Esophagus Bougie Set

K161576 · Varian Medical Systems, Inc. · JAQ · Oct 2, 2016 · Radiology

Device Facts

• Record ID: K161576
• Device Name: Esophagus Bougie Set
• Applicant: Varian Medical Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Oct 2, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Esophagus Bougie Set was designed to treat cancer of the esophagus. The Esophagus Bougie Set is an applicator used to facilitate delivery of a radiation source to the esophagus when used with a Varian high dose rate afterloader.

Device Story

Esophagus Bougie Set is a non-electronic, non-software radiation applicator; used in brachytherapy treatment rooms by clinicians. Device facilitates delivery of high dose rate (HDR) radioactive source to esophagus; source driven from afterloader through coupling catheters (Transfer Guide Tubes) into applicator positioned in patient. Applicator holds source in specific position for duration defined by clinical irradiation treatment prescription. Device components include bougies (8-14mm), tube catheters, bite protectors, and guidewires. Benefits include precise radiation delivery to esophageal tumors. Device is reusable (up to 20 cycles) and requires cleaning/disinfection or steam sterilization between uses.

Clinical Evidence

No clinical data. Bench testing only. Validation included cleaning/disinfection efficacy per DIN EN ISO 17664 and biocompatibility testing per ISO 10993-5 and 10993-10. Design verification confirmed that the material change (DEHP-free PVC) met all predefined acceptance criteria.

Technological Characteristics

Applicator system; non-electronic; non-software. Materials: DEHP-free PVC (bougies), FEP (tube catheter), PPSU (bite protector/fixation), PTFE-coated stainless steel (guidewire). Dimensions: 8-14mm bougie diameters, 3.2mm catheter. Sterilization: Manual/machine cleaning and high-level disinfection (bougies/catheters); steam sterilization (bite protector/fixation). Connectivity: None. Environment: Brachytherapy treatment room; CT compatible.

Indications for Use

Indicated for patients with esophageal cancer requiring radiation therapy delivered via a high dose rate afterloader.

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

• Esophagus Bougie Set (K130251)

Reference Devices

• Guidewire (K082094)
• Strap for bite protector bougie (K955564)

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

October 2, 2016

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

Re: K161576

Trade/Device Name: Esophagus Bougie Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: September 7, 2016 Received: September 9, 2016

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

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)

Device Name Esophagus Bougie Set

Indications for Use (Describe)

The Esophagus Bougie Set was designed to treat cancer of the Esophagus Bougie Set is an applicator used to facilitate delivery of a radiation source to the esophagus when used with a high dose rate afterloader.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel [phone] www.varian.com

# Premarket Notification [510(k)] Summary

## GM11008880 Esophagus Bougie Set

The following information is provided following the format of 21 CFR 807.92(c).

| Submitter's Name: | Varian Medical Systems, Inc.<br>3100 Hansen Way E-110<br>Palo Alto, CA 94304<br>Contact Name: Peter J. Coronado<br>Phone: [phone]<br>Fax: [phone]<br>Date: June 6, 2016 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Esophagus Bougie Set - GM11008880 |
| Classification Name: | Remote controlled radionuclide applicator system<br>21 CFR 892.5700, Class II<br>Product Code: JAQ |
| Common/Usual Name: | Remote controlled radionuclide applicator system |
| Predicate Devices: | K130251 Esophagus Bougie Set |
| Device Description: | The Varian Medical Esophagus Bougie is an HDR applicator designed to facilitate<br>delivery of radiation to the Esophagus and has been modified to work with Varian<br>Medical afterloaders. The product can be steam sterilized up to 20 times and has<br>a maximum implantation time of 24 hours. The device does not contain any<br>electronics or software. A high activity radioactive source is placed within the<br>applicator which has previously been placed for a specified clinical purpose in a<br>patient. The radioactive source (enclosed within the wire/cable) is driven via<br>coupling catheters (Transfer Guide Tubes) from the Afterloader into the applicator<br>within the patient. The length of time and position that the High Dose Rate source<br>spends within the applicator is controlled in accordance with an Irradiation<br>Treatment Prescription. |
| Intended Use Statement | The Esophagus Bougie Set was designed to treat cancer of the esophagus. The<br>Esophagus Bougie Set is an applicator used to facilitate delivery of a radiation<br>source to the esophagus when used with a Varian high dose rate afterloader. |
| Indications for Use<br>Statement | The Esophagus Bougie Set was designed to treat cancer of the esophagus. The<br>Esophagus Bougie Set is an applicator used to facilitate delivery of a radiation<br>source to the esophagus when used with a Varian high dose rate afterloader. |

