Interstitial Needles

K160815 · Varian Medical Systems, Inc. · JAQ · Mar 10, 2017 · Radiology

Device Facts

• Record ID: K160815
• Device Name: Interstitial Needles
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Mar 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Interstitial Needles and their corresponding obturators are indicated for use for interstitial irradiation treatments of soft tissues such as breast, head and neck, tongue.

Device Story

Interstitial needles and obturators/mandrins used for interstitial irradiation of soft tissues (breast, head, neck, tongue). Device functions as a conduit for radioactive sources during HDR or PDR brachytherapy. Used in hospital brachytherapy treatment rooms by radiation oncologists, physicians, radiologists, dosimetrists, medical physicists, and nurses/technicians. Needles are inserted into target tissue; afterloader (VariSource or GammaMedplus series) delivers radioactive source through needle to treatment site. Output is precise delivery of radiation to target tissue; assists clinicians in localized cancer treatment. Benefits include targeted radiation delivery while sparing surrounding healthy tissue. Device is non-sterile upon delivery; requires steam sterilization by user.

Clinical Evidence

No clinical data. Bench testing only. Testing included functional compatibility with afterloaders, mechanical durability over specified cycles, source positioning accuracy, radiation resistance of materials, sterilization efficacy, biocompatibility (ISO 10993), and CT compatibility. Usability assessed per IEC 62366:2007.

Technological Characteristics

Needles constructed of titanium or stainless steel; obturators/mandrins of stainless steel. Sharp trocar points. Dimensions: 16G, 17G, 18G diameters; lengths 113mm-320mm. Compatible with VariSource iX, VariSource 200, GammaMedplus iX, and GammaMedplus afterloaders. Biocompatibility per ISO 10993. Sterilization via steam (manual/machine cleaning).

Indications for Use

Indicated for interstitial irradiation treatments of soft tissues including breast, head and neck, and tongue in patients requiring HDR or PDR 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

• Varian Interstitial Titanium Needles (K093291)

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, 2017

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

Re: K160815

Trade/Device Name: Interstitial Needles Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: February 27, 2017 Received: March 1, 2017

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

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

For

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below

510(k) Number (if known)

K160815

Device Name Interstitial Needles

Indications for Use (Describe)

The Interstitial Needles and their corresponding obturators are indicated for use for interstitial irradiation treatments of soft tissues such as breast, head and neck, tongue.

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

| > 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

# Interstitial Needles

## As required by 21 CFR 807.92

| Submitter's Name: | Varian Medical Systems<br>3100 Hansen Way, m/s E110<br>Palo Alto CA94304 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Peter J. Coronado |
| Phone: | 650/424.6320 |
| Fax: | 650/646.9200 |
| Date: | 2 ^nd March 2017 |
| Proprietary Name: | Interstitial Needles |
| Classification Name: | Remote controlled radionuclide applicator system<br>21CFR892.5700<br>Class II |
| Common/Usual Name: | Interstitial Needles |
| Predicate Devices: | K093291. Varian Interstitial Titanium Needles. |
| Device Description: | The Interstitial Needles and their corresponding Obturators/Mandrins are intended for interstitial irradiation treatments of soft tissues including breast, head and neck, and tongue using HDR or PDR brachytherapy and are compatible with the following afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™ and can be used in combination with the appropriate accessories.<br>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.<br>There are two versions of the needle included in this submission: titanium and stainless steel. |
| Indications for Use: | The Interstitial Needles and their corresponding obturators are indicated for use for interstitial irradiation treatments of soft tissues such as breast, head and neck, tongue. |

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#### Technological Characteristics:

