(69 days)
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.
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.
This 510(k) summary describes a medical device, the Varian Esophagus Bougie Applicator, which is an applicator for delivering radiation to the esophagus. It is not an AI/ML powered device, so many of the requested criteria, such as acceptance criteria based on performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, expert-established ground truth, adjudication methods, multi-reader multi-case studies, and training set information, are not applicable.
The submission is for a traditional medical device (an applicator for radiation delivery) and focuses on establishing substantial equivalence to previously cleared predicate devices. Therefore, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence based on technological characteristics and intended use, rather than performance metrics of an AI algorithm.
Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (Summary of Technological Characteristics) |
|---|---|
| Intended Use: Facilitate delivery of a prescription of radiation to the esophagus when used with a Varian high dose rate afterloader. | Intended 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. (Matches predicate) |
| Technological Characteristics: Similar design and function to predicate devices, enabling radiation delivery to the esophagus. | Description: An HDR applicator designed to facilitate delivery of radiation to the Esophagus and modified to work with Varian afterloaders. Can be steam sterilized up to 20 times, max implantation time 24 hours. No electronics or software. Facilitates placement of a high activity radioactive source for controlled radiation delivery. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to predicate devices. | The FDA letter implicitly accepts that no new issues of safety or effectiveness were raised, concluding the device is "substantially equivalent." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a physical device submission demonstrating substantial equivalence to predicates, not an AI/ML algorithm requiring a specific test set for performance evaluation. Product testing would involve engineering and sterilization validations, potentially using physical samples of the device, but not "data" in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth, in the context of diagnostic accuracy or AI performance, was established for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or related adjudication process for performance evaluation was conducted.
5. 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
- Not Applicable. This is not an AI-powered device, so no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this device. The "truth" for this device would relate to its physical properties, material compatibility, and ability to house and facilitate the movement of a radioactive source as intended, which would be validated through engineering and biocompatibility testing, not clinical "ground truth" data.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML algorithm, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth for it.
In summary: The provided document is a 510(k) summary for a physical medical applicator, not an AI/ML device. Therefore, the "acceptance criteria" and "study" largely revolve around demonstrating substantial equivalence to existing devices based on intended use and technological characteristics, rather than performance metrics derived from large datasets using AI algorithms.
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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.
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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.
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Protecting and Promoting Public Health
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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
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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
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§ 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.