(310 days)
No
The device description clearly states it is a "passive device" and is a physical marker made of platinum. There is no mention of any computational or analytical functions that would involve AI or ML.
No
The device is a marker for future therapeutic procedures, not a therapeutic device itself.
No
Explanation: The device is a marker used to "radiographically mark soft tissue for future therapeutic procedures," indicating it aids in treatment planning or execution rather than diagnosing a condition. Its primary function is visualization for therapeutic purposes, not for identifying diseases or conditions.
No
The device description clearly states it is a physical, sterile device in the form of a platinum coil, available on a carrier or pre-loaded in a needle. It is a passive, permanently implanted device. There is no mention of software as a component or the primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "radiographically mark soft tissue for future therapeutic procedures." This is a physical marking of tissue within the body for imaging purposes, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a physical implant (a platinum coil) that is permanently placed in the patient. IVDs are typically reagents, instruments, or systems used to examine specimens (like blood, urine, or tissue samples) outside the body.
- Environment for Use: While it's used in healthcare settings, this refers to the implantation procedure, not the analysis of a sample.
- Mechanism of Action: The device works by being visible under imaging modalities due to its material properties. It does not perform any chemical, biological, or immunological analysis on a sample.
In summary, the Visicoil MR Marker is a medical device used for imaging guidance during procedures, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The Visicoil MR Marker and the Pre-Loaded Visicoil MR Marker are indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Product codes
IYE
Device Description
The Visicoil MR is a helically wound coil of platinum wire. The product is available on a carrier for user-loaded implantation or pre-loaded in a needle. The Visicoil MR is a linear fiducial marker. It is used for marking soft tissue for future therapeutic procedures. The Visicoil MR Marker and the Pre-loaded Visicoil MR Marker is a sterile device, in the form of a platinum coil. Visicoil MR comes on a delivery system, packaged in a Mylar/Tyvek pouch, sterilized by gamma sterilization. The Pre-Loaded Visicoil MR comes in a 18, 19, 20, 21, or 22g 304 stainless steel needle and stylet with a beeswax plug at the tip, packaged in a Mylar/Tyvek pouch sterilized by EO sterilization. The coils ranges in length from 0.3cm to 2cm and have an outside diameter that ranges between 0.3mm and 1.0mm. Platinum has a dense mass which allows for imaging in all x-ray based imaging devices and other electro-magnetic properties help to enhance visibility within Magnetic Resonance Imaging (MRI). The device is a passive device and is permanently implanted in the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray based imaging devices, Magnetic Resonance Imaging (MRI)
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility, free standing clinic or physician's office.
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)
Biocompatibility testing per ISO 10993-1:2009 for the Visicoil MR has demonstrated biocompatibility for a permanent implant device that contacts tissue and bone. Functional testing conducted to verify that the Visicoil MR is visible and stable and can be used safely under Magnetic Resonance Imaging (MRI) provides further demonstration that the Visicoil MR is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2017
RadioMed Corporation % Ms. Leah Easley Ouality and Regulatory Manager 3150 Stage Post Drive Suite 110 BARTLETT TN 38133
Re: K161724
Trade/Device Name: Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 22, 2016 Received: June 22, 2016
Dear Ms. Easley:
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
Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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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.
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,
Michael D'Hara
For
Robert A. Ochs. Ph.D. 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) K161724
Device Name Visicoil MR Marker Pre-Loaded Visicoil MR Marker
Indications for Use (Describe)
The Visicoil MR Marker and the Pre-Loaded Visicoil MR Marker are 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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-
- Sponsor Name (Manufacturer)
RadioMed Corporation
- Sponsor Name (Manufacturer)
3150 Stage Post Drive
Submission Dates: K161724/S002 April 04, 2017 K161724/S001 Jan 18, 2017 K161724 May 26, 2016
| Suite 110 | |
|---|---|
| Bartlett, Tennessee 38133 | |
| Telephone: | (901) 432 7202 voice |
| (901) 432 7206 fax | |
| Contact Individual: | Leah Easley |
-
- Device Name
Proprietary Name:
- Device Name
• Visicoil MR Marker, Pre-Loaded Visicoil MR Marker Common/Usual Name:
. Visicoil MR Marker, Pre-loaded Visicoil MR Marker Classification Name:
Medical charged-particle radiation therapy system (21 CFR 892.5050) . Device Class:
-
. =
Product Code: -
. IYE
-
- Identification of Predicate or Legally Marketed Device
The predicate devices for RadioMed™ Visicoil MR Marker are:
-
- Pre-loaded Visicoil Marker (K070305)
Other Reference Devices:
- Pre-loaded Visicoil Marker (K070305)
-
- Visicoil Marker (K031206)
-
- Summary Device Description
Device Identification: the Visicoil MR is a helically wound coil of platinum wire. The product is available on a carrier for user-loaded implantation or pre-loaded in a needle.
