(13 days)
Not Found
No
The description focuses on the hardware (scintillation detectors, PMTs, collimators) and basic image acquisition/processing. There is no mention of AI, ML, or related concepts in the provided text.
No.
The device is used to detect and image the distribution of radionuclides for diagnostic purposes, not to treat a condition.
Yes
The device is described as detecting and imaging the distribution of radionuclides in the human body to identify the location and distribution of gamma ray emitting radionuclides. This process aids in diagnosis by providing visual information about physiological processes or abnormalities.
No
The device description explicitly details hardware components like scintillation detectors, PMTs, collimators, and the ability to rotate detectors, indicating it is a physical medical device system, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device "detect[s] the location and distribution of gamma ray emitting radionuclides in the human body" and "detect & image the distribution of radionuclides in the body, when the radiopharmaceutical is administered in the body." This involves detecting signals from within the living body, not from a sample taken from the body.
- Anatomical Site: The anatomical site is the "human body," indicating the device is used directly on the patient.
Therefore, this device falls under the category of an in vivo diagnostic imaging system, specifically a gamma camera for SPECT/ECT imaging.
N/A
Intended Use / Indications for Use
The intended use of the CardioSPECT SC and the CardioSPECT D90 is to detect the location and distribution of gamma ray emitting radionuclides in the human body and store the data for analysis
Intended use is to detect & image the distribution of radionuclides in the body, when the radiopharmaceutical is administered in the body .
Product codes (comma separated list FDA assigned to the subject device)
90KPS
Device Description
The CardioSPECT SC and CardioSPECT D90 are scintillation detector, Nal, systems with PMT light gathering capacity. The D90 has two (2) detectors and the SC has one detector both with the ability to rotate these detectors around the patient. The system uses a collimator on each detector to permit spatial image resolution of the gamma photons emitted from the patient. The collimators lock in place. There is no built-in radioactive scanning source and none is required. The SC and D90 are capable of both Planar (Class I) and SPECT or ECT (Class ii) operation. The acquisition/processing computer is a presently approved system sold and supported by NC Systems, Inc. but manufactured by Segami Corporation. This application is for the ECT device-qamma camera-system(s) and not the previously approved computer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Gamma Camera-SPECT (Emission Computed Tomography System (ECT))
Anatomical Site
Human body
Indicated Patient Age Range
Adults
Intended User / Care Setting
Physician licensed to perform these procedures.
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
The clinical tests submitted were performed on, and clearly identified, the SC and D90. The subjects were adults who were under the care of a physician licensed to perform these procedures. These procedures were performed as requested for the application.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed on the applicant systems, the SC and D90, in the same manner as the pre-approved QUAD system and under the same standards. Clinical tests were performed on the SC and D90 with adult subjects. The conclusion of the non-clinical and clinical tests demonstrate that the device (SC & D90) is safe, as effective and performs well or better than the legally marketed device identified in paragraph 3.(a) of this section. The differences between the legally marketed system QUAD and the applicant systems SC and D90 are in the number of detectors used for data acquisition (QUAD 4, SC 1, D90 2). These changes permit changes in the area imaged and the image acquisition time but do not alter the safety and effectiveness of the systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 1 7 2002
510(K) SUMMARY
21CFR 807.92
INTRODUCTION
This 510(K) Premarket Notification has been prepared to demonstrate that the CardioSPECT SC and CardioSPECT D90 Gamma ECT, manufactured by NC Systems, Inc. is substantially equivalent to the NC Systems, Inc. QUAD which has previously under went the 510(K) premarket notification process and approved (K013353).
SUBMITTER IDENTIFICATION 1.
| Applicant's Name and Street Address: | Nuclear Cardiology Systems, Inc. |
|---|---|
| dba NC Systems, Inc. | |
| 5660 Airport Blvd., Suite 101 | |
| Boulder, Colorado 80301 |
Charles H. Rose Contact Person:
T-(303) 541-0044 Telephone and Fax Numbers of Contact Person: 800-548-4024 F-(303) 541-0066
Address of Manufacturing Site: Alsotorokvesz 14 H-1022 Budapest, Hungary
Date of Submission:February 4, 2002
1
DEVICE NAME 2.
Gamma Camera-SPECT Gamma Camera Device Name (common): CardioSPECT SC and CardioSPECT D90 Proprietary Name: Emission Computed Tomography System Classification Name: (ECT)
| Regulatory Class: | II |
|---|---|
| Product Code: | 90KPS |
| Regulation Number: | 21CFR 892.1200 |
| Classification Panel | Radiological |
IDENTIFICATION OF EQUIVALENT DEVICE ന്
The equivalent device is the:
Re: K013353
Trade/Device Name: NeuroSpect QUAD ECT System Requlation Number: 21CFR 892.1200 Requlation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS
This device, the QUAD, is also manufactured by the applicant, NC Systems, Inc. and has the same technology characteristics as the applicant device.
