The HDR MRI Lumen Marker is indicated as an accessory for use with FDA Market Cleared remote controlled radionuclide applicator systems that are used to treat tumors that are indicated for treatment with high dose rate (HDR) brachytherapy. The HDR MRI Lumen Marker is indicated for temporary placement in HDR applicator lumens.

The HDR MRI Lumen Marker is intended to facilitate the identification of HDR applicator treatment lumens. It is intended to be non-patient contacting and only placed in applicators that are designed to prevent patient tissue or bodily fluids accessing the inner lumen.

Once placed in an HDR applicator lumen the HDR MRI Lumen Marker is intended to be imaged with MRI. It is removed after MR imaging and prior to the placement of a radioactive source. The HDR MRI Lumen Marker is intended for use in a single patient and can be used more than once if required for a single course of treatment in a single patient.

Device Description

The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline solution. The HDPE tube is up to 350.0 mm in length and 1.0 mm in diameter, with the distal 19.0 mm of the tube accommodating a HDPE sealing plug. The distal end of the device is provided with an attached HDPE end-cap for handling. This end cap is approximately 3.0 mm in length.

The HDR MRI Lumen Marker is an accessory to remote controlled high dose rate (HDR) radionuclide applicator systems and facilitates the identification of lumens within MRI compatible HDR brachytherapy applicators. Each HDR MRI Lumen Marker is supplied with a silicone stopper designed to hold the device in place once fully inserted into an applicator.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HDR MRI Lumen Marker, based on the provided FDA 510(k) summary:

The provided document does NOT contain a study with acceptance criteria in the format typically seen for AI/CAD devices, nor does it discuss human reader performance, AI assistance, or standalone algorithm performance.

This device, the HDR MRI Lumen Marker, is a physical accessory used with existing medical equipment. The 510(k) submission focuses on demonstrating substantial equivalence to a predicate device, meaning it performs similarly and is as safe and effective. It does not involve AI, computer-aided detection (CAD), or complex diagnostic performance metrics that would require the kind of clinical study details you've requested.

The "study" in this context refers to the comparison made for substantial equivalence, which is primarily a comparative analysis of the device's design, materials, and intended use against a legally marketed predicate device.

However, I can extract the information that is present and explain why some of your requested points are not applicable to this type of device submission.

Acceptance Criteria and Reported Device Performance

Since this is a physical accessory and not a diagnostic algorithm, the "acceptance criteria" are related to its physical properties, MRI visibility, and compatibility with existing systems, rather than diagnostic accuracy metrics. The "reported device performance" demonstrates it meets these functional expectations.

Acceptance Criterion (Inferred from device description and comparison)	Reported Device Performance
Material Composition: HDPE tube and cobalt chloride N-Acetylcysteine saline solution.	Device is comprised of a polymer tube (HDPE) filled with a fluid (cobalt chloride N-Acetylcysteine saline solution).
Dimensions: Up to 350.0 mm in length, 1.0 mm in diameter, 19.0 mm distal sealing plug, 3.0 mm end-cap.	Meets specified dimensions. (Implicitly accepted by FDA clearance based on provided description).
MRI Visibility: Fluid clearly visible on MRI to facilitate identification of lumens.	"Filled with a fluid that is clearly visible on MRI."
Compatibility: Accessory for FDA Market Cleared remote controlled radionuclide applicator systems.	Indicated for use with FDA Market Cleared remote controlled radionuclide applicator systems.
Non-Patient Contacting: Device does not come into direct contact with the patient.	"Intended to be non-patient contacting and only placed in applicators that are designed to prevent patient tissue or bodily fluids accessing the inner lumen."
Temporary Placement: Removed after MR imaging and prior to radioactive source placement.	"Removed after MR imaging and prior to the placement of a radioactive source."
Single Patient Use: Can be used once or more for a single course of treatment in a single patient.	"Intended for use in a single patient and can be used more than once if required for a single course of treatment in a single patient."

Details Not Applicable / Not Provided in the Document:

The following points are typically relevant for AI/Diagnostic imaging devices and are not applicable or not provided in this 510(k) summary for a physical medical device accessory:

Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" of patient data in the sense of a diagnostic classification study. The "testing" would involve physical and imaging compatibility tests, which are not detailed in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth is established for this device.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done because this is not a diagnostic device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an algorithm.
The type of ground truth used: Not applicable. The "ground truth" for this device relates to its physical performance and MRI visibility, confirmed through engineering tests, not clinical diagnostic truth.
The sample size for the training set: Not applicable. There is no concept of a "training set" for this kind of physical device.
How the ground truth for the training set was established: Not applicable.

