DECLIPSESPECT LAPAROSCOPY

K133781 · Surgiceye GmbH · IZD · Apr 11, 2014 · Radiology

Device Facts

• Record ID: K133781
• Device Name: DECLIPSESPECT LAPAROSCOPY
• Applicant: Surgiceye GmbH
• Product Code: IZD · Radiology
• Decision Date: Apr 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1320
• Device Class: Class 1

Indications for Use

declipseSPECT Laparoscopy is an enhancement of the declipseSPECT system for minimal invasive surgery using a laparoscopic gamma probe. declipseSPECT Laparoscopy works in conjunction with a laparoscopic nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Laparoscopy 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 Laparoscopy is used intraoperatively or on pathological specimens. For any intraoperative usage the laparoscopic gamma probe needs to be covered by a protective sterile cover. The scan and operation of the system can be performed by medical staff, including technicians, nurses, 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 Story

System enhances minimal invasive surgery via laparoscopic gamma probe; inputs include radionuclide emission data from body/specimens and spatial tracking data of surgical instruments. Device transforms inputs using image reconstruction and tracking technologies to generate 3D images of radionuclide distribution relative to instruments. Used intraoperatively or on pathological specimens by trained medical staff. Viewer module supports in-situ hybrid nuclear medicine image viewing (SPECT/CT, PET/CT). Output provides visual guidance for surgical localization; assists clinicians in identifying target tissues; aids documentation and reporting.

Clinical Evidence

No clinical data provided; device relies on technological characteristics and intended use equivalence to existing nuclear uptake probes.

Technological Characteristics

System utilizes laparoscopic gamma probe (e.g., Crystal Photonics SG04, 60-245 keV range) for radionuclide detection. Employs tracking technologies and image reconstruction algorithms for 3D localization. Software-based viewer supports hybrid image formats (SPECT/CT, PET/CT). Requires sterile protective covers for intraoperative use.

Indications for Use

Indicated for use in minimal invasive surgery to generate images of radionuclide distribution and determine 3D localization of radionuclides relative to surgical instruments. Used intraoperatively or on pathological specimens by trained medical staff (physicians, nurses, technicians). Compatible with specific laparoscopic nuclear uptake detectors (e.g., Crystal Photonics SG04).

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 11, 2014

SurgicEye GmbH % Mr. Moritz Hoyer Friedentstrasse 18A Munich, Bavaria 81671 GERMANY

Re: K133781

Trade/Device Name: declipseSPECT Laparoscopy Regulation Number: 21 CFR 892.1320 Regulation Name: Nuclear uptake probe Regulatory Class: I Product Code: IZD Dated: April 4, 2014 Received: April 7, 2014

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. 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic i product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Hoyer

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [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

K133781 510(k) Number (if known):

Device Name:

declipseSPECT Laparoscope

Indications for Use:

declipseSPECT Laparoscopy is an enhancement of the declipseSPECT system for minimal invasive surgery using a laparoscopic gamma probe. declipseSPECT Laparoscopy works in conjunction with a laparoscopic nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Laparoscopy 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 Laparoscopy is used intraoperatively or on pathological specimens. For any intraoperative usage the laparoscopic gamma probe needs to be covered by a protective sterile cover. The scan and operation of the system can be performed by medical staff, including technicians, nurses, 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. declipseSPECT Laparoscopy is compatible currently to following nuclear uptake detectors:

| Probe<br>Manufacturer | Probe Model | Probe Handle Model | Energy range of<br>gamma rays |
|-----------------------|-------------|--------------------|-------------------------------|
| Crystal Photonics: | SG04 | CXS-OP-SZL-45 | 60-245 keV |

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 Diagnostic Devices (OIVD)

Michael D. O'Hara

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(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) _ K133781 .