(70 days)
The C-Quest system is a dual head system designed to acquire data for cardiac multislice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using approved radionuclides within the energy range of 60 – 170 keV such as Tc-99m or TI-201.
A compact, dual-head dedicated cardiac camera system comprised of a gantry supporting a fixed 90 degree dual head detector and a patient table. The C-Quest system is operated through interaction with an acquisition and processing computer system (NuQuest) or dedicated handheld controller or touch screen.
Here's a breakdown of the acceptance criteria and study information for the C-Quest System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Predicate: Cardiocam K011611) | Reported Device Performance (C-Quest) |
|---|---|---|
| Intrinsic spatial resolution - Center FOV | FWHM: ≤2.8mmFWTM: ≤2.9mm | FWHM: ≤3.5mmFWTM: ≤7.4mm |
| Intrinsic spatial resolution - Useful FOV | FWHM: ≤5.4mmFWTM: ≤5.6mm | FWHM: ≤3.7mmFWTM: ≤7.6mm |
| Intrinsic Spatial Linearity - Center FOV | Differential: 0.18mmIntegral: 0.38mm | Differential: ≤0.4mmIntegral: ≤0.8mm |
| Intrinsic Spatial Linearity - Useful FOV | Differential: 0.20mmIntegral: 0.40mm | Differential: ≤0.5mmIntegral: ≤1.0mm |
| Intrinsic Uniformity - Center FOV | Integral: +/- 2.4%Differential: +/- 1.9% | Integral: +/- 2.5%Differential: +/- 1.5% |
| Intrinsic Uniformity - Useful FOV | Integral: +/- 2.9%Differential: +/- 2.4% | Integral: +/- 3.0%Differential: +/- 2.0% |
Note: The acceptance criteria are inferred from the predicate device's performance, as the document states that the C-Quest system performs "as well as the predicate device" and provides a direct comparison table of technical characteristics. The C-Quest device generally shows performance that is either comparable to or slightly different from the predicate, but implicitly accepted as meeting the "as well as" criterion for 510(k) substantial equivalence. For spatial resolution (FWHM, FWTM), the C-Quest performs worse in the center FOV compared to the predicate, but better in the useful FOV. For spatial linearity and uniformity, the C-Quest's reported maximums are often higher than the predicate's reported values, indicating slightly worse performance in some technical aspects, yet still deemed substantially equivalent.
2. Sample size used for the test set and the data provenance
The provided 510(k) summary does not contain information about a test set involving patient data for clinical performance evaluation. The study presented focuses on a technical comparison of intrinsic device characteristics against a predicate device. Therefore, clinical sample size and data provenance are not applicable to the information given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study does not involve expert review of patient data to establish ground truth.
4. Adjudication method for the test set
Not applicable. No clinical test set or adjudication process is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This document does not mention an MRMC comparative effectiveness study. This device is a cardiac gamma camera system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence. The evaluation presented is a standalone technical performance study of the C-Quest system's physical characteristics (e.g., spatial resolution, linearity, uniformity) compared to its predicate. It is not evaluating an algorithm in isolation, but rather the intrinsic imaging capabilities of the hardware.
7. The type of ground truth used
The "ground truth" for this technical study is established by physical measurements and phantom studies for parameters like intrinsic spatial resolution, linearity, and uniformity, conforming to industry standards for gamma cameras. The 510(k) summary implicitly uses the established performance of the predicate device (Cardiocam) as a benchmark.
8. The sample size for the training set
Not applicable. This document describes a medical imaging device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this device is not an AI model, there is no training set mentioned or ground truth associated with it.
