DECLIPSESPECT VIEWER by SURGICEYE GMBH

declipseSPECT Viewer works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Viewer is intended to use the said detector and generate images of the distribution of radionuclides in the human body and determine the 3D localization of these radionuclides relative to surgical instruments by means of tracking technologies and image reconstruction techniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing in-situ, such as SPECT/CT and PET/CT.

declipseSPECT Viewer may also be used intraoperatively or on pathological specimens if a protective cover is used to cover the nuclear uptake detector. dedipseSPECT Viewer may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicist and physicians that are trained to use the system.

The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

Device Description

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AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the "declipseSPECT Viewer" device. It does not contain the detailed information required to answer the prompt regarding acceptance criteria and performance studies.

The prompt asks for specific details about the study design (sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details), which are typically found in the summary of safety and effectiveness or in the full submission, not in the clearance letter itself.

Therefore, I cannot provide the requested information based solely on the provided text.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Mr. Moritz Hover Quality and Regulatory Affairs Manager SurgicEye GmbH Friedenstrasse 18a 81671 Munich, Bavaria GERMANY

Re: K123917

Trade/Device Name: declipseSPECT Viewer Regulation Number: 21 CFR 892.1320 Regulation Name: Nuclear uptake probe Regulatory Class: II Product Code: IZD Dated: December 14, 2012 Received: December 19, 2012

Dear Mr. Hoyer:

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 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

January 25, 2013

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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.

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 Diagnostics and Radiological Health 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,

Michael D. O'Hara

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): K123917

Device Name: declipseSPECT Viewer

Indications for Use:

The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

ProbeManufacturer	Probe Model	Probe Handle Model	Energy range ofgamma rays
Crystal Photonics:	SG03	Gamma Probe CXS-OP-SZBN	70 - 245 keV
	SG04	Gamma Probe, CXS-OP-SPBeta Probe, CXS-OP-SB	70 - 245 keV27 - 30 keV
RMD	NavigatorGPS	Gamma Probe; SP2A14curved	27 - 245 keV
		Gamma Probe; SP2S14straight	27 - 245 keV
Eurorad	Europrobe 3	Gamma Probe SOE311	27 - 245 keV

declipseSPECT Viewer is compatible currently to following nuclear uptake detectors:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Andrew D. Hanson
Division Sign Off Date

Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k)

Regulation Number and Section

§ 892.1320 Nuclear uptake probe.

(a)
Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.