(27 days)
Not Found
No
The summary describes standard SPECT image reconstruction and quantification software (QPS and QGS) which are well-established techniques that do not inherently utilize AI/ML. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is used for diagnostic imaging to detect the location and distribution of radionuclides and produce images, not for therapeutic purposes.
Yes
The D-SPECT system is designed to detect the location and distribution of gamma ray radionuclides in the body to produce cross-sectional images, primarily for cardiac applications. This process involves gathering data about the body's internal state to assist in identifying abnormalities, which is the definition of a diagnostic device. Furthermore, the inclusion of QPS and QGS software for review and quantification of cardiac SPECT data further supports its diagnostic purpose.
No
The device description explicitly states it is comprised of a detector head, gantry, and patient chair, which are hardware components. While it includes software for processing, it is not solely software.
Based on the provided information, the D-SPECT device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The D-SPECT system, as described, is an imaging device that detects gamma rays within the body (in vivo) after a radiopharmaceutical has been administered.
- The intended use and device description clearly state it's an emission computed tomography system for detecting radionuclides in the body and producing images. This is a form of medical imaging, not laboratory testing of samples.
- The device description mentions a patient chair and gantry, which are typical components of imaging systems, not IVD devices.
Therefore, the D-SPECT device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The D-Spect™ is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce crosssectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-Spect™ is primarily intended for cardiac applications. D-Spect™ supports radionuclides within the energy range of 40 -170 keV.
Product codes
KPS
Device Description
Spectrum Dynamics' D-Spect™ Cardiac Scanner System is a SPECT device, which is designed to perform myocardial perfusion imaging. The device is comprised of a detector head, gantry, and patient chair. Device operation is controlled from an acquisition station console. The system is supported by use of data-transfer accessories (RFID tags), which are attached to the patient's wrist and to the syringe containing the radiopharmaceutical agent, for patient and syringe positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector boards rotate within the closed detector head. The special scanning geometry and detector technology, enable shorter scan times. In the modified D-Spect™ device, a Processing Station was added. The Processing Station, which is part of the display equipment, contains a software application with the Cedars Sinai Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) software that enables a review and quantification of cardiac SPECT data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
emission computed tomography
Anatomical Site
cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
- A. Software Validation
- Electromagnetic Compatibility/ Electrical Safety Testing B.
Functionality tests were performed as part of the software validation testing to demonstrate that each software application functioned as per its specifications. Computer platform testing was performed by running QGS and QPS programs on computer systems with the proposed platform using gold standard Cedars- Sinai test cases.
Testing results for all validation tests demonstrated that the D-Spect™ device performs according to its specifications.
Clinical validation for the QGS and QPS programs was conducted by Cedars-Sinai Medical Center.
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
OCT 1 2007
SECTION 6 – 510(k) SUMMARY
072468
(Premarket Notification [510(k)] Number)
1. Applicant
Spectrum Dynamics Ltd. 22 Bareket St. North Industrial Park POB 3033 Caesarea 30889 ISRAEL Tel: +972-73-7374500 Fax: +972-73-7374501
Corresponding Official:
Ahava M. Stein, Consultant A. Stein - Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL Tel: +972-9-767 0002 Fax: +972-9-766 8534
| Device Name: | D-Spect™ Cardiac Scanner System |
|---|---|
| Device trade/proprietary name: | D-Spect™ Cardiac Scanner System |
| Common Name: | SPECT system |
| Classification Name: | Emission Computed Tomography System (product code KPS, class II, classification section 892.1200). |
1
3. Predicate Devices
The modified D-Spect™ system is substantially equivalent to the following device:
| Device | Manufacturer | 510(k) No. |
|---|---|---|
| D-Spect™ Cardiac Scanner System | Spectrum Dynamics Ltd. | K062450 |
| ADAC AutoQuant | ADAC | K980715 |
| ADAC JETStream Workspace | ADAC | K061029 |
4. Intended Use
The D-Spect™ is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce crosssectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-Spect™ is primarily intended for cardiac applications. D-Spect™ supports radionuclides within the energy range of 40 -170 keV.
5. Description of the Device
Spectrum Dynamics' D-Spect™ Cardiac Scanner System is a SPECT device, which is designed to perform myocardial perfusion imaging. The device is comprised of a detector head, gantry, and patient chair. Device operation is controlled from an acquisition station console. The system is supported by use of data-transfer accessories (RFID tags), which are attached to the patient's wrist and to the syringe containing the radiopharmaceutical agent, for patient and syringe positive identification. The cardiac gamma camera is designed such that there are no external moving parts that surround the patient. Detector boards rotate within the closed detector head. The special scanning geometry and detector technology, enable shorter scan times. In the modified D-Spect™ device, a Processing Station was added. The Processing Station, which is part of the display equipment, contains a software application with the Cedars Sinai Quantitative Perfusion SPECT
6-2
2
(QPS) and Quantitative Gated SPECT (QGS) software that enables a review and quantification of cardiac SPECT data.
6. Technological Characteristics Compared to Predicate Device
The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the D-Spect™ device are substantially equivalent to the predicate devices cited above.
7. Performance Testing
The following performance testing activities were performed for the modified D-Spect™ device:
- A. Software Validation
- Electromagnetic Compatibility/ Electrical Safety Testing B.
Functionality tests were performed as part of the software validation testing to demonstrate that each software application functioned as per its specifications. Computer platform testing was performed by running QGS and QPS programs on computer systems with the proposed platform using gold standard Cedars- Sinai test cases.
Testing results for all validation tests demonstrated that the D-Spect™ device performs according to its specifications.
Clinical validation for the QGS and QPS programs was conducted by Cedars-Sinai Medical Center.
3
Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES". The symbol in the center appears to be three curved lines forming a stylized representation of a person or figure. The logo has a simple, clean design and is rendered in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Spectrum Dynamics Ltd % Ms. Ahava Stein Regulatory Consultant A. Stein Regulatory Affairs Consulting 20 Hata'as St., Kfar Saba, 44425 ISRAEL
2007
Re: K072468
Trade/Device Name: D-Spect Cardiac Scanner System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 17, 2007 Received: September 4, 2007
Dear Ms. Stein:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image shows a circular logo with the text "1826-1926" at the top. Below the text are the letters "PA" in a stylized font. Underneath the letters is the word "Centennial" in a cursive font. There are three stars at the bottom of the logo.
closing and Promoting Public Hoalth
4
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy Crogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Page 1 of 1
510(k) Number (if known): K072468
Device Name: D-Spect Cardiac Scanner system
Indications for use:
D-SPECT is an emission computed tomography system intended to detect the location and distribution of gamma ray radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. The device includes display equipment, patient and equipment supports, component parts, and accessories. D-SPECT is primarily intended for cardiac applications. D-SPECT supports radionuclides within the energy range of 40 -170 keV.
Prescription Use V (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arnie M. Whay
Sian-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number