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KC 823-81
Submitter: MEDX
C-Quest Premarket Notification: Traditional 510(k)
510(k) Summary
NOV 1 4 2008
| Submitter Name: | MEDX, Inc. |
|---|---|
| Submitter Address: | 3456 N. Ridge Avenue, Suite 100Arlington Heights, IL 60004 |
| Establishment Reg. #: | 1419459 |
| Phone Number: | 847.463.2020 |
| Fax Number: | 847.463.2019 |
| Contact Person: | Eric Ellingson |
| Date Prepared: | 02 September 2008 |
| Device Trade Name: | C-Quest System |
| Common Name | Cardiac Gamma Camera System |
| Classification Name, | Emission Computed Tomography System |
| Number &Product Code: | 892.1200KPS |
| Predicate Devices: | Cardiocam |
| Device Descriptionand Statement ofIntended Use | Device Description : A compact, dual-head dedicated cardiac camerasystem comprised of a gantry supporting a fixed 90 degree dual headdetector and a patient table. The C-Quest system is operatedthrough interaction with an acquisition and processing computersystem (NuQuest) or dedicated handheld controller or touch screen.Statement of Intended Use : C-Quest equipped with NuQuest(hereinafter referred to as C-Quest system) forms an emissioncomputed tomography system intended to detect the location anddistribution of gamma-ray emission radionuclides in the body andproduce cross-sectional images through computer reconstruction ofthe data. C-Quest system is primarily intended for cardiacapplications, however the C-Quest system design also supportsnon-cardiac procedures of the patient's chest region and bodyextremities |
| Summary ofTechnological | The C-Quest cardiology scintillation camera design comprises an opengantry supporting a fixed 90 degree dual head detector and a patienttable. C-Quest is operated through interaction with an acquisition and |
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| Characteristics | processing computer system (NuQuest), or the C-Quest's dedicated handheld controller or touch screen. The patient table can perform vertical and horizontal (along long axis) motor-driven movement for patient positioning. Tomographic studies can be performed in a circular or elliptical orbit with or without gating. Each detector head consists of a rectangular Nal(TI) crystal, photo-multiplier tubes (PMTs) and the detector electronics. Planar static and dynamic studies can be performed. The C-Quest system supports gamma-ray emission radionuclides within the energy range of 60 - 170 keV. |
|---|---|
| Conclusion | The information discussed above demonstrates that C-Quest system performs as well as the predicate device |
| Declarations | This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. This summary does not contain any raw data, i.e., contains only summary data. This summary does not contain any trade secret or confidential commercial information. This summary does not contain any patient identification information |
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Summary of Technical Characteristics
| Feature | C-Quest | CardiocamK011611 |
|---|---|---|
| 510(k) Number | ||
| Manufacturer | MEDX | DANISH DIAGNOSTIC DEVELOPMENTA/S |
| Classification # &Product Code | KPS892.1200 Emission computedtomography system | KPS892.1200 Emission computedtomography system |
| Intended Use | The C-Quest system is a dual headsystem designed to acquire data forcardiac multi-slice images. Thesystem is intended for use as adiagnostic imaging device. Whenused with the appropriate radiopharmaceuticals, images areproduced representing the internaldistribution of radioactivity in thebody. The system allows you toacquire data from high resolutionthree dimensional, static, gated ordynamic imaged of biochemical andmetabolic processes using approvedradionuclides within the range of 60- 170 keV such asTc-99m, TI-201, orCo-57. | The Cardiocam system is a dual headsystem designed to acquire data forcardiac multi-slice images. The system isintended for use as a diagnostic imagingdevice. When used with the appropriateradio pharmaceuticals, images areproduced representing the internaldistribution of radioactivity in the body.The system allows you to acquire datafrom high resolution three dimensional,static, gated or dynamic imaged ofbiochemical and metabolic processesusing Tc-99m, Ti-201, or Co-57. |
| Mode of Action | Image acquisition of radioactivenucleotide distribution by scintillationcameras | Image acquisition of radioactivenucleotide distribution by scintillationcameras |
| Design | Open gantry supporting a fixed 90degree dual head detector and apatient table | Open gantry supporting a fixed 90degree dual head detector and a patienttable |
| Method of Operation | Operated through interaction with anacquisition and processing computersystem | Operated through interaction with anacquisition and processing computersystem |
| Intrinsic spatialresolution - CenterFOV | FWHM: ≤3.5mmFWTM: ≤7.4mm | FWHM: ≤2.8mmFWTM: ≤2.9mm |
| Intrinsic spatialresolution - UsefulFOV | FWHM: ≤3.7mmFWTM: ≤7.6mm | FWHM: ≤5.4mmFWTM: ≤5.6mm |
| Intrinsic SpatialLinearity - CenterFOV | Differential: ≤0.4mmIntegral: ≤0.8mm | Differential: 0.18mmIntegral 0.38mm |
| Intrinsic SpatialLinearity - UsefulFOV | Differential: ≤0.5mmIntegral: ≤1.0mm | Differential: 0.20mmIntegral: 0.40mm |
| Intrinsic Uniformity -Center FOV | Integral: +/- 2.5%Differential: +/- 1.5% | Integral: +/- 2.4%Differential: +/- 1.9% |
| Intrinsic Uniformity -Useful FOV | Integral: +/- 3.0%Differential: +/- 2.0% | Integral: +/- 2.9%Differential: +/- 2.4% |
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDX, Inc. % Mr. William Greenrose President & CEO Oserve America, Inc. 220 River Road CLAREMONT NH 03743
NOV 1 4 2008
Re: K082581
Trade/Device Name: C-Quest Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: September 2, 2008 Received: September 5, 2008
Dear Mr. Greenrose:
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 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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Page 2
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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely vours.
hope Mr. thang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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:
4.1 Indications for Use Statement
510(k) Number (if known):
K08258/
Device Name: C-Quest
Indications for Use:
The C-Quest system is a dual head system designed to acquire data for cardiac multislice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using approved radionuclides within the energy range of 60 – 170 keV such as Tc-99m or TI-201.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
Prescription
Use
(Per 21 CFR 801.109)
OR
Over-The-Counter
Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
510(k) Number K082581
Section 4.0
CONFIDENTIAL
§ 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.