(47 days)
Gold Anchor is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
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 If the stylet is advanced rather than the needle withdrawn, the Gold Anchor Marker will collapse and fold into different shapes.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.
This 510(k) submission (K091645) from Naslund Medical AB for the "Gold Anchor" device does not contain a study section that describes acceptance criteria and proves the device meets them with performance data.
Instead, this submission is a Traditional 510(k) submission based on substantial equivalence to a predicate device.
Here's why the requested information cannot be found in the provided text:
- No Clinical Information: The document explicitly states: "Does the submission include clinical information? No". This indicates that no clinical studies were performed or submitted.
- Focus on Substantial Equivalence: The bulk of the information in sections 8.1-8.7 is dedicated to comparing the Gold Anchor to its predicate device (Preloaded RadioMed Soft Tissue Marker, K070305) to demonstrate substantial equivalence based on design, materials, intended use, and general performance characteristics, rather than presenting original performance data against specific acceptance criteria.
- "Performance: Same as predicate device": In section 8.5, under "Scientific technology - Preloaded RadioMed Soft Tissue Marker", it states "Performance: Same as predicate device". This further confirms that no new performance data is being presented, but rather the performance is assumed to be equivalent to the predicate.
- "No change in scientific technology": The comparative tables repeatedly assert "No Change in scientific technology" for various characteristics, implying that the device's fundamental function and resultant performance are not expected to differ significantly from the predicate.
Therefore, the specific information requested in the prompt (acceptance criteria, reported device performance, sample size, ground truth, expert qualifications, adjudication, MRMC, standalone studies, and training set details) is not available in this 510(k) submission.
The FDA's clearance letter (pages 5-7) confirms that the device was deemed substantially equivalent based on the provided information, which primarily focused on the comparison to the predicate device to establish safety and effectiveness.
To directly answer the prompt's requirements based on the provided text, I must state that the information is absent:
- A table of acceptance criteria and the reported device performance: Not provided. The submission relies on establishing substantial equivalence to a predicate device, assuming similar performance.
- Sample size used for the test set and the data provenance: Not applicable, as no test set data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set data is presented.
- Adjudication method for the test set: Not applicable, as no test set data is presented.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a passive marking device, not an AI-assisted diagnostic or therapeutic system. No MRMC study was performed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable, as no performance data based on ground truth is presented.
- The sample size for the training set: Not applicable, as no training set for an algorithm is used.
- How the ground truth for the training set was established: Not applicable, as no training set for an algorithm is used.
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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 TissueMarker | K070305 |
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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.
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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 ><============================================================================================================================================================================= | 510(k) # | |
|---|---|---|
| New | Gold Anchor | anolicable |
| Proloaded RadioMed Soft Tissue Marker " | K070305 |
*Aslo known as Visicoil
8.2. Indications for Use, Intended Use
The Intended Use of the new device is shown below.
| Device | Intended Use |
|---|---|
| Cleared | The Preloaded RadioMed Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures. |
| New | The Gold Anchor Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures. |
8.3. Comments on the Preloaded RadioMed Soft Tissue Marker predicate Device
The Preloaded RadioMed Soft Tissue Marker is a sterile device, in the form of a gold coil loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.1 mm. Depending on the coil size (0.35mm. 0.75mm, or 1.10mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coil is supplied loaded and ready for use in the applicable needle. It is sterilized using EO.
Predicate Device technical characteristics - Preloaded RadioMed 8.4. Soft Tissue Marker
The predicate device is made out of pure gold. It is delivered sterile, for single use, preloaded and preplugged in 17, 18, 19 gauge needles. The markers range from 0.35-1.1 mm in diameter and 10-60 mm in length. It is Sterililized using EO.
Scientific technology - Preloaded RadioMed Soft Tissue Marker 8.5.
