(54 days)
For use in the acquisition of Single Photon Emission Computed Tomography (SPECT) and Planar gamma camera images.
The C! SPECT Imaging System is an open gantry (with no external moving parts), upright seated device with an integrated patient chair, an acquisition station, two detectors, and hardware and software components. The patient chair is mechanized to accommodate patient loading and centering in the detector field of view.
This document describes the C! SPECT Imaging System. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated) | Reported Device Performance (as per submission) |
|---|---|
| Performance met or exceeded predicate devices | Performance of the C! device met or exceeded that of predicate devices (using NEMA NU1 phantoms and NEMA Standard test protocols). |
| Tomographic image quality at least equal to predicate devices | Clinical images obtained in human subjects demonstrated tomographic image quality at least equal to images produced by reference predicate devices. |
| Electrical safety met applicable standards | Electrical safety testing has been performed and found to meet applicable standards and defined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical images were obtained using the C! in human subjects," but it does not specify the sample size for this clinical test set.
The data provenance is prospective as clinical images were "obtained ... in human subjects." The document does not specify the country of origin of the data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used, nor their qualifications, for evaluating the clinical images. The evaluation states "Tomographic image quality was at least equal to images produced by reference predicate devices," implying an expert comparison, but details are absent.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method for the clinical image evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size for human reader improvement with or without AI assistance.
6. If a Standalone (Algorithm Only) Performance Study Was Done
The C! SPECT Imaging System is a hardware and software system for image acquisition. The performance testing described focuses on the overall system's image quality and does not specifically detail a standalone algorithm-only performance assessment separate from the imaging system. The performance testing refers to the "C! device" as a whole.
7. The Type of Ground Truth Used
For the phantom studies, the ground truth is based on the known physical properties of NEMA NU1 phantoms and NEMA Standard test protocols, which provide objective benchmarks.
For the clinical images, the ground truth appears to be a qualitative comparison to "reference predicate devices" by unspecified evaluators. It is not explicitly stated if this was expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. The device is a SPECT imaging system, and its performance evaluation focuses on its ability to acquire images, not on an algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned (as the device is an imaging system, not an AI algorithm trained on data for interpretation), this question is not applicable.
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Image /page/0/Picture/0 description: The image shows a logo or emblem that includes the word "Photon" with a superscripted "2". To the left of the word "Photon" is a stylized graphic that resembles a flower or an asterisk-like symbol. The text is slightly stylized with a cursive-like font.
14350 S.W. 142nd Ave., Miami, FL 33186 Phone: 305-234-0836
Image /page/0/Picture/2 description: The image shows the number K070589 in a handwritten style. Below the number, the text "510(k) Premarket Notification" is printed. The text indicates that the image is related to a premarket notification document, possibly for a medical device or other product requiring FDA approval.
SECTION G 510(K) SUMMARY
In accordance with 21CFR 807.92
APR 2 4 2007
1.0 Submitter Information
| Name: | Transphoton Corporation(dba Photon²) |
|---|---|
| Address: | 14350 S.W. 142nd AvenueMiami, FL 33186 |
| Phone: | 305-234-0836 |
| Fax: | 305-234-2398 |
Contact Person: Brant Wigger, Chief Operations Officer
Date of Submission: February 28, 2007
2.0 Device Identification
| Name of Device: | C! SPECT Imaging System |
|---|---|
| Common Name: | Gamma Camera – SPECT Imaging System |
| Classification Name: | Emission Computed Tomography System (ECT) |
3.0 Predicate Devices
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- Myolight GE Medical Systems F.I. Haifa [K033874]
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- CardiArc Ltd. -- CardiArc SPECT Imaging Device [K053062]
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- Transphoton Corporation APEX XL-4 [K033001]
4.0 Intended Use / Indications for Use
For use in the acquisition of Single Photon Emission Computed Tomography (SPECT) and Planar gamma camera images.
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5.0 Technological Characteristics
The C! SPECT Imaging System is an open gantry (with no external moving parts), upright seated device with an integrated patient chair, an acquisition station, two detectors, and hardware and software components. The patient chair is mechanized to accommodate patient loading and centering in the detector field of view.
Thus, the C! SPECT Imaging System raises no new issues of safety or efficacy.
6.0 Performance Testing and Data
Performance testing was performed using NEMA NU1 phantoms, under the NEMA Standard test protocols. In all cases, performance of the C! device met or exceeded that of predicate devices.
Clinical images were obtained using the C! in human subjects. Tomographic image quality was at least equal to images produced by reference predicate devices.
Furthermore, electrical safety testing has been performed and found to meet applicable standards and defined acceptance criteria.
7.0 Substantial Equivalence
The C! SPECT Imaging System has the same intended use, similar principles of operation, and consistent technological characteristics as the predicate devices. Thus, the C! is substantially equivalent to the predicate devices and no new safety or effectiveness concerns are raised.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 4 2007
Mr. Brant Wigger Chief Operations Officer Transphoton Corporation (dba Photo2) 14350 S. W. 142nd Avenue MIAMI FL 33186
Re: K070589
Trade/Device Name: C! Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: February 28, 2007 Received: March 1, 2007
Dear Mr. Wigger:
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.
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Protecting and Promoting Public Health
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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 guality 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 yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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14350 S.W. 142nd Ave., Miami, FL 33186 Phone: 305-234-0836
Ci 510(k) Premarket Notification
Indications for Use Form
Page 1 of 1
510(k) Number (if known):
K070589
Device Name: C!
Indications For Use:
The C! is indicated for use in the acquisition of Single Photon Emission Computed Tomography (SPECT) and Planar gamma camera images.
(Please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X (Per 21 CFR 801.109)
OR
Over-The-Counter Use:
David h. hayson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 17050 510(k) Number __
§ 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.