(12 days)
Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body.
The intended use of the c.cam Attenuation Correction option is to provide the customer with means to measure the attenuation of gamma rays within the body of a patient, when using a c.cam gamma camera system for SPECT studies, and to map the measured attenuation into images that can be used to compensate emission images for the attenuation. The c.cam-AC includes additional acquisition of data for scatter correction of these images.
The c.cam-AC is an attenuation correction device, which will be marketed as an optional device for the c.cam gamma camera.
C.cam gamma camera is a dual detector system and the attenuation correction device (two units) will be mounted opposite of the two detectors, one device on each detector. The attenuation correction device is formed as two housings each containing 14 line sources in fixed positions, shutter and all shutter control.
The following described functions are performed on both detectors simultaneously.
When the scanning is initiated the emission image and the transmission images are acquired sequentially. When the emission image has been acquired, a shutter, common for all sources, located in the device housing will open for exposure from 14 line sources (max. 20 mCi each 153 Gd with a total of max. 96 mCi). A collimated beam of gamma ray photons is focused on the opposite detector field of view to create the transmission images of the patient placed in the field of view of the detector. Having acquired both emission and transmission images, the data for emission, transmission, emission scatter and transmission scatter are stored in one dataset. A scaled version of the blank transmission scan is stored in another dataset. The complete study can be export via DICOM to the OEM customer provided processing station for later processing and reviewing.
Here's a breakdown of the acceptance criteria and study information for the c.cam-AC device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for K051460 describes a device that is essentially equivalent to existing devices and focuses on its design and radioactive source rather than specific performance metrics tied to acceptance criteria. The only performance-related data explicitly stated are for Radiation Leakage.
| Acceptance Criteria (What the device aims to achieve) | Reported Device Performance |
|---|---|
| Radiation Leakage: | |
| Exposure from surface of housing, shutter closed | < 0.2 mR/hr @ 100cm |
| Exposure during scan, at 30 cm, shutter opened | < 10 mR/hr @ 30cm |
| (Implicit) Attenuation Correction Functionality | The device performs attenuation correction and scatter correction by measuring gamma ray attenuation to compensate emission images. It is technologically similar to its predicate devices, CardioMD-AC (K040616) and e.cam-AC (K963983) (for the radioactive source). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated for performance evaluation that would lead to quantitative acceptance criteria beyond radiation leakage. The text mentions "acquiring Myocardial Perfusion stress studies on a Siemens e.cam system" as part of non-clinical test results collection, which implies a dataset, but the size is not specified.
- Data Provenance: The acquisition of "Myocardial Perfusion stress studies on a Siemens e.cam system" suggests clinical data. The country of origin is not specified, but the device manufacturer is Danish (3D, Danish Diagnostic Development A/S). The study appears to be retrospective in its description of collected clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study described focuses on non-clinical tests and a comparison of technological characteristics to predicate devices. There is no mention of expert involvement in establishing ground truth for a test set in the context of diagnostic performance.
4. Adjudication Method for the Test Set
This information is not provided. As no expert-based ground truth establishment is described, an adjudication method is not applicable here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or at least not described in the provided text. The device is an attenuation correction device, a component of a larger imaging system, and its evaluation centered on its technical performance and equivalence to predicate devices, not on direct human reader performance improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device itself, the c.cam-AC, is an algorithm/hardware combination designed for attenuation correction, which operates in a standalone manner as a component of the c.cam gamma camera system. The "non clinical test results have been collected by acquiring Myocardial Perfusion stress studies," suggesting the output of the attenuation correction was likely evaluated, but specific metrics of its standalone performance (e.g., accuracy of attenuation maps) are not provided beyond the radiation leakage. The focus is on its function within the entire imaging workflow.
7. The Type of Ground Truth Used
For the radiation leakage acceptance criteria, the ground truth would be established by physical measurement using appropriate radiation detectors. For the implicit functionality of attenuation correction, the "ground truth" for comparison would likely be the expected or desired attenuation map/corrected image quality, a comparison against which is implied in the "non clinical test results," but the specific methodology or precise ground truth used for that evaluation is not explicitly detailed.
