(95 days)
The Sirius MRI Marker NS 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: Iodine 125 (1251), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
The Sirius MRI Marker NS is intended to facilitate the anatomical localization of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. It is intended to be imaged under MRI within sixty (60) days of implantation.
The Sirius MRI Marker NS is supplied non-sterile and will need to be sterilized by the end-user using either gamma radiation or ethylene oxide.
C4 Imaging's Sirius MRI Marker NS consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride:N-Acetylcysteine 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.
The Sirius MRI Marker NS will be supplied non-sterile and will be sterilized by the end-user using ethylene oxide or gamma radiation.
The provided text is a 510(k) summary for the Sirius MRI Marker NS, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for acceptance criteria in the traditional sense of a diagnostic or interventional AI/CADe/CADx device.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission as it does not describe a clinical performance study of the device's diagnostic or interventional capabilities.
The submission is primarily concerned with proving that the Sirius MRI Marker NS, which is an accessory device, is as safe and effective as a legally marketed predicate device (MRI Marker K131689), despite minor differences in sterilization and packaging. It explicitly states there are "no differences between the proposed device Sirius MRI Marker NS and the predicate device with regard to dimension, composition of the fill solution, and manufacturing process of the marker itself that would affect the safety or effectiveness of the proposed device."
The "Indications for Use" section (page 3 and 5) describes the intended purpose of the device: "to facilitate the anatomical localization of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. It is intended to be imaged under MRI within sixty (60) days of implantation." This is a functional description, not a performance metric that would require a study with the criteria listed in the prompt.
{0}------------------------------------------------
Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
C4 Imaging, LLC % Stephen Goldner, J.D. President Regulatory Affairs Associates 4761 Tara Court WEST BLOOMFIELD MI 48323
Re: K171487
Trade/Device Name: Sirius MRI Marker NS Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: July 28, 2017 Received: July 31, 2017
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 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 (reporting of medical device
{1}------------------------------------------------
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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}------------------------------------------------
Attachment 1
Revised Indications for Use (Form FDA 3881)
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K171487
Device Name Sirius MRI Marker NS
Indications for Use (Describe)
The Sirius MRI Marker NS 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: Iodine 125 (1251), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
The Sirius MRI Marker NS is intended to facilitate the anatomical localization of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. It is intended to be imaged under MRI within sixty (60) days of implantation.
The Sirius MRI Marker NS is supplied non-sterile and will need to be sterilized by the end-user using either gamma radiation or ethylene oxide.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
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 USA |
|---|---|
| Phone: +1 (609) 933-5895Email: abright@c4imaging.com | |
| Contact Person: | Stephen J. Goldner, JD, RACRegulatory Affairs Associates, LLC4761 Tara CourtWest Bloomfield, MI 48323 USA |
| Phone: +1 (248) 515-0097Fax: +1 (313) 557-4200Email: sgoldner@regaffairs.net | |
| Date Prepared: | July 28, 2017 |
| Trade Name: | Sirius MRI Marker NS |
| 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: | Radionuclide brachytherapy source |
source
{5}------------------------------------------------
Predicate Devices
MRI Marker
K131689 C4 Imaging
Device Description
C4 Imaging's Sirius MRI Marker NS consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride:N-Acetylcysteine 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.
The Sirius MRI Marker NS will be supplied non-sterile and will be sterilized by the end-user using ethylene oxide or gamma radiation.
Indications
The Sirius MRI Marker NS 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: Iodine 125 (125), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
The Sirius MRI Marker NS is intended to facilitate the anatomical localization of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. It is intended to be imaged under MRI within sixty (60) days of implantation.
The Sirius MRI Marker NS is supplied non-sterile and will need to be sterilized by the end-user using either ethylene oxide or gamma radiation.
Comparison to Predicate Devices
The proposed device, Sirius MRI Marker NS, is a seed spacer intended to maintain spacing between radioactive seeds when delivered by a preloaded seeding needle.
The manufacturing process for the Sirius MRI Marker NS is the same as the previously cleared MRI Marker (K131689) except for the sterilization method and site. The MRI Marker was supplied sterile. The sterilization method used was gamma radiation (Cobalt 60). The Sirius MRI Marker NS will be supplied non-sterile and will be sterilized by the end-user using ethylene oxide or gamma radiation (Cobalt 60).
The Sirius MRI Marker NS is supplied in packs of up to 250 units within a primary container, which is contained within a secondary protective barrier. The pack is supplied within an outer box.
The predicate device, MRI Marker, is provided sterile in packs of 100 units within a primary container, which is contained within a secondary sterility barrier. The sterile pack is supplied within an outer protective box.
{6}------------------------------------------------
Conclusion
There are no differences between the proposed device Sirius MRI Marker NS and the predicate device with regard to dimension, composition of the fill solution, and manufacturing process of the marker itself that would affect the safety or effectiveness of the proposed device.
The differences in the packaging process are due to the Sirius MRI Marker NS being supplied non-sterile and held in bulk until order fulfillment. The container/closure system for the bulk packaged markers is the same as the system for the original MRI Marker, 4 mL amber, borosilicate glass vial with a black polypropylene cap.
Supplying the marker as nonsterile to be sterilized by the end user and the addition of ethylene oxide sterilization as an alternative sterilization method should not affect the performance of the marker.
§ 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.