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.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, study methodologies, or performance metrics in a way that allows for a direct answer to the requested table and study details.

The document states: "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." This indicates that some form of testing was conducted to demonstrate equivalence, but the specifics are not provided.

Therefore, most of the requested information cannot be extracted from the given text.

Here's what can be gathered and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not specified in the document.
Reported Device Performance: The document only vaguely states that "the device meets its performance requirements, and that the device performance is equivalent to the Lumencath Applicator Set." No specific quantitative or qualitative performance metrics are provided.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size: Not specified.
Data Provenance: Not specified.
Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable / Not mentioned. The document refers to "bench testing," which typically does not involve expert readers establishing ground truth in the same way as studies involving image interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable / Not mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device is an intraluminal brachytherapy applicator, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable / Not mentioned. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated for the "bench testing." For a physical device, ground truth would typically relate to physical properties, mechanical integrity, material performance, and functional tests against specified engineering requirements.

8. The sample size for the training set:

Not applicable / Not mentioned. This device is a physical medical instrument, not an AI algorithm requiring a training set in the conventional sense.

9. How the ground truth for the training set was established:

Not applicable / Not mentioned.

Summary

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K132874
Page 1 of 2

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	K091598of the program and the comments of the commended to the commended to the comments of

Description:

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K132874
page 2 of 2

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.

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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.

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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

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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

Regulation Number and Section

§ 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.