(117 days)
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
Explanation: The device is designed to facilitate the delivery of radiation to the esophagus for the treatment of esophageal cancer, which is a therapeutic intervention.
No
The device is an applicator used to deliver radiation for cancer treatment, 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 to diagnose a condition.
- Lack of Diagnostic Function: There is no mention of the device analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. 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 with a Varian high dose rate afterloader.
Product codes (comma separated list FDA assigned to the subject device)
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 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
Brachytherapy treatment room
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)
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.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract design of three human profiles facing to the right, stacked on top of each other. The profiles are stylized and appear to be connected by a flowing line.
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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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3
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 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.
3100 Hansen Way E-110
Palo Alto, CA 94304
Contact Name: Peter J. Coronado
Phone: 650.424.6320
Fax: 650.646.9200
Date: June 6, 2016 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Esophagus Bougie Set - GM11008880 |
| Classification Name: | Remote controlled radionuclide applicator system
21 CFR 892.5700, Class II
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
delivery of radiation to the Esophagus and has been modified to work with Varian
Medical 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 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. |
| 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 with a Varian high dose rate afterloader. |
4
Technological Characteristics:
| | GM11008880 Esophagus
Bougie Set (K130251) | Modified Esophagus Bougie Set |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 in conjunction
with a high dose rate afterloader. | 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 high dose
rate afterloader. |
| 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. | 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 high dose
rate afterloader. |
| Compatible Afterloaders | GammaMed plus
GammaMed 12i(t)
VariSource | GammaMed plus
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
diameter | For 8, 10, 12, and 14 mm bougie
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
(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
disinfection up to 20 cycles | Manual cleaning and high Level
disinfection up to 20 cycles
Machine cleaning and thermal
disinfection up to 20 cycles |
| Bite protector, clamping screws,
threaded ring | Steam sterilization up to 100 cycles | Steam sterilization up to 100 cycles
Machine cleaning |
| Biocompatibility | Full biocompatibility
Polymeric materials and stainless steel
used. | Full biocompatibility
Polymeric materials and stainless steel
used. |
| Anatomical sites | Esophagus | Esophagus |
| Compatibility with the
environment and other devices | CT compatible | CT compatible |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |
5
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.