| | CLEARED DEVICE FEATURE/SPECIFICATION | NEW / MODIFIED DEVICE | NEW / MODIFIED DEVICE |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE AND/OR SPECIFICATION<br>OF NEW/MODIFIED DEVICE | K093291=PREDICATE<br>17G INTERSTITIAL TITANIUM NEEDLES:<br>GM11009700, GM11009710, GM11009720,<br>GM11009730 | 17G INTERSTITIAL TITANIUM NEEDLES:<br>GM11009700, GM11009710, GM11009720,<br>GM11009730<br>16G TITANIUM INTERSTITIAL NEEDLES:<br>GM11010210, GM11010220, GM11010230,<br>GM11010240, GM11010410, GM11010420,<br>GM11010430, GM11010440<br>MANDRIN FOR 16G NEEDLE: GM11003340,<br>GM11003270, GM1101080, GM11003100 | 17G STAINLESS STEEL NEEDLE:<br>GM11009500, GM11009510, GM11009520,<br>GM11009530<br>18G STAINLESS STEEL NEEDLE:<br>GM11009550, GM11009560, GM11009570,<br>GM11009580<br>OBTURATOR FOR 17G AND 18G NEEDLE:<br>GM11009800, GM11009810, GM11009820,<br>GM11009830 |
| Intended use | The Interstitial Needles are used with Varian<br>High Dose Rate Afterloaders | The Interstitial Needles and their<br>corresponding obturators are intended for<br>use in interstitial irradiation treatments of<br>soft tissues such as breast, head and neck,<br>tongue, using HDR or PDR brachytherapy. | The Interstitial Needles and their<br>corresponding obturators are intended for<br>use in interstitial irradiation treatments of<br>soft tissues such as breast, head and neck,<br>tongue, using HDR or PDR brachytherapy. |
| Indication for use | The Interstitial Needles are used with Varian<br>High Dose Rate Afterloaders | The Interstitial Needles and their<br>corresponding obturators are indicated for<br>use for interstitial irradiation treatments of<br>soft tissues such as breast, head and neck,<br>tongue, using HDR or PDR brachytherapy. | The Interstitial Needles and their<br>corresponding obturators are intended for<br>use in interstitial irradiation treatments of<br>soft tissues such as breast, head and neck,<br>tongue, using HDR or PDR brachytherapy. |
| Compatible Afterloader | GammaMedplus afterloader series<br>VariSource 200 and iX afterloader | GammaMedplus afterloader series<br>VariSource 200 and iX afterloader | GammaMedplus afterloader series<br>VariSource 200 and iX afterloader<br>18G Stainless Steel Needle and Obturator<br>only compatible with VariSource 200 and iX<br>afterloader |
| | | | |
| Design | 17G Titanium Needle<br>The needles have a sharp trocar point and will be<br>available in the following dimensions:<br>Length: 113mm, 220mm, 250mm and 320 mm<br>Diameter: 17 Gauge (ø 1.47 mm)<br>● | 17G Titanium Needle<br>The needles have a sharp trocar point and will<br>be available in the following dimensions:<br>Length: 113mm, 220mm, 250mm and 320<br>mm<br>Diameter: 17 Gauge (ø 1.47 mm) | The needles have a sharp trocar point and will<br>be available in the following dimensions:<br>Length: 113mm, 220mm, 250mm and 320<br>mm<br>Diameter: 17 Gauge and 18 Gauge( ø 1.47 |
| | | 16G Titanium Needle<br>The needles have a sharp and blunt trocar<br>point and will be available in following<br>dimensions:<br>Length: 113 mm, 200 mm, 250 mm, 320<br>mm<br>Diameter: 16 Gauge (ø 1.65 mm) | mm and ø1.27 mm)<br>The obturators will be suitable for following<br>dimensions:<br>Length: 113mm, 200mm, 250mm and<br>320mm<br>Diameter: 17 Gauge and 18 Gauge (ø 1.47mm<br>and ø 1.27mm) |
| Materials | Needle: Titanium | Needle: Titanium | Needle: Stainless steel |
| | Obturator: Stainless steel | Obturator, Mandrin: Stainless steel | Obturator: Stainless steel |
| Packing | Individual | Individual | Individual |
| Sterility | Delivered in non-sterile condition. To be sterilized<br>at customer site<br>Needle 25 cycles<br>Obturator: 100 cycles | Delivered in non-sterile condition. To be<br>sterilized at customer site<br>Needle 25 cycles<br>Obturator, Mandrin: 100 cycles | Delivered in non-sterile condition. To be<br>sterilized at customer site.<br>Number of sterilization cycle:<br>Needle 25 cycles<br>Obturator: 100 cycles |
| Sterilization method | Manual Cleaning<br>Steam sterilization | Manual and Machine Cleaning<br>Steam sterilization | Manual and Machine Cleaning<br>Steam sterilization |
| Biocompatibility | Biocompatible titanium and stainless steel<br>(mandrins and obturators only) used. (ISO 10993) | Biocompatible titanium and stainless steel<br>(mandrins and obturators only) used. (ISO<br>10993) | Biocompatible Stainless Steel used. (ISO<br>10993) |
| Anatomical sites | Breast, prostate, head and neck, tongue or soft<br>tissue structure | Breast, prostate, head and neck, tongue or<br>soft tissue structure | Breast, prostate, head and neck, tongue or<br>soft tissue structure |
| Compatibility with the<br>environment and<br>other devices | Compatible with CT imaging modalities | Compatible with CT imaging modalities | Compatible with CT imaging modalities |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room | Brachytherapy treatment room |

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Non Clinical Tests Bench Testing has been performed to demonstrate that

- the devices function correctly with the specified afterloaders;
- the devices can withstand the number of cycles of use they will experience in its lifetime;
- the devices enable the radioactive source to be located to the accuracy required,
- the devices are constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- · the devices may be sterilized effectively
- the devices can be used and sterilized for the specified number of times
- the positional accuracy of the source within the devices is adequate.
- the devices are biocompatible as per ISO10933 standards
- the devices can be used safely and effectively in CT environments

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