(69 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.
No.
The device is an applicator used to facilitate delivery of radiation, which is the therapeutic agent, not the therapeutic agent itself.
No
The device is described as an applicator used to facilitate the delivery of radiation for treatment, not for diagnosis. It is used in conjunction with a high dose rate afterloader for radiation prescription, indicating a therapeutic purpose.
No
The device description explicitly states, "The device does not contain any electronics or software." It is a physical applicator.
Based on the provided information, the Varian Esophagus Bougie is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Varian Esophagus Bougie Function: The description clearly states that the Varian Esophagus Bougie is an applicator used to deliver radiation directly to the esophagus within the patient's body. This is an in vivo (within the living organism) procedure, not an in vitro test.
The device is a therapeutic device used in radiation therapy, not a diagnostic device used for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
The Varian Esophagus Bougie is an applicator used to facilitate delivery of a prescription of radiation to the esophagus when used in conjunction with a Varian high dose rate afterloader.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The Varian Esophagus Bougie is an HDR applicator designed to facilitate delivery of radiation to the Esophagus and has been modified to work with Varian afterloaders. The product can be steam sterilized up to 20 times and has a maximum implantation time of 24 hours. 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAR 01 2007
510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the Esophagus Bougie Applicator.
- Varian Medical Systems Submitter: . 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Ms. Vy Tran Phone: (650) 424-5731 (650) 842-5040 Fax: Email: vy.tran@varian.com Date summary was prepared: December 18, 2006
- Varian Esophagus Bougie Applicator Name of the Device: . Varian Esophagus Bougie Applicator Trade/Proprietary Name: Varian Esophagus Bougie Applicator Common or Usual Name: Classification Name: System, Applicator, Radionuclide, Remote-Controlled 21 CFR §892.5700 Class II Product Code: JAQ
- Predicate Devices to claim substantial equivalence: . K891131 & K983436
- Description of the Device: The Varian Esophagus Bougie is an HDR applicator . designed to facilitate delivery of radiation to the Esophagus and has been modified to work with Varian afterloaders. The product can be steam sterilized up to 20 times and has a maximum implantation time of 24 hours. 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 Varian Esophagus Bougie is an applicator used to . facilitate delivery of a prescription of radiation to the esophagus when used in conjunction with a Varian high dose rate afterloader.
- Summary of the Technological Characteristics: The Substantial Equivalence . Comparison Chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Tab 8 of the submission.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR 0 1 2007
Ms. Vy Tran Corporate Director Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALTO CA 94304-1038
Re: K063815
Trade/Device Name: Esophagus Bougie Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: December 18, 2006 Received: December 22, 2006
Dear Ms. Tran:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/1/Picture/10 description: The image is a circular logo commemorating the centennial of an organization, spanning from 1906 to 2006. At the center of the logo are the bold letters 'FDA', with the word 'Centennial' written below. The logo is surrounded by text and stars, forming a complete circular seal.
Protecting and Promoting Public Health
2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2 --
3
Varian Medical Systems, Inc, Esophagus Bougie 510k Submission
Varian Esophagus Bougie Applicator - Statement of Intended Use
510(k) Number (if known): _
Device Name: Varian Esophagus Bougie Applicator
Intended Use Statement: The Varian Esophagus Bougie is an applicator used to facilitate delivery of a prescription of radiation to the esophagus when used in conjunction with a Varian high dose rate afterloader.
David b. Segur
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Prescription Use
✓