The equivalent device, the QUAD, is a scintillation detector. Nal, system with PMT light gathering capacity. The system configuration is a four (4) detector system with the mechanical ability to rotate the detectors around the patient. The system uses a collimator on each detector to permit spatial image resolution of the gamma photons emitted from the patient. The collimators lock in place. There is no built-in radioactive scanning source and none is required. The QUAD is capable of both Planar (Class I) and SPECT (ECT) (Class II) operation. The acquisition/processing computer is a presently approved system sold and supported by NC Systems, Inc. but manufactured by the Segami Corporation.
2
4、DEVICES SUBJECT TO PRE-MARKET NOTIFICATION (APPLICANT DEVICE)
The applicant device subject to this pre-market notification submission are the SC and D90 ECT systems which are submitted under a single application as they are equivalent devices with substantially equivalent specifications, safety and intended use.
- The SC and D90 are scintillation detector, Nal, systems with PMT a) light gathering capacity. The D90 has two (2) detectors and the SC has one detector both with the ability to rotate these detectors around the patient. The system uses a collimator on each detector to permit spatial image resolution of the gamma photons emitted from the patient. The collimators lock in place. There is no built-in radioactive scanning source and none is required. The SC and D90 are capable of both Planar (Class I) and SPECT or ECT (Class ii) operation. The acquisition/processing computer is a presently approved system sold and supported by NC Systems, Inc. but manufactured by Segami Corporation. This application is for the ECT device-qamma camerasystem(s) and not the previously approved computer.
- The electrical and mechanical components as well as the b) manufacturing specifications of the applicant systems, the SC and D90 are substantially equivalent to the QUAD, the legally marketed device.
- Specifications: Are provided in Attachment 2. c)
3
INTENDED USE 5.
The intended use of the CardioSPECT SC and the CardioSPECT D90 is to detect the location and distribution of gamma ray emitting radionuclides in the human body and store the data for analysis as the same equivalent device, K013353.
DETERMINE OF SUBSTANTIAL EQUIVALENCE ર.
The SC and D90 systems have been compared to the legally marketed QUAD system and determined to be substantially equivalent.
- a) The specifications are compared on Enclosure G.a.
- b) The Hazard Analysis is compared on Enclosure 6.b pgs 1-2.
- c) The labeling, technology, engineering, performance and materials are compared on Enclosure 6.c.
- d) References to Mediso have been previously addressed as referring to the manufacturing of NC Systems.
- e) The non-clinical tests submitted were performed on the applicant systems, the SC and D90 in the same manner as the pre-approved QUAD system. These tests were performed under the same standards as the pre-approved QUAD systems.
- The clinical tests submitted were performed on, and clearly identified, f) the SC and D(). The subjects were adults who were under the care of a physician licensed to perform these procedures. These procedures were performed as requested for the application.
4
- g) The conclusion of the non-clinical and clinical tests demonstrate that the device (SC & D90) is safe, as effective and performs well or better than the legally marketed device identified in paragraph 3.(a) of this section.
- h) The differences between the legally marketed system QUAD and the applicant systems SC and D() are in the number of detectors used for data acquisition. The change in the number of detectors:
QUAD 4
SC 1
D90 2
permit changes in the area imaged and the image acquisition time. These changes do not alter the safety and effectiveness of the systems.
5
Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that features a stylized image of an eagle with three human profiles incorporated into its design. The eagle's head and neck are clearly visible, while the bodies of the three human profiles are suggested by the curves and lines of the eagle's body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2002
Nuclear Cardiology Systems, Inc. % Mr. Wolfram Gmelin Technical Manager, Third Party Review TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K021823
Trade/Device Name: CardioSPECT SC and CardioSPECT D90 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system
Regulatory Class: II Product Code: 90 KPS Dated: May 30, 2002 Received: June 4, 2002
Dear Mr. Gmelin:
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); 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.
6
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Page 1 of 2
U.S. Food and Drug Administration - Genter for Devices and Radiological Health
Page _ of _ of _
510(k) Number (if known): KO21923
Device Name: CARDIOSPECT SC AND CARDIOSPECT D 90
Indications for Use:
Intended use is to detect & image the distribution of radionuclides in the body, when the radiopharmaceutical is administered in the body .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Division Sign-Off)
Deproductive Abdominal
prescription use $\checkmark$
Division of Reproductive, Abdomin and Radiological Devices 510(k) Number -