The Scientific Technology of the new device is essentially the same as the Scientific Technology for the cleared device, the Preloaded RadioMed Soft Tissue Marker, as shown below. The following table demonstrates that the modified device has the same technological characteristics and is similar in design, function, and application to the predicate device.
| Item | Statement of Equivalence or Difference com-pared to Predicate device |
|---|---|
| Indications for Use | Same as predicate device |
| Target Population | Same as predicate device |
| Design | Same as predicate device |
| Materials | Same as predicate device |
| Performance | Same as predicate device |
| Sterility | Different - Electronic Beam Radiation |
| Biocompatibility | Same as predicate device |
| Mechanical Safety | Same as predicate device |
| Chemical Safety | Same as predicate device |
| Anatomical Sites | Same as predicate device |
| Human Factors | Same as predicate device |
| Energy Used and/or Delivered | Same as predicate device |
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| Item | Statement of Equivalence or Difference com-pared to Predicate device |
|---|---|
| Compatibility with Environment and Other Devices | Same as predicate device |
| Where Used (Hospital) | Same as predicate device |
| Standards | Same as predicate device |
| Electrical Safety | Same as predicate device |
| Thermal Safety | Same as predicate device |
| Radiation Safety | Same as predicate device |
| Prescription use only | Same as predicate device |
8.6. Technical Characteristics: Detailed Comparison with Predicate Devices
The new device is in conformance with the recognized and international standards, which cover the Safety and Effectiveness of the modified device as discussed in chapter 14.
The similarity and differences between the modified device and the legally marketed predicate device are listed below:
| Technical Characteristics | ClearedPre-LoadedRadioMed Soft TissueMarkerK070305 | NewGold Anchor | Change inscientifictechnology | Changesin In-tendeduse |
|---|---|---|---|---|
| Dimensions | ||||
| Material | Pure metallic gold99.95% | Pure metallic goldMinimum 99.95% | No | No |
| Length of marker | 10-60mm | 10-50mm | No | No |
| Intended use | The Preloaded RadioMedSoft Tissue Marker is indi-cated for use to radio-graphically mark soft tissuefor future therapeutic pro-cedures. | identical | No | No |
| Preloaded in needle | yes | yes | No | No |
| Preplugged/vaxed needle | yes | yes | No | No |
| Other | ||||
| Operating areas | Hospital | Same | No | No |
| Operated by | Physician | Same | No | No |
| Standards met | FDA QSR 2 1 CFR Part820 Good ManufacturingPractices | Same | No | No |
| Differences | ||||
| Needle size | 17,18,19 g | 22,25 g | No | No |
| Diameter of marker | 0,35-1,10 mm | 0,28 mm | No | No |
| Sterility | EO | Electronic Beam Radia-tion | Yes | No |
8.7. Summary of Technological Characteristics and Intended Use
The intended use for this new device is identical to that of its predicate device.
The Gold Anchor is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
The fundamental scientific technology of the modified device has not changed.
- The material used for both the predicate device and the new device is pure . metallic gold.
- The intended use for both the predicate device and the new device are identical. .
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-
Both the predicate device and the new device are delivered sterile in pre-. plugged/vaxed introducer needles.
The change to this product includes the following: -
Predicate device exist in the form of a coil. The new device exists in a form of thin . wire with cut-outs.
-
Predicate device uses 17, 18, 19 gauge needles while the new device uses 22, 25 � gauge needles.
-
Predicate device uses EO sterilization while the new device uses Electron Beam . Radiation.
These differences do not add any new hazards to the Gold Anchor system compared with the Predicate device and thus Gold Anchor is substantially similar to the Predicate Device
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 2009
Mr. Tomas Naslund · Product Manager Naslund Medical AB Vassvagen 21, Huddinge, 14139 SWEDEN
Re: K091645
Trade/Device Name: Gold Anchor Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 1, 2009 Received: June 4, 2009
Dear Mr. 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.
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
{6}------------------------------------------------
device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Naslund Medical AB
Indications for Use Statement
510(k) Number
Device Name
Indications for Use
091645 Gold Anchor.
Gold Anchor is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Prescription Use X
(Part 21 CFR 801 subpart D)
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Hoover
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page 1 of 1
§ 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.