The MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the MRI Marker, addressing your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the safety and effectiveness of the MRI Marker, rather than specific performance metrics against pre-defined acceptance criteria in the traditional sense of diagnostic accuracy or sensitivity/specificity. The criteria are largely related to established medical device standards and the device's intended function.

Acceptance Criterion (Implicit)	Reported Device Performance
Sterilization Efficacy (Sterility Assurance Level - SAL)	Validated to provide a Sterility Assurance Level (SAL) of 10-6 (per ISO 11137).
Biocompatibility	Nonirritant, nontoxic, with no concerns for long-term safety (per ISO 10993-1, addressed through in vivo and in vitro tests for irritation, sensitization, cytotoxicity, sub-acute and sub-chronic toxicity, and implantation). Animal testing also indicated a very low potential for toxicity.
MRI Safety (Induced Displacement Force, Torque, Heating)	Labeled as MR Conditional. No induced displacement force or torque observed. Not expected to pose a hazard (per ASTM F2052, F2213, F2119, F2182).
Radiographic Visualization (MR Imaging)	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.
Radiographic Visualization (X-ray Imaging)	X-ray imaging of the seeds and MRI Markers loaded in strands and brachytherapy needles demonstrated the MRI Marker performed as intended in effectively spacing the seeds.
Effective Spacing of Brachytherapy Seeds	X-ray imaging (as above) demonstrated effective spacing. The device description also states its use as an accessory to maintain spacing between radioactive seeds.
Substantial Equivalence to Predicate Devices	The technological characteristics are similar to or equivalent to the predicate devices. Differences in design do not raise new issues of safety and effectiveness. (This is the overarching acceptance criterion for 510(k) clearance).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of diagnostic performance (e.g., a specific number of images or patients for evaluation). The performance demonstrations are through:

Sterilization Validation: No explicit sample size mentioned for this, as it's a validation of a process.
Biocompatibility Testing: "In vivo and in vitro tests were performed." No specific numbers of samples or animals are provided.
MRI Safety Testing: No specific sample size mentioned for the devices tested.
Radiographic Visualization: "Phantom prostate imaging testing" (implies one or more phantoms) and "X-ray imaging of the seeds and MRI Markers loaded in strands and brachytherapy needles." No specific number of phantoms, strands, or needles are given.
Animal Testing: "Animal testing indicates..." No specific number of animals or data provenance (e.g., country of origin, retrospective/prospective) is provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies described are technical performance tests (e.g., sterilization, biocompatibility, MRI compatibility) and visualization tests using phantoms or animal models, rather than clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided as there is no mention of a human-read test set requiring adjudication in the context of the described performance testing.

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 (MRI Marker) is a physical marker for brachytherapy seeds, not an AI or software algorithm itself that would assist human readers in interpretation.

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

No, a standalone performance study in the context of an algorithm or AI was not done, as the MRI Marker is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the various tests was primarily based on:

Sterilization: Industry standards (ISO 11137) and laboratory verification (e.g., absence of microbial growth).
Biocompatibility: Established biological endpoints (e.g., absence of irritation, toxicity) as defined by ISO 10993-1 and observed in in-vitro, in-vivo, and animal models.
MRI Safety: Measurement of physical forces (displacement, torque) and temperature changes according to ASTM standards.
Radiographic Visualization & Spacing: Direct observation of images (MRI and X-ray) to confirm the presence of a positive signal and appropriate spacing in phantoms and simulated setups.

8. The Sample Size for the Training Set

This information is not applicable/provided. The MRI Marker is a physical device and does not involve AI or machine learning algorithms that would require a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable/provided. As above, there is no training set for this device.

Summary

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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. LLC4337 Vivian StreetBellaire, TX 77401Phone: +1 (713) 280-1843Email: abright@c4imaging.com
Contact Person:	Stephen J. Goldner, JD. RACRegulatory Affairs Associates. Inc.2550 South Telegraph RoadSuite 108Bloomfield Hills. MI 48302Phone: +1 (248) 747-8008Fax: +1 (203) 413-4320Email: sgoldner@regaffairs.net
Date Prepared:	June 25, 2013

Device Name

Trade Name:	MRI Marker™
Common Name(s):	Accessory to applicator and accessory to brachytherapysource

Classification

Regulation:	21 CFR §892.5730
Class:	Class II
Product Code:	KXK
Classification Name:	System, applicator, radionuclide manual & Source,brachytherapy, radionuclide (accessory to); Radionuclidebrachytherapy source

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Predicate Devices

RP Spacer	K103449	Riverpoint Medical
Worldwide Medical Technologies AnchorMarker	K083274	Biocompatibles
Accu-Space™ Absorbable Seeding Spacer	K010621	CP Medical
Optisource103	K040766	IBt s.a.

Device Description

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.

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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

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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

Regulation Number and Section

§ 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.