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 Description

The Plastic Interstitial Needles with mandrin, ø 2.0 mm diameter, are designed for interstitial radiotherapy treatments. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories. They 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.

AI/ML Overview

The provided FDA 510(k) document for the "Interstitial Plastic Needles" (K141624) by Varian Medical Systems, Inc. details the device's technical specifications and non-clinical testing. However, it explicitly states: "No clinical tests have been included in this pre-market submission."

Therefore, a complete description of acceptance criteria and a study proving the device meets those criteria, as typically understood in a clinical efficacy or performance study, cannot be provided based on this document. The information below reflects what is available in the document regarding non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical bench testing and states that all tests met "pass criteria." However, specific numerical acceptance criteria (e.g., "positional accuracy within X mm") are not provided, nor are the detailed quantitative results for each test. Instead, the document lists areas of performance verified.

Acceptance Criteria (General Description)	Reported Device Performance (Summary)
Device functions correctly with specified afterloaders.	Bench testing demonstrated correct function with specified afterloaders.
Device can withstand the number of cycles of use in its lifetime.	Bench testing demonstrated the device can withstand the specified number of cycles.
Device enables radioactive source to be located with required accuracy.	Bench testing confirmed adequate positional accuracy of the source within the applicator. (Specific accuracy not given)
Device materials are not significantly affected by radiation exposure over product lifetime.	Bench testing confirmed material integrity under radiation exposure.
Device can be effectively sterilized.	Bench testing confirmed effective sterilization.
Device can be used and sterilized for the specified number of times.	Bench testing confirmed the device can be used and sterilized for the specified number of times.
Positional accuracy of the source within the applicator is adequate.	Bench testing confirmed adequate positional accuracy of the source within the applicator. (Specific accuracy not given)
Usability conforms to IEC 62366:2007.	Usability assessment showed conformance to IEC 62366:2007 requirements.

2. Sample size used for the test set and the data provenance

As per the document, no clinical tests were performed or submitted. The testing was non-clinical bench testing. The sample size for materials and devices tested on the bench is not specified in this summary. Data provenance is internal laboratory testing by Varian Medical Systems, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical tests were performed requiring expert ground truth for a test set. The non-clinical tests would have pass/fail criteria based on engineering specifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical tests were performed requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an interstitial plastic needle for brachytherapy, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical bench testing, the "ground truth" would be established by engineering specifications, validated measurement equipment, and adherence to industry standards (e.g., IEC 62366:2007 for usability). No clinical ground truth (like pathology or outcomes data) was used or required for this 510(k) submission.

8. The sample size for the training set

Not applicable, as no AI/machine learning component is described, and no clinical data was used for training purposes in this submission.

9. How the ground truth for the training set was established

Not applicable, as no AI/machine learning component is described, and no clinical data was used for training purposes in this submission.

Summary

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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PREMARKET NOTIFICATION

510(k) Summary

Plastic Interstitial Needles

As required by 21 CFR 807.92

Submitter's Name:	Varian Medical Systems3100 Hansen Way, m/s E-110Palo Alto CA94304Contact Name: Peter J. CoronadoPhone: 650/424.6230Fax: 650/646.9200
Date:	30th May 2014
Proprietary Name:	Plastic Needles with Mandrin, 2.0 mm diameter,
Classification Name:	Remote controlled radionuclide applicator system21CFR892.5700Class II
Common/Usual Name:	Plastic Needle, Interstitial Needle, Brachytherapy Needle,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,are designed for interstitial radiotherapy treatments. They arecompatible with Varian afterloaders and can be used incombination with the appropriate accessories.
	They are intended to be used by trained and qualified personnelsuch as Radiation Oncologists, Physicians, Radiologists,Dosimetrists, Medical Physicists, and Nurses/MTRAs/RadiologyTechnicians/Radiographers in a hospital environment.
Indications for Use:	The interstitial plastic needles with 2mm diameter are designedfor interstitial treatment in areas such as the head and neck,gynaecological, breast and prostate.

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Technological Characteristics:

	GM11007560, 7570, 7580Interstitial plastic needles	GM11007560, 7570, 7580Interstitial plastic needles andGM11010750Plastic needle with mandrin, 2.0mm diameter, 320 mm length,blunt tip
Predicate DeviceClearance Number:	K120341	N/A
Compatible Afterloader	GammaMed plusGammaMed 12(i)VariSource	GammaMed plusVariSourceGammaMed 12(i) (Not with blunt
Intended use	The interstitial plastic needles with2mm diameter are designed forinterstitial brachytherapytreatment in areas such as thehead and neck, gynecological,breast and prostate.	tip needle).The interstitial plastic needles with2mm diameter are designed forinterstitial brachytherapytreatment in areas such as the headand neck, gynecological, breast andprostate.
Indications for Use	The interstitial plastic needles with2mm diameter are designed forinterstitial brachytherapytreatment in areas such as thehead and neck, gynecological,breast and prostate.	The interstitial plastic needles with2mm diameter are designed forinterstitial brachytherapytreatment in areas such as the headand neck, gynecological, breast andprostate.
Design	Plastic needle:● Diameter: 2 mm● Length: 113, 200, 320mm● Tip style: Sharp tip	Plastic needle:● Diameter: 2 mm● Length: 113, 200, 320mm● Tip styles:Sharp tipBlunt tip (320mm length only)
Materials	Needles: PEEK/TitaniumObturator/Mandrin: Stainless Steel	Needles: PEEK/TitaniumObturator/Mandrin: Stainless Steel,
Packing	individual	individual
Sterility	Provided non sterile	Provided non sterile
Sterilization method	Steam sterilization up to 25 times(15 cycles when using 18 minutesat 134°C)	Steam sterilization up to 25 times(15 cycles when using 18 minutesat 134°C)
Biocompatibility	Full biocompatibility	Full biocompatibility
Anatomical sites	Head and neck, gynecological,breast and prostate	Head and neck, gynecological,breast and prostate
Compatibility with theenvironment and otherdevices	CT compatible, MR conditional 1.5and 3 T	CT compatible, MR conditional 1.5and 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

Regulation Number and Section

§ 892.5700 Remote controlled radionuclide applicator system.

(a)
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.(b)
Classification. Class II.