(163 days)
No
The device description and performance studies focus on the physical properties, biocompatibility, and imaging visibility of a passive marker, with no mention of AI/ML algorithms for image processing, analysis, or any other function.
No
This device is described as an "accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources." Its purpose is to facilitate the localization and spacing of radioactive seeds, not to directly treat the disease itself.
No.
The device is an MRI Marker, explicitly described as an "accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources." Its purpose is to facilitate the localization of adjacent radioactive seeds and spacing during brachytherapy procedures, not to diagnose a condition.
No
The device description clearly states it is a physical capsule made of PEEK polymer containing a solution, and the performance studies involve in vitro and in vivo testing of this physical component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy, used as an accessory for brachytherapy. This is a therapeutic and interventional use within the body, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is a physical implantable marker.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, this device falls under the category of an implantable medical device used in a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuchde brachytherapy sources containing one of the following isotopes: Iodine 125 (1-1). Palladium 103 (139Pd) or Cesium 131 (11)Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancv.
Product codes
KXK
Device Description
C4 Imaging's MRI Marker™ consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride:N-Acetylcysteine (CoCl2:NAC) solution. It is used as an accessory to radionuclide sources (seeds) during prostate brachytherapy procedures. The length of the capsule is 5.5 mm and the diameter is 0.8 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, X-ray
Anatomical Site
prostate
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)
In Vitro and In vivo preclinical testing was performed to verify and validate the safety and effectiveness of the MRI Marker. These tests included sterilization to ISO 11137; biocompatibility testing per ISO 10993-1; MRI safety testing per ASTM F2052. F2213. F2119. and F2182; and radiographic visualization.
Sterilization conditions have been validated in accordance to provide a Sterility Assurance Level (SAL) of 10th.
In vivo and in vitro tests were performed to address irritation, sensitization, cytotoxicity, sub-acute and sub-chronic toxicity, and implantation. Results identified the MRI Marker as a nonirritant, and nontoxic with no concerns for long-term safety.
The results of the MRI compatibility testing indicate that, in accordance with the guidance of relevant ASTM standards, the MRI marker should be labeled MR Conditional. There was no induced displacement force or torque observed for the device, and therefore, is not expected to pose a hazard.
Phantom prostate imaging testing produced a positive-signal MRI image demonstrating the ability of the MRI Marker to perform the intended use of facilitating localization of adjacent radioactive seeds. X-ray imaging of the seeds and MR1 Markers loaded in strands and brachytherapy needles demonstrated the MRI Marker performed as intended in effectively spacing the seeds.
Animal testing indicates that the MRI Markers has a very low potential for toxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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NOV 2 0 2013
K131689
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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
4337 Vivian Street
Bellaire, TX 77401
Phone: +1 (713) 280-1843
Email: abright@c4imaging.com |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen J. Goldner, JD. RAC
Regulatory Affairs Associates. Inc.
2550 South Telegraph Road
Suite 108
Bloomfield Hills. MI 48302
Phone: +1 (248) 747-8008
Fax: +1 (203) 413-4320
Email: sgoldner@regaffairs.net |
| Date Prepared: | June 25, 2013 |
Device Name
| Trade Name: | MRI Marker™ |
|---|---|
| Common Name(s): | Accessory to applicator and accessory to brachytherapy |
| source |
Classification
| Regulation: | 21 CFR §892.5730 |
|---|---|
| Class: | Class II |
| Product Code: | KXK |
| Classification Name: | System, applicator, radionuclide manual & Source, |
| brachytherapy, radionuclide (accessory to); Radionuclide | |
| brachytherapy source |
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Predicate Devices
| RP Spacer | K103449 | Riverpoint Medical |
|---|---|---|
| Worldwide Medical Technologies Anchor | ||
| Marker | K083274 | Biocompatibles |
| Accu-Space™ Absorbable Seeding Spacer | K010621 | CP Medical |
| Optisource103 | K040766 | IBt s.a. |
Device Description
C4 Imaging's MRI Marker™ consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride:N-Acetylcysteine (CoCl2:NAC) solution. It is used as an accessory to radionuclide sources (seeds) during prostate brachytherapy procedures. The length of the capsule is 5.5 mm and the diameter is 0.8 mm.
Indications
The MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy seeds containing one of the following isotopes: lodine 125 (1851). Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
Comparison to Predicate Devices
The proposed device, MRI Marker, is a seed spacer intended to maintain spacing between radioactive seeds when delivered by a preloaded seeding needle. Similarly, three of the predicate devices (RP Spacer, Anchor Marker, and Accu-Space Absorbable Seeding Spacer) are intended to maintain spacing between radioactive seed when delivered by a seeding needle. Both the MRI Marker and Anchor Maker are intended to facilitate the anatomical localization of seeds.
