(133 days)
No
The summary describes standard image processing techniques and reconstruction methods for SPECT imaging, without mentioning AI or ML.
No
The device is an imaging system intended for detection, localization, and diagnosis, not for providing therapy. It aids in planning, guiding, and monitoring therapy but does not directly deliver therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "The D-SPECT® Cardiac Scanner is intended for use by the appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of (but not limited) cardiac or individual organs diseases." This directly indicates its role in diagnosis.
No
The device description explicitly lists hardware components such as a detector head, gantry, patient supports, and UPS, indicating it is a physical system, not software-only.
Based on the provided text, the D-SPECT® Cardiac Scanner is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- D-SPECT® Function: The D-SPECT® Cardiac Scanner is an imaging system that detects radioisotope tracer uptake within the patient's body and produces images through computer reconstruction. It does not analyze specimens taken from the body.
The device falls under the category of medical imaging equipment, specifically a Single Photon Emission Computed Tomography (SPECT) system.
N/A
Intended Use / Indications for Use
The D-SPECT® Cardiac Scanner is an emission computed tomography system intended for detection of radioisotope tracer uptake in the patient's body and produce cross-sectional images through computer reconstruction of the data. The system uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated and Dynamic) and tomographic mode (Static, Multi-gated and Dynamic). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include gating by physiological signals, real-time body movement control, and low count rate (low dose) acquisition without loss of image quality.
The D-SPECT® Cardiac Scanner may consist and display equipment contain data and image processing software to produce images in a variety of trans-axial and reformatted planes. To perform analysis and uptake quantitation and to apply the appropriate filters. The system utilizes combined images for attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion).
The D-SPECT® Cardiac Scanner is intended for use by the appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of (but not limited) cardiac or individual organs diseases. The system output can be used for planning, guiding, and monitoring therapy.
Product codes
KPS
Device Description
Spectrum Dynamics D-SPECT® Cardiac Scanner System is a single photon emission computing tomography system intended for detection of radioisotope tracer uptake in the body and produce cross-sectional images through computer reconstruction of the data.
The device uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. System's scanning modes include planar mode (Static, Multi-Gated and Dynamic) and tomographic mode (Static, Multi-Gated and Dynamic). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include gating by physiological signals, real-time body movement control. The device may proceed a low count rate (low dose) acquisition without loss of image quality. The device may utilize variate modalities to create attenuation corrected images along with functional and anatomical mapping imaging (localization, registration and fusion).
The device is a high performance and compact Single Photon Emission Computed Tomography system intended for imaging of the breast and additional small organs in order to aid in the evaluation of lesions.
The system detectors support radionuclides within the energy range of 40 -170 Kev.
D-SPECT® Cardiac Scanner System comprising detector head, gantry, patient supports, uninterruptible power supply (UPS), image display and processing equipment, gating and real-time body movement control tools, interconnecting cables and related appurtenances.
The device is available in two models, D-SPECT with nine detectors configuration and the D-SPECT L with six detectors configuration.
D-SPECT® Cardiac Scanner System consist integrated signal analysis and display equipment or may use an FDA cleared D-SPECT® Processing and Reviewing Workstation (K160120) for image processing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
emission computed tomography (single photon emission computed tomography)
Anatomical Site
cardiac or individual organs, breast and additional small organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained healthcare professionals
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)
Performance testing:
D-SPECT® Cardiac Scanner System is designed in accordance with the EN 60601 series of standards, including all relevant collateral standards, i.e. IEC 60601-1, 1-2. etc. Device performance validation testing conducted according to NEMA NU-1:2012. All testing results are met the predetermined acceptance values.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2016
Spectrum Dynamics Medical Ltd % Mr. Igor Naroditsky Director QA/RA 22 Bareket Street Caesarea, 3088900 ISRAEL
Re: K161740
Trade/Device Name: D-SPECT® Cardiac Scanner System D-SPECT® L Cardiac Scanner System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 1, 2016 Received: August 11, 2016
Dear Mr. Naroditsky:
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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
Robert Oels
Robert Ochs, Ph.D. 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
510(k) Number (if known) K161740
Device Name D-SPECT® Cardiac Scanner D-SPECT® L Cardiac Scanner
Indications for Use (Describe)
The D-SPECT® Cardiac Scanner is an emission computed tomography system intended for detection of radioisotope tracer uptake in the patient's body and produce cross-sectional images through computer reconstruction of the data. The system uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated and Dynamic) and tomographic mode (Static, Multi-gated and Dynamic). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include gating by physiological signals, real-time body movement control, and low count rate (low dose) acquisition without loss of image quality.
The D-SPECT® Cardiac Scanner may consist and display equipment contain data and image processing software to produce images in a variety of trans-axial and reformatted planes. To perform analysis and uptake quantitation and to apply the appropriate filters. The system utilizes combined images for attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion).
The D-SPECT® Cardiac Scanner is intended for use by the appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of (but not limited) cardiac or individual organs diseases. The system output can be used for planning, guiding, and monitoring therapy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/0 description: The image shows the logo for Spectrum Dynamics Medical. The logo consists of a blue triangular prism on the left, followed by the company name in blue text. The words "SPECTRUM" and "DYNAMICS MEDICAL" are on separate lines, with the latter being smaller and underlined. Below that, it says "A BIOSENSORS INTERNATIONAL GROUP COMPANY" in smaller, lighter blue text, also underlined.
