(186 days)
Not Found
No
The description focuses on the physical components and functionality of a brachytherapy applicator set, with no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used for "treatments of cancer or other superficial disease using HDR or PDR brachytherapy," which is a therapeutic intervention.
No.
Explanation: The Mould Applicator Set is described as an applicator for brachytherapy, which is a form of radiotherapy for cancer treatment. Its function is to guide a radioactive source for treatment, not to diagnose a condition. The sections "Intended Use / Indications for Use" and "Device Description" clearly state its role in treatment delivery.
No
The device description clearly details physical components (applicator, probes, mandrins) made of materials that are sterilized and implanted, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Mould Applicator Set is used for "IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy." This describes a therapeutic procedure involving the delivery of radiation directly to a treatment area within the body.
- Device Description: The description details an "applicator for intraoperative, interstitial, intraluminal or surface brachytherapy" that "acts to guide the radioactive source to the correct location or locations for treatment." This further reinforces its role in a therapeutic intervention.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. The Mould Applicator Set does not perform any such tests on biological samples. It is a tool used during a medical treatment.
Therefore, the Mould Applicator Set is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy.
Product codes (comma separated list FDA assigned to the subject device)
JAO
Device Description
The Mould Applicator Set is an applicator for intraoperative, interstitial, intraluminal or surface brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
The Mould Applicator Set can be steam sterilized with common parameters using Pre-vacuum sterilization.
The mould probes Ø 2.8mm (GM11002280), which are part of the set, have a maximum implantation time of up to 24 hours. According to ISO 10993-1 they are categorised as medical devices, external communicating with tissue/bone communicating and a limited contact duration (A). They can be steam sterilized and used 25 times.
The mould probes Ø 1.8mm (GM11002290) have a maximum implantation time of up to 7 days. According to ISO 10993-1 they are categorised as a medical device, external communicating with tissue/bone communicating and prolonged contact duration (B). When steam sterilised, they are a single use product and can be used for IORT, interstitial and intraluminal treatments. If only disinfected the probe can be used up to 10 times for treatment of superficial diseases. The Mould Applicator Set is CT compatible. The Mould Applicator Set is MR conditional for 1.5 and 3 Tesla when the mandrins have been removed from the mould probes after insertion in the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
Not Found
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 has been performed to demonstrate that
- the devices function correctly with the specified afterloader;
- the devices can withstand the number of cycles of use they will experience in its lifetime;
- the devices enable the radioactive source to be located to the accuracy required,
- the devices are constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- the devices may be sterilized effectively
- the devices can be used and sterilized for the specified number of times
- the positional accuracy of the source within the devices is adequate.
- the devices are biocompatible as per ISO10993 standards
- the devices can be used safely and effectively in CT environments
- testing of the Mould Applicator in MRI environments has demonstrated it is safe to use under the conditions specified in the labelling.
Usability has been assessed to the requirements of IEC 62366:2007.
Results of Bench Testing showed conformance to applicable requirements and specifications.
Clinical Tests: No clinical tests have been included in this pre-market submission.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
March 24, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K162615 Trade/Device Name: Mould Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: February 22, 2017 Received: February 23, 2017
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Mould Applicator Set
Indications for Use (Describe)
The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or other superficial disease using HDR or PDR brachytherapy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
FORM FDA 3881 (1/14)
3
PREMARKET NOTIFICATION
510(k) Summary
Mould Applicator Set
As required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems
3100 Hansen Way, m/s E110
Palo Alto CA94304 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado
Phone: 650/424.6320
Fax: 650/646.9200
Date: 9th Sep 2016 |
| Proprietary Name: | Mould Applicator Set |
| Classification Name: | Remote controlled radionuclide applicator system
21CFR892.5700
Class II |
| Common/Usual Name: | Mould Applicator Set |
| Predicate Devices: | GammamedPlus HDR Afterloading System (K983436). |
| Device Description: | The Mould Applicator Set is an applicator for intraoperative,
interstitial, intraluminal or surface brachytherapy. Brachytherapy
is a form of radiotherapy using Gamma rays from a radioactive
source placed at locations close to or within a tumor or other
treatment area to a predefined treatment plan. The treatment
plan defines the positions and times for the source to ensure the
correct dose for the treatment area. The applicator acts to guide
the radioactive source to the correct location or locations for
treatment. |
| | The Mould Applicator Set can be steam sterilized with common
parameters using Pre-vacuum sterilization. |
| | The mould probes Ø 2.8mm (GM11002280), which are part of the
set, have a maximum implantation time of up to 24 hours.
