(89 days)
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Not Found
No
The summary describes a collimator for a nuclear medicine camera, which is a hardware component that shapes the radiation beam. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as an "E.CAM Extra High Energy Collimator" used for imaging and detecting radionuclides, which indicates a diagnostic rather than therapeutic function.
Yes
The device is described as detecting or imaging the distribution of radionuclides in the body or organ, which is a process used for diagnostic purposes in nuclear medicine to identify various medical conditions.
No
The device description explicitly states "E.CAM Extra High Energy Collimator," which is a hardware component used in nuclear medicine imaging. The intended use also describes detecting and imaging radionuclides, which requires hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "detect or image the distribution of radionuclides in the body or organ." This describes an in vivo (within the living body) diagnostic procedure, not an in vitro (outside the living body) diagnostic procedure.
- Device Description: The device is an "E.CAM Extra High Energy Collimator," which is a component used in nuclear medicine imaging systems. These systems are used to image the distribution of radioactive tracers administered to a patient, which is an in vivo process.
- Input Imaging Modality: The input imaging modality is "Nuclear Medicine," which is an in vivo imaging technique.
IVD devices are typically used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. This device operates directly on the patient's body to capture images of radionuclide distribution.
N/A
Intended Use / Indications for Use
To detect or image the distribution of radionuclides in the body or organ, using the following techinique(s):
A. Planar Imaging
B. Whole Body Imaging
E. Positron imaging with out coincidence. Camera range increases to 588 keV
Product codes
90KPS
Device Description
The Siemens E.CAM Extra High Energy Collimator is a product which is substantially equivalent to legally marketed devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Nuclear Medicine Device
Anatomical Site
All
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
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
Redical Systems, Inc., Nuclear Medicine Group E.CAM Extra High Energy Collimator
OCT
SUMMARY OF SAFETY AND EFFECTIVENESS July 8, 1998
| I. General Information | |
|---|---|
| Classification Name: | System, Tomography, Computed Emission |
| Product Code: | 90KPS |
| Device Trade Name: | E.CAM 511keV Collimator |
| Classification: | Class II Medical Device |
| Intended Uses: | Anatomical Region: All |
| Diagnostic Uses: Imaging | |
| Establishment Name and Address: | Siemens Medical Systems, Inc. |
| Nuclear Medicine Group | |
| 2501 N. Barrington Road | |
| Hoffman Estates, Illinois 60195-7372 | |
| Establishment Registration Number: | Owner/Operator No. 9010023 |
| Performance Standard: | None established under Section 514 of the |
| Food, Drug and Cosmetic Act |
II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device.
Substantial Equivalence
The Siemens E.CAM Extra High Energy Collimator is a product which is substantially equivalent to legally marketed devices.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 1998
Andrea DiSani Regulatory Affairs Associate Siemens Medical Systems, Inc. 2501 North Barrington Road Hoffman Estates, IL 60195-7372 Re:
E.CAM Extra High Energy Collimator Dated: July 8, 1998 Received: July 9, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. DiSani:
We have reviewed your Section $10(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 Beckeral Food, Drug, and Cosmetion of Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing gractice, labeling; and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially ecuivalience compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices of cenerative (21 CFR Part 820) and that, through periodic OS inspections the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Rederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in viro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.ida.govedrividsmaldsmamain.html".
Sincerely yours,
Lillian Yip, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal. Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Siemens Medical Systems, Inc., Nuclear Medicine Group E.CAM Extra High Energy Collimator
ﺎ
510(k) Number (If known): K982387
Siemens E.CAM Extra High Energy Collimator Option Device Name:
Nuclear Medicine Device
Indications For Use: To detect or image the distribution of radionuclides in the body or organ, using the following techinique(s):
| YES | NO | Energy Range (keV) | ||
|---|---|---|---|---|
| A. | Planar Imaging | X | ||
| B. | Whole Body Imaging | X | ||
| C. | Tomographic Imaging (SPECT) for non | |||
| Positron emitter | X | |||
| D. | Positron imaging by coincidence | X | ||
| E. | Positron imaging with out coincidence | X | Camera range increases | |
| to 588 keV | ||||
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription Use_ (per 21 CFR 801.109)
OR
Over-the counter Use
(Optional Format 1-2-96)
David L. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number
510(k) Submission Section 1 - Page 2