Who is the manufacturer of C.CAM-AC?

Danish Diagnostic Development A/S filed the 510(k) submission for C.CAM-AC (K051460).

What is the FDA product code for C.CAM-AC?

KPS. It is classified under 21 CFR 892.1200 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for C.CAM-AC?

510(k) clearance (submission type: Traditional).

What are the predicate devices for C.CAM-AC?

CardioMD-AC (K040616); E.cam-AC (K963983).

Who can help prepare an FDA 510(k) submission like C.CAM-AC?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

C.CAM-AC

K051460 · Danish Diagnostic Development A/S · KPS · Jun 15, 2005 · Radiology

Device Facts

Record ID	K051460
Device Name	C.CAM-AC
Applicant	Danish Diagnostic Development A/S
Product Code	KPS · Radiology
Decision Date	Jun 15, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1200
Device Class	Class 2
Attributes	3rd-Party Reviewed

Intended 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 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.

Device Story

The c.cam-AC is an optional attenuation correction device for the c.cam dual-detector gamma camera. It consists of two housings, each containing 14 fixed-position Gd-153 line sources and an electrically controlled shutter. During operation, the device is manually positioned opposite the detectors. It acquires transmission images by focusing a collimated beam of gamma photons through the patient, stored alongside emission, emission scatter, and transmission scatter data. The system exports data via DICOM to an OEM processing station. Clinicians use the resulting corrected images to compensate for gamma ray attenuation within the patient body, improving image quality for SPECT studies. The device is manually rotated to a park position for patient loading/unloading.

Clinical Evidence

Bench testing included radiation leakage measurements (< 0.2 mR/hr at 100cm with shutter closed; < 10 mR/hr at 30cm with shutter open). Clinical data was obtained by acquiring myocardial perfusion stress studies on a Siemens e.cam system to validate the attenuation correction methodology.

Technological Characteristics

Dual-housing system mounted to gamma camera detectors; 14 fixed-position Gd-153 line sources per housing; anodized aluminum and lead/lead-alloy shielding; 120 VAC power; manual positioning/rotation mechanism; DICOM connectivity for external processing.

Indications for Use

Indicated for patients undergoing SPECT studies using a c.cam gamma camera system to provide attenuation and scatter correction of emission images.

Regulatory Classification

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.

Predicate Devices

CardioMD-AC (K040616)
E.cam-AC (K963983)

Related Devices

K991318 — CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS · Hitachi Medical Corp. of America · Jun 18, 1999
K991565 — TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S · Smv America · Aug 2, 1999
K971980 — MCD-AC · Adac Laboratories · Oct 23, 1997
K980959 — VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA · Ge Medical Systems F.I. Haifa · Jun 4, 1998
K040616 — CARDIOMD-AC · Danish Diagnostic Development A/S · Mar 24, 2004

Submission Summary (Full Text)

{0}------------------------------------------------ K051460 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/S Dr. Neergaardsvej 5F 2970 Horsholm, Denmark Tel: + 45 45 768888 Fax: + 45 45 164659 | | |---|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | Contact person: | Niels Sorensen Tel: + 45 45 768888 Fax: + 45 45 164659 E-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 and Predicate Device, subpart; Performance. | | | 4 | Device description: | The c.cam-AC is an attenuation correction device, which will be marketed as an optional device for the c.cam gamma camera. | | | | Functional description: | 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 | | : {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 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. | | 6 a | Summary of technological characteristics: | The device has the same technological and functional characteristics as the predicate device. However the design of the submitted device is different on the following points: 1. Manually positioning of the device housing. 2. The use of 14 fixed positioned sources. | | | |--------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Submitted device: c.cam-AC | Predicate device: CardioMD-AC | Predicate device: e.cam-AC (equivalence claimed to radioactive source only) | | | Design: | The submitted attenuation correction device is formed as a single housing containing 14 line sources in fixed positions, shutter and all shutter control. | The predicate attenuation correction device is formed as a single housing containing all motion control, electronics and motors including the scanning line source. | | | | | The device is secured to the side of the detector casting by means of a bracket. The bracket is designed for manual positioning of the device housing to enable patient access to the system. | The device is secured to the side of the detector casting by means of a bracket that enables the device housing to slide in and out. | | | | | In operation the device housing is manually positioned opposite to the detector. When not in use the device housing can manually be rotated to its park position enabling access for patient loading and un-loading. | In operation the device housing is positioned opposite to the detector (motorized motion). When not in use the device housing can slide to its park position enabling access for patient loading and un- loading. | | | | Radioactive source: | The submitted device utilises 14 fixed positioned line sources exposing the complete detector field of view. Each source is collimated to minimize exposure to the surroundings and the patient exposure is controlled by an electrical controlled shutter common for all 14 sources. | The predicate device utilises one collimated line sources exposing by scanning over the detector field of view. The shutter controlling the patient exposure is an integrated part of the source holder. | The predicate device utilises 14 fixed positioned line sources exposing the complete detector field of view. Each source is collimated to minimize exposure to the surroundings and the patient exposure is controlled by an electrical controlled shutter common for all 14 sources. The two devices utilises the same line sources type from the same supplier in the same housing. | | | Material: | Anodized aluminium plates, lead and lead alloy shielding. Painted aluminium plate covers. | Anodized aluminium plates, lead and lead-bronze alloy shielding. Painted aluminium plate covers. | | | | Energy source: | Powered from an isolated power outlet on the mains supply. 120 VAC | Powered from an isolated power outlet on the mains supply. 120 VAC | | | 6 b | Description of how the non clinical test results have been collected. | Clinical data has been collected by acquiring Myocardial Perfusion stress studies on a Siemens e.cam system. Refer to section C-4-2 Phantom Data Images and to C-6-1 A brief description of how the 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