The RP Spacer has a similar intended use as the MRI Marker, as a brachytherapy accessory indicated to be placed between seeds in a carrier sleeve that facilitates the implant of seeds at predetermined intervals within body tissue. RP Spacers are composed of copolymer made from 90% glycolide and 10% L-lactide (PLGA). The MRI Marker consists of a sealed non-biodegradable, biocompatible polyether ether ketone (PEEK) polymer capsule containing a CoCl2:NAC solution. Both the MRI Marker and the RP Spacer are available as sterile products with identical dimensions (5.5 mm in length and 0.8 mm in diameter).
The Anchor Marker has a similar intended use as an accessory component of a brachytherapy system intended to provide clear identification of anatomic regions by providing reference positions around the proposed treatment site. The Anchor Marker is intended to be implanted in a carrier sleeve in a manner identical to the MRI Marker. The Anchor Marker has similar technological characteristics to the MRI
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K131689
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Marker in that the active element is encapsulated in a synthetic biocompatible polymer and has identical dimensions (5.5 mm in length and 0.8 mm in diameter). The Anchor Marker active element is a Gold Fiducial Marker, Both the MRI Marker and the Anchor Marker can be visualized when imaged with MR and facilitate locating radioactive seeds.
CP Medical Accu-Space Absorbable Sceding Spacer is similar in that it is intended to maintain spacing between radioactive seeds when delivered by a preloaded seeding needle. The Accu-Space Absorbable Sceding Spacer consists of absorbable spacer material and is a small cylindrical component device.
Optisource 103 has similar technological characteristics to the MRI Marker, with the outer shell comprised of the same biocompatible polymer: polyether ether ketone (PEEK). As is the case with the MRI Marker the PEEK shell is sealed through heat induced welding to contain an active clement. Optisource 103 is a permanent interstitial implant 5.0 mm long by 0.88 mm in diameter with a polymeric shell and containing Pd-103 in two solid polymeric cylinders separated by a gold marker to provide MRI visibility. The MRI Marker exhibits a positive signal when imaged with MR.
Performance Testing
In Vitro and In vivo preclinical testing was performed to verify and validate the safety and effectiveness of the MRI Marker. These tests included sterilization to ISO 11137; biocompatibility testing per ISO 10993-1; MRI safety testing per ASTM F2052. F2213. F2119. and F2182; and radiographic visualization.
Sterilization conditions have been validated in accordance to provide a Sterility Assurance Level (SAL) of 10th.
In vivo and in vitro tests were performed to address irritation, sensitization, cytotoxicity, sub-acute and sub-chronic toxicity, and implantation. Results identified the MRI Marker as a nonirritant, and nontoxic with no concerns for long-term safety.
The results of the MRI compatibility testing indicate that, in accordance with the guidance of relevant ASTM standards, the MRI marker should be labeled MR Conditional. There was no induced displacement force or torque observed for the device, and therefore, is not expected to pose a hazard.
Phantom prostate imaging testing produced a positive-signal MRI image demonstrating the ability of the MRI Marker to perform the intended use of facilitating localization of adjacent radioactive seeds. X-ray imaging of the seeds and MR1 Markers loaded in strands and brachytherapy needles demonstrated the MRI Marker performed as intended in effectively spacing the seeds.
Animal testing indicates that the MRI Markers has a very low potential for toxicity.
Conclusion
The technological characteristics are similar to or equivalent to the predicate devices. Differences in design between the devices do not raise any new issues of safety and effectiveness.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and flow together, resembling a stylized human figure or a flowing ribbon.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
November 20, 2013
C4 Imaging LLC % Stephen J. Goldner, JD, RAC President Regulatory Affairs Associates, Inc. 2550 South Telegraph Road BLOOMFIELD HILLS MI 48302
Re: K131689
Trade/Device Name: C4 Imaging MRI Marker Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: K.XK Dated: October 7, 2013 Received: October 11, 2013
Dear Mr. Goldner:
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 vou, 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.
4
Page 2-Mr. Goldner
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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,
Michael 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
5
Indications for Use
510(k) Number (if known): K131689
Device Name: MRI Marker
Indications for Use:
The MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuchde brachytherapy sources containing one of the following isotopes: Iodine 125 (1-1). Palladium 103 (139Pd) or Cesium 131 (11)Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancv.
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)
Michael D. O'Hara
510(k) K131689
Page 1 of 1
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health