(40 days)
Not Found
No
The device description explicitly states that the device does not contain any electronics or software, and there are no mentions of AI, DNN, or ML in the summary.
Yes
The device is used to treat cancer of the esophagus by facilitating the delivery of a radiation source, indicating a therapeutic purpose.
No
The device is an applicator used to deliver radiation, not to diagnose a condition.
No
The device description explicitly states, "The device does not contain any electronics or software."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate delivery of a radiation source to the esophagus" for treating cancer. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is an applicator for delivering radiation. It does not perform any tests on biological samples (blood, tissue, etc.) to diagnose a condition.
- Lack of Diagnostic Function: The description focuses on the physical delivery of radiation and the device's compatibility with an afterloader. There is no mention of analyzing samples or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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 in conjunction with a Varian high dose rate afterloader.
Product codes
JAQ
Device Description
The Varian Medical Esophagus Bougie is an HDR applicator designed to facilitate delivery of radiation to the Esophagus and has been modified to work with Varian Medical afterloaders. The bougie tube and catheter can be cleaned and disinfected with high level disinfectants and has a maximum insertion time of 24 hours. The clamping screw, bite protector and threaded ring can be steam sterilized. The fixation strap and guide wire are single use. The device does not contain any electronics or software.
A high activity radioactive source is placed within the applicator which has previously been placed for a specified clinical purpose in a patient.
The radioactive source (enclosed within the wire/cable) is driven via coupling catheters (Transfer Guide Tubes) from the Afterloader into the applicator within the patient.
The length of time and position that the High Dose Rate source spends within the applicator is controlled in accordance with an Irradiation Treatment Prescription.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The esophagus bougie sterilization efficacy and suitability of the manual cleaning and disinfection process was evaluated through design verification and testing. Non-clinical 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 10993-1, 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. One of the components used in the composite material is no longer available; however, the composite material remains the same. The reformulated material was evaluated through design verification and testing. Non-clinical testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating the reformulated material did not impact device performance or biocompatibility.
The change to the esophagus bougie does not raise new questions of safety or effectiveness when compared to the predicate device and, therefore, is substantially equivalent to the predicate esophagus bougie.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Varian Esophagus bougie set
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K130251
page 1 of 2
Premarket Notification [510(k)] Summary Esophagus bougie
The following information is provided following the format of 21 CFR 807.92. MAR 1 3 2013
| Submitter's Name: | Varian Medical Systems, Inc.
3120 Hansen Way C-260
Palo Alto, CA 94304 |
|----------------------|-----------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado
Phone: 650.424.5731
Fax: 650.842.5040
Date: December 2012 |
| Proprietary Name: | Varian Medical Systems, Inc. Esophagus bougie set |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5700, Class II
Product Code: JAQ |
| Common/Usual Name: | Varian Medical Systems, Inc. Esophagus bougie set |
| Predicate Device: | Varian Esophagus bougie set |
The Varian Medical Esophagus Bougie is an HDR applicator designed to Device Description: facilitate delivery of radiation to the Esophagus and has been modified to work with Varian Medical afterloaders. The bougie tube and catheter can be cleaned and disinfected with high level disinfectants and has a maximum insertion time of 24 hours. The clamping screw, bite protector and threaded ring can be steam sterilized. The fixation strap and guide wire are single use. The device does not contain any electronics or software.
A high activity radioactive source is placed within the applicator which has previously been placed for a specified clinical purpose in a patient.
The radioactive source (enclosed within the wire/cable) is driven via coupling catheters (Transfer Guide Tubes) from the Afterloader into the applicator within the patient.
The length of time and position that the High Dose Rate source spends within the applicator is controlled in accordance with an Irradiation Treatment Prescription.
Intended Use Statement
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 in conjunction with a Varian high dose rate afterloader.
Indications for Use Statement
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 in conjunction with a Varian high dose rate afterloader.
1
K130251
Page 2 of 2
Premarket Notification [510(k)] Summary Esophagus bougie
Technological Characteristics
Significant change to the predicate device is listed below.
| Performance | Cleared device | Device with change |
|---|---|---|
| Sterilization method: | ||
| Bougie tube, catheter | Sterilized | Disinfected |
The clamping screw, bite protector, threaded ring, fixation strap and guide wire sterilization remains the same.
Discussion of nonclinical testing;
The esophagus bougie sterilization efficacy and suitability of the manual cleaning and disinfection process was evaluated through design verification and testing. Non-clinical 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 10993-1, 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. One of the components used in the composite material is no longer available; however, the composite material remains the same. The reformulated material was evaluated through design verification and testing. Non-clinical testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating the reformulated material did not impact device performance or biocompatibility.
Conclusion of nonclinical testing:
The change to the esophagus bougie does not raise new questions of safety or effectiveness when compared to the predicate device and, therefore, is substantially equivalent to the predicate esophagus bougie.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings, rendered in a thick, black line. The bird is positioned to the right of a circular emblem. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2013
Peter J. Coronado Director, Varian Oncology Systems Regulatory Affairs Varian Medical Systems. Inc. 911 Hansen Way, m/s E-110 PALO ALTO CA 94304-1038
Re: K130251
Trade/Device Name: Esophagus bougie Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: January 30, 2013 Received: February 7, 2013
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. Drue, 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. Iisting 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.
3
Page 2-Mr. Coronado
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
for
Janine M. Morris, M.S. Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K130251
Device Name: Esophagus bougie
Indications for 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 in conjunction with a high dose rate afterloader.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
· Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K130251
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