(45 days)
Not Found
No
The device description and performance studies focus on the physical properties, biocompatibility, and MR compatibility of a passive implant (gold marker). There is no mention of software, image processing, AI, or ML.
No.
The device is a marker used for radiographic identification of soft tissue for future therapeutic procedures, but it does not directly provide therapeutic treatment itself.
No
The device is a marker used to radiographically mark soft tissue for future therapeutic procedures, meaning it helps to visualize and locate an area. It does not diagnose a condition itself but rather aids in the identification of a site for future therapeutic procedures.
No
The device description clearly states it is a physical fiducial gold marker intended for implantation, pre-loaded in needles, and sterilized. This indicates a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic or monitoring purposes. This examination is performed outside of the body (in vitro).
- Device Description: The Gold Anchor marker is described as a "fiducial gold marker intended to be implanted within the body." This means it is an implantable device used inside the body (in vivo).
- Intended Use: The intended use is to "radiographically mark soft tissue for future therapeutic procedures." This is a marking or localization function performed within the body, not an in vitro diagnostic test on a specimen.
The device's function is to provide a visible marker within the body for imaging purposes, not to analyze a biological sample for diagnostic information.
N/A
Intended Use / Indications for Use
The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Product codes
IYE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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:
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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 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:
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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.