(220 days)
No
The summary describes a passive implanted marker and does not mention any computational or analytical capabilities, let alone AI/ML.
No
The device is described as an implanted marker to identify tissue location for future procedures and guide treatment, not to directly treat a condition.
No
Explanation: The device is an implanted marker used to identify the location of normal or diseased tissue for future treatments. It provides a reference for treatment guidance and visualization, but does not provide information about the presence, absence, or condition of a disease.
No
The device description clearly states that the FlexiMarc is an implanted marker fabricated of pure gold, available in varying lengths and diameters, and delivered in needles or pouches. 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 (like 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. It is placed inside the body to identify the location of tissue for future procedures.
- Intended Use: The intended use is to serve as a "surrogate locator" for future procedures by being visualized using medical imaging devices. This is a function performed in vivo (within the living body).
The device is a medical device used for marking anatomical locations within the body, not for performing diagnostic tests on samples taken from the body.
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 FlexiMarcs 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 will be available in varying lengths from 3 MM to 4 CM overall and will range in diameter from 0.35 MM to 1.6 MM. It will be available in single and multi-node formats. These are detailed in the table below. FlexiMarc is delivered in sterile preexisting needles ranging from 25 GA to 14 GA, solo in a sterile pouch, or in nonsterile bulk.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, CBCT, kV x-ray and MV x-ray
Anatomical Site
torso region of the body specifically including the GI tract and pancreas
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)
"There is a substantial body of published work indicating that smaller diameter markers down to 0.35 MM do not pose an increased risk in marker migration. In these studies markers were placed in live participants in the torso region of the body specifically including the GI tract and pancreas. In these studies several markers in the 0.35 MM diameter range were implanted. The distances between the markers were compared overtime and the migration patterns found were not significantly different to that of the larger diameter markers."
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
§ 892.5050 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2015
Cortex Manufacturing, Inc. % Mr. Andrew Jones Director 421 South Davies Road LAKE STEVENS WA 98258
Re: K142294 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: March 14, 2015 Received: March 18, 2015
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. 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-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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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 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. 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 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 yours.
for
Robert Ochs, Ph.D. Acting 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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142294
Device Name FlexiMarc
Indications for Use (Describe)
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 FlexiMarcs can be visualized using medical imaging devices and they provide a reference from which the treatment can be guided.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "CORTEX" in black letters against an orange background. The letters are a serif font, and the background has a gradient effect, with the orange color being lighter at the top and darker at the bottom. The word is centered in the image and takes up most of the space.
Special 510(k) Summary for FlexiMarc
Cortex Manufacturing Inc. 621 SR 9 NE PMB-B8 Lake Stevens, WA 98258
Contact: Andrew Jones Phone: (425) 334 - 2277
Preparation date: March 15, 2015
Trade Name: FlexiMarc (K142294) Common Name: Implanted Marker Classification Name: 892.5050
Predicate Device: K100267
Additional Reference Device: RadioMed, Visicoil (K031206 and K070305)
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 will be available in varying lengths from 3 MM to 4 CM overall and will range in diameter from 0.35 MM to 1.6 MM. It will be available in single and multi-node formats. These are detailed in the table below. FlexiMarc is delivered in sterile preexisting needles ranging from 25 GA to 14 GA, solo in a sterile pouch, or in nonsterile bulk.
| Description | FlexiMarc K100267 | Desired Range (K142284) |
|---|---|---|
| Diameter (range) | 0.50 - 1.60 MM | 0.35 - 1.60 MM |
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| Number of Nodes | Node Length | Diameter Range |
|---|---|---|
| 1 | 3 – 10 MM | 0.35 – 1.60 MM |
| 2 | 3 MM (10 MM O.C. Spacing) | 0.90 -1.60 MM |
| 3 | 3 MM (10 MM O.C. Spacing) | 0.90 -1.60 MM |
| 4 | 3 MM (10 MM O.C. Spacing) | 0.90 -1.60 MM |
| 5 | 3 MM (10 MM O.C. Spacing) | 0.90 -1.60 MM |
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 with Additional Use Data
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 FlexiMarcs can be visualized using medical imaging devices and they provide a reference from which the treatment can be guided.
Technological Comparison to Predicate Device
The predicate device has a diameter range from 0.50 to 1.6 MM the new specification would increase the range to 0.35 to 1.6 MM. This is the only modification; otherwise all other technical aspects are identical including but not exclusive to:
- Indication for use
- Materiel used to manufacture
- Packaging
- Sterility process
Clinical Performance Comparison
The markers have been imaged using the typical imaging devices including, CT, CBCT, kV x-ray and MV xray, both markers are visible in all of these modalities. It is noted that Gold Markers under 0.40 MM in diameter may not be visible with all MV x-ray imaging systems.
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Image /page/5/Picture/0 description: The image shows the word "CORTEX" in black font against an orange background. The background has a gradient, with the orange color being lighter on the left side and darker on the right side. The letters are bold and have serifs.
There is a substantial body of published work indicating that smaller diameter markers down to 0.35 MM do not pose an increased risk in marker migration. In these studies markers were placed in live participants in the torso region of the body specifically including the GI tract and pancreas. In these studies several markers in the 0.35 MM diameter range were implanted. The distances between the markers were compared overtime and the migration patterns found were not significantly different to that of the larger diameter markers.
Conclusion
The markers have identical material, irregular surface and are deployed into the body using the same techniques. They are packaged and sterilized in the same fashion. There is no change to the safety and effectiveness when comparing the new smaller marker size with the existing predicate device.