(145 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a passive implant (gold marker) and do not mention any software, algorithms, or image processing capabilities that would suggest the use of AI/ML.
No.
The device is a marker used to identify soft tissue for future therapeutic procedures, but it does not perform a therapeutic function itself.
No
Explanation: The device is a marker used to identify soft tissue for future therapeutic procedures. It is used to delineate a tumor, lesion, or other site of interest for future procedures, not to diagnose a condition. It is a passive implant that helps locate a site for treatment, not for diagnosis.
No
The device description clearly states it is a physical fiducial marker made of gold wire, pre-loaded in needles, and intended for implantation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside 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 a device that is placed 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.
The device is a passive implant used for imaging purposes after implantation, not for testing samples taken from the body.
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
radiographic film or digital images, MR (MRI)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Dis-. Placement Force on Medical Devices in the Magnetic Resonance Environment.
- 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(2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.
Because of the minor amount of translational attraction (1-degree deflection angle) and no torque (qualitatively determined) at 3-Tesla, it was deemed unnecessary to conduct a quantitative evaluation of torque according to ASTM F2213-2006 (2011), Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
A biocompatibility evaluation has been performed based on a chemical characterization risk assessment in accordance with ISO 10993-17 and ISO 10993-18.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2016
NASLUND MEDICAL Ab Tomas Naslund Head of Supply Chain Vassvagen 21 Huddinge, 14139 SE
Re: K160209
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: January 25, 2016 Received: January 28, 2016
Dear Tomas Naslund:
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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Robert Ochs, Ph.D
For
Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160209
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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5. 510(k) Summary
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section
510(k) Summary of safety and effectiveness Information as required by section 807.92(c)
I. SUBMITTER OF 510(k):
| Company name: | Naslund Medical AB |
|---|---|
| Address: | Vassvagen 21 |
| 141 39 Huddinge | |
| Sweden | |
| Phone: | +46 732 620 717 |
| Fax: | +46 850 900 381 |
| Correspondent: | Tomas Naslund |
II. DEVICE
| Name of Device: | Gold Anchor™ |
|---|---|
| Common or Usual Name: | Fiducial marker |
| Classification Name: | Accelerator, Linear, Medica |
| Regulatory Class: | II |
| Product Code: | IYE |
III. PREDICATE DEVICE
The predicate devices are:
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 Gold Anchor (K091645):
- The Gold Anchor marker is indicated for use to radiographically mark soft tissue for future ● therapeutic procedures.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
At a high level, the subject device and the predicate device Gold Anchor (K091645) are based on the following same technological characteristics:
- Device delivered sterilized using Electron Beam Radiation. �
- Device delivered pre-loaded in 25G or 22G needles. .
- Use of a needle to reach the target tissue. �
- Use of a stylet to deploy the fiducial gold marker to mark the soft tissue. �
- Use of a material that lubricates the inside of the needle. .
- . Use of a marker with a unique and patented design (wire with cutouts).
The following technological differences exist between the subject device and the predicate device Gold Anchor (K091645):
- The subject device is also available pre-loaded in a 20G needle. .
- . The 25G needle of the predicate device was 120 mm long. The 25G needle of the subject device is 150 mm long.
- � The material used to lubricate the inside of the subject device is Nusil Med-360 unrestricted silicone oil.
- . The fiducial marker in the subject device contains a small amount of pure iron (0.5% of mass) mixed with the pure gold as an alloy to enhance the visibility of the marker on MRI.
- . The predicate device only came with a Ø 0.28 mm marker. The subject device comes with either a Ø 0.40 mm marker or a Ø 0.28 mm marker.
Comparison to the predicate device VisiCoil Marker (K070305):
- The subject device is available pre-loaded in a 20G needle. The predicate device is avail-. able pre-loaded in thicker 17G. 18G, or 19G needles.
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:
- ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Dis-. placement Force on Medical Devices in the Magnetic Resonance Environment.
- 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(2013) Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.
Because of the minor amount of translational attraction (1-degree deflection angle) and no torque (qualitatively determined) at 3-Tesla, it was deemed unnecessary to conduct a quantitative evaluation of torque according to ASTM F2213-2006 (2011), Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
A biocompatibility evaluation has been performed based on a chemical characterization risk assessment in accordance with ISO 10993-17 and ISO 10993-18.