(26 days)
Not Found
Not Found
No
The summary describes a passive implanted marker and its visualization using standard medical imaging. There is no mention of AI/ML for image analysis, treatment planning, or any other function.
No
The device is described as an implanted marker used to identify the location of normal or diseased tissue for future treatments, providing a reference for guiding treatment, rather than providing therapy itself.
No
This device is a marker for identifying the location of normal or diseased tissue for future procedures, not for diagnosing a condition itself. It aids in guiding treatment, not in initial diagnosis.
No
The device description clearly states that FlexiMarc is an implanted marker fabricated from pure gold, available in varying lengths and diameters, and delivered in sterile needles. This describes a physical, implanted medical device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The FlexiMarc is described as an implanted marker that is placed inside the body to identify the location of tissue for future procedures. It is a physical object that remains within the patient.
- Intended Use: The intended use is to serve as a surrogate locator for future procedures, visualized using medical imaging devices. This is a physical marking function, not a diagnostic test performed on a sample.
The device is a medical device used for localization and guidance during medical procedures, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
In situations where the location of specific anatomy, normal and diseased needs to be marked for future procedures this device will serve as a surrogate locator. The all gold FlexiMarc is placed either in advance or during a treatment procedure. These all gold FlexiMarc can be visualized using medical imaging devices and they provide a reference from which the treatment can be guided.
Product codes
IYE
Device Description
FlexiMarc is an implanted marker used to identify the location of normal or diseased tissue for future treatments. The marker is placed at or near the treatment site and can easily be visualized in subsequent imaging studies. The location of the treatment area is then identified with respect to the marker.
The FlexiMarc soft tissue marker is fabricated of all biocompatible pure gold. It is available in varying lengths from 2 mm overall to 4 CM overall and ranges in diameter from 0.5 mm to 1.6 mm so that it can be identified in the varying medical imaging formats. FlexiMarc is delivered in sterile preexisting needles ranging from 20 GA to 16 GA.
FlexiMarc is intended for single use and is permanently implanted in the body. They are available presterilized in accordance with FDA QSR sterilization procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, CBCT, MR, kV x-ray and MV x-ray
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
Both markers have been imaged using the typical imaging devices including, CT, CBCT, MR, kV x-ray and MV x-ray both markers are visible in all of these modalities. Note: Diameter is a consideration with respect to MV x-ray imaging -- meaning the larger diameter markers are required for both devices.
Key Metrics
Not Found
Predicate Device(s)
Visicoil, RadioMed (an IBA Co.)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) Summary for FlexiMarc
Cortex Manufacturing Inc. 621 SR 9 NE PMB-B8 Lake Stevens, WA 98258
FEB 2 4 2010
Contact: Andrew Jones Phone: (425) 334-2277
Preparation date: Feb. 23, 2010
Trade Name: FlexiMarc Implanted Marker Common Name: Classification Name: 892.5050
SE Device:
Visicoil, RadioMed (an IBA Co.)
Brief Description:
FlexiMarc is an implanted marker used to identify the location of normal or diseased tissue for future treatments. The marker is placed at or near the treatment site and can easily be visualized in subsequent imaging studies. The location of the treatment area is then identified with respect to the marker.
The FlexiMarc soft tissue marker is fabricated of all biocompatible pure gold. It is available in varying lengths from 2 mm overall to 4 CM overall and ranges in diameter from 0.5 mm to 1.6 mm so that it can be identified in the varying medical imaging formats. FlexiMarc is delivered in sterile preexisting needles ranging from 20 GA to 16 GA.
FlexiMarc is intended for single use and is permanently implanted in the body. They are available presterilized in accordance with FDA QSR sterilization procedures.
Intended Use Statement
In situations where the location of specific anatomy, normal and diseased needs to future procedures this device will serve as a surrogate locator. The all gold FlexiMarc is placed either in advance or during a treatment procedure. These all gold FlexiMarcs can be
1
visualized using medical imaging devices and they provide a reference from which the treatment can be guided.
Technological Characteristics
Both FlexiMarc and the predicate device are fabricated in such a fashion as to make them flexible in nature. This serves to reduce the potential for migration of the marker. It also provides a unique shape form which the treatment area can be identified.
Clinical Performance Comparison (Image Based)
Both markers have been imaged using the typical imaging devices including, CT, CBCT, MR, kV x-ray and MV x-ray both markers are visible in all of these modalities. Note: Diameter is a consideration with respect to MV x-ray imaging -- meaning the larger diameter markers are required for both devices.
Conclusion
Both markers systems are deployed in the same fashion making this portion actually equivalent in its entirety.
CORTEX MANUFACTURING
421 SOUTH DAVIES RD.
LAKE STEVENS, WA 98258
(425)-334-2277
CORTEX ADMINISTRATIVE OFFICE
621 SR9 NE
PMB-B8
LAKE STEVENS, WA 98258
page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Andrew Jones Cortex Manufacturing. Inc.
Re: K100267
421 S Davies Rd.
LAKE STEVENS WA 98258
Owner
Trade/Device Name: FlexiMarc Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: January 28, 2010
FEB 24 2010
Received: February 1, 2010
Dear Mr. Jones:
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. ·
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K100267
Device Name: FlexiMarc
Indications For Use:
In situations where the location of specific anatomy, normal and diseased needs to be marked for future procedures this device will serve as a surrogate locator. The all gold FlexiMarc is placed either in advance or during a treatment procedure. These all gold FlexiMarc can be visualized using medical imaging devices and they provide a reference from which the treatment can be guided.
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 Diagnostic Devices (OIVD)
Donald H. Bae
(Dwision Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K100267