(314 days)
No
The device description and performance studies focus on the physical applicator and its compatibility with brachytherapy afterloaders and imaging modalities, with no mention of AI or ML capabilities.
No
The device is an applicator designed to guide radioactive sources for brachytherapy treatment, not a therapeutic device itself. The afterloader (predicate device) delivers the therapy.
No
The device is described as an applicator for brachytherapy that guides a radioactive source for cancer treatment, not to diagnose a condition.
No
The device description clearly states it consists of physical components (Heyman-capsules, guide tubes, accessories) and is an applicator for intracavitary brachytherapy, which are hardware elements.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating endometrial cancer using brachytherapy. This is a therapeutic procedure, not a diagnostic test performed on samples from the body.
- Device Description: The device is an applicator used to guide a radioactive source for treatment. It is a medical device used directly on the patient for therapy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on biological samples.
The device is clearly a therapeutic medical device used in the treatment of cancer.
N/A
Intended Use / Indications for Use
Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.
Product codes
JAQ
Device Description
The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes. The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets). The Heyman Packing Applicator Set is intended for cancer treatment of the endometrium using HDR or PDR brachytherapy. The Heyman Packing Applicator Set is an applicator for intracavitary Brachytherapy. The applicator acts to quide the radioactive source to the correct location or locations for treatment.
The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. This device is used on female patients.
The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endometrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
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:
Biocompatibility Testing: The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,'" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. This included cytotoxicity, sensitization, irritation, systemic toxicity, subacute toxicity, and implantation tests.
Sterilization Testing: Sterilization testing was performed to assess the effectiveness of the provided cleaning, disinfection, and sterilization procedures. Components were subjected to sterilization cycles up to the stated use life and evaluated for performance and damage.
Electrical Safety and Electromagnetic Compatibility (EMC): Not applicable.
Software Verification and Validation Testing: Not applicable.
Mechanical and Acoustic Testing: MRI Safety Tests and Analysis, CT Compatibility Tests and Analysis, Validation with the VariSource afterloader series.
Animal Study / Clinical Tests: No animal studies or clinical tests have been included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2016
Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K160045
Trade/Device Name: Hevman Packing Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: November 3, 2016 Received: November 4, 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 O'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 Heyman Packing Applicator Set
Indications for Use (Describe)
Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
A partner for life
Varian Medical Systems, Inc. Corporate Headquarters 3100 Hansen Way Palo Alto, CA 94304-1038
Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com
510k Summary
510(k) Submission for Heyman Packing Applicator Set
As required by 21 CFR 807.92, Reference: FDA's Guidance Document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (June 2014).
l. SUBMITTER
| Submitter's Name: | Varian Medical Systems
3100 Hansen Way, m/s E-110
Palo Alto CA 94304-1038 |
|-------------------|---------------------------------------------------------------------------------|
| Contact Name: | Peter J. Coronado |
| Position: | Director, Regulatory Affairs |
| Phone: | 1.650.424.6230 |
| Fax: | 1.650.646.9200 |
| Email: | submissions.support@varian.com |
| Date Prepared: | Thursday January 07, 2016 |
II. DEVICE
| Name of Device: | Heyman Packing Applicator Set |
|---|---|
| Common/Usual Name: | System, Applicator, Radionuclide, |
| Remote-controlled | |
| Regulation Name: | Remote controlled radionuclide applicator |
| system (21 CFR 892.5700) | |
| Regulatory Class: | Class II |
| Product Code: | JAQ |
4
PREDICATE DEVICE .
Name of Predicate: GammaMed Plus High Dose Rate Remote Afterloading System 510k Number: K983436
This predicate has not been subject to a design-related recall. K152018 (Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets) is used as a reference device for this submission.
IV. DEVICE DESCRIPTION
The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes. The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets). The Heyman Packing Applicator Set is intended for cancer treatment of the endometrium using HDR or PDR brachytherapy. The Heyman Packing Applicator Set is an applicator for intracavitary Brachytherapy. The applicator acts to quide the radioactive source to the correct location or locations for treatment.
The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. This device is used on female patients.
The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
5
| Product Number | Component List | Associated
510(k) Number |
|----------------|---------------------------------------------------------------|-----------------------------|
| GM11005280 | Heyman-capsule, 4mm diameter x
17.5mm length, with mandrin | This 510(k) |
| GM11005110 | Heyman-capsule, 6mm diameter x
17.5mm length, with mandrin | |
| GM11005040 | Heyman-capsule, 8mm diameter x
17.5mm length, with mandrin | |
| GM11010510 | Leak Stop Channel Marker Set, 1 - 12 | Cleared under
K152018 |
| GM11003810 | Leak stop button, pack of 50 | |
| GM11010770 | Cleaning Cap, dark blue (pack of 25) | |
The associated accessories include:
INDICATIONS FOR USE V.
Indications for Use Statement: The Heyman Packing Applicator Set is indicated for cancer treatment of the endometrium using HDR or PDR brachytherapy.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both the subject and predicate devices are intended for use in the treatment of cancer through intracavitary brachytherapy. The subject device is based on a subset of applicator accessories from the predicate device.
6
At a high level, the subject and predicate devices are based on the following same technological elements:
- Biocompatible Heyman-capsules of various sizes .
- Application in intracavitary brachytherapy treatments ●
- . Same anatomical treatment site/application
- Sterilized by user prior to use (and reuses) .
The following main differences exist between the subject and predicate devices:
- Material change in the probe connect of the Heyman-capsule
- . Validation of machine cleaning and the associated accessories
- . Heyman capsules for the subject device are MR conditional
- Added VariSource afterloader compatibility .
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Tests:
Biocompatibility Testing:
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. This included the following tests:
- . Cytotoxicity
- Sensitization ●
7
- Irritation
- Systemic Toxicity ●
- Subacute Toxicity ●
- . Implantation
The Heyman Packing Applicator Set is a surface device in contact with mucosal membrane and prolonged contact duration of 24 hours up to 30 days.
Sterilization Testing:
Sterilization testing was performed for the subject device was conducted to assess the effectiveness of the provided cleaning, disinfection, and sterilization procedures for the device. Furthermore, the components of the subject set were subjected to sterilization cycles up to the stated use life and evaluated for performance and any damage that might affect safety or effectiveness.
- . Validation/Efficacy Testing of Cleaning, Disinfection, Sterilization Cycles
- . Verification of the Suitability of Applicator Design and Material for the Stated Use Life and Reprocessing Cycles
Electrical Safety and Electromagnetic Compatibility (EMC):
This item is not applicable to the subject device. No electrical safety and electromaqnetic compatibility tests have been included in this submission in support of the substantial equivalence determination.
Software Verification and Validation Testing:
This item is not applicable to the subject device; the device does not contain or consist of software/firmware. No software verification and validation testing has been included in this submission in support of the substantial equivalence determination.
Mechanical and Acoustic Testing:
- MRI Safety Tests and Analysis ●
8
- CT Compatibility Tests and Analysis ●
- Validation with the VariSource afterloader series
Animal Study / Clinical Tests:
No animal studies or clinical tests have been included in this submission in support of the substantial equivalence determination.
VIII. CONCLUSIONS
The results of the non-clinical tests support the safety and effectiveness of the device under the specified use conditions. Varian believes that the validation and verification testing demonstrates that the subject device performs comparably to the predicate device, meeting the intended use.