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 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.
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.
There are two versions of the needle included in this submission: titanium and stainless steel.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for "Interstitial Needles" by Varian Medical Systems, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI/ML-driven medical device against specific acceptance criteria through a study involving human readers or standalone algorithm performance.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set ground truth are not applicable to this document. The device in question appears to be a physical medical instrument (needles for brachytherapy), not a software or AI-based diagnostic tool.

However, I can extract information related to the non-clinical testing performed to demonstrate the device's basic functionality and safety.

Here's a breakdown of what can be inferred from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines various "Non Clinical Tests" and states that "All the tests that were performed met the applied pass criteria." However, it does not explicitly list the quantitative acceptance criteria or detailed numerical results. Instead, it describes general functionalities that were tested.

Acceptance Criteria (Inferred from "Non Clinical Tests")	Reported Device Performance
Correct functioning with specified afterloaders	Met applied pass criteria
Withstand specified number of cycles of use (lifetime)	Met applied pass criteria
Enable radioactive source to be located with required accuracy	Met applied pass criteria (positional accuracy is adequate)
Constructed of materials not significantly affected by radiation over product lifetime	Met applied pass criteria
Effective sterilization	Met applied pass criteria
Usable and sterilizable for specified number of times	Met applied pass criteria
Adequate positional accuracy of source within devices	Met applied pass criteria
Biocompatible as per ISO10993 standards	Met applied pass criteria
Safe and effective use in CT environments	Met applied pass criteria
Conformance to usability requirements of IEC 62366:2007 (for Usability assessment)	Met applied pass criteria (Results of Bench Testing showed conformance)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. The document refers to "Bench Testing" but does not detail the number of units or test repetitions.
Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are non-clinical, likely performed in a lab setting by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. This is a physical device, and performance is assessed through engineering and material tests, not expert interpretation of outputs like in an AI/ML study.

4. Adjudication Method for the Test Set:

Not applicable. Performance determined by instrument measurements and material tests, not expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "No clinical tests have been included in this pre-market submission." An MRMC study would be a clinical test.

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

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

7. The type of Ground Truth Used:

Engineering specifications and material standards: For example, compliance with ISO10993 for biocompatibility and IEC 62366:2007 for usability. The "ground truth" for these tests would be established by the defined parameters and expected outcomes of the specific engineering and materials tests.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable (no training set for a physical device).

Summary

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Image /page/0/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 design featuring three human profiles facing to the right, with flowing lines above them.

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 (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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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PREMARKET NOTIFICATION

510(k) Summary

Interstitial Needles

As required by 21 CFR 807.92

Submitter's Name:	Varian Medical Systems3100 Hansen Way, m/s E110Palo 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 system21CFR892.5700Class 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.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.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:

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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

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.

	CLEARED DEVICE FEATURE/SPECIFICATION	NEW / MODIFIED DEVICE	NEW / MODIFIED DEVICE
FEATURE AND/OR SPECIFICATIONOF NEW/MODIFIED DEVICE	K093291=PREDICATE17G INTERSTITIAL TITANIUM NEEDLES:GM11009700, GM11009710, GM11009720,GM11009730	17G INTERSTITIAL TITANIUM NEEDLES:GM11009700, GM11009710, GM11009720,GM1100973016G TITANIUM INTERSTITIAL NEEDLES:GM11010210, GM11010220, GM11010230,GM11010240, GM11010410, GM11010420,GM11010430, GM11010440MANDRIN FOR 16G NEEDLE: GM11003340,GM11003270, GM1101080, GM11003100	17G STAINLESS STEEL NEEDLE:GM11009500, GM11009510, GM11009520,GM1100953018G STAINLESS STEEL NEEDLE:GM11009550, GM11009560, GM11009570,GM11009580OBTURATOR FOR 17G AND 18G NEEDLE:GM11009800, GM11009810, GM11009820,GM11009830
Intended use	The Interstitial Needles are used with VarianHigh Dose Rate Afterloaders	The Interstitial Needles and theircorresponding obturators are intended foruse in interstitial irradiation treatments ofsoft tissues such as breast, head and neck,tongue, using HDR or PDR brachytherapy.	The Interstitial Needles and theircorresponding obturators are intended foruse in interstitial irradiation treatments ofsoft tissues such as breast, head and neck,tongue, using HDR or PDR brachytherapy.
Indication for use	The Interstitial Needles are used with VarianHigh Dose Rate Afterloaders	The Interstitial Needles and theircorresponding obturators are indicated foruse for interstitial irradiation treatments ofsoft tissues such as breast, head and neck,tongue, using HDR or PDR brachytherapy.	The Interstitial Needles and theircorresponding obturators are intended foruse in interstitial irradiation treatments ofsoft tissues such as breast, head and neck,tongue, using HDR or PDR brachytherapy.
Compatible Afterloader	GammaMedplus afterloader seriesVariSource 200 and iX afterloader	GammaMedplus afterloader seriesVariSource 200 and iX afterloader	GammaMedplus afterloader seriesVariSource 200 and iX afterloader18G Stainless Steel Needle and Obturatoronly compatible with VariSource 200 and iXafterloader

Design	17G Titanium NeedleThe needles have a sharp trocar point and will beavailable in the following dimensions:Length: 113mm, 220mm, 250mm and 320 mmDiameter: 17 Gauge (ø 1.47 mm)●	17G Titanium NeedleThe needles have a sharp trocar point and willbe available in the following dimensions:Length: 113mm, 220mm, 250mm and 320mmDiameter: 17 Gauge (ø 1.47 mm)	The needles have a sharp trocar point and willbe available in the following dimensions:Length: 113mm, 220mm, 250mm and 320mmDiameter: 17 Gauge and 18 Gauge( ø 1.47
		16G Titanium NeedleThe needles have a sharp and blunt trocarpoint and will be available in followingdimensions:Length: 113 mm, 200 mm, 250 mm, 320mmDiameter: 16 Gauge (ø 1.65 mm)	mm and ø1.27 mm)The obturators will be suitable for followingdimensions:Length: 113mm, 200mm, 250mm and320mmDiameter: 17 Gauge and 18 Gauge (ø 1.47mmand 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 sterilizedat customer siteNeedle 25 cyclesObturator: 100 cycles	Delivered in non-sterile condition. To besterilized at customer siteNeedle 25 cyclesObturator, Mandrin: 100 cycles	Delivered in non-sterile condition. To besterilized at customer site.Number of sterilization cycle:Needle 25 cyclesObturator: 100 cycles
Sterilization method	Manual CleaningSteam sterilization	Manual and Machine CleaningSteam sterilization	Manual and Machine CleaningSteam sterilization
Biocompatibility	Biocompatible titanium and stainless steel(mandrins and obturators only) used. (ISO 10993)	Biocompatible titanium and stainless steel(mandrins and obturators only) used. (ISO10993)	Biocompatible Stainless Steel used. (ISO10993)
Anatomical sites	Breast, prostate, head and neck, tongue or softtissue structure	Breast, prostate, head and neck, tongue orsoft tissue structure	Breast, prostate, head and neck, tongue orsoft tissue structure
Compatibility with theenvironment andother 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