(37 days)
Not Found
Not Found
No
The provided text describes image generation, reconstruction, and viewing techniques, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets.
No
The device is used for generating images of radionuclide distribution and 3D localization, and for viewing nuclear medicine images (SPECT/CT, PET/CT). It is an imaging and diagnostic tool, not one that directly provides therapy or treatment.
Yes
The device is described as generating images to "determine the 3D localization of these radionuclides relative to surgical instruments" and the images can be "used also for documentation and reporting." It is also used for "hybrid nuclear medicine image viewing." While it does not explicitly state "diagnosis," these functions are inherent to diagnostic processes in nuclear medicine.
No
The device description is not provided, but the intended use explicitly states that the software "works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region" and is intended to "use the said detector". This indicates a dependency on a specific hardware component (the detector) for its core function, making it a system that includes hardware, not a software-only device.
Based on the provided information, the declipseSPECT Viewer is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens taken from the human body. The intended use of the declipseSPECT Viewer is to generate images of the distribution of radionuclides within the human body and determine their 3D localization relative to surgical instruments. It also mentions viewing hybrid nuclear medicine images in-situ.
- The device works in conjunction with a nuclear uptake detector. This detector measures radionuclides in vivo (within the living body), not in a sample taken from the body.
- The output is images of the distribution of radionuclides in the human body. This is an imaging device, not a device that analyzes biological samples.
While it mentions potential use on "pathological specimens," this is a secondary use case and the primary intended use is clearly focused on in vivo imaging and localization. The core function is not the analysis of a specimen in vitro.
N/A
Intended Use / Indications for Use
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.
Product codes
IZD
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear uptake detector (gamma rays)
Anatomical Site
Human body / particular organ or body region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical staff, including technicians, nurses, physicist and physicians that are trained to use the system.
Patient's bedside, or in an Emergency Room or Intensive Care Unit.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. The text "HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
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
1
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
2
Indications for Use
510(k) Number (if known): K123917
Device Name: declipseSPECT Viewer
Indications for Use:
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.
| Probe
Manufacturer | Probe Model | Probe Handle Model | Energy range of
gamma rays |
|-----------------------|------------------|-------------------------------------------------|-------------------------------|
| Crystal Photonics: | SG03 | Gamma Probe CXS-OP-
SZBN | 70 - 245 keV |
| | SG04 | Gamma Probe, CXS-OP-SP
Beta Probe, CXS-OP-SB | 70 - 245 keV
27 - 30 keV |
| RMD | Navigator
GPS | Gamma Probe; SP2A14
curved | 27 - 245 keV |
| | | Gamma Probe; SP2S14
straight | 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)