The Gold Anchor™ Marker is a fiducial gold marker intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. The marker is formed as a wire with cutouts and used to locate and delineate a tumor, lesion, or other site of interest. The marker comes pre-loaded in 25G, 22G and 20G needles delivered sterile and ready for use. Sterilization is achieved by E-Beam Radiation. This is a single-use device. The device is a passive implant.

AI/ML Overview

This FDA 510(k) summary describes a new version of the Gold Anchor™ fiducial marker, K201117, which is a modification of a previously cleared device, Gold Anchor™, K160209. The primary change is an increase in the iron content of the marker material to enhance visibility on MRI.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The submission does not provide specific, quantifiable acceptance criteria in a tabular format as would typically be seen for a performance study. Instead, it relies on a comparison to established standards and the predicate device.

Acceptance Criteria Category	Reported Device Performance
Magnetic Resonance (MR) Environment Compatibility	Conducted Tests: - ASTM F2052-15: Measurement of Magnetically Induced Displacement Force - ASTM F2182–11a: Measurement of Radio Frequency Induced Heating - ASTM F2119-07: Evaluation of MR Image Artifacts - ASTM F2213-17: Measurement of Magnetically Induced Torque Performance Claim: The submission implies that the device successfully met the requirements of these ASTM standards, indicating its safety and compatibility within the MR environment. The specific numerical thresholds or "pass/fail" results are not detailed, but the conclusion states "The subject device can, however, be better visualized on MRI."
Biocompatibility	Conducted Evaluation: - Evaluation in accordance with FDA guidance "Use of International Standard ISO-10993..." and ISO 10993-1. - Evaluation based on a chemical characterization risk assessment in accordance with ISO 10993-17 and ISO 10993-18. Performance Claim: The submission implies that the device successfully met biocompatibility requirements based on these evaluations. Specific metrics or results are not detailed.
Substantial Equivalence to Predicate	Performance Claim: "The changes between the predicate device and the new device do not affect the intended use in terms of safety and effectiveness." and "The subject device is as safe, as effective, and performs as well as or better than the predicate device."

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the tests. It refers to "tests were conducted" without specifying the number of samples (e.g., individual markers) subjected to each ASTM standard test. Since the tests are primarily mechanical, thermal, and imaging artifact assessments, sample sizes are typically determined by the particular ASTM standard recommendations. The document also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the type of studies conducted. The studies mentioned (ASTM standards and biocompatibility risk assessment) do not involve expert interpretation or ground truth establishment in the way, for example, a diagnostic image analysis algorithm would require. They are objective, physical, and chemical evaluations.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above. There wasn't an "adjudication" process for establishing ground truth in these types of physical performance and biocompatibility studies.

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

There was no MRMC comparative effectiveness study done, as this device is a physical fiducial marker and not an AI-powered diagnostic or assistive tool. The "better visualized on MRI" claim refers to the physical properties of the marker itself, not its impact on human reader performance with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical marker, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., expert consensus, pathology) is not applicable here. The "ground truth" for the performance of this device is its adherence to universally accepted physical, mechanical, and safety standards (ASTM for MR compatibility, ISO 10993 for biocompatibility). The "truth" is whether it passed these objective tests.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning model. Therefore, there is no "training set."

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this device.

Summary

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June 11, 2020

Naslünd Medical AB % Tomas Naslünd VP Supply Chain Avägen 40 B 14 130 Huddinge, Stockholm SWEDEN

Re: K201117

Trade/Device Name: Gold Anchor"™ Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: April 21, 2020 Received: April 27, 2020

Dear Tomas Naslünd:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201117

Device Name Gold Anchor™

Indications for Use (Describe)

The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

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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510(k) Summary

I. SUBMITTER

Submitter's name:	Naslund Medical AB
Address:	Åvägen 40 B141 30 HuddingeSweden
Phone:	+46 732 620 717
Fax:	+46 850 900 381
Contact Person:	Tomas Naslund
Date Prepared:	April 21, 2020

II. DEVICE

Name of Device:	Gold Anchor™
Common or Usual Name:	Fiducial marker
Classification Name:	Accelerator, Linear, Medical
Regulatory Class:	II
Product Code:	IYE

III. PREDICATE DEVICE

Gold Anchor, K160209 Predicate device:

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Indications for Use statement for the subject device is identical to that of its predicate device:

The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future o therapeutic procedures.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device is identical with the predicate device except that the iron content of our patented marker material has increased in order to further enhance the visibility on MRI.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Tests were conducted in accordance with FDA's guidance document "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment - Guidance for Industry and Food and Drug Administration Staff" and the following ASTM standards:

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ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced o Displacement Force on Medical Devices in the Magnetic Resonance Environment.
o ASTM F2182–11a Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
ASTM F2119-07 (Reapproved 2013) Standard Test Method for Evaluation of MR 0 Image Artifacts from Passive Implants.
o ASTM F2213-17, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.

A biocompatibility evaluation was conducted in accordance with the FDA guidance document "Use of International Standard ISO-10993, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA. The evaluation was based on a chemical characterization risk assessment in accordance with ISO 10993-17 and ISO 10993-18.

VIII. Conclusion

The changes between the predicate device and the new device do not affect the intended use in terms of safety and effectiveness. The subject device can, however, be better visualized on MRI. Thus, the subject device is as safe, as effective, and performs as well as or better than the predicate device.

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.