Standard Catheter Set

K171631 · Varian Medical Systems, Inc. · JAQ · Feb 9, 2018 · Radiology

Device Facts

• Record ID: K171631
• Device Name: Standard Catheter Set
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Feb 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Standard Catheter Set functions as an applicator for intraluminal brachytherapy; guides radioactive source from remote afterloader (VariSource iX/200) to tumor site. Catheters (4.7 French, 1.6 mm diameter, 100/150 cm length) consist of PTFE tubing with either metal (tungsten plug) or plastic tips. Used in hospital brachytherapy treatment rooms by radiation oncologists, physicians, radiologists, dosimetrists, medical physicists, and nurses/technicians. Device provides physical pathway for source wire; enables precise delivery of radiation dose to target tissue. Benefits patient by facilitating targeted internal radiation therapy while allowing remote operation to protect medical personnel from radiation exposure. Single-use, non-sterile, steam-sterilizable.

Clinical Evidence

No clinical data or animal studies included. Substantial equivalence supported by non-clinical bench testing: biocompatibility (cytotoxicity, sensitization, irritation, systemic/subchronic toxicity, genotoxicity, implantation), sterilization validation (steam autoclave), and mechanical testing (CT compatibility, MR properties).

Technological Characteristics

PTFE catheters (1.6 mm diameter); metal-tipped (tungsten plug) or plastic-tipped. Biocompatible materials. Steam autoclave sterilization. CT compatible; MR conditional (plastic-tipped) or MR unsafe (metal-tipped). No electrical components, software, or firmware.

Indications for Use

Indicated for patients requiring access to tumor sites for high dose rate (HDR) brachytherapy irradiation.

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

• Standard Catheters (as part of the Applicators for Varian Varisource Remote High Dose Rate Afterloader) (K952913)

Reference Devices

• K113766
• K945383

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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A partner for life

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

Telephone: [phone] 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 Systems<br>3100 Hansen Way, m/s C260<br>Palo Alto CA 94304-1038 |
|-------------------|--------------------------------------------------------------------------------|
| Contact Name: | Peter J. Coronado |
| Position: | Director, Regulatory Affairs |
| Phone: | 1.650.424. 6320 |
| Fax: | 1.650.646.9200 |
| Email: | [e-mail] |
| 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 (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.

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 DEVICE<br>FEATURE/SPECIFICATION | NEW / MODIFIED DEVICE |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE<br>AND/OR<br>SPECIFICATION | PREDICATE DEVICE: | SUBJECT DEVICE: |
| | Standard Catheters | STANDARD CATHETER SET |
| | (K952913 Applicators for Varian<br>Varisource Remote High Dose Rate<br>Afterloader) | |
| Compatible<br>Afterloader | • VariSource 200 and ID | • VariSource 200 and iX Series |
| Intended Use | The VariSource applicators and<br>accessories complete the VariSource<br>system, and as such their intended use<br>is the same as the parent VariSource<br>device.<br><br>The Varian VariSource Remote High<br>Dose Rate Afterloader system,<br>including the applicators and<br>accessories, is a device intended to be<br>used by properly trained and licensed<br>medical personnel to provide radiation<br>brachytherapy with a high specific<br>activity radioisotope source to reduce<br>the exposure times required to achieve<br>a prescribed dose. Remote operation of<br>the afterloader eliminates the necessity<br>of exposing medical personnel to<br>radiation during hand loading or hand<br>placement of radioactive sources on or<br>within the body of a patient. The<br>radioactive source is Iridium-192,<br>encapsulated in the end of a wire stored<br>in the afterloader and mechanically<br>driven from it to a precisely described<br>position for a specified dwell time during<br>treatment. Between treatments the wire<br>is retracted into the afterloader and the<br>source end resides in a tungsten-<br>shielded safe to limit personnel<br>exposures to an acceptable, safe level.<br>The Afterloader contains a radiation<br>detector which signals whenever the<br>source is not in the safe. | The Standard Catheter Set is<br>intended to provide access to<br>tumor sites for treatment of<br>any case where high dose rate<br>irradiation is an accepted<br>clinical practice. |
| | CLEARED DEVICE<br>FEATURE/SPECIFICATION | NEW / MODIFIED DEVICE |
| | PREDICATE DEVICE: | SUBJECT DEVICE: |
| FEATURE<br>AND/OR<br>SPECIFICATION | Standard Catheters | STANDARD CATHETER SET |
| | (K952913 Applicators for Varian<br>Varisource Remote High Dose Rate<br>Afterloader) | |
| Indications for<br>Use | The VariSource applicators and<br>accessories complete the VariSource<br>system, and as such their intended use<br>is the same as the parent VariSource<br>device. The statement of Indications for<br>Use is the same as above.<br>The applicator, Standard Catheters,<br>from the predicate device states the<br>following indications in the Instruction<br>Manual:<br>The Standard Catheters are used to<br>provide access to tumor sites for<br>treatment of any case where high dose<br>rate irradiation is an accepted clinical<br>practice. | The Standard Catheter Set is indicated<br>for use to provide access to tumor sites<br>for treatment of any case where high<br>dose rate irradiation is an accepted<br>clinical practice. |
| Design | Catheters:<br>Diameter:<br>• 1.6 mm | Catheters:<br>Diameter:<br>• 1.6 mm |
| | Length: | Length: |
| | • 100 cm | • 100 cm |
| | • 150 cm | • 150 cm |
| Material | • Catheter Material :<br>• PTFE | • Catheter Material :<br>• PTFE |
| | • Plastic Tipped Catheter : Nylon | • Plastic Tipped Catheter : PTFE |
| | • Metal Tipped Catheter :<br>• Tungsten coated with PTFE | • Metal Tipped Catheter :<br>• Tungsten coated with PTFE |
| | • Metal Tipped Catheter Plug<br>• (distal end): Tungsten | • Metal Tipped Catheter Plug<br>• (distal end): Tungsten |
| | • Plastic and Metal Tipped Catheter<br>• Pin Plug (open end):<br>Delrin and stainless steel | • Plastic and Metal Tipped Catheter<br>• Pin Plug (open end)::<br>Delrin and stainless steel |
| | CLEARED DEVICE<br>FEATURE/SPECIFICATION | NEW / MODIFIED DEVICE |
| FEATURE<br>AND/OR<br>SPECIFICATION | PREDICATE DEVICE:<br>Standard Catheters<br>(K952913 Applicators for Varian<br>Varisource Remote High Dose Rate<br>Afterloader) | SUBJECT DEVICE:<br>STANDARD CATHETER SET |
| Packing | • Individual | • Individual |
| Sterility | • Provided non-sterile | • Provided non-sterile |
| Sterilization<br>method | • Ethylene Oxide<br>• Plasma | • Steam autoclave |
| Biocompatibility | • Full biocompatibility | • Full biocompatibility |
| Anatomical<br>sites | • Small lumen | • Small lumen |
| Compatibility<br>with the<br>environment<br>and other<br>devices | NA | • CT compatible & MR conditional<br>(for plastic-tipped catheter only)<br><br>• CT compatible & MR unsafe<br>(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.