(28 days)
Pre-Loaded CK Visicoil Gold Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
The Pre-Loaded CK Visicoil a sterile device, in the form of two gold coils and a PGLA spacer loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.2mm.
The Pre-Loaded CK Visicoil is packaged sterile, for single use. Sterilization is achieved by a validated EO sterilization method.
The Pre-Loaded CK Visicoil will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures.
Depending on the coil size (0.35mm, 0.50mm, 0.75mm, or 1.2mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coils and spacer are supplied loaded and ready for use in the applicable needle.
The provided text describes the 510(k) submission for the RadioMed™ Pre-Loaded CK Visicoil Marker. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through comparison of technological characteristics and compliance with recognized standards.
Here's an attempt to answer the questions based on the provided text, indicating when information is not present:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and compliance with general medical device standards. No specific acceptance criteria or quantitative performance metrics for the device itself are reported in this text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document does not describe a clinical performance study with a distinct test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As there's no described performance study or test set, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No adjudication method is mentioned for a test set.
5. 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
This information is not provided. The device is a physical marker and not an AI or imaging system, so an MRMC study related to AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a physical marker; it does not involve algorithms or human-in-the-loop performance in the context of an AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. The document does not describe a study that would require establishing a ground truth for device performance in the sense of diagnostic accuracy or efficacy. The "ground truth" for this type of device would likely be its physical properties and functionality.
8. The sample size for the training set
This information is not provided. There is no mention of a training set as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not provided. No training set is mentioned.
Summary of available "Performance Testing" information:
The document mentions "Performance Testing" in Section 7, but it refers to compliance with general standards rather than specific device performance criteria:
- Standards Achieved:
- ISO 10993: Biological Evaluation of Medical Devices (This indicates biocompatibility testing was performed, but specific results are not detailed).
- FDA QSR 21 CFR Part 820: Good Manufacturing Practices (This indicates compliance with manufacturing processes and quality systems).
The submission relies on demonstrating that the new device (Pre-Loaded CK Visicoil Gold Marker) shares the "fundamental scientific technology" with and is "identical" in certain design aspects to its predicate devices:
The key modification described is the configuration of loading two gold coils and a PGLA spacer into a needle, which is stated to be identical to one of the predicate products (K103449). The intended use is also stated as "has not changed."
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RadioMed Corporation March 20, 2012
APR 1 9 2012
Visicoil ( Special 510k Submission
Section J
510k Summary
- Sponsor Name
RadioMed Corporation 3150 Stage Post Drive Bartlett, Tennessee 38133 (978) 807 1017 voice Telephone: (901) 432 7206 fax Gordon Roberts
Contact Individual:
-
- Device Name
Proprietary Name: Common/Usual Name: Classification Name:
- Device Name
RadioMed™ Pre Loaded CK Visicoil Marker RadioMed™ Pre Loaded CK Visicoil Marker System X-Ray, Tomography, Computed
3. Identification of Predicate or Legally Marketed Device
The predicate devices for RadioMed™ Soft Tissue Marker are:
4. Device Description
The Pre-Loaded CK Visicoil a sterile device, in the form of two gold coils and a PGLA spacer loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.2mm.
The Pre-Loaded CK Visicoil is packaged sterile, for single use. Sterilization is achieved by a validated EO sterilization method.
The Pre-Loaded CK Visicoil will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures.
Depending on the coil size (0.35mm, 0.50mm, 0.75mm, or 1.2mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coils and spacer are supplied loaded and ready for use in the applicable needle.
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RadioMed Corporation March 20, 2012
5. Intended Use
The intended use and indications for use of the modified device, as described in its labeling has not changed.
The Pre-Loaded CK Visicoil is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
- Comparison of Technological Characteristics
The fundamental scientific technology of the modified device has not changed.
Predicate Device: Pre Loaded Visicoil Marker
K 070305 510(k) Number:
Predicate Device: Brachy Needles/Sleeves/Spacers/Markers
510(k) Number: K103449
The design of the predicate Visicoil CK Marker is identical to the Pre-Loaded Marker as it is a gold metallic coil, ranging from 0.5cm-3cm in length. However, 2 coils will be loaded into a needle and separated by a spacer. This configuration is identical to the second predicate product (K103449)
7. Performance Testing
Summary of standards achieved:
ISO 10993 Biological Evaluation of Medical Devices FDA QSR 21 CFR Part 820 Good Manufacturing Practices
19
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Gordon Roberts Director. OA/RA RadioMed Corporation 3150 Stage Post Drive BARTLETT TN 38133
APR 1 9 2012
Re: K120859
Trade/Device Name: Pre-Loaded CK Visicoil Gold Marker Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: March 20, 2012 Received: March 22, 2012
Dear Mr. Roberts:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours. Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use . 510(k) Number (if kr own): 120859
Device Name: Pre-L paded CK Visicoil Gold Marker
Indications For Use: Pre-Loaded CK Visicoil Gold Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
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(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
610K
K120859
510K
AND/OR Over-The-Counter Use Prescription Use × .. (Part 21 CFR 801 Subpart D) (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) Page 1 of 1
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.