Summary of the "Study" (Substantial Equivalence Analysis)

The "study" proving the device meets its (implicit) acceptance criteria is the substantial equivalence analysis detailed in Section 02 of the 510(k) summary.

Comparison to Predicate Device: The HDR MRI Lumen Marker is compared to the Interstitial Ring CT/MR Applicator Set (K091154 Nucletron).
Key Similarities highlighted:
- Same intended uses (facilitate identification of lumens in HDR brachytherapy applicators).
- Same technological characteristics (polymer tube filled with MRI-visible fluid).
- Both are placed in pre-inserted HDR applicators and imaged with MRI.
- Neither comes into direct patient contact.
- Both are removed after MR imaging and before treatment.
Conclusion: The HDR MRI Lumen Marker is found substantially equivalent to the predicate device, with "no differences that would affect the safety or effectiveness of the proposed device."

In essence, for a device like the HDR MRI Lumen Marker, the "acceptance criteria" are its functional and safety requirements, and the "study" is the demonstration through comparison to a similar, already-cleared device that it meets these requirements and is as safe and effective.

Summary

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April 27, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and below that, the word "ADMINISTRATION" in blue.

C4 Imaging LLC % Mr. Andrew Bright President and CEO 196 West Ashland Street DOYLESTOWN PA 18901

Re: K180069

Trade/Device Name: HDR MRI Lumen Marker Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: April 2, 2018 Received: April 4, 2018

Dear Mr. Bright:

We have reviewed vour 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 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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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara
For

Robert Ochs, Ph.D 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) K180069

Device Name HDR MRI Lumen Marker

Indications for Use (Describe)

Once placed in an HDR applicator lumen Marker is intended to be imaged with MRI. It is removed after MR imaging and prior to the placement of a radioactive source. The HDR MRI Lumen Marker is intended for use in a single patient and can be used more if required for a single course of treatment in a single patient.

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)

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Section 02 510(k) Summary

[as required by section 807.92(c)]

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

General Information

Submitted by:	C4 Imaging, LLC196 West Ashland StreetSuite 109Doylestown, PA 18901 USAPhone: +1 (609) 933-5895Email: abright@c4imaging.comContact Person: Andrew Bright
Date Prepared:	December 29, 2017

Device Name

Trade Name:	HDR MRI Lumen Marker
Common Name(s):	HDR applicator lumen marker

Classification

Regulation:	21 CFR §892.5700
Class:	Class II
Product Code:	JAQ
Classification name:	Remote controlled radionuclide applicator system accessory

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Predicate Device

Interstitial Ring CT/MR Applicator Set

K091154 Nucletron

Device Description

Indications

Comparison to Predicate Devices

C4 Imaging's HDR MRI Lumen Marker is an accessory to high dose rate (HDR) brachytherapy remote controlled radionuclide applicator systems and is intended to be used to identify treatment lumens in FDA approved MR compatible HDR applicators once the applicator has been placed in the treatment site. It is placed in a HDR applicator lumen and imaged with MRI. It is removed prior to treatment.

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The Interstitial Ring CT/MR Applicator Set (Nucletron BV - K091154) is identified as the principal predicate device to which the HDR MRI Lumen Marker is substantially equivalent (SE). The Interstitial Ring CT/MR Applicator Set is a legally marketed device that has the same intended uses, and the same technological characteristics as proposed for the HDR MRI Lumen Marker.

The Interstitial Ring CT/MR Applicator Set includes a polymer tube (Teflon) that can be filled with an appropriate fluid that can be clearly visualized on MRI. The HDR MRI Lumen Marker has essentially the same technological characteristics in that it's comprised of a polymer tube (HDPE) that is filled with a fluid that is clearly visible on MRI. Both devices are placed in HDR applicators that have been pre-inserted into the target treatment area of a patient and are MR imaged to facilitate a physician and dosimetrist identifying the location of the treatment source(s) during subsequent therapy. Neither devices are intended to come into direct contact with a patient and both are placed in the interior of applicators that are designed to prevent tissue or bodily fluids entering the inner lumen. Both devices are removed after MR imaging and before treatment begins.

Conclusion

The HDR MRI Lumen Marker is substantially equivalent to the MRI line marker that is a part of the previously cleared Interstitial Ring CT/MR Applicator Set (K091154). There are no differences that would affect the safety or effectiveness of the proposed device.

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.