium and vagina

Device Story

Titanium Fletcher-Style Applicator Set facilitates intracavitary radiotherapy; used in hospital environments by radiation oncologists, physicists, and technicians. Device consists of intrauterine probes and colpostats; compatible with Varian afterloaders (GammaMedplus, GammaMed 12i(t), VariSource). Input involves radioactive sources delivered via afterloader system; device guides source positioning within target anatomy (uterus, cervix, endometrium, vagina). Output is precise radiation delivery to tumor sites. Clinical benefit includes targeted cancer treatment with defined geometry. Device is CT compatible and MR Conditional (3 Tesla). Interstitial Plastic Needles also indicated for interstitial brachytherapy in head, neck, breast, and prostate. Healthcare providers use device to ensure accurate source placement; output directly informs radiation dose distribution planning. System includes optional rectal retractor.

Clinical Evidence

No clinical data. Bench testing only. Testing included biocompatibility (ISO 10993), sterilization validation, mechanical cycling/durability, radiation resistance of materials, positional accuracy, and usability (IEC 62366). MRI compatibility assessed for 3 Tesla environment.

Technological Characteristics

Materials: PEEK, Titanium, stainless steel, PPSU. Sensing/Actuation: Mechanical applicator for radionuclide source. Energy: Ionizing radiation (via afterloader). Form factor: Intrauterine probe (30-80mm) and colpostats (20-30mm spread). Connectivity: Compatible with Varian afterloaders. Sterilization: Steam (121°C/134°C). Standards: ISO 10993-1, IEC 62366.

Indications for Use

Indicated for interstitial brachytherapy treatments in head, neck, gynecological, breast, and prostate areas. Also indicated for intracavitary radiotherapy for cancer of the uterus, cervix, endometrium, and vagina.

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

• Henschke Type GYN Applicator Set (K980590)

Submission Summary (Full Text)

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KI20341

## PREMARKET NOTIFICATION

### 510(k) Summary

Titanium Fletcher-Style Applicator Set

As required by 21 CFR 807.92

Submitter's Name: (Paragraph (a) (1))

Varian Medical Systems 3100 Hansen Way, m/s E110 Palo Alto CA94304

Contact Name: Vy Tran Phone: [phone] Fax:[phone] Date: 07 October 2011

Proprietary Name: (Paragraph (a) (2))

Classification Name: (Paragraph (a) (2))

Common/Usual Name: (Paragraph (a) (2))

Predicate Devices: (Paragraph (a) (3))

Device Description: (Paragraph (a) (4))

Intended Use: (Paragraph (a) (5)) GM11006200 Titanium Fletcher-Style Applicator Set-Defined Geometry

Remote controlled radionuclide applicator system 21CFR892.5700 Class II

GM11006200 Titanium Fletcher-Style Applicator Set

K980590Henschke Type GYN Applicator Set

The GM11006200 Titanium Fletcher-Style Applicator Sets are designed for intracavitary radiotherapy treatments in the uterus, cervix, endometrium and vagina. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories.

The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.

The Fletcher Style Applicator Sets (defined geometry) are intended to treat cancer of the uterus, cervix, endometrium and vagina

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Technological Characteristics of the device compared with the predicate device: (Paragraph (a) (6))

