MRI MARKER

K131689 · C4 Imaging, LLC · KXK · Nov 20, 2013 · Radiology

Device Facts

• Record ID: K131689
• Device Name: MRI MARKER
• Applicant: C4 Imaging, LLC
• Product Code: KXK · Radiology
• Decision Date: Nov 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2

Indications for Use

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 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.

Device Story

MRI Marker is a sterile, non-biodegradable accessory for prostate brachytherapy. It consists of a 5.5 mm x 0.8 mm PEEK polymer capsule containing a cobalt chloride:N-Acetylcysteine (CoCl2:NAC) solution. During prostate brachytherapy, the marker is implanted alongside radioactive seeds within carrier sleeves. The CoCl2:NAC solution provides a positive signal during MRI, allowing clinicians to visualize and localize the radioactive seeds post-implantation. The device is used by physicians in a clinical setting to facilitate anatomical localization of seeds, aiding in treatment verification and assessment. It does not contain software or algorithms.

Clinical Evidence

Bench testing included sterilization validation (ISO 11137), biocompatibility (ISO 10993-1), and MRI safety (ASTM F2052, F2213, F2119, F2182). Phantom prostate imaging confirmed positive-signal MRI visibility. X-ray imaging confirmed effective seed spacing. Animal testing demonstrated low toxicity and no safety concerns. No human clinical trial data provided.

Technological Characteristics

Materials: PEEK polymer capsule, CoCl2:NAC solution. Dimensions: 5.5 mm length, 0.8 mm diameter. Principle: Positive MRI signal generation via CoCl2:NAC. Connectivity: None. Sterilization: Validated to SAL 10^-6 per ISO 11137. MRI Safety: MR Conditional per ASTM F2052, F2213, F2119, F2182.

Indications for Use

Indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy, used as an accessory with brachytherapy seed carrier sleeves and radionuclide seeds (I-125, Pd-103, or Cs-131).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• RP Spacer (K103449)
• Worldwide Medical Technologies Anchor Marker (K083274)
• Accu-Space™ Absorbable Seeding Spacer (K010621)
• Optisource103 (K040766)

Submission Summary (Full Text)

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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<br>4337 Vivian Street<br>Bellaire, TX 77401<br>Phone: [phone]<br>Email: [e-mail] |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen J. Goldner, JD. RAC<br>Regulatory Affairs Associates. Inc.<br>2550 South Telegraph Road<br>Suite 108<br>Bloomfield Hills. MI 48302<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | June 25, 2013 |

## Device Name

| Trade Name: | MRI Marker™ |
|-----------------|------------------------------------------------------------------|
| Common Name(s): | Accessory to applicator and accessory to brachytherapy<br>source |

### Classification

| Regulation: | 21 CFR §892.5730 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Class: | Class II |
| Product Code: | KXK |
| Classification Name: | System, applicator, radionuclide manual & Source,<br>brachytherapy, radionuclide (accessory to); Radionuclide<br>brachytherapy source |

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#### Predicate Devices

| RP Spacer | K103449 | Riverpoint Medical |
|-------------------------------------------------|---------|--------------------|
| Worldwide Medical Technologies Anchor<br>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.

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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 [phone] or [phone] 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 [phone] or [phone] 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