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 Gold Anchor™ Introducer ("Introducer") is delivered pre-loaded with the Gold Anchor™ marker inside. It comes in a blister single pack, sterilized, ready for use. The Introducer is used to transfer the marker over into a 22 gauge endoscopic ultrasound aspiration needle ("22G EUS Needle").

Sterilization is achieved by E-Beam Radiation. This is a single-use device. The device is a passive implant.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Gold Anchor™" device, a fiducial marker used to radiographically mark soft tissue for future therapeutic procedures. The submission states that the device is substantially equivalent to a previously cleared predicate device (K201117). The key difference in the subject device is that the Gold Anchor™ marker comes preloaded in an "Introducer" for transfer into a 22G EUS Needle, whereas the predicate device's marker was preloaded in a needle used directly for implantation.

The submission focuses on the differences between the subject device and the predicate device, specifically regarding the introduction mechanism. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to evaluating the performance of this new Introducer component.

Here's the breakdown of the requested information based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Pertaining to the Introducer:	Non-clinical performance bench testing and simulated use testing were completed.
The Introducer will make it easier to transfer the Gold Anchor marker into a 22G EUS Needle.	The subject device "make it easier to transfer the Gold Anchor marker over into a 22G EUS Needle."
Maintain safety and effectiveness compared to the predicate device.	"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 (e.g., country of origin of the data, retrospective or prospective)

The document does not specify exact sample sizes for the bench testing or simulated use testing. It only states that these tests were "completed." The provenance of the data (country of origin, retrospective/prospective) is also not specified.

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. Given that the testing was "non-clinical performance bench testing and simulated use testing," it's unlikely that "experts" in the clinical sense were establishing ground truth for the Introducer's transfer mechanism. These types of tests typically rely on engineering specifications and direct measurement/observation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe any adjudication method. This type of method is usually relevant for clinical studies with human assessors, which is not what is solely described here for the "Introducer."

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

No such study was conducted or mentioned. The device, Gold Anchor™, is a fiducial marker, not an AI-powered diagnostic or assistive tool for human readers. The change being reviewed is a physical component (Introducer) for delivering the marker.

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

This is not applicable. The Gold Anchor™ is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the Introducer itself, the "ground truth" would likely be engineering specifications, physical measurements, and observational data during the simulated use testing to verify successful and easy transfer of the marker into a 22G EUS Needle. The document does not explicitly state the specific types of "ground truth" (e.g., specific dimensions, forces, successful deployment rates).

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not a machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

Summary

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Näslund Medical AB % Tomas Näslund VP Supply Chain Åvägen 40 B 14 130 Huddinge SWEDEN

Re: K213053

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: September 17, 2021 Received: September 22, 2021

Dear Tomas Näslund:

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 medical devices and radiation-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.

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) K213053

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 Näslund
Date Prepared:	September 17, 2021

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

Predicate device: Gold Anchor, K201117

IV. DEVICE DESCRIPTION

Sterilization is achieved by E-Beam Radiation. This is a single-use device. The device is a passive implant.

V. INDICATIONS FOR USE

The Indications for Use statement for the subject device is identical to that of its predicate device (K201117):

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

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device is identical with the predicate device (K201117) except that the marker, in the case of the subject device, comes preloaded in an Introducer while, in the case of the predicate device (K201117), the marker comes preloaded in a needle used to implant the marker in soft tissue.

5.

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VII. PERFORMANCE DATA

Non-clinical performance bench testing and simulated use testing were completed to evaluate the design of the Gold Anchor Introducer for transferring the marker over into 22G EUS Needles.

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 will, however, make it easier to transfer the Gold Anchor marker over into a 22G EUS Needle. 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.