Who is the manufacturer of Gold Anchor?

Naslund Medical AB filed the 510(k) submission for Gold Anchor (K201117).

What is the FDA product code for Gold Anchor?

IYE. It is classified under 21 CFR 892.5050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Gold Anchor?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Gold Anchor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Gold Anchor

K201117 · Naslund Medical AB · IYE · Jun 11, 2020 · Radiology

Device Facts

Record ID	K201117
Device Name	Gold Anchor
Applicant	Naslund Medical AB
Product Code	IYE · Radiology
Decision Date	Jun 11, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5050
Device Class	Class 2

Intended Use

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

Device Story

Gold Anchor is a passive fiducial marker implanted into soft tissue to delineate tumors or lesions for radiographic imaging. Device consists of a gold wire with cutouts, pre-loaded into 25G, 22G, or 20G needles. Implanted temporarily or permanently by clinicians to serve as a reference point on radiographic film or digital images. Increased iron content in marker material enhances visibility on MRI. Device is single-use and sterile. No active components, software, or algorithms involved.

Clinical Evidence

Bench testing only. Performance data included MR safety and compatibility testing (displacement force, RF heating, image artifacts, torque) per ASTM standards and biocompatibility evaluation via chemical characterization risk assessment per ISO 10993-1, 10993-17, and 10993-18.

Technological Characteristics

Passive fiducial marker; gold wire with cutouts. Materials: Gold with increased iron content. Dimensions: Pre-loaded in 25G, 22G, 20G needles. Sterilization: E-Beam Radiation. Standards: ASTM F2052-15, ASTM F2182-11a, ASTM F2119-07, ASTM F2213-17, ISO 10993-1, ISO 10993-17, ISO 10993-18.

Indications for Use

Indicated for radiographic marking of soft tissue in patients requiring future therapeutic procedures (e.g., tumor or lesion delineation).

Regulatory Classification

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.

Predicate Devices

Gold Anchor (K160209)

Related Devices

K160209 — Gold Anchor · Naslund Medical AB · Jun 21, 2016
K091645 — GOLD ANCHOR · Naslund Medical AB · Jul 21, 2009
K213053 — Gold Anchor · Naslund Medical AB · Jan 6, 2022
K120859 — PRE-LOADED GOLD VISICOIL CK MARKER · Radiomed Corporation · Apr 19, 2012
K070436 — BIOMARC GOLD TISSUE MARKER · Carbon Medical Technologies, Inc. · Mar 16, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary #### I. SUBMITTER | Submitter's name: | Naslund Medical AB | |-------------------|------------------------------------------| | Address: | Åvägen 40 B 141 30 Huddinge Sweden | | 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 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. #### 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: {4}------------------------------------------------ - 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.