QuantumCam

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles three human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 20, 2016 DDD-Diagnostic A/S % Mr. Niels Sørensen RA & Product Engineer Dr. Neergaards Vej 5E Horsholm, 2970 DENMARK Re: K161674 Trade/Device Name: QuantumCam 9SYS2070-B02 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 9, 2016 Received: June 16, 2016 Dear Mr. Sørensen: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael O'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use K161674 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ## 510(k) Number (if known) Device Name QuantumCam, 9SYS2070-B02 ## Indications for Use (Describe) The QuantumCam is a gamma camera system designed to acquire data for whole body static, gated or dynamic and multislice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in head or body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, TI-201, I-123, I-131, In-111, Ga-67, Co-57. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/14) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for DDD Diagnostic. The logo consists of three capital "D"s, with the first two "D"s in black and the third "D" in purple. Below the "D"s is the word "Diagnostic" in a smaller font and in red. 510(k) Submission QuantumCam 1PMN3099-A01 ### 510(k) Summary or 510(k) Statement 5. #### 510(k) Summary 5.1 Ref. to 21 CFR 807.92 | 1 | Submitted by: | DDD-Diagnostic A/S<br>Dr. Neergaards Vej 5E<br>2970 Horsholm, Denmark<br>Tel: +45 45 768888<br>Fax: + 45 45 164659 | |---|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Contact person: | Niels Sørensen<br>Tel: + 45 45 768888<br>Fax: + 45 45 164659<br>E-mail: niels.sorensen@ddd-diagnostic.dk | | | Preparation date: | 02 May 2016 | | 2 | Device Trade Name: | QuantumCam (Commercial name) 9SYS2070-B02<br>(BodyMD is the development name) | | | Common Name: | Gamma Camera System | | | Classification name: | Emission computed tomography system | | 3 | Predicate Device: | QuantumCam 9SYS2070-A01,<br>DDD-Diagnostic A/S | | | 510(k) Number: | K140206 | | 4 | Device description: | The QuantumCam is a general purpose dual detector gamma camera<br>system comprised of a mechanical gantry allowing the Detectors to<br>be positioned and moved in close proximity to the patient for<br>scanning. The Gantry provides for positioning of the detectors in<br>location(s) suitable for patient to be brought in position for<br>tomographic, whole body scanning as well as planar scanning in<br>sitting or standing position | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for DDD Diagnostic. The logo consists of three large letters, "DDD", with the first two letters in black and the third letter in purple. Below the letters, the word "Diagnostic" is written in purple. 1PMN3099-A01 --- | Functional description: | The Detectors are standard Nal (Sodium Iodide) / Photomultiplier based scintillation detectors designed following the Anger Camera principles first described by Hal Oscar Anger. This detector technology has been used effectively in Nuclear Medicine for decades. The Detectors are equipped with standard Collimators following the principles known to the industry and this submission is specific about the HEGP collimator. The image data from the detectors are collected by hardware in the detector and the data acquisition is controlled by software running on a standard personal computer with a suitable operating system. The data may subsequently be transferred to a Nuclear Medicine Workstation for processing and interpretation. This Workstation is not part of the QuantumCam system. | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 5 Intended use: | The intended use of the QuantumCam gamma camera system is to perform general nuclear medicine imaging procedures. This is intended to be accomplished by imaging the distribution of a radiopharmaceutical within the human body. Gamma rays emitted from the radiopharmaceutical are detected by the gamma camera system and formed into images characterizing and showing the state of organs or structures in the form of functional images. When QuantumCam is connected to a nuclear medicine workstation, these images can be used in concert with other clinical data to assist in making clinical diagnoses by authorized medical personnel.<br>Indications for use. The QuantumCam is a gamma camera system designed to acquire data for whole body static, gated or dynamic and multi-slice images. The system is intended for use as diagnostic imaging device. When used with appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in head or body. The system allows you to acquire data for high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using Tc-99m, TI-201, I-123, I-131, In-111, Ga-67, Co-57. | | 6 a Summary of technological characteristics: | The submitted device has the same technological and functional characteristics as the predicate device. However the energy range is | expanded for the submitted device: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for DDD Diagnostic. The logo consists of three capital "D" letters, with the first two "D" letters in black and the third "D" letter in purple. Below the letters, the word "Diagnostic" is written in purple. 1PMN3099-A01 | | Submitted device:<br>QuantumCam, 9SYS2070-B02 | Predicate device:<br>QuantumCam, 9SYS2070-A01 | |----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design: | The QuantumCam is an open<br>gantry design supported on an<br>open base frame. The complete<br>system is comprised of: a gantry<br>base, detector tower, detector<br>gear box and two imaging<br>detectors, collimator cart, PC,<br>and electronics including a main<br>PSU. | The QuantumCam is an open<br>gantry design supported on an<br>open base frame. The complete<br>system is comprised of: a gantry<br>base, detector tower, detector<br>gear box and two imaging<br>detectors, collimator cart, PC, and<br>electronics including a main PSU. | | Material: | The QuantumCam employs<br>detector of scintillation crystals<br>in a traditional Anger design. The<br>gantry and patient table employs<br>steel and anodized aluminum,<br>steel plate and aluminum covers. | The QuantumCam employs<br>detector of scintillation crystals in<br>a traditional Anger design. The<br>gantry and patient table employs<br>steel and anodized aluminum,<br>steel plate and aluminum covers. | | Energy source: | Mains supply.<br>200VAC - 240VAC | Mains supply.<br>200VAC - 240VAC | | Detector: | The QuantumCam has two<br>separate detectors. Each<br>detector casting is supported by<br>means of a U-shaped detector<br>arm in a balanced design<br>enabling manual tilt of the<br>detector. The complete detector<br>is comprised of: a detector<br>casting, a Nal detector crystal,<br>PM tubes, collimators and<br>electronics for data processing. | The QuantumCam has two<br>separate detectors. Each detector<br>casting is supported by means of a<br>U-shaped detector arm in a<br>balanced design enabling manual<br>tilt of the detector. The complete<br>detector is comprised of: a<br>detector casting, a Nal detector<br>crystal, PM tubes, collimators and<br>electronics for data processing. | | Energy range: | 40 - 400 keV | 40 - 300 keV | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for DDD Diagnostic. The logo consists of three large letters "D", with the first two "D"s in black and the third "D" in purple. Below the letters, the word "Diagnostic" is written in purple. 1PMN3099-A01 | Software: | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The QuantumCam acquisition station is based on a PC architecture with Windows 7 64bit operating system and Microsoft SQL for database handