(220 days)
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.
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.
This submission for Cortex Manufacturing Inc.'s FlexiMarc (K142294) is a special 510(k) submission, indicating that the device has been modified to address a specific change from a previously cleared device. In this instance, the modification is solely to the diameter range of the implanted marker. As such, the submission primarily focuses on demonstrating that this single change does not impact the safety and effectiveness of the device compared to its predicate.
Here's an analysis of the provided text in the context of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" or a "reported device performance" table in the way one might expect for a comprehensive clinical study. Given that this is a 510(k) for a modification (a smaller diameter range), the primary acceptance criterion is demonstrating that the modified device is substantially equivalent to the predicate device and that the change does not introduce new safety or effectiveness concerns.
The core of the performance demonstration relates to marker visibility and migration, particularly for the smaller diameter.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Visibility: Be visualized using typical medical imaging devices. | FlexiMarc (including smaller diameters) is visible with CT, CBCT, kV x-ray, and MV x-ray. Note: Gold Markers under 0.40 MM in diameter may not be visible with all MV x-ray imaging systems. |
| Migration: Smaller diameter markers (down to 0.35 MM) do not pose an increased risk in marker migration compared to larger diameter markers. | A substantial body of published work indicates that smaller diameter markers down to 0.35 MM do not pose an increased risk in marker migration. Studies in live participants (torso, GI tract, pancreas) found migration patterns of markers in the 0.35 MM range were not significantly different from larger diameter markers. |
| Overall Safety & Effectiveness: The change in diameter does not impact overall safety and effectiveness. | The markers have identical material, irregular surface, deployment techniques, packaging, and sterilization. No change to safety and effectiveness is expected when comparing the new smaller marker size with the existing predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to a "substantial body of published work" for the marker migration data, stating: "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."
- Sample Size: The exact sample size for these "published studies" is not provided in this document. It only mentions "several markers in the 0.35 MM diameter range were implanted."
- Data Provenance: Not specified (e.g., country of origin).
- Retrospective or Prospective: Not explicitly stated, but the description "markers were placed in live participants" and "distances between the markers were compared overtime" suggests these were prospective clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The general reference to "published work" implies that experts in the field conducted and assessed these studies, but their specific number or qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a passive implanted marker, not an AI-assisted diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone algorithm performance study was not done. This device is an implanted medical marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the marker migration assessment, the ground truth appears to be based on direct measurement of marker distances over time in live participants, presumably evaluated against a baseline measurement. This would be considered outcomes data (i.e., the physical outcome of marker position). For visibility, the ground truth would be the physical presence of the marker as confirmed by imaging modalities.
8. The sample size for the training set
This is not applicable as FlexiMarc is a physical implanted medical device, not an AI/ML algorithm that requires a training set. The "published work" referenced is for clinical validation of marker properties, not for training a model.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
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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.
§ 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.