(47 days)
No
The device description focuses on the physical components and delivery mechanism of a soft tissue marker, with no mention of AI or ML capabilities.
No
The device is used to mark soft tissue for future therapeutic procedures, not to perform a therapeutic procedure itself.
No
The device is described as a marker for future therapeutic procedures, not for diagnosing a condition. It is used to mark soft tissue for later reference, not to identify or characterize a disease.
No
The device description clearly describes a physical medical device consisting of a gold wire marker delivered via a needle, not a software-only product.
Based on the provided information, the Gold Anchor device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The Gold Anchor is a physical marker implanted into soft tissue within the body.
- IVDs are used to provide information about a patient's health status. The Gold Anchor's purpose is to radiographically mark tissue for future procedures, not to diagnose or provide information about a disease state based on a sample.
- The description focuses on the physical characteristics of the marker and its implantation method. There is no mention of analyzing biological samples or performing tests on them.
The Gold Anchor is a medical device used for marking tissue in vivo (within the living body), not in vitro (in glass, referring to tests performed outside 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
IVE
Device Description
The Gold Anchor Marker consists of a thin gold wire with cutouts delivered in a fine needle. The Gold Anchor Marker is available pre-loaded in two different sizes of fine needles: Gold Anchor 120 comes in a 0.53 mm x 120 mm (25 G x 4 3/4") fine needle with an attached injector, and Gold Anchor 200 comes in a 0.7mm x 203mm (22G x 8") fine needle.
The Gold Anchor comes in blister single packs, sterilized, ready for use, in lengths of 1-5cm, clearly indicated on the package. They shall be implanted under guidance of ultrasound or CT or during manual palpation of the tumor.
The Gold Anchor Marker can be inserted in the tissue in two ways, either through advancing the stylet or by withdrawing the needle. If the stylet is advanced rather than the needle withdrawn, the Gold Anchor Marker will collapse and fold into different shapes. By withdrawing the needle the Gold Anchor Marker will be deposited as a straight line in the needle track.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound or CT
Anatomical Site
Soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical staff trained in using fine needle operations, e.g. radiologist, radiotherapist, cytologist or equivalent.
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)
Not Found
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.
0
Naslund Medical AB
510(k) Application Gold Anchor
Page: 11(36) Date: 2009-06-01
JUL 21 2009
Received
FDACDRH DMC
JUN 24-2009
510(k) Notification Cover Letter 3.
3.1. Administrative Information
Type:
Traditional 510(k) submission
Device type: accelerator, linear, medical
510(k) submitter: Naslund Medical AB
Contact persons: Tomas Naslund
No confidentiality needed concerning the existence of this premarket notification
Regulation Number: 892.5050
Class:
90 (Radiology) Review Panel:
Product Code: IVE
No prior correspondence exists related to this device
2
Establishment Regestration nr: Will register following FDA clerance
3.2.
Design and Use of the Device
| Is the device intended for prescription use? | Yes |
|---|---|
| Is the device intended for over-the-counter use? | No |
| Does the device contain components derived from a tissue or other biologic source? | No |
| Is the device provided sterile? | Yes |
| Is the device intended for single use? | Yes |
| Is the device a reprocessed single use device? | No |
| If yes, does this device type require reprocessed validation data? | N/A |
| Does the device contain a drug? | No |
| Does the device contain a biologic? | No |
| Does the device use software? | No |
| Does the submission include clinical information? | No |
| Is the device implanted? | Yes |
3.3. 510(K): Comparison with a predicate device
| Manufacturer | Device | 510(k) # | |
|---|---|---|---|
| New | Naslund Medical AB | Gold Anchor | Not applicable |
| Cleared | Radiomed Corporation | Preloaded Radi- | |
| oMed Soft Tissue | |||
| Marker | K070305 |
1
Device Information 7.
7.1. Description of New Device Gold Anchor
The Gold Anchor Marker consists of a thin gold wire with cutouts delivered in a fine needle. The Gold Anchor Marker is available pre-loaded in two different sizes of fine needles: Gold Anchor 120 comes in a 0.53 mm x 120 mm (25 G x 4 3/4") fine needle with an attached injector, and Gold Anchor 200 comes in a 0.7mm x 203mm (22G x 8") fine needle.
The Gold Anchor comes in blister single packs, sterilized, ready for use, in lengths of 1-5cm, clearly indicated on the package. They shall be implanted under guidance of ultrasound or CT or during manual palpation of the tumor.
The Gold Anchor Marker can be inserted in the tissue in two ways, either through advancing the stylet or by withdrawing the needle. If the stylet is advanced rather than the needle withdrawn, the Gold Anchor Marker will collapse and fold into different shapes. By withdrawing the needle the Gold Anchor Marker will be deposited as a straight line in the needle track.
(ref 1.1) Gold Anchor GA120 product overview
(ref 2.2) Gold Anchor GA200 product overview
7.2. Intended Use of Gold Anchor
The Gold Anchor Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
7.3. User Characteristics
Gold Anchor is intended to be used by qualified medical staff trained in using fine needle operations, e.g. radiologist, radiotherapist, cytologist or equivalent.
2
Substantial Equivalence Discussion 8.
8.1. Comparison to Predicate Devices
| | 11 - 13 - 13 10 - 13 10 - 13 - 19 10 - 14 -
1-55 - 3-2 - 14 26 >