PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113

K141624 · Varian Medical Systems, Inc. · JAQ · Mar 10, 2015 · Radiology

Device Facts

• Record ID: K141624
• Device Name: PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Mar 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The interstitial plastic needles with 2mm diameter are designed for interstitial treatment in areas such as the head and neck, gynaecological, breast and prostate.

Device Story

Interstitial plastic needles (2mm diameter) used for brachytherapy; designed for insertion into target tissue (head/neck, gynecological, breast, prostate) to guide radioactive sources from Varian afterloaders. Operated by radiation oncologists, physicians, radiologists, dosimetrists, medical physicists, and nurses/technicians in hospital brachytherapy suites. Device acts as a conduit for radioactive source delivery; ensures accurate source positioning within the tumor volume. Benefits include precise radiation delivery to localized disease sites. Compatible with CT and MR (1.5T/3T) imaging for treatment planning.

Clinical Evidence

No clinical data. Bench testing only. Testing verified device functionality with afterloaders, cycle durability, source positioning accuracy, radiation resistance of materials, and sterilization efficacy. Usability assessed per IEC 62366:2007.

Technological Characteristics

Needles: PEEK/Titanium; Obturator/Mandrin: Stainless Steel. 2mm diameter; lengths 113, 200, 320mm. Sharp and blunt tip options. Steam sterilizable (up to 25 cycles). CT compatible; MR conditional (1.5T and 3T).

Indications for Use

Indicated for interstitial brachytherapy treatment in patients requiring radiation therapy to the head and neck, gynecological, breast, or prostate 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

• Plastic Needle with Mandrin 2.0 Diameter Length 113mm (K120341)

Submission Summary (Full Text)

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

March 10, 2015

Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Wav PALO ALTO CA 94304

Re: K141624

Trade/Device Name: Interstitial Plastic Needles Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: January 7, 2015 Received: January 23, 2015

Dear Mr. Coronado:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K141624

Device Name Interstitial Plastic Needles

Indications for Use (Describe)

The interstitial plastic needles with 2mm diameter are designed for interstitial treatment in areas such as the head and neck, gynaecological, breast and prostate.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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### PREMARKET NOTIFICATION

# 510(k) Summary

### Plastic Interstitial Needles

# As required by 21 CFR 807.92

| Submitter's Name: | Varian Medical Systems<br>3100 Hansen Way, m/s E-110<br>Palo Alto CA94304<br>Contact Name: Peter J. Coronado<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 30th May 2014 |
| Proprietary Name: | Plastic Needles with Mandrin, 2.0 mm diameter, |
| Classification Name: | Remote controlled radionuclide applicator system<br>21CFR892.5700<br>Class II |
| Common/Usual Name: | Plastic Needle, Interstitial Needle, Brachytherapy Needle,<br>Interstitial plastic needle with 2mm diameter. |
| Predicate Devices: | K120341 Plastic Needle with Mandrin 2.0 Diameter Length 113mm |
| Device Description: | The Plastic Interstitial Needles with mandrin, ø 2.0 mm diameter,<br>are designed for interstitial radiotherapy treatments. They are<br>compatible with Varian afterloaders and can be used in<br>combination with the appropriate accessories. |
| | They are intended to be used by trained and qualified personnel<br>such as Radiation Oncologists, Physicians, Radiologists,<br>Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology<br>Technicians/Radiographers in a hospital environment. |
| Indications for Use: | The interstitial plastic needles with 2mm diameter are designed<br>for interstitial treatment in areas such as the head and neck,<br>gynaecological, breast and prostate. |

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#### Technological Characteristics:

| | GM11007560, 7570, 7580<br>Interstitial plastic needles | GM11007560, 7570, 7580<br>Interstitial plastic needles and<br>GM11010750<br>Plastic needle with mandrin, 2.0<br>mm diameter, 320 mm length,<br>blunt tip |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device<br>Clearance Number: | K120341 | N/A |
| Compatible Afterloader | GammaMed plus<br>GammaMed 12(i)<br>VariSource | GammaMed plus<br>VariSource<br>GammaMed 12(i) (Not with blunt |
| Intended use | The interstitial plastic needles with<br>2mm diameter are designed for<br>interstitial brachytherapy<br>treatment in areas such as the<br>head and neck, gynecological,<br>breast and prostate. | tip needle).<br>The interstitial plastic needles with<br>2mm diameter are designed for<br>interstitial brachytherapy<br>treatment in areas such as the head<br>and neck, gynecological, breast and<br>prostate. |
| Indications for Use | The interstitial plastic needles with<br>2mm diameter are designed for<br>interstitial brachytherapy<br>treatment in areas such as the<br>head and neck, gynecological,<br>breast and prostate. | The interstitial plastic needles with<br>2mm diameter are designed for<br>interstitial brachytherapy<br>treatment in areas such as the head<br>and neck, gynecological, breast and<br>prostate. |
| Design | Plastic needle:<br>● Diameter: 2 mm<br>● Length: 113, 200, 320mm<br>● Tip style: Sharp tip | Plastic needle:<br>● Diameter: 2 mm<br>● Length: 113, 200, 320mm<br>● Tip styles:<br>Sharp tip<br>Blunt tip (320mm length only) |
| Materials | Needles: PEEK/Titanium<br>Obturator/Mandrin: Stainless Steel | Needles: PEEK/Titanium<br>Obturator/Mandrin: Stainless Steel, |
| Packing | individual | individual |
| Sterility | Provided non sterile | Provided non sterile |
| Sterilization method | Steam sterilization up to 25 times<br>(15 cycles when using 18 minutes<br>at 134°C) | Steam sterilization up to 25 times<br>(15 cycles when using 18 minutes<br>at 134°C) |
| Biocompatibility | Full biocompatibility | Full biocompatibility |
| Anatomical sites | Head and neck, gynecological,<br>breast and prostate | Head and neck, gynecological,<br>breast and prostate |
| Compatibility with the<br>environment and other<br>devices | CT compatible, MR conditional 1.5<br>and 3 T | CT compatible, MR conditional 1.5<br>and 3 T |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |

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Non Clinical Tests Bench Testing has been performed to demonstrate that

- the device functions correctly with the specified afterloaders;
- the device can withstand the number of cycles of use that it will experience in its lifetime;
- . the device enables the radioactive source to be located to the accuracy required,
- . the device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- . the device may be sterilized effectively
- the device can be used and sterilized for the specified number of times
- the positional accuracy of the source within the applicator is adequate.

Usability was assessed to the requirements of IEC 62366:2007. Results of Bench Testing showed conformance to applicable requirements and specifications

Clinical Tests No clinical tests have been included in this pre-market submission.

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