| FEATURE AND/OR<br>SPECIFICATION OF<br>NEW/MODIFIED DEVICE | CLEARED DEVICE<br>FEATURE/SPECIFICATION | NEW DEVICE |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device<br>Clearance Number: | Henschke Type GYN Applicator<br>Set K980590 | N/A |
| Compatible Afterloader | VarlSource | GammaMedplus<br>GammaMed 12i(t)<br>VariSource |
| Intended use | The Varian VariSource Remote<br>High Dose Rate Afterloader<br>(system including applicators<br>and accessories) is a device<br>intended to be used by trained<br>and licensed medical personnel<br>to provide radiation<br>brachytherapy. The VariSource<br>Henschke Type GYN applicator<br>which is the subject of this<br>510(k) is a component of the<br>VariSource system. | The GammaMed Titanium<br>Fletcher-style Applicator Set<br>with defined geometry was<br>developed to treat cancer of the<br>uterus, cervix, endometrium<br>and vagina. |
| Indications for Use | The Henschke Type Applicator<br>is indicated for use in any case<br>where High Dose Rate (HDR)<br>radiation treatment of the<br>cervix and uterus Is accepted<br>clinical practice. | The GammaMed Titanium<br>Fletcher-style Applicator Set<br>with defined geometry was<br>developed to treat cancer of the<br>uterus, cervix, endometrium<br>and vagina. |
| Design | Rigid intra-uterine tandem and<br>a pair of interlocking colpostats<br>with Henschke type ovoids. The<br>hemispsherical ovoids are<br>segemented and will accept<br>either tungsten or plastic<br>inserts so that shielding is<br>optional. Distance between<br>ovoids is adjustable. Three<br>tandems are provided: one<br>straight and two with a<br>minimum and maximum<br>curvature of the distal end to<br>accommodate intrauterine tilt. | Intrauterine Probe with stopper<br>30 °, length: 40mm, 60mm,<br>80mm (optional 30mm, 50mm,<br>70mm<br>Colpostats: 20mm, 25mm,<br>30mm spread |
| Materials | Stainless Steel, Polysulphone,<br>Tungsten | PEEK Titanium, stainless steel,<br>PPSU. |
| Packing | individual | individual |
| Sterility | Provided Non sterile | Provided Non sterile |
| Sterilization method | EtO Gas sterilization or Steam<br>sterilization | Steam sterilization |
| Sterilization conditions | 30minutes ±2 minutes at<br>250°F±5°F (121°C±1°C). | 15minutes @121°C<br>5 minutes @134°C<br>18 minutes @134°C |
| Biocompatibility | Biocompatibility not<br>mentioned. | Full biocompatibility |
| Anatomical sites | uterus, cervix, | uterus, cervix, endometrium,<br>vagina |
| Compatibility with the<br>environment and other<br>devices | Not stated to be CT compatible<br>or MR Conditional for 3 Tesla | CT compatible<br>MR Conditional for 3 Tesla |
| Rectal Retractor | Rectal Retractor not included as<br>optional accessory | Rectal Retractor included as<br>optional accessory |

.

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#### Non Clinical Tests (Paragraph (b) (1))

Biocompatibility tests were selected by reference to ISO 10933-1:2009, Biologicol Evaluation of Medical Devices Part 1: Evoluation & Testing and 510(k) Memorandum - #G95-1 Initial Evaluation Tests for Consideration. The over- all results for the materials were as follows:

- 1.Released no leachable cytotoxic materials
2. Caused no reactions identified as sensitization

- 3. Showed no irritant/corrosive effect
4. Requirements of BS EN ISO 10993-1:2003 Biological evaluation of Medical Devices Part 1 and FDA#G95-1 have been met

Sterilization and Shelf Life tests have been undertaken on components that are representative of the Titanium Fletcher-style Applicator. The first group of tests was to verify that the proposed cleaning, disinfection and sterilization cycles were effective. The second was to verify the suitability of the design and material of the applicator components by inspecting for damage that might affect safety or effectiveness caused by the proposed number of cycles. In both types of test, components from other applicators that were representative of the components in the GM11006200 were used.

Other Bench Testing was performed to demonstrate that the device, functions correctly with both VariSource and GammaMedplus afterloaders; that the device can withstand the number of cycles of use that it will endure in its lifetime; that materials used are not significantly affected by the radiation they meet in the lifetime of the product; that the positional accuracy is adequate. The effects of Magnetic Resonance Imaging on the device when in patent contact were assessed. Usability was assessed to the requirements of IEC 62366:2007.

| Clinical Tests |
|---------------------|
| (Paragraph (b) (2)) |

Conclusions (Paragraph (b) (2)) No Clinical Tests have been included in this pre-market submission

All the tests that were performed met the applied pass criteria. Varian considers the device to be safe and effective and to perform as well or better than the predicate.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle. The eagle is depicted with three lines forming its body and wings, giving it a modern and abstract appearance. The logo is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Vy Tran Vice President, Regulatory Affairs and Quality Systems Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304

APR 2 7 2012

Re: K120341

Trade/Device Name: Interstitial Plastic Needles Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: January 20, 2012 Received: February 3, 2012

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

510(k) Number (if known): K12034

### Device Name: Interstitial Plastic Needles

#### Indications for Use:

The Interstitial Plastic Needles are designed for interstitial brachytherapy treatments in areas such as the head and neck, gynecological, breast and prostate.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

´ AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Marlon D. Odom

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and 510(k)

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