(161 days)
Not Found
No
The summary describes a physical medical device (a catheter and accessories) used for brachytherapy. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The validation focuses on physical performance and sterilization.
Yes
The device is described as being used for "treatment of the lung or other lumen" via "intraluminal brachytherapy," which is a form of radiation therapy aimed at treating diseases, thereby fulfilling the definition of a therapeutic device.
No
The device is intended for "intraluminal brachytherapy" and is used for "treatment" of the lung or other lumens, not for diagnosis.
No
The device description explicitly states it is a "flexible thin catheter and accessories" and mentions "catheter diameter" and "total length of the catheter," indicating it is a physical medical device, not software-only.
Based on the provided text, the LumenCare Azure is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "intraluminal brachytherapy" for the treatment of the lung or other lumens. This is a therapeutic procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a flexible catheter and accessories used for delivering radiation therapy (brachytherapy) within the body. This is consistent with a therapeutic device.
- No mention of in vitro testing: The text does not mention any testing of samples (blood, tissue, etc.) outside of the body, which is a defining characteristic of IVD devices.
Therefore, the LumenCare Azure is a therapeutic device used for delivering radiation treatment, not an IVD.
N/A
Intended Use / Indications for Use
The LumenCare Azure is intended for intraluminal brachytherapy and is used for treatment of the lung or other lumen, e.g. bronchus and bile duct.
The LumenCare Azure is designed to fit in the working channel of an endoscope.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The LumenCare Azure is a modification of the Lumencath Applicator Set. It is intended for intraluminal brachytherapy and is used for treatment of the lung and any lumen that allow the insertion of this flexible applicator, e.g. bronchus and bile duct. The applicator consists of a flexible thin catheter and accessories that assist during applicator placement, imaging and treatment. The catheter fits in the working channel of an endoscope. This way, the catheter can be positioned into the treatment area under direct visual control.
The catheter of the LumenCare Azure can be delivered in three variants. These variants only differ in dimensions, i.e. catheter diameter (outer diameter and inner diameter) and total length of the catheter.
The devices are used as accessories to Nucletron afterloaders.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung, bronchus, bile duct, any lumen
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)
Validation of sterilization processes and biocompatibility is provided. Bench testing (similar to bench testing done to the Legally Marketed Device) shows that the device meets its performance requirements, and that the device performance is equivalent to the Lumencath Applicator Set.
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
K132874
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Image /page/0/Picture/1 description: The image shows the word "Nucletron" in a bold, sans-serif font. To the left of the word is a stylized logo consisting of three overlapping circles. The logo is also in black and white, matching the text.
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
FEB 2 1 2014
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(k) Summary
10 February 2014
Submitter of 510(k):
Nucletron BV Company name: Registration number: 611894 Waardgelder 1, 3905 TH Veenendaal, The Netherlands Address: Phone: +31 318 557 133 Fax: +31 318 557 118 Rudolf Vos Correspondent:
New Device Name:
Trade/Proprietary Name: Common/Usual Name: Classification Name: Classification: Product code:
LumenCare Azure Intraluminal Brachvtherapy applicator Remote controlled radionuclide applicator system accessory 21CFR892.5700 Class II JAQ
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| Manufacturer Device | AndreAmAndiaAustryToTalLandsMarryTonymaAdaAVY VTMS Comment | 510(k) # |
|---|---|---|
| Nucletron BV | LUMENCATH APPLICATOR SET | K091598 |
| of the program and the comments of the commended to the commended to the comments of |
Description:
The LumenCare Azure is a modification of the Lumencath Applicator Set. It is intended for intraluminal brachytherapy and is used for treatment of the lung and any lumen that allow the insertion of this flexible applicator, e.g. bronchus and bile duct. The applicator consists of a flexible thin catheter and accessories that assist during applicator placement, imaging and treatment. The catheter fits in the working channel of an endoscope. This way, the catheter can be positioned into the treatment area under direct visual control.
1
K132874
page 2 of 2
The catheter of the LumenCare Azure can be delivered in three variants. These variants only differ in dimensions, i.e. catheter diameter (outer diameter and inner diameter) and total length of the catheter.
The devices are used as accessories to Nucletron afterloaders.
Intended use:
The LumenCare Azure is intended for intraluminal brachytherapy and is used for treatment of the lung or other lumen, e.g. bronchus and bile duct. The LumenCare Azure is designed to fit in the working channel of an endoscope.
Summary of technological considerations:
The intended use was rephrased to make the wording more consistent, but is essentially the same as the intended use for the cleared device. The catheter is made of another material (which is more kink resistant), the dimensions are similar. All other components are identical.
Summary of testing:
Validation of sterilization processes and biocompatibility is provided. Bench testing (similar to bench testing done to the Legally Marketed Device) shows that the device meets its performance requirements, and that the device performance is equivalent to the Lumencath Applicator Set.
Conclusion:
Nucletron considers the LumenCare Azure to be substantially equivalent to legally marketed predicate device through the data and information presented. No safety or effectiveness issues were identified.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2014
Nucletron B.V. % Mr. Rudolf Vos QA/RA Engineer Waardgelder 1, Veenendaal, 3905 TH THE NETHERLANDS
Re: K132874
Trade/Device Name: LumenCare Azure Set 6F, 150cm, LumeCare Azure Set Sf, 150cm, and LumenCare Azure Set 5f, 140 cm Regulation Number: 21 CFR 892.5700 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: JAQ Dated: January 22, 2014 Received: January 24, 2014
Dear Mr. Vos:
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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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/MedicalDcvices/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,
Jamingh. Menge
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K132874
Device Name: LumenCare™ Azure
Indications for Use:
The LumenCare Azure is intended for intraluminal brachytherapy and is used for treatment of the lung or other lumen, e.g. bronchus and bile duct.
The LumenCare Azure is designed to fit in the working channel of an endoscope.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Medard D. O'Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiotogical Health 510(k) _ K132874