Device Characteristics: The Visicoil MR is a linear fiducial marker. It is used for marking soft tissue for future therapeutic procedures.
Environment for Use: The Visicoil MR and Pre-Loaded Visicoil MR may be implanted in a healthcare facility, free standing clinic or physician's office.
Description of Device: The Visicoil MR Marker and the Pre-loaded Visicoil MR Marker is a sterile device, in the form of a platinum coil. Visicoil MR comes on a delivery
4
system, packaged in a Mylar/Tyvek pouch, sterilized by gamma sterilization. The Pre-Loaded Visicoil MR comes in a 18, 19, 20, 21, or 22g 304 stainless steel needle and stylet with a beeswax plug at the tip, packaged in a Mylar/Tyvek pouch sterilized by EO sterilization.
The coils ranges in length from 0.3cm to 2cm and have an outside diameter that ranges between 0.3mm and 1.0mm. Platinum has a dense mass which allows for imaging in all x-ray based imaging devices and other electro-magnetic properties help to enhance visibility within Magnetic Resonance Imaging (MRI).
The device is a passive device and is permanently implanted in the patient.
The Pre-loaded Visicoil MR will be manufactured, labeled, and packaged in accordance with the current FDA QSR and UDI regulation. To ensure compliance to specifications, upon completion of the manufacturing process and prior to release, the device will be inspected and tested in accordance with RadioMed standard operating procedures.
The product is not Electro Mechanical in nature so does not require EMC review.
Patient contacting materials: Visicoil MR and Pre-Loaded MR are comprised of Platinum and are permanently implanted. The Pre-Loaded Visicoil MR is loaded in a 304 stainless steel needle and stylet. The needle and stylet are for momentary patient contact for duration of procedure. The needle has a small amount of beeswax (Bone wax) at the tip to prevent the coil from falling out. A portion of the wax is permanently implanted into the body along with the coil as with the predicate device.
5. Intended Use
The intended use and indications for use of the modified device, as described in its labeling has not changed.
The Visicoil MR Marker and the Pre-Loaded Visicoil MR Marker are indicated for use to radiographically mark soft tissue for future therapeutic procedures.
6. Comparison of Technological Characteristics
The fundamental scientific technology of the modified device has not changed. The Visicoil MR Marker is manufactured from platinum (99.95%) as opposed to gold (99.95%). All other technology characteristics are identical.
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Predicate Device: Pre-Loaded Visicoil Marker 510(k) Number: K070305
Other Reference Devices: Visicoil Marker 510(k) Number: K031206
7. Basis for Substantial Equivalence and Conclusion
The design of the Pre-Loaded Visicoil MR marker and the Visicoil MR marker is different from the predicate Pre-loaded Visicoil Marker and Visicoil products in the following ways:
The Visicoil MR Marker is manufactured from platinum as opposed to gold. All other characteristics are identical.
The design of the Pre-Loaded Visicoil MR marker and the Visicoil MR marker is similar to the predicate Pre-loaded Visicoil Marker and Visicoil products in the following ways:
The Visicoil MR indications for use are the same as the indications for use of the predicate device.
Biocompatibility testing per ISO 10993-1:2009 for the Visicoil MR has demonstrated biocompatibility for a permanent implant device that contacts tissue and bone.
Functional testing conducted to verify that the Visicoil MR is visible and stable and can be used safely under Magnetic Resonance Imaging (MRI) provides further demonstration that the Visicoil MR is safe and effective for its intended use.
Conclusion
The change in material composition does not adversely affect the safety or effectiveness of the new device. The new markers are functionally equivalent to the predicate device, with the additional characteristic of now being that they are highly visible when using MRI.