D-SPECT ™ Cardiac Scanner
510(k) Summary
D-SPECT® Cardiac Scanner System
510(k) Number K161740
| Identification of the Submitter | ||
|---|---|---|
| Submitter: | Igor Naroditsky, Director QA/RA | |
| Spectrum Dynamics Medical Ltd. | ||
| 22 Bareket St. Caesarea, Israel 3088900. | ||
| Telephone Number: | + (972) 73-737-4500, | |
| Fax Number: | + (972) 73-737-4501 | |
| Name / Address of Manufacturer: | Spectrum Dynamics Medical Ltd. | |
| 22 Bareket St. Caesarea, Israel 3088900. | ||
| Date of Submission: | 30 May 2016 | |
| Identification of the product | ||
| Device Proprietary Names: | D-SPECT® Cardiac Scanner System | |
| D-SPECT® L Cardiac Scanner System | ||
| Common/Classification Names: | Emission computed tomography system | |
| Class: | II | |
| Product Code: | KPS | |
| Classification Panel: | Radiology | |
| Regulation No: | 21 CFR 892.1200 | |
| Marketed Devices to which Equivalence is claimed | ||
| Device | Manufacturer | 510(k) Number |
Spectrum Dynamics Medical Ltd.
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Reference Devices:
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| D-SPECT® Processing and Reviewing | ||
| Workstation | Spectrum Dynamics Medical Ltd. | K160120 |
| Discovery NM/CT 670 CZT | GE Healthcare | K153402 |
Device Description:
Spectrum Dynamics D-SPECT® Cardiac Scanner System is a single photon emission computing tomography system intended for detection of radioisotope tracer uptake in the body and produce cross-sectional images through computer reconstruction of the data.
The device uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. System's scanning modes include planar mode (Static, Multi-Gated and Dynamic) and tomographic mode (Static, Multi-Gated and Dynamic). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include gating by physiological signals, real-time body movement control. The device may proceed a low count rate (low dose) acquisition without loss of image quality. The device may utilize variate modalities to create attenuation corrected images along with functional and anatomical mapping imaging (localization, registration and fusion).
The device is a high performance and compact Single Photon Emission Computed Tomography system intended for imaging of the breast and additional small organs in order to aid in the evaluation of lesions.
The system detectors support radionuclides within the energy range of 40 -170 Kev.
D-SPECT® Cardiac Scanner System comprising detector head, gantry, patient supports, uninterruptible power supply (UPS), image display and processing equipment, gating and real-time body movement control tools, interconnecting cables and related appurtenances.
The device is available in two models, D-SPECT with nine detectors configuration and the D-SPECT L with six detectors configuration.
D-SPECT® Cardiac Scanner System consist integrated signal analysis and display equipment or may use an FDA cleared D-SPECT® Processing and Reviewing Workstation (K160120) for image processing.
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D-SPECT Cardiac Scanner System is intended for use by the appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of (but not limited) cardiac diseases. The system output can be used for planning, guiding, and monitoring therapy.
Intended Use Statement:
The D-SPECT Cardiac Scanner System is an emission computed tomography system intended for detection of radioisotope tracer uptake in the patient's body and produce crosssectional images through computer reconstruction of the data. The system uses a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated and Dynamic) and tomographic mode (Static, Multi-gated and Dynamic). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include gating by physiological signals, real-time body movement control, and low count rate (low dose) acquisition without loss of image quality.
The D-SPECT Cardiac Scanner System may consist analysis and display equipment contain data and image processing software to produce images in a variety of trans-axial and reformatted planes. To perform analysis and uptake quantitation and to apply the appropriate filters. The system utilizes combined images for attenuation corrected imaging as well as functional and anatomical mapping imaging (localization, registration and fusion).
The D-SPECT Cardiac Scanner System is intended for use by the appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of (but not limited) cardiac or individual organs diseases. The system output can be used for planning, guiding, and monitoring therapy.
Predicate Devices:
| Device | D-SPECT tm Cardiac Scanner |
|---|---|
| Manufacturer | Spectrum Dynamics Medical Ltd. |
| 510(k) Number | K110507 |
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Reference Devices:
| Device | Manufacturer | 510(k) Number |
|---|---|---|
| D-SPECT® Processing and Reviewing | ||
| Workstation | Spectrum Dynamics Medical Ltd. | K160120 |
| Discovery NM/CT 670 CZT | GE Healthcare | K153402 |
Substantial Equivalence to Predicate Devices
D-SPECT scanner is a modification of the D-SPECT Cardiac Scanner (K110507) that reorganizes the system's indications for use and introduces an additional device model. D-SPECT® Scanner and its predicate, the Spectrum Dynamics D-SPECT Cardiac Scanner (K110507) have the similar indication for use and both utilize same fundamental technology. Discovery NM/CT 670 CZT (K153402), in particular its NM part, is supporting modified intended use. D-SPECT® Processing and Reviewing Workstation (K160120) supports image post processing modalities.
Both devices the modified D-SPECT Cardiac Scanner System and its predicate D-SPECT Cardiac Scanner are intended for use by the appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of (but not limited) cardiac or individual organs diseases. The system output can be used for planning, guiding, and monitoring therapy. The intended use of the subject device has been reorqanized and extended to support and clarify a well-established imaging modalities.
Discovery NM/CT 670 CZT (K153402), especially its NM part, uses to support intended use reorganization.
Technology characteristic
D-SPECT® Cardiac Scanner System based on the commercially available D-SPECT ™ Cardiac Scanner (K110507). The modified D-SPECT Cardiac Scanner System hardware based on the same fundamental technology and utilize same CZT detectors, collimators and image reconstruction tools. The device efficacy and safety as well as the performance specifications remain the same.
Performance testing
D-SPECT® Cardiac Scanner System is designed in accordance with the EN 60601 series of standards, including all relevant collateral standards, i.e. IEC 60601-1, 1-2. etc. Device
8
performance validation testing conducted according to NEMA NU-1:2012. All testing results are met the predetermined acceptance values.