According to ISO 10993-1 they are categorised as medical devices,
external communicating with tissue/bone communicating and a
limited contact duration (A). They can be steam sterilized and
used 25 times. |
| | The mould probes Ø 1.8mm (GM11002290) have a maximum
implantation time of up to 7 days. According to ISO 10993-1 they |
4
are categorised as a medical device, external communicating with tissue/bone communicating and prolonged contact duration (B). When steam sterilised, they are a single use product and can be used for IORT, interstitial and intraluminal treatments. If only disinfected the probe can be used up to 10 times for treatment of superficial diseases. The Mould Applicator Set is CT compatible. The Mould Applicator Set is MR conditional for 1.5 and 3 Tesla when the mandrins have been removed from the mould probes after insertion in the patient. Indications for Use: The Mould Applicator Set is indicated for IORT, interstitial and intraluminal treatments of cancer and treatments of cancer or
other superficial disease using HDR or PDR brachytherapy.
| | 1.5 and 2.8mm Catheters as part of
GammaMedplus HDR Afterloading | Mould Applicator set |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | System K983436. | |
| Intended use | Covered by intended use of complete
afterloader system in original submission:
The intended use of the GammaMed Plus
transportable high-dose-rate remotely
controlled afterloading brachytherapy
device is for the treatment of cancer by
intracavitary, interstitial, intraluminal and
intraoperative irradiation. | The Mould Applicator Set is intended for
IORT, interstitial and intraluminal
treatments of cancer and treatments of
cancer or other superficial disease using
HDR or PDR brachytherapy. |
| Indications for Use | Covered by indication for use of complete
afterloader system in original submission:
The intended use of the GammaMed Plus
transportable high-dose-rate remotely
controlled afterloading brachytherapy
device is for the treatment of cancer by
intracavitary, interstitial, intraluminal and
intraoperative irradiation. | The Mould Applicator Set is indicated for
IORT, interstitial and intraluminal
treatments of cancer and treatments of
cancer or other superficial disease using
HDR or PDR brachytherapy. |
| Compatible Afterloader | GammaMedplus | GammaMedplus |
| Design | Catheters:
• Diameter: 1.5 or 2.8mm
• Length: 130cm | Mould Probe Diameter: 1.8 or 2.8mm
Length: 320 mm
1.8mm Mould Probe supplied with mandrin |
| Materials | 1.5mm Catheter: Polyamide
2.8mm Catheter: Fluorinated ethylene
propylene (FEP)
Probe connectors: Stainless steel | 1.8mm Mould Probe: Polyamide (PA)
2.8mm Mould Probe: Fluorinated ethylene
propylene (FEP)
Probe connectors: Titanium
Mandrin: Stainless steel |
| Packing | individual | Individual |
| Sterility | Provided non sterile | Provided non sterile |
Technological Characteristics:
5
| Sterilization method | Steam sterilization | 1.8mm and 2.8mm Mould Probes:
Manual Cleaning, Steam sterilization.
1.8mm Mould Probe is a single use product
when steam sterilized. |
|------------------------------------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Full biocompatibility | Full biocompatibility
Max 24 hours contact for the 2.8mm Mould
Probe.
Max7 days contact for 1.8mm Mould Probe |
| Compatibility with the
environment and other
devices | No CT or MR claims | CT compatible, MR conditional 1.5 and 3 T |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |
Non Clinical Tests Bench Testing has been performed to demonstrate that
- the devices function correctly with the specified afterloader;
- . the devices can withstand the number of cycles of use they will experience in its lifetime;
- . the devices enable the radioactive source to be located to the accuracy required,
- the devices are constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- . the devices may be sterilized effectively
- . the devices can be used and sterilized for the specified number of times
- the positional accuracy of the source within the devices is adequate.
- . the devices are biocompatible as per ISO10993 standards
- the devices can be used safely and effectively in CT environments
- testing of the Mould Applicator in MRI environments has demonstrated it is safe to use under the conditions specified in the labelling.
Usability has been assessed to the requirements of IEC 62366:2007.
Results of Bench Testing showed conformance to applicable requirements and specifications.
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