8. The Sample Size for the Training Set
This information is not provided. The c.cam-AC device is described as an "attenuation correction device" and not explicitly as an AI/machine learning algorithm that would require a distinct "training set" in the modern sense. It implements a method to compensate for attenuation, which might involve pre-defined models or calculations, but not necessarily a trained AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as the document does not describe the use of a "training set" for an AI algorithm.
{0}------------------------------------------------
JUN 1 5 2005
DDD
1PMN0638-A03
C.cam AC 510(K) SUBMISSION
2 March 2005
ADMINISTRATIVE INFORMATION B
B-1 Summary of Safety and Effectiveness Statement
Ref. CFR 807.92 B-1-1
| 1 | Submitted by: | 3D, Danish Diagnostic Development A/SDr. Neergaardsvej 5F2970 Horsholm, DenmarkTel: + 45 45 768888Fax: + 45 45 164659 | |
|---|---|---|---|
| Contact person: | Niels SorensenTel: + 45 45 768888Fax: + 45 45 164659E-mail: nes@3dnm.dk | ||
| Preparation date: | 2 March 2005 | ||
| 2 | Device Trade Name: | c.cam-AC | |
| Common Name: | Attenuation Correction Device | ||
| Classification name: | Emission computed tomography system | ||
| 3 | Predicate Device: | 1. CardioMD-AC. 3D, Danish Diagnostic Development A/S. | |
| 510(K) Number: | K040616. | ||
| 2. E.cam-AC. Siemens Medical Solutions USA, Inc.K963983. | |||
| Refer to section C3 Comparison of the New and Predicate Device, subpart;Radioactive source, and to section C3 Comparison of the New andPredicate Device, subpart; Performance. | |||
| 4 | Device description: | The c.cam-AC is an attenuation correction device, which will be marketed asan optional device for the c.cam gamma camera. | |
| Functional description: | C.cam gamma camera is a dual detector system and the attenuation correctiondevice (two units) will be mounted opposite of the two detectors, one deviceon each detector. The attenuation correction device is formed as two housingseach containing 14 line sources in fixed positions, shutter and all shuttercontrol. | ||
| The following described functions are performed on both detectorssimultaneously.When the scanning is initiated the emission image and the transmissionimages are acquired sequentially. When the emission image has beenacquired, a shutter, common for all sources, located in the device housing willopen for exposure from 14 line sources (max. 20 mCi each 153 Gd with a total |
:
{1}------------------------------------------------
C.cam AC 510(K) SUBMISSION
2 March 2005
1PMN0638-A03
| of max. 96 mCi). A collimated beam of gamma ray photons is focused on the |
|---|
| opposite detector field of view to create the transmission images of the patient |
| placed in the field of view of the detector. Having acquired both emission and |
| transmission images, the data for emission, transmission, emission scatter and |
| transmission scatter are stored in one dataset. A scaled version of the blank |
| transmission scan is stored in another dataset. The complete study can be |
| export via DICOM to the OEM customer provided processing station for later |
| processing and reviewing. |
| 5 Intended use: | Attenuation correction is a method where the emission images acquiredduring SPECT acquisitions are compensated for attenuation within thepatient. The purpose of attenuation correction is to compensate for varyingattenuation of gamma rays in the body. |
|---|---|
| The intended use of the c.cam Attenuation Correction option is to provide thecustomer with means to measure the attenuation of gamma rays within thebody of a patient, when using a c.cam gamma camera system for SPECTstudies, and to map the measured attenuation into images that can be used tocompensate emission images for the attenuation. The c.cam-AC includesadditional acquisition of data for scatter correction of these images. |
| 6a | Summary of technologicalcharacteristics: | The device has the same technological and functional characteristics as thepredicate device. However the design of the submitted device is different onthe following points: 1. Manually positioning of the device housing. 2. Theuse of 14 fixed positioned sources. | ||
|---|---|---|---|---|
| Submitted device:c.cam-AC | Predicate device:CardioMD-AC | Predicate device:e.cam-AC(equivalence claimed toradioactive source only) | ||
| Design: | The submitted attenuationcorrection device is formedas a single housingcontaining 14 line sourcesin fixed positions, shutterand all shutter control. | The predicate attenuationcorrection device is formedas a single housingcontaining all motioncontrol, electronics andmotors including thescanning line source. | ||