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## Technological Characteristics:

| | GM11008880 Esophagus<br>Bougie Set (K130251) | Modified Esophagus Bougie Set |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Esophagus Bougie Set was<br>designed to treat cancer of the<br>esophagus. The Esophagus Bougie Set<br>is an applicator used to facilitate<br>delivery of a radiation source to the<br>esophagus when used in conjunction<br>with a high dose rate afterloader. | The Esophagus Bougie Set was<br>designed to treat cancer of the<br>esophagus. The Esophagus Bougie Set<br>is an applicator used to facilitate<br>delivery of a radiation source to the<br>esophagus when used with a high dose<br>rate afterloader. |
| Indications for Use | The Esophagus Bougie Set was<br>designed to treat cancer of the<br>esophagus. The Esophagus Bougie Set<br>is an applicator used to facilitate<br>delivery of a radiation source to the<br>esophagus when used in conjunction<br>with a high dose rate afterloader. | The Esophagus Bougie Set was<br>designed to treat cancer of the<br>esophagus. The Esophagus Bougie Set<br>is an applicator used to facilitate<br>delivery of a radiation source to the<br>esophagus when used with a high dose<br>rate afterloader. |
| Compatible Afterloaders | GammaMed plus<br>GammaMed 12i(t)<br>VariSource | GammaMed plus<br>VariSource |
| Components and Dimensions: | | |
| Bougies | 8, 10, 12 and 14 mm diameter | 8, 10, 12 and 14 mm diameter |
| Tube catheter | 3.2 mm diameter | 3.2 mm diameter |
| Bite protector and fixation | For 8, 10, 12, and 14 mm bougie<br>diameter | For 8, 10, 12, and 14 mm bougie<br>diameter |
| Guidewire | 0.032" x 2600mm (K082094) | 0.032" x 2600mm (K082094) |
| Strap for bite protector bougie | (K955564) | (K955564) |
| Materials: | | |
| Bougies | PVC (Polyvinylchloride) | PVC (Polyvinylchloride) without DEHP |
| Tube catheter | FEP (Fluorinated ethylene propylene) | FEP (Fluorinated ethylene propylene) |
| Bite protector and fixation | PPSU (Polyphenylsulfone) | PPSU (Polyphenylsulfone) |
| Guidewire | Stainless Steel PTFE coated | Stainless Steel PTFE coated |
| Packaging | Individual | Individual |
| Sterility (Bougie, tube catheter, Bite protector, clamping screws, threaded ring) | Non sterile | Non sterile |
| Sterility<br>(Guidewire) | sterile, single use | sterile, single use |
| Sterilization method: | | |
| Tube catheter | High Level disinfection up to 20 cycles | High Level disinfection up to 20 cycles |
| Bougie | Manual cleaning and high Level<br>disinfection up to 20 cycles | Manual cleaning and high Level<br>disinfection up to 20 cycles<br>Machine cleaning and thermal<br>disinfection up to 20 cycles |
| Bite protector, clamping screws,<br>threaded ring | Steam sterilization up to 100 cycles | Steam sterilization up to 100 cycles<br>Machine cleaning |
| Biocompatibility | Full biocompatibility<br>Polymeric materials and stainless steel<br>used. | Full biocompatibility<br>Polymeric materials and stainless steel<br>used. |
| Anatomical sites | Esophagus | Esophagus |
| Compatibility with the<br>environment and other devices | CT compatible | CT compatible |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |

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### Non Clinical Tests

Bench testing was performed to evaluate the efficacy of the automatic manual cleaning and disinfection process. Testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating the effectiveness of the cleaning and disinfection process plus the cleaning and disinfection agents according to DIN EN ISO 17664 (July 2004). Biocompatibility testing performed in accordance with ISO 10993-5 and 10993-10 show the device is safe for bodily contact.

Per the FDA's Guidance document Deciding When to Submit a 510(k) for a Change to an Existing Device, only the formulation of this non-implant PVC material was changed. This plasticizer DEHP is considered a potentially dangerous substance and has been replaced with a safer alternative. The reformulated material was evaluated through design verification and testing. Non-clinical test articles met the predefined acceptance criteria, thereby demonstrating the reformulated material did not impact device performance or biocompatibility.

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.