(266 days)
Not Found
No
The summary describes a physical medical device (needles) used in radiotherapy and focuses on its compatibility, durability, and accuracy, with no mention of AI or ML capabilities.
Yes
The device is designed for interstitial radiotherapy treatments, which are a form of therapy to treat medical conditions like cancer.
No
The device is described as a "plastic needle" designed for "interstitial radiotherapy treatments." Its function is to enable the radioactive source to be located accurately for treatment, not to diagnose a condition.
No
The device is described as "interstitial plastic needles" and "Plastic Interstitial Needles with mandrin," which are physical hardware components used for interstitial radiotherapy. The description focuses on material properties, compatibility with afterloaders, and bench testing related to physical performance and sterilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is an "interstitial plastic needle" designed for "interstitial radiotherapy treatments." This means it's a physical device inserted into the body to deliver radiation, not a device used to analyze samples outside the body.
- Intended Use: The intended use is for delivering radiation treatment in specific anatomical areas. This is a therapeutic use, not a diagnostic use involving the analysis of biological samples.
The information provided describes a device used in vivo (within the body) for treatment, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The interstitial plastic needles with 2mm diameter are designed for interstitial treatment in areas such as the head and neck, gynaecological, breast and prostate. The interstitial plastic needles with 2mm diameter are designed for interstitial brachytherapy treatment in areas such as the head and neck, gynecological, breast and prostate.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The Plastic Interstitial Needles with mandrin, ø 2.0 mm diameter, are designed for interstitial radiotherapy treatments. They are compatible with Varian afterloaders and can be used in combination with the appropriate accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head and neck, gynaecological, breast and prostate.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
They are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment. 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 device functions correctly with the specified afterloaders;
- the device can withstand the number of cycles of use that it will experience in its lifetime;
- . the device enables the radioactive source to be located to the accuracy required,
- . the device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- . the device may be sterilized effectively
- the device can be used and sterilized for the specified number of times
- the positional accuracy of the source within the applicator is adequate.
Usability was 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
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 shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures facing to the right. The figures are connected and appear to be in motion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2015
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Wav PALO ALTO CA 94304
Re: K141624
Trade/Device Name: Interstitial Plastic Needles Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: January 7, 2015 Received: January 23, 2015
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. Acting 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) K141624
Device Name Interstitial Plastic Needles
Indications for Use (Describe)
The interstitial plastic needles with 2mm diameter are designed for interstitial treatment in areas such as the head and neck, gynaecological, breast and prostate.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
PREMARKET NOTIFICATION
510(k) Summary
Plastic Interstitial Needles
As required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems
3100 Hansen Way, m/s E-110
Palo Alto CA94304
Contact Name: Peter J. Coronado
Phone: 650/424.6230
Fax: 650/646.9200 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 30th May 2014 |
| Proprietary Name: | Plastic Needles with Mandrin, 2.0 mm diameter, |
| Classification Name: | Remote controlled radionuclide applicator system
21CFR892.5700
Class II |
| Common/Usual Name: | Plastic Needle, Interstitial Needle, Brachytherapy Needle,
Interstitial plastic needle with 2mm diameter. |
| Predicate Devices: | K120341 Plastic Needle with Mandrin 2.0 Diameter Length 113mm |
| Device Description: | The Plastic Interstitial Needles with mandrin, ø 2.0 mm diameter,
are designed for interstitial radiotherapy treatments. They are
compatible with Varian afterloaders and can be used in
combination with the appropriate accessories. |
| | They are intended to be used by trained and qualified personnel
such as Radiation Oncologists, Physicians, Radiologists,
Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology
Technicians/Radiographers in a hospital environment. |
| Indications for Use: | The interstitial plastic needles with 2mm diameter are designed
for interstitial treatment in areas such as the head and neck,
gynaecological, breast and prostate. |
4
Technological Characteristics:
| | GM11007560, 7570, 7580
Interstitial plastic needles | GM11007560, 7570, 7580
Interstitial plastic needles and
GM11010750
Plastic needle with mandrin, 2.0
mm diameter, 320 mm length,
blunt tip |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device
Clearance Number: | K120341 | N/A |
| Compatible Afterloader | GammaMed plus
GammaMed 12(i)
VariSource | GammaMed plus
VariSource
GammaMed 12(i) (Not with blunt |
| Intended use | The interstitial plastic needles with
2mm diameter are designed for
interstitial brachytherapy
treatment in areas such as the
head and neck, gynecological,
breast and prostate. | tip needle).
The interstitial plastic needles with
2mm diameter are designed for
interstitial brachytherapy
treatment in areas such as the head
and neck, gynecological, breast and
prostate. |
| Indications for Use | The interstitial plastic needles with
2mm diameter are designed for
interstitial brachytherapy
treatment in areas such as the
head and neck, gynecological,
breast and prostate. | The interstitial plastic needles with
2mm diameter are designed for
interstitial brachytherapy
treatment in areas such as the head
and neck, gynecological, breast and
prostate. |
| Design | Plastic needle:
● Diameter: 2 mm
● Length: 113, 200, 320mm
● Tip style: Sharp tip | Plastic needle:
● Diameter: 2 mm
● Length: 113, 200, 320mm
● Tip styles:
Sharp tip
Blunt tip (320mm length only) |
| Materials | Needles: PEEK/Titanium
Obturator/Mandrin: Stainless Steel | Needles: PEEK/Titanium
Obturator/Mandrin: Stainless Steel, |
| Packing | individual | individual |
| Sterility | Provided non sterile | Provided non sterile |
| Sterilization method | Steam sterilization up to 25 times
(15 cycles when using 18 minutes
at 134°C) | Steam sterilization up to 25 times
(15 cycles when using 18 minutes
at 134°C) |
| Biocompatibility | Full biocompatibility | Full biocompatibility |
| Anatomical sites | Head and neck, gynecological,
breast and prostate | Head and neck, gynecological,
breast and prostate |
| Compatibility with the
environment and other
devices | CT compatible, MR conditional 1.5
and 3 T | CT compatible, MR conditional 1.5
and 3 T |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room |
5
Non Clinical Tests Bench Testing has been performed to demonstrate that
- the device functions correctly with the specified afterloaders;
- the device can withstand the number of cycles of use that it will experience in its lifetime;
- . the device enables the radioactive source to be located to the accuracy required,
- . the device is constructed of materials that are not significantly affected by the radiation to which they are exposed in the lifetime of the product;
- . the device may be sterilized effectively
- the device can be used and sterilized for the specified number of times
- the positional accuracy of the source within the applicator is adequate.
Usability was 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