(351 days)
Not Found
No
The 510(k) summary describes interstitial needles and obturators for brachytherapy, which are physical devices used to deliver radiation. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML for image processing, treatment planning, or any other function. The performance studies focus on the physical properties and functionality of the needles themselves.
Yes
The device is used for "interstitial irradiation treatments of soft tissues," which is a medical treatment.
No
The device is an interstitial needle used for therapeutic radiation treatments (brachytherapy), not for diagnosing conditions. It facilitates the delivery of radiation rather than identifying or characterizing a disease.
No
The device description explicitly states it is comprised of "Interstitial Needles and their corresponding Obturators/Mandrins," which are physical hardware components used in brachytherapy. The performance studies also focus on bench testing of these physical devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description: The provided description clearly states that the Interstitial Needles and Obturators are used for interstitial irradiation treatments of soft tissues. This is a therapeutic procedure, not a diagnostic test performed on specimens outside the body.
- Intended Use: The intended use is for delivering radiation therapy (brachytherapy) directly into tissues. This is a treatment, not a diagnostic process.
The device is a tool used in a medical procedure (brachytherapy) to deliver radiation, which is a form of treatment. It does not analyze biological samples to provide diagnostic information.
N/A
Intended Use / Indications for Use
The Interstitial Needles and their corresponding obturators are indicated for use for interstitial irradiation treatments of soft tissues such as breast, head and neck, tongue.
Product codes
JAO
Device Description
The Interstitial Needles and their corresponding Obturators/Mandrins are intended for interstitial irradiation treatments of soft tissues including breast, head and neck, and tongue using HDR or PDR brachytherapy and are compatible with the following afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™ and can be used in combination with the appropriate accessories.
The devices 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.
There are two versions of the needle included in this submission: titanium and stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Compatible with CT imaging modalities
Anatomical Site
soft tissues such as breast, head and neck, tongue.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The devices 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
Non Clinical Tests Bench Testing has been performed to demonstrate that
- the devices function correctly with the specified afterloaders;
- 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 ISO10933 standards
- the devices can be used safely and effectively in CT environments
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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 & 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 design featuring three human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2017
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K160815
Trade/Device Name: Interstitial Needles Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: February 27, 2017 Received: March 1, 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
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
2
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 Interstitial Needles
Indications for Use (Describe)
The Interstitial Needles and their corresponding obturators are indicated for use for interstitial irradiation treatments of soft tissues such as breast, head and neck, tongue.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
PREMARKET NOTIFICATION
510(k) Summary
Interstitial Needles
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: | 2 nd March 2017 |
| Proprietary Name: | Interstitial Needles |
| Classification Name: | Remote controlled radionuclide applicator system
21CFR892.5700
Class II |
| Common/Usual Name: | Interstitial Needles |
| Predicate Devices: | K093291. Varian Interstitial Titanium Needles. |
| Device Description: | The Interstitial Needles and their corresponding Obturators/Mandrins are intended for interstitial irradiation treatments of soft tissues including breast, head and neck, and tongue using HDR or PDR brachytherapy and are compatible with the following afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™ and can be used in combination with the appropriate accessories.
The devices 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.
There are two versions of the needle included in this submission: titanium and stainless steel. |
| Indications for Use: | The Interstitial Needles and their corresponding obturators are indicated for use for interstitial irradiation treatments of soft tissues such as breast, head and neck, tongue. |
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Technological Characteristics:
| CLEARED DEVICE FEATURE/SPECIFICATION | NEW / MODIFIED DEVICE | NEW / MODIFIED DEVICE | |
|---|---|---|---|
| FEATURE AND/OR SPECIFICATION | |||
| OF NEW/MODIFIED DEVICE | K093291=PREDICATE | ||
| 17G INTERSTITIAL TITANIUM NEEDLES: | |||
