(27 days)
Not Found
No
The device description is purely mechanical and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device, interstitial needles, is used in conjunction with a high dose rate (HDR) brachytherapy afterloading device. While it plays a role in radiation therapy, it does not directly provide therapy itself. It is an accessory for the therapeutic device.
No
The device is described as interstitial needles and obturators used with high dose rate brachytherapy afterloaders, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines physical components (needles and obturators) and their intended use in a physical procedure (brachytherapy). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the needles are used with Varian High Dose Rate Afterloaders for brachytherapy. This is a therapeutic procedure involving the delivery of radiation directly to a tumor, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details physical needles and obturators used for implantation into a patient. This is consistent with a medical device used for treatment delivery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Interstitial Needles are used with Varian High Dose Rate Afterloaders.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The device is a family of closed-ended, interstitial needles and associated obturators to be used in conjunction with a high dose rate (HDR) brachytherapy afterloading device. The needles are available in either 17 gauge O.D. or 18 gauge O.D. and in lengths of 113mm, 200 mm, 250mm and 320mm. The associated obturators are inserted into needles to stiffen the needles during implantation of the needles into the patient and to stiffen the needles between radiation therapy fractions. The obturators are available in lengths of 113mm, 200 mm, 250mm and 320mm. The needles are provided unsterile with instructions for steam sterilization. The obturators are provided unsterile with instructions for steam sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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/0 description: The image contains a sequence of alphanumeric characters, seemingly handwritten. The sequence appears to be "K093291". The characters are written in black ink on a white background. The style of writing is cursive.
Premarket Notification 510(k) Summary
| Submitter's Name: | Varian Medical Systems, Inc.
3100 Hansen Way, E-110
Palo Alto, CA 94304
Contact Name: Vy Tran
Phone: (650) 424-5731
Fax: (650) 424-5040
Date: October 2009 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name: | Varian Interstitial Needles |
| Classification Name: | System, Applicator, Radionuclide, Remote - Controlled
21 CFR 892.5700, Class II, JAQ |
| Common/Usual Name: | Varian Interstitial Needles |
| Predicate Devices: | Varian Interstitial Needles, K073133 |
NOV 1 7 2009## Device Description:
The device is a family of closed-ended, interstitial needles and associated obturators to be used in conjunction with a high dose rate (HDR) brachytherapy afterloading device. The needles are available in either 17 gauge O.D. or 18 gauge O.D. and in lengths of 113mm, 200 mm, 250mm and 320mm. The associated obturators are inserted into needles to stiffen the needles during implantation of the needles into the patient and to stiffen the needles between radiation therapy fractions. The obturators are available in lengths of 113mm, 200 mm, 250mm and 320mm. The needles are provided unsterile with instructions for steam sterilization. The obturators are provided unsterile with instructions for steam sterilization.
| Statement of | |
|---|---|
| Indications for Use: | The Interstitial Needles are used with Varian High Dose |
| Rate Afterloaders. |
Technological Characteristics:
Refer to the Substantial Equivalence Comparison Chart.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Vy Tran Corporate Vice President, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
NOV 1 7 2009
Re: K093291
Trade/Device Name: Interstitial Titanium Needles Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: October 16, 2009 Received: October 21, 2009
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 (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
2
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
| Indications for Use |
|---|
| --------------------- |
| 510(k) Number (if known): | K093291 |
|---|---|
| Device Name: | Interstitial Titanium Needles |
| Indications for Use: |
The Interstitial Needles are used with Varian High Dose Rate Afterloaders.
| Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|---|---|
| ---------------------------------------------- | -------------- | -------- | --------------------------------------------- | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helena
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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