(70 days)
Not Found
No
The description focuses on the material and physical characteristics of a fiducial marker and its placement method, with no mention of AI or ML.
No
The device is a fiducial marker used to mark soft tissue for future therapeutic procedures, not to perform therapy itself.
No
The device is a fiducial marker used for marking soft tissue for future therapeutic procedures, not for diagnosing a condition or disease. Its purpose is to make tissue visible radiographically for treatment planning or delivery, rather than to provide diagnostic information.
No
The device description clearly states it is a physical, helically wound coil made of a platinum alloy wire, which is a hardware component.
Based on the provided information, the LumiCoil Platinum Fiducial Marker 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 describes a device used in vivo (within the body) for marking purposes, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical implantable device (a coil made of platinum alloy) designed to be placed within soft tissue. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition based on in vitro testing.
Therefore, the LumiCoil Platinum Fiducial Marker is a medical device intended for in vivo use, not an IVD.
N/A
Intended Use / Indications for Use
The LumiCoil Platinum Fiducial Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Product codes
IYE
Device Description
The LumiCoil Platinum Fiducial Marker is a helically wound coil made of a platinum alloy wire. The outer diameter of the coil is 0.46mm. The alloy wire is comprised of ~92% platinum and ~8% tungsten. The LumiCoil Marker is available in two shape configurations: straight and figure 8. The length of the fiducial markers when implanted is 5mm.
The LumiCoil Marker is recommended to be placed using the 22ga Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle.
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
Non-clinical performance bench testing and simulated use testing were completed to evaluate the design of the LumiCoil Marker for its indications for use.
Comparative testing was performed to demonstrate the visibility of the LumiCoil Marker and the predicate Visicoil Marker.
Key Metrics
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
December 19, 2017
Image /page/0/Picture/1 description: The image shows the logo of 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, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Boston Scientific Corporation % Lindsay Forys Senior Regulatory Affairs Specialist 100 Boston Scientific Way MARLBOROUGH MA 01752
Re: K173251
Trade/Device Name: LumiCoil Platinum Fiducial Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: October 5, 2017 Received: October 10, 2017
Dear Ms. Lindsay Forys:
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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Robert Ochs
Robert 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)
K173251
Device Name LumiCoil Platinum Fiducial Marker
Indications for Use (Describe)
The LumiCoil Platinum Fiducial Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 5. 510(K) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Primary Contact: Lindsay Forys Senior Regulatory Affairs Specialist Telephone: 508-683-6317 Fax: 508-683-5939
Secondary Contact: Ashley Santos Senior Regulatory Affairs Manager Telephone: 508-683-4359 Fax: 508-683-5939
Date Prepared: 05 October 2017
-
- Device:
| Trade Name: | LumiCoil™ Platinum Fiducial Marker |
|---|---|
| Device Common Name: | Soft Tissue Marker |
| Regulation Name: | Medical charged-particle radiation therapy |
| system | |
| Regulation Number: | 21CFR 892.5050 |
| Product Code: | IYE |
| Regulatory Class: | Class II |
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3. Predicate Device:
| Trade Name: | Visicoil Marker |
|---|---|
| 510(k) Number: | K070305 |
| Device Common Name: | RadioMed Soft Tissue Marker |
| Regulation Name: | Medical charged-particle radiation therapy |
| system | |
| Computed tomography x-ray system | |
| Regulation Number: | 21CFR 892.5050 |
| 21CFR 892.1750 | |
| Product Code: | IYE |
| JAK | |
| Regulatory Class: | Class II |
| Trade Name: | Visicoil MR Marker |
|---|---|
| 510(k) Number: | K161724 |
| Device Common Name: | Visicoil MR Marker, Pre-Loaded Visicoil |
| MR Marker | |
| Regulation Name: | Medical charged-particle radiation therapy |
| system | |
| Regulation Number: | 21CFR 892.5050 |
| Product Code: | IYE |
| Regulatory Class: | Class II |
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4. Device Description
The LumiCoil Platinum Fiducial Marker is a helically wound coil made of a platinum alloy wire. The outer diameter of the coil is 0.46mm. The alloy wire is comprised of ~92% platinum and ~8% tungsten. The LumiCoil Marker is available in two shape configurations: straight and figure 8. The length of the fiducial markers when implanted is 5mm.
The LumiCoil Marker is recommended to be placed using the 22ga Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle.
5. Indications for Use:
The LumiCoil Platinum Fiducial Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
6. Technological Characteristics
The intended use of the proposed LumiCoil Marker is identical to the predicate Visicoil Marker (K070305) and Visicoil MR Marker (K161724). The fiducial markers are comprised of helically wound wire and can be implanted using an endoscopic ultrasound (EUS) needle. In addition, both the LumiCoil Marker and the Visicoil MR Marker (K161724) are primarily made of platinum.
7. Performance Data
Non-clinical performance bench testing and simulated use testing were completed to evaluate the design of the LumiCoil Marker for its indications for use.
Comparative testing was performed to demonstrate the visibility of the LumiCoil Marker and the predicate Visicoil Marker.
Conclusion
The information provided in this submission demonstrates that the proposed LumiCoil Marker is substantially equivalent to the Visicoil Marker (K070305) and the Visicoil MR Marker (K161724).