The Standard Catheter Set is indicated for use to provide access to tumor sites for treatment of any case where high dose rate irradiation is an accepted clinical practice.

Device Description

The Standard Catheter Set (AL1311XXXX) is designed as an applicator for intraluminal Brachytherapy. The Standard Catheters are 4.7 French (1.6 mm in diameter) PTFE (Polytetrafluroethalene) catheters, which are supplied in nominal lengths of 100cm and 150cm with either a metal tip or plastic tip. The catheters can be readily inserted into small lumen. The metal tip catheter is sealed at the distal end with a small tungsten pluq for easy visualization under fluoroscopy. The distal end of the plastic catheter is tightly sealed to prevent body fluids from entering the lumen or extension of the source wire beyond the tip. The catheters are shipped with a pin plug in the open end to keep the lumen clean and to keep the opening round. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "Standard Catheter Set" by Varian Medical Systems, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in a quantitative sense for clinical or algorithm performance. Instead, it details various non-clinical tests conducted to support substantial equivalence and safety. The acceptance criteria are implicitly met by successfully passing these tests, indicating the device performs as intended and is safe.

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance
Biocompatibility	Cytotoxicity	Compliant with ISO 10993-1 and FDA G95-1 Memorandum
	Sensitization	Compliant with ISO 10993-1 and FDA G95-1 Memorandum
	Irritation	Compliant with ISO 10993-1 and FDA G95-1 Memorandum
	Systemic Toxicity	Compliant with ISO 10993-1 and FDA G95-1 Memorandum
	Subchronic Toxicity	Compliant with ISO 10993-1 and FDA G95-1 Memorandum
	Genotoxicity	Compliant with ISO 10993-1 and FDA G95-1 Memorandum
	Implantation	Compliant with ISO 10993-1 and FDA G95-1 Memorandum
Sterilization	Steam Sterilization Validation Reports	Effectiveness of cleaning, disinfection, and sterilization procedures assessed and deemed acceptable. Components evaluated for performance and damage after sterilization cycles.
	Validation/Efficacy Testing of Cleaning, Disinfection,	Effectiveness of cleaning, disinfection, and sterilization procedures assessed and deemed acceptable. Components evaluated for performance and damage after sterilization cycles.
	Sterilization Cycles	Effectiveness of cleaning, disinfection, and sterilization procedures assessed and deemed acceptable. Components evaluated for performance and damage after sterilization cycles.
Mechanical & Acoustic	CT Compatibility Test and Analysis	Verification of CT compatibility.
	Rationale MR Properties	Verification of MR compatibility/safety (plastic-tipped catheter is MR conditional; metal-tipped catheter is MR unsafe).

Specific quantitative thresholds for "acceptance" (e.g., maximum allowable cytotoxic response, specific log reduction in microbial load) are not detailed in this summary document but would have been part of the full test reports referenced. The general statement is that the results support the safety and effectiveness and that the device performs as well as or better than the predicate device.

Study Details

The provided document describes the evaluation of a medical device (Standard Catheter Set), not an AI algorithm. Therefore, many of the typical AI-specific questions are not applicable.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The studies described are non-clinical, involving physical device testing (biocompatibility, sterilization, mechanical properties) rather than a "test set" of patient data for an algorithm.
- Data Provenance: Not applicable in the context of patient data. The tests were performed in a laboratory/testing environment on device samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there is no "test set" of patient data requiring expert ground truth or an AI algorithm being evaluated. The evaluations were performed by laboratories/personnel competent in the specific types of non-clinical tests (e.g., biocompatibility specialists, sterilization validation experts).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human reader interpretation or annotation of data.
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:
- No. This is a medical device (catheter) submission, not an AI or software product.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical device (catheter) submission, not an AI or software product. The document explicitly states: "This item is not applicable to the subject device; the device does not contain or consist of software/firmware." (page 9)
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of an AI algorithm. For non-clinical tests, "ground truth" would correspond to established scientific principles, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and established test methods, with results assessed against predefined acceptance criteria from these standards.
The sample size for the training set:
- Not applicable. This is not an AI or software product.
How the ground truth for the training set was established:
- Not applicable. This is not an AI or software product.

In summary, the provided information pertains to the premarket notification of a physical medical device (Standard Catheter Set) and its equivalence to a predicate device, focusing on non-clinical performance data to establish safety and effectiveness. It does not involve AI or clinical performance studies with patient data, hence many of the requested AI-specific details are not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in a way that "FDA" is on top, followed by "U.S. FOOD & DRUG", and then "ADMINISTRATION" at the bottom.

Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

February 9, 2018

Re: K171631

Trade/Device Name: Standard Catheter Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: December 22, 2017 Received: January 3, 2018

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 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);

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Page 2 - Mr. Peter Coronado

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D'Hara For

Robert Ochs, Ph.D. 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)

K171631

Device Name Standard Catheter Set

Indications for Use (Describe)

The Standard Catheter Set is indicated for use to provide access to tumor sites for treatment of any case where high dose rate irradiation is an accepted clinical practice.

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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Image /page/3/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a blue accent mark above the "I". Below the word "VARIAN" is the phrase "medical systems" in a smaller font. To the right of the word "VARIAN" is a vertical line, followed by the phrase "A part" in a light gray font.

A partner for life

Varian Medical Systems, Inc. Corporate Headquarters 3100 Hansen Way Palo Alto, CA 94304-1038

Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com

510k Summary

510(k) Submission for Standard Catheter Set

As required by 21 CFR 807.92, Reference: FDA's Guidance Document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (June 2014).

I. SUBMITTER

Submitter's Name:	Varian Medical Systems3100 Hansen Way, m/s C260Palo Alto CA 94304-1038
Contact Name:	Peter J. Coronado
Position:	Director, Regulatory Affairs
Phone:	1.650.424. 6320
Fax:	1.650.646.9200
Email:	submissions.support@varian.com
Date Prepared:	May 12, 2017

II. DEVICE

Name of Device:	Standard Catheter Set
Common/Usual Name:	System, Applicator, Radionuclide, Remote-
	Controlled
Regulation Name:	Remote controlled radionuclide applicator
	system (21 CFR 892.5700)
Regulatory Class:	Class II
Product Code:	JAQ

In this submission, some documents may reference the Standard Catheter Set by the common name Standard Catheters (AL1311XXXX).

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III. PREDICATE DEVICE

Name of Predicate: Standard Catheters (as part of the Applicators for Varian Varisource Remote High Dose Rate Afterloader). K952913 510k Number:

Please note that the required and optional accessories listed in Section 3.4 of the Device Description have been previously cleared under the 510(k) premarket notifications K113766, K945383, and K952913.

IV. DEVICE DESCRIPTION

The Standard Catheter Set is 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 Standard Catheter Set is compatible with the Varian Afterloaders: VariSource iX™ and VariSource 200™.

The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is supplied non-sterile and is intended for single use only. This device is used on female and male patients. The device can be steam sterilized with common parameters using pre-vacuum steam autoclave sterilization.

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V. INDICATIONS FOR USE

Indications for Use Statement:

The Standard Catheter Set is indicated for use to provide access to tumor sites for treatment of any case where high dose rate irradiation is an accepted clinical practice.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both the subject and predicate devices are intended for use in the treatment of cancer through intraluminal brachytherapy. The subject device is based on a subset of applicators from the predicate device, Standard Catheters (as part of the K952913 Applicators for Varian Varisource Remote High Dose Rate Afterloader).

At a high level, the subject and predicate devices are based on the following similar technological elements:

. Biocompatible Standard Catheters
Same design ●
Application in intraluminal brachytherapy treatments o
Same anatomical treatment site/application ●

The following main differences exist between the subject and predicate devices:

. Change and clarification to Intended Use and Indications for Use to apply specifically to Standard Catheter Set instead of the applicators for Varian Varisource Remote High Dose Rate Afterloader (K952913)
The sterilization method for the standard catheter set is changed from . ethylene oxide and plasma sterilization to steam sterilization only
A change to the material of the plastic tipped catheter from Nylon to . PTFE.

In addition to the changes listed above, other changes since the predicate device include the following:

Verification of CT and MR compatibility

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	CLEARED DEVICEFEATURE/SPECIFICATION	NEW / MODIFIED DEVICE
FEATUREAND/ORSPECIFICATION	PREDICATE DEVICE:	SUBJECT DEVICE:
	Standard Catheters	STANDARD CATHETER SET
	(K952913 Applicators for VarianVarisource Remote High Dose RateAfterloader)
CompatibleAfterloader	• VariSource 200 and ID	• VariSource 200 and iX Series
Intended Use	The VariSource applicators andaccessories complete the VariSourcesystem, and as such their intended useis the same as the parent VariSourcedevice.The Varian VariSource Remote HighDose Rate Afterloader system,including the applicators andaccessories, is a device intended to beused by properly trained and licensedmedical personnel to provide radiationbrachytherapy with a high specificactivity radioisotope source to reducethe exposure times required to achievea prescribed dose. Remote operation ofthe afterloader eliminates the necessityof exposing medical personnel toradiation during hand loading or handplacement of radioactive sources on orwithin the body of a patient. Theradioactive source is Iridium-192,encapsulated in the end of a wire storedin the afterloader and mechanicallydriven from it to a precisely describedposition for a specified dwell time duringtreatment. Between treatments the wireis retracted into the afterloader and thesource end resides in a tungsten-shielded safe to limit personnelexposures to an acceptable, safe level.The Afterloader contains a radiationdetector which signals whenever thesource is not in the safe.	The Standard Catheter Set isintended to provide access totumor sites for treatment ofany case where high dose rateirradiation is an acceptedclinical practice.
	CLEARED DEVICEFEATURE/SPECIFICATION	NEW / MODIFIED DEVICE
	PREDICATE DEVICE:	SUBJECT DEVICE:
FEATUREAND/ORSPECIFICATION	Standard Catheters	STANDARD CATHETER SET
	(K952913 Applicators for VarianVarisource Remote High Dose RateAfterloader)
Indications forUse	The VariSource applicators andaccessories complete the VariSourcesystem, and as such their intended useis the same as the parent VariSourcedevice. The statement of Indications forUse is the same as above.The applicator, Standard Catheters,from the predicate device states thefollowing indications in the InstructionManual:The Standard Catheters are used toprovide access to tumor sites fortreatment of any case where high doserate irradiation is an accepted clinicalpractice.	The Standard Catheter Set is indicatedfor use to provide access to tumor sitesfor treatment of any case where highdose rate irradiation is an acceptedclinical practice.
Design	Catheters:Diameter:• 1.6 mm	Catheters:Diameter:• 1.6 mm
	Length:	Length:
	• 100 cm	• 100 cm
	• 150 cm	• 150 cm
Material	• Catheter Material :• PTFE	• Catheter Material :• PTFE
	• Plastic Tipped Catheter : Nylon	• Plastic Tipped Catheter : PTFE
	• Metal Tipped Catheter :• Tungsten coated with PTFE	• Metal Tipped Catheter :• Tungsten coated with PTFE
	• Metal Tipped Catheter Plug• (distal end): Tungsten	• Metal Tipped Catheter Plug• (distal end): Tungsten
	• Plastic and Metal Tipped Catheter• Pin Plug (open end):Delrin and stainless steel	• Plastic and Metal Tipped Catheter• Pin Plug (open end)::Delrin and stainless steel
	CLEARED DEVICEFEATURE/SPECIFICATION	NEW / MODIFIED DEVICE
FEATUREAND/ORSPECIFICATION	PREDICATE DEVICE:Standard Catheters(K952913 Applicators for VarianVarisource Remote High Dose RateAfterloader)	SUBJECT DEVICE:STANDARD CATHETER SET
Packing	• Individual	• Individual
Sterility	• Provided non-sterile	• Provided non-sterile
Sterilizationmethod	• Ethylene Oxide• Plasma	• Steam autoclave
Biocompatibility	• Full biocompatibility	• Full biocompatibility
Anatomicalsites	• Small lumen	• Small lumen
Compatibilitywith theenvironmentand otherdevices	NA	• CT compatible & MR conditional(for plastic-tipped catheter only)• CT compatible & MR unsafe(for metal-tipped catheter)
Where used	• Brachytherapy treatment room	• Brachytherapy treatment room

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Tests:

Biocompatibility Testing:

The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within

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a Risk Management Process," as recognized by FDA. This included the following tests:

Cytotoxicity
Sensitization ●
Irritation ●
Systemic Toxicity ●
Subchronic Toxicity
Genotoxicity
Implantation ●

The Standard Catheters are intended for continuous use for less than 30 days of contact with patients. According to ISO 10993-1 the standard catheters are categorized as a medical device, external communicating device, Tissue/Bone communicating and prolonged contact duration (B).

Sterilization Testing:

Sterilization testing was performed for the subject device and conducted to assess the effectiveness of the provided cleaning, disinfection, and sterilization procedures for the device. Furthermore, the components of the subject set were subjected to sterilization cycles up to the stated use life and evaluated for performance and any damage that might affect safety or effectiveness.

o Steam Sterilization Validation Reports
Validation/Efficacy Testing of Cleaning, Disinfection, Sterilization Cycles .

Electrical Safety and Electromagnetic Compatibility (EMC):

This item is not applicable to the subject device. No electrical safety and electromaqnetic compatibility tests have been included in this submission in support of the substantial equivalence determination.

Software Verification and Validation Testing:

This item is not applicable to the subject device; the device does not contain or consist of software/firmware. No software verification and validation testing has been included in this submission in support of the substantial equivalence determination.

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Mechanical and Acoustic Testing:

CT Compatibility Test and Analysis
Rationale MR Properties ●

Animal Study / Clinical Tests:

No animal studies or clinical tests have been included in this submission in support of the substantial equivalence determination.

VIII. CONCLUSIONS

The results of the non-clinical tests support the safety and effectiveness of the device under the specified use conditions. Varian believes that the validation and verification testing demonstrates that the subject device performs as well as or better than the predicate device.

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.