Sentinella 102; Sentinella 102 Horus

K143156 · General Equipment For Medical Imaging (Oncovision- · IYX · Nov 18, 2014 · Radiology

Device Facts

• Record ID: K143156
• Device Name: Sentinella 102; Sentinella 102 Horus
• Applicant: General Equipment For Medical Imaging (Oncovision-
• Product Code: IYX · Radiology
• Decision Date: Nov 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1100
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

Sentinella 102 (Models Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel. Sentinella 102 (Models Sentinella 102 Horus) may be used intraoperatively, if a protective sterile sheath is used. Sentinella 102 (Models Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.

Device Story

Sentinella 102/102 Horus is a mobile gamma camera system; detects photons emitted by radionuclides in human body. Operates as mobile imaging unit; used in OR, bedside, ER, or ICU. Physician or qualified personnel operate device; requires protective sterile sheath for intraoperative use. Transforms photon detection into visual images for clinical interpretation. Assists healthcare providers in visualizing radionuclide distribution to support diagnostic decision-making; provides portable imaging capability for patients unable to be transported to traditional radiology suites.

Clinical Evidence

No clinical data provided; device cleared based on substantial equivalence to existing gamma camera technology.

Technological Characteristics

Mobile gamma camera system; photon detection technology; intended for use with sterile sheaths in intraoperative settings. System is designed for portability in clinical environments (bedside, ER, ICU).

Indications for Use

Indicated for imaging radionuclide distribution in the human body via photon detection. Applicable for use in patients requiring nuclear medicine imaging in clinical settings including OR (with sterile sheath), bedside, ER, or ICU. Images intended for interpretation by qualified personnel.

Regulatory Classification

Identification

A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

General Equipment for Medical Imaging S.A. (Oncovision-Gem Imaging S.A.) November 18, 2014 % Mr. Harry van Vugt DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O.Box. 5185, 6802 ED Arnhem THE NETHERLANDS

Re: K143156

Trade/Device Name: Sentinella 102 and 102 Horus (Models: FP-0040 and FP-0055) Regulation Number: 21 CFR 892.1100 Regulation Name: Scintillation (gamma) camera Regulatory Class: I Product Code: IYX Dated: October 29, 2014 Received: November 3, 2014

Dear Mr. van Vugt:

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 (reporting of medical 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.

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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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

for

Janine M. Morris 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) K143156

Device Name

Sentinella 102 (Models Sentinella 102 and Sentinella 102 Horus)

#### Indications for Use (Describe)

Sentinella 102 (Models Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel.

Sentinella 102 (Models Sentinella 102 Horus) may be used intraoperatively, if a protective sterile sheath is used.

Sentinella 102 (Models Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.

| Type of Use (Select one or both, as applicable) | |
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> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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