(108 days)
Not Found
No
The device description and intended use focus on a physical marker for MRI imaging and do not mention any computational or algorithmic components.
No
The device is described as an accessory for identifying lumens in applicator systems used for brachytherapy, not directly applying therapy itself. It is removed prior to radioactive source placement.
No
The device is an accessory that facilitates the identification of lumens within MRI compatible HDR brachytherapy applicators for treatment, not for diagnosing a medical condition.
No
The device description explicitly states it is a sealed high-density polyethylene (HDPE) tube containing a solution, which is a physical object and not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the HDR MRI Lumen Marker is placed within an HDR applicator lumen, which is a part of a medical device used for treatment. It does not interact with or analyze any bodily fluids or tissues.
- IVDs are used to provide information about a physiological or pathological state. The purpose of this device is to facilitate the identification of lumens within an applicator during MRI imaging, which is a procedural aid, not a diagnostic test.
- The device is non-patient contacting. This is explicitly stated in the intended use, which is contrary to the nature of IVDs that interact with patient specimens.
The device is an accessory to a therapeutic device (HDR brachytherapy applicator systems) and is used for imaging purposes to aid in the treatment planning process.
N/A
Intended Use / Indications for Use
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 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.
Product codes
JAO, JAQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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.
1
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
2
Indications for Use
510(k) Number (if known) K180069
Device Name HDR MRI Lumen Marker
Indications for Use (Describe)
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 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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3
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, LLC
196 West Ashland Street
Suite 109
Doylestown, PA 18901 USA
Phone: +1 (609) 933-5895
Email: abright@c4imaging.com
Contact 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 |
4
Predicate Device
Interstitial Ring CT/MR Applicator Set
K091154 Nucletron
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.
Indications
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.
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.
5
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.