C015

K192182 · Micronica Srl · OWB · Jan 17, 2020 · Radiology

Device Facts

• Record ID: K192182
• Device Name: C015
• Applicant: Micronica Srl
• Product Code: OWB · Radiology
• Decision Date: Jan 17, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The C015 device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates (birth to one month), within the limits of the device. The device is to be used in healthcare facilities both inside and outside the operating room, in sterile as well as nonsterile environments, in a variety of procedures. - Applications: - Orthopedic - Neuro - Abdominal - Vascular - Thoracic - Cardiac The device is intended to be used and operated by adequately tramed, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, and radiographers, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.

Device Story

C015 is an image-intensified fluoroscopic x-ray system; provides real-time radiological guidance and visualization for diagnostic, interventional, and surgical procedures. Used in healthcare facilities, including ORs, in sterile/non-sterile environments. Operated by trained professionals (physicians, surgeons, cardiologists, radiographers). System captures x-ray signals; transforms inputs into visual output for clinical guidance. Output assists clinicians in procedural navigation and decision-making; benefits patients through improved visualization during minimally invasive or surgical interventions.

Technological Characteristics

Image-intensified fluoroscopic x-ray system; Class II; Product Codes OWB, OXO, JAA, LMC. Regulated under 21 CFR 892.1650.

Indications for Use

Indicated for radiological guidance and visualization during diagnostic, interventional, and surgical procedures (orthopedic, neuro, abdominal, vascular, thoracic, cardiac). Patient population: all patients except neonates (birth to one month).

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Submission Summary (Full Text)

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January 17, 2020

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Micronica SRL % Ms. Marisa Testa QA/RA Consultant Thema S.r.1. Via Saragat, 5 Imola. Bo 40026 ITALY

Re: K192182

Trade/Device Name: C015 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA, LMC Dated: December 19, 2019 Received: December 23, 2019

Dear Ms. Testa:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

## K192182

Device Name C015

Indications for Use (Describe)

The C015 device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures on all patients except neonates (birth to one month), within the limits of the device.

The device is to be used in healthcare facilities both inside and outside the operating room, in sterile as well as nonsterile environments, in a variety of procedures.

- Applications:
- Orthopedic
- Neuro
- Abdominal
- Vascular
- Thoracic
- Cardiac

The device is intended to be used and operated by adequately tramed, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, and radiographers, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.

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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