(114 days)
Not Found
No
The description focuses on hardware components, signal processing, and data transfer, with no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No
The device is described as an imaging system (gamma camera) used to detect and obtain images of radionuclide distribution, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is intended to "detect and obtain Planar and SPECT images of the distribution of a gamma emitting radionuclide in the organs or bone," which is a process used for diagnostic purposes.
No
The device description explicitly details hardware components such as a gantry, gamma camera detectors, a patient table, a high integrated board (LQN), a Nal crystal, photomultipliers, collimators, and a patient monitor. While it includes software for acquisition and processing, it is clearly a system with significant hardware elements.
Based on the provided information, the MultiCam 3000 eco is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "detect and obtain Planar and SPECT images of the distribution of a gamma emitting radionuclide in the organs or bone and store the data, when the radionuclide is administered in the body." This describes an in vivo imaging procedure, where a substance is administered to a living patient and the device images its distribution within the body.
- Device Description: The description details a gamma camera system with detectors, a patient table, and an acquisition workstation. This is consistent with a medical imaging device used for in vivo procedures.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. The MultiCam 3000 eco does not examine specimens in vitro.
Therefore, the MultiCam 3000 eco is a medical imaging device used for in vivo nuclear medicine procedures, not an IVD.
N/A
Intended Use / Indications for Use
Multi Cam 3000 eco is intended to detect and obtain Planar - and SPECT Images of the distribution of a gamma emitting radionuclide in the organs or bone and store the data, when the radionuclide is administered in the body. Like all Gamma Cameras with the dedicated radiopharmaceutical it is possible to show functional imaging for diagnostic purpose. See also the indication statements of the predicate devices.
The MultiCam 3000 eco is due to the high resolution and sensitivity which are caused by the high number of photomultiplier per crystal field and the 3 detectors it is ideal for neurological and craniological functional diagnostic purposes
Product codes
KPS
Device Description
The MultiCam 3000 eco consist of the gantry with 3 Gamma Camera detectors, a patient table together with an Acquisition Workstation. The Performance or Quality assurance can be done on the Acquisition Workstation with the integrated quality software or on the connected Processing Workstations.
The data will be transferred via the DICOM 3.0 Standard to a Nuclear Medicine Workstations of another Manufacturer, where the patient documentation will be done.
The signal processing is done similar to the existing Prism 3000 or the CX 250 but on one high integrated board - LQN - which provides the Detector data via TCP/IP network to the Acquisition Computer. Also in the MultiCam 3000 eco a Nal crystal is used with 49 Photomultiplier. The Field of View is 13" x 7,9". Please refer for further details in the attached MultiCam 3000 eco Specification.
For the system there are 7 different collimators are optional available. The collimator exchange can be done manual. Each collimator has its own collimator switch which disables the dedicated motion over a separate electronic circuitry. The function of the collimator is also checked continuously by this safety circuits.
The patient monitor is used for patient positioning. It consists of a color monitor for the display of the patient study during acquisition. Additional on it is a window with numeric information for the gantry motion information and the collimator information. It shows also Warning - and Error - Messages of the gantry.
Functional characteristics: Each photomultiplier is precisely digitized with a resolution of 18 bit ADC's. No electronic is anymore needed on the photomultiplier. => Please refer the brochure 'LQN' our Camera electronic.
The output of all 3 detectors are combined in a 1000 Mbit switch and connected over a proprietary TCP/IP network to the Acquisition Computer.
Mentions image processing
The signal processing is done similar to the existing Prism 3000 or the CX 250 but on one high integrated board - LQN - which provides the Detector data via TCP/IP network to the Acquisition Computer.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma emitting radionuclide imaging (Planar and SPECT)
Anatomical Site
Organs or bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The device has been designed, verified and validated complying with applicable safety standards for this type of medical equipment. Bench and clinical data demonstrate that images otandards for this type of comparing to the predicate devices. No adverse effect has been detected. Additionally, a laboratory test has been carried out to validate the electromagnetic compatibility and biocompatibility by a third party organization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
Inter Medical
510(k) Summary (21 CFR 807.92(c))
| 510(k) Owner's Name: | InterMedical Medizintechnik GmbH
Daimlerstrasse 34-36
D-32312 Luebbecke
Germany |
|------------------------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Hans Guenter Osiek
Tel: ++49 5741 2359-0
Fax: ++49 5741 2359-10
Email: osiek@intmed.de |
| Establishment Registration Number: | 3006611212 |
| Date Prepared: | 25 June 2013 |
| Name of Device: | |
| Trade Name: | MultiCam 3000 eco |
| Common Name: | Radiology Device |
| Classification Name:
System | 21CFR 892.1200, Emission Computed Tomography |
| Product Code: | KPS |
ldentification of Predicate Device(s):
| Manufacturer | Device Name | 510(k) Number |
|---|---|---|
| Nuclear Cardiology Systems | Neurospect Quad Gamma Camera | K013353 |
| Ohio Imaging | Prism 3000 Nuclear Gamma System | |
| Modification | K934722 | |
| InterMedical | CX 250 C Plus with Gamma XP Software | K052473 |
Device Description:
- The MultiCam 3000 eco consist of the gantry with 3 Gamma Camera detectors, a patient 1. table together with an Acquisition Workstation. The Performance or Quality assurance can be done on the Acquisition Workstation with the integrated quality software or on the connected Processing Workstations.
