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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FlexiMarc device based on the provided text:

Important Note: The provided 510(k) summary primarily focuses on the substantial equivalence of the FlexiMarc to a predicate device based on technological characteristics and image visibility. It does not detail a formal clinical study with acceptance criteria for device performance as would be expected for a complex AI/software device. Instead, the "study" is a comparison validating visual equivalence in various imaging modalities.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (FlexiMarc)
Visibility across imaging modalities: - CT - CBCT - MR - kV x-ray - MV x-ray	Visible in all modalities: - CT: Visible - CBCT: Visible - MR: Visible - kV x-ray: Visible - MV x-ray: Visible (larger diameter markers required for both devices)
Flexibility: Reduce potential for migration and provide a unique shape.	Fabricated to be flexible, which "serves to reduce the potential for migration of the marker" and "provides a unique shape form which the treatment area can be identified."
Deployment method: Equivalent to predicate device.	"Both markers systems are deployed in the same fashion making this portion actually equivalent in its entirety."
Material: Biocompatible.	Fabricated of all biocompatible pure gold.
Availability (lengths/diameters): Varying sizes for different imaging and use cases.	Available in varying lengths (2 mm to 4 CM) and diameters (0.5 mm to 1.6 mm).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients" in the traditional sense. The "clinical performance comparison (image based)" describes testing both the FlexiMarc and the predicate device across various imaging modalities.
Data Provenance: Not specified. It appears to be an internal comparison or bench testing rather than using patient data from a specific country or setting.
Retrospective/Prospective: Not specified, but given the nature of the comparison, it likely involves imaging of the markers themselves rather than a clinical study on patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. Given the nature of a 510(k) for a physical marker, the "ground truth" for visibility would likely be established through objective observation by qualified personnel, possibly engineers or imaging specialists, rather than clinical experts.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The comparison focuses on the technological characteristics and imaging visibility of the device itself, not on human reader performance with or without AI assistance. This is a physical medical device, not an AI/software device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical implanted marker, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" primarily involved objective observation of marker visibility across different medical imaging modalities (CT, CBCT, MR, kV x-ray, MV x-ray) for both the FlexiMarc and the predicate device. It also included verification of physical characteristics like flexibility and material composition.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no concept of a "training set" as would apply to a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8 above).

Summary

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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 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

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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

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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,

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:

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

Regulation Number and Section

§ 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.