(87 days)
Luneray is intended for interstitial brachytherapy of soft tissue that allows the insertion of this flexible applicator, e.g .:
- Abdominal structures / organs (e.g. urinary . bladder)
- Head and neck (e.g. ear, lip, nose, tongue, oral . mucosa)
- Skin (e.g. keloids) .
- Soft tissue sarcoma .
Luneray enables minimally invasive procedures to be performed both manually and laparoscopically.
Luneray is a pre-assembled, sterile needle-catheter combination for interstitial brachytherapy treatments. The needle is inserted into the tissue and pulls the catheter through the tissue. After insertion the needle is removed from the catheter by cutting it off the catheter.
Radiation treatment planning can be based on X-ray and CT images. X-ray markers shall be used during the imaging procedure, to enable catheter reconstruction in the planning software.
The applicator is connected to a Nucletron brachytherapy afterloader for radiation treatment.
I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) summary for a medical device (Luneray) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than detailing the acceptance criteria and study proving performance as typically found in clinical trials or performance verification reports.
The document discusses:
- Device description and indications for use.
- Comparison to predicate devices.
- Summary of testing: It mentions "Sterilization, Shelf Life, Biocompatibility, Functional verification testing and testing to Standards" and states that "Performance testing was performed at a hospital site, under clinical conditions and with the involvement of clinical personnel but excluding the delivery of treatment of patients." It also says, "Experienced users reviewed the device design and executed validation tests."
However, it does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details on ground truth establishment for specific performance metrics.
- Number/qualifications of experts for ground truth.
- Adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance, as the device is a physical medical instrument, not an AI algorithm.
- Sample size for training sets, as concept of training sets is not applicable to a physical medical device.
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Image /page/0/Picture/0 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a black atom-like symbol. The symbol consists of a black circle with two smaller white circles on the outside.
NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557 133 Fax +31 318 557 118 2140803
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(k) Summary
April 9, 2014
JUN 2 6 2014
Submitter of 510(k):
| Company name: | Nucletron BV |
|---|---|
| Registration number: | 611894 |
| Address: | Waardgelder 1, 3905 TH Veenendaal, The Netherlands |
| Phone: | +31 318 557 133 |
| Fax: | +31 318 557 118 |
| Correspondent: | Rudolf Vos |
New Device Name:
| Trade/Proprietary Name: | Luneray |
|---|---|
| Common/Usual Name: | Interstitial brachytherapy applicator for remote-afterloading |
| Classification Name: | Remote controlled radionuclide applicator systemaccessory |
| Classification: | 21CFR892.5700, Class II |
| Product code: | JAQ |
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Nucletron BV | Comfort Catheter System | K032377 |
| Nucletron BV | NAG brachvflex | KORROJE225 22 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 |
Description:
Luneray is a pre-assembled, sterile needle-catheter combination for interstitial brachytherapy treatments. The needle is inserted into the tissue and pulls the catheter through the tissue. After insertion the needle is removed from the catheter by cutting it off the catheter.
Radiation treatment planning can be based on X-ray and CT images. X-ray markers shall be used during the imaging procedure, to enable catheter reconstruction in the planning software.
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The applicator is connected to a Nucletron brachytherapy afterloader for radiation treatment.
Indications for use:
Lunerav is intended for interstitial brachytherapy of soft tissue that allows the insertion of this flexible applicator, e.g .:
- Abdominal structures / organs (e.g. urinary bladder) .
- Head and neck (e.g. ear, lip, nose, tongue, oral mucosa) .
- Skin (e.g. keloids) .
- Soft tissue sarcoma .
Luneray enables minimally invasive procedures to be performed both manually and laparoscopically.
The indications for use of Luneray are more specific than the indications for use of the predicate devices. More specificity is added to the tissue type and insertion techniques are specifically mentioned. These modifications do not constitute a new intended use. Submitted validation and clinical literature data demonstrates that the device is as safe and effective as the predicate and support addition of specific indications in this submission.
Summary of technological considerations:
Luneray and the predicate devices provide an unobstructed, closed path for the radioactive source. The devices are used in the hospital by trained professionals. With all devices, imaging for treatment planning possible with X-ray, CT, and MR. All devices are connected to remote afterloader systems.
The differences between Luneray and the predicate devices are related to differences in design and handling of the device. With Luneray, needles and catheters are preassembled. With the predicates, needles and catheters are separate components. The predicate devices are handled manually: Luneray can also be handled with laparoscopic tools.
Luneray is delivered sterile. The predicate devices are delivered unsterile (K953946) or some components are delivered sterile (K032372).
The differences do not affect the similarity in principal technology, function and operational characteristics of the devices. As a result. it is determined that the Luneray interstitial brachytherapy applicator is substantially equivalent to the legally marketed predicate devices.
Summary of testing:
Luneray has been tested to meet the product requirements from (safety) standards and clinical expectations. Verification tests cover Sterilization, Shelf Life, Biocompatibility, Functional verification testing and testing to Standards.
Performance testing was performed at a hospital site, under clinical conditions and with the involvement of clinical personnel but excluding the delivery of treatment of patients. Experienced users reviewed the device design and executed validation tests.
The results of the testing provided in this submission adequately demonstrate that the interstitial brachytherapy applicator Luneray performs as defined in the requirements, in accordance with the recognized standards, meets clinical expectations and is safe and effective for clinical use.
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Conclusion:
1
:
Nucletron considers the Luneray interstitial brachytherapy applicator to be substantially equivalent to legally marketed predicate device through the data and information presented. No safety or effectiveness issues were identified.
.
: .
Nucletron BV, 510(k) summary Luneray
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2014
NUCLETRON B.V. RUDOLF VOS QA/RA ENGINEER WAARDGELDER I VEENENDAAL 3905 TH THE NETHERLANDS
Re: K140803
Trade/Device Name: Luneray:catheter 6f 50cm. Needle 37mm R30mm/47mm R45mm/57mm R60mm/67mm R75 Mm
Regulation Number: 21 CFR 892.5700
Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: 11 Product Codc: JAQ Dated: March 27, 2014 Received: March 31, 2014
Dear Mr. Vos:
ﺴ
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. Ilisting 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 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.
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Page 2-Mr. Vos
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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hrecher D. O'Hara
for
Janine M Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Luneray
Device Name:
Indications for Use:
Luneray is intended for interstitial brachytherapy of soft tissue that allows the insertion of this flexible applicator, e.g .:
- Abdominal structures / organs (e.g. urinary . bladder)
- Head and neck (e.g. ear, lip, nose, tongue, oral . mucosa)
- Skin (e.g. keloids) .
- Soft tissue sarcoma .
Luneray enables minimally invasive procedures to be performed both manually and laparoscopically.
Prescription Use × (Part 21 CFR 801 subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 subpart C)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Page 1 of 1
§ 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.