(120 days)
Not Found
Not Found
No
The summary describes image reconstruction and tracking technologies, which are standard techniques in medical imaging and navigation, but does not mention AI or ML.
No
The device is used to generate images of radionuclide distribution and localization, primarily for diagnostic or intraoperative guidance, rather than directly treating a condition.
Yes
The device is described as generating images of radionuclide distribution and determining 3D localization, and the generated images are used for interpretation by trained personnel. This process of generating images and interpreting them to understand the distribution of radionuclides in the body for medical purposes falls under diagnostic activities.
No
The device description is not provided, but the intended use clearly describes the device working in conjunction with a laparoscopic gamma probe (hardware) and mentions the need for a protective sterile cover for the probe during intraoperative use. This indicates the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the living body.
- declipseSPECT Laparoscopy Function: The description clearly states that declipseSPECT Laparoscopy is used intraoperatively (during surgery) and on pathological specimens. It uses a laparoscopic gamma probe to measure radionuclide uptake within the human body and generates images of radionuclide distribution in the human body.
- Focus on In Vivo Imaging: The primary function is to visualize and localize radionuclides in vivo (within the living body) during surgical procedures. While it can be used on pathological specimens, its core intended use is for guiding surgery based on in-body measurements.
Therefore, because the device operates primarily within the human body for diagnostic and surgical guidance purposes, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 Manufacturer: Crystal Photonics
Probe Model: SG04
Probe Handle Model: CXS-OP-SZL-45
Energy range of gamma rays: 60-245 keV
Product codes
IZD
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
Nuclear medicine (gamma probe)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical staff, including technicians, nurses, physicians that are trained to use the system. Used intraoperatively or on pathological specimens.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings.
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.
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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
Manufacturer | Probe Model | Probe Handle Model | Energy range of
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
Page 1 of
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) _ K133781 .