| The device is secured to theside of the detector castingby means of a bracket. Thebracket is designed formanual positioning of thedevice housing to enablepatient access to the system. | The device is secured to theside of the detector castingby means of a bracket thatenables the device housingto slide in and out. | |||
| In operation the devicehousing is manuallypositioned opposite to thedetector. When not in usethe device housing canmanually be rotated to itspark position enablingaccess for patient loadingand un-loading. | In operation the devicehousing is positionedopposite to the detector(motorized motion). Whennot in use the devicehousing can slide to its parkposition enabling access forpatient loading and un-loading. | |||
| Radioactivesource: | The submitted deviceutilises 14 fixed positionedline sources exposing thecomplete detector field ofview. Each source iscollimated to minimizeexposure to thesurroundings and the patientexposure is controlled by anelectrical controlled shuttercommon for all 14 sources. | The predicate deviceutilises one collimated linesources exposing byscanning over the detectorfield of view. The shuttercontrolling the patientexposure is an integratedpart of the source holder. | The predicate deviceutilises 14 fixedpositioned line sourcesexposing the completedetector field of view.Each source is collimatedto minimize exposure tothe surroundings and thepatient exposure iscontrolled by an electricalcontrolled shuttercommon for all 14sources. The two devicesutilises the same linesources type from thesame supplier in the samehousing. | |
| Material: | Anodized aluminium plates,lead and lead alloyshielding.Painted aluminium platecovers. | Anodized aluminium plates,lead and lead-bronze alloyshielding.Painted aluminium platecovers. | ||
| Energy source: | Powered from an isolatedpower outlet on the mainssupply.120 VAC | Powered from an isolatedpower outlet on the mainssupply.120 VAC | ||
| 6b | Description of howthe non clinical testresults have beencollected. | Clinical data has been collected by acquiring Myocardial Perfusion stress studies on aSiemens e.cam system.Refer to section C-4-2 Phantom Data Images and to C-6-1 A brief description of howthe clinical data has been obtained. | ||
| Radiation Leakage | Exposure from surface of housing, shutter closed: < 0.2 mR/hr @ 100cm.Exposure during scan, at 30 cm, shutter opened: < 10 mR/hr @ 30cm. |
{2}------------------------------------------------
2 March 2005
1PMN0638-A03
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white emblem for the Department of Health and Human Services. The emblem features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2005
Danish Diagnostic Development A/S % Mr. Jeffrey D. Rongero Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, NC 27709-3995 Re: K051460
Trade/Device Name: c.cam-AC Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system -Regulatory Class: II Product Code: KPS Dated: April 21, 2005 Received: June 3, 2005
Dear Mr. Rongero:
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.
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.
{4}------------------------------------------------
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 promance motived 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | - | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
{5}------------------------------------------------
i PMN0638-A03
DDD
2 March 2005
B-2 FDA Indications for Use Form
Indications for Use Form
510(k) Number (if known): Not Ha
Indications For Use:
Attenuation correction is a method where the emission images acquired during SPECT acquisitions are compensated for attenuation within the patient. The purpose of attenuation correction is to compensate for varying attenuation of gamma rays in the body.
The intended use of the c.cam Attenuation Correction option is to provide the customer with means to measure r he attenuation of gamma rays within the body of a patient, when using a c.cam gamma camera system for the attendation of gamina his or want the 800 man into images that can be used to compensate emission images for the attenuation. The c.cam-AC includes additional acquisition of data for scatter correction of these images.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Syverson
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number
Page of
(Posted November 13, 2003)
Page 7 of 42
§ 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.