(106 days)
Not Found
No
The device description and intended use focus on a passive implantable marker and its delivery system, with no mention of any computational or analytical functions that would involve AI/ML.
No
The device is a marker used for imaging purposes to delineate a tumor or lesion for future therapeutic procedures, but it does not perform a therapeutic function itself.
No
The device is a fiducial marker used to mark soft tissue for future therapeutic procedures, meaning it helps locate areas of interest for treatment, not diagnose conditions.
No
The device description clearly states it is a physical gold marker and an introducer, which are hardware components intended for implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Gold Anchor marker is a physical implant used to mark soft tissue for future therapeutic procedures. It is a passive device that is placed within the body.
- Intended Use: The intended use is to radiographically mark soft tissue for future therapeutic procedures, not to analyze a sample taken from the body.
The device description and intended use clearly indicate that this is an implantable medical device used for localization and guidance during procedures, not for diagnostic testing of biological samples.
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 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 B |
| 141 30 Huddinge | |
| Sweden | |
| 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
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.
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.