The data will be transferred via the DICOM 3.0 Standard to a Nuclear Medicine Workstations of another Manufacturer, where the patient documentation will be done.
1
Inter Medical
- The signal processing is done similar to the existing Prism 3000 or the CX 250 but on one 2. high integrated board - LQN - which provides the Detector data via TCP/IP network to the Acquisition Computer. Also in the MultiCam 3000 eco a Nal crystal is used with 49 Photomultiplier. The Field of View is 13" x 7,9". Please refer for further details in the attached MultiCam 3000 eco Specification.
- For the system there are 7 different collimators are optional available. The collimator 3. exchange can be done manual. Each collimator has its own collimator switch which disables the dedicated motion over a separate electronic circuitry. The function of the collimator is also checked continuously by this safety circuits.
The patient monitor is used for patient positioning. It consists of a color monitor for the display of the patient study during acquisition. Additional on it is a window with numeric information for the gantry motion information and the collimator information. It shows also Warning - and Error - Messages of the gantry.
Functional characteristics: Each photomultiplier is precisely digitized with a resolution of 18 bit ADC's. No electronic is anymore needed on the photomultiplier. => Please refer the brochure 'LQN' our Camera electronic.
The output of all 3 detectors are combined in a 1000 Mbit switch and connected over a proprietary TCP/IP network to the Acquisition Computer.
- For the photographs see the attached MultiCam Brochure, LQN Brochure and further 4. details are in the MultiCam 3000 eco Specification.
Intended Use Statement:
Multi Cam 3000 eco is intended to detect and obtain Planar - and SPECT Images of the distribution of a gamma emitting radionuclide in the organs or bone and store the data, when the radionuclide is administered in the body. Like all Gamma Cameras with the dedicated radiopharmaceutical it is possible to show functional imaging for diagnostic purpose. See also the indication statements of the predicate devices.
The MultiCam 3000 eco is due to the high resolution and sensitivity which are caused by the high number of photomultiplier per crystal field and the 3 detectors it is ideal for neurological and craniological functional diagnostic purposes
2
Inter Medical
Predicate Device Comparision
The purpose of this 510(k) is to inform the FDA of a new design similar to the following predicate devices
refer to 'Substancial Equivalent Discussion'
3
Safety and Effectiveness:
The device has been designed, verified and validated complying with applicable safety standards for this type of medical equipment. Bench and clinical data demonstrate that images otandards for this type of comparing to the predicate devices. No adverse effect has been detected. Additionally, a laboratory test has been carried out to validate the electromagnetic compatibility and biocompatibility by a third party organization.
Before placing the system on the market and use on human beings Inter Medical has reviewed all known information and carried out a risk analysis for the modified hardware.
Substantial Equivalency:
A matrix was made comparing the MultiCam 3000 eco to predicate devices and therefore we concluded that it is substantially equitalent to the legally marketed device.
(Signature)
Hans Guenter Osiek (Typed Name)
M. Aprič 2013
Date
Inter Medical
Medizintechnik GmbH
Medizintechnik GmbH
Daimlerstraße 34-36 D- 32312 Lûbbecko Tel. 05741 2359-0 Fax 05741 2359-10
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20. 2013
InterMedical Medizintechnik GmbH % Mr. William Carroll Managing Director Eclipse Systems. Inc. 14 Commercial Street, Unit B BRANFORD CT 06405
Re: K132347
Trade/Device Name: MultiCam 3000 eco Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 26. 2013 Received: August 26. 2013
Dear Mr. Carroll:
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.
5
Page 2-Mr. Carroll
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/ResourcesforYou/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/ReportalProblem/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/Industrv/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
6
Indications for Use
510(k) Number (if known): K132347
Device Name: MultiCam 3000 eco
Indications for Use:
MultiCam 3000 eco is intended to detect and obtain Planar and SPECT images of the distribution of a gamma emitting radionuclide in the organs or bone and store the data, when the radionuclide is administered in the body.
Prescription Use X (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)
Michael O. D'Hasa
(Division Sign Off) Division of Radiological Health Office of In Virro Diagnostic and Radiological Health
510(k) K132347