| GM11009700, GM11009710, GM11009720, | |||
| GM11009730 | 17G INTERSTITIAL TITANIUM NEEDLES: | ||
| GM11009700, GM11009710, GM11009720, | |||
| GM11009730 | |||
| 16G TITANIUM INTERSTITIAL NEEDLES: | |||
| GM11010210, GM11010220, GM11010230, | |||
| GM11010240, GM11010410, GM11010420, | |||
| GM11010430, GM11010440 | |||
| MANDRIN FOR 16G NEEDLE: GM11003340, | |||
| GM11003270, GM1101080, GM11003100 | 17G STAINLESS STEEL NEEDLE: | ||
| GM11009500, GM11009510, GM11009520, | |||
| GM11009530 | |||
| 18G STAINLESS STEEL NEEDLE: | |||
| GM11009550, GM11009560, GM11009570, | |||
| GM11009580 | |||
| OBTURATOR FOR 17G AND 18G NEEDLE: | |||
| GM11009800, GM11009810, GM11009820, | |||
| GM11009830 | |||
| Intended use | The Interstitial Needles are used with Varian | ||
| High Dose Rate Afterloaders | The Interstitial Needles and their | ||
| corresponding obturators are intended for | |||
| use in interstitial irradiation treatments of | |||
| soft tissues such as breast, head and neck, | |||
| tongue, using HDR or PDR brachytherapy. | The Interstitial Needles and their | ||
| corresponding obturators are intended for | |||
| use in interstitial irradiation treatments of | |||
| soft tissues such as breast, head and neck, | |||
| tongue, using HDR or PDR brachytherapy. | |||
| Indication for use | The Interstitial Needles are used with Varian | ||
| High Dose Rate Afterloaders | The Interstitial Needles and their | ||
| corresponding obturators are indicated for | |||
| use for interstitial irradiation treatments of | |||
| soft tissues such as breast, head and neck, | |||
| tongue, using HDR or PDR brachytherapy. | The Interstitial Needles and their | ||
| corresponding obturators are intended for | |||
| use in interstitial irradiation treatments of | |||
| soft tissues such as breast, head and neck, | |||
| tongue, using HDR or PDR brachytherapy. | |||
| Compatible Afterloader | GammaMedplus afterloader series | ||
| VariSource 200 and iX afterloader | GammaMedplus afterloader series | ||
| VariSource 200 and iX afterloader | GammaMedplus afterloader series | ||
| VariSource 200 and iX afterloader | |||
| 18G Stainless Steel Needle and Obturator | |||
| only compatible with VariSource 200 and iX | |||
| afterloader | |||
| Design | 17G Titanium Needle | ||
| The needles have a sharp trocar point and will be | |||
| available in the following dimensions: | |||
| Length: 113mm, 220mm, 250mm and 320 mm | |||
| Diameter: 17 Gauge (ø 1.47 mm) | |||
| ● | 17G Titanium Needle | ||
| The needles have a sharp trocar point and will | |||
| be available in the following dimensions: | |||
| Length: 113mm, 220mm, 250mm and 320 | |||
| mm | |||
| Diameter: 17 Gauge (ø 1.47 mm) | The needles have a sharp trocar point and will | ||
| be available in the following dimensions: | |||
| Length: 113mm, 220mm, 250mm and 320 | |||
| mm | |||
| Diameter: 17 Gauge and 18 Gauge( ø 1.47 | |||
| 16G Titanium Needle | |||
| The needles have a sharp and blunt trocar | |||
| point and will be available in following | |||
| dimensions: | |||
| Length: 113 mm, 200 mm, 250 mm, 320 | |||
| mm | |||
| Diameter: 16 Gauge (ø 1.65 mm) | mm and ø1.27 mm) | ||
| The obturators will be suitable for following | |||
| dimensions: | |||
| Length: 113mm, 200mm, 250mm and | |||
| 320mm | |||
| Diameter: 17 Gauge and 18 Gauge (ø 1.47mm | |||
| and ø 1.27mm) | |||
| Materials | Needle: Titanium | Needle: Titanium | Needle: Stainless steel |
| Obturator: Stainless steel | Obturator, Mandrin: Stainless steel | Obturator: Stainless steel | |
| Packing | Individual | Individual | Individual |
| Sterility | Delivered in non-sterile condition. To be sterilized | ||
| at customer site | |||
| Needle 25 cycles | |||
| Obturator: 100 cycles | Delivered in non-sterile condition. To be | ||
| sterilized at customer site | |||
| Needle 25 cycles | |||
| Obturator, Mandrin: 100 cycles | Delivered in non-sterile condition. To be | ||
| sterilized at customer site. | |||
| Number of sterilization cycle: | |||
| Needle 25 cycles | |||
| Obturator: 100 cycles | |||
| Sterilization method | Manual Cleaning | ||
| Steam sterilization | Manual and Machine Cleaning | ||
| Steam sterilization | Manual and Machine Cleaning | ||
| Steam sterilization | |||
| Biocompatibility | Biocompatible titanium and stainless steel | ||
| (mandrins and obturators only) used. (ISO 10993) | Biocompatible titanium and stainless steel | ||
| (mandrins and obturators only) used. (ISO |
-
| Biocompatible Stainless Steel used. (ISO -
|
| Anatomical sites | Breast, prostate, head and neck, tongue or soft
tissue structure | Breast, prostate, head and neck, tongue or
soft tissue structure | Breast, prostate, head and neck, tongue or
soft tissue structure |
| Compatibility with the
environment and
other devices | Compatible with CT imaging modalities | Compatible with CT imaging modalities | Compatible with CT imaging modalities |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room | Brachytherapy treatment room |
5
6
Non Clinical Tests Bench Testing has been performed to demonstrate that
- the devices function correctly with the specified afterloaders;
- 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 ISO10933 standards
- the devices can be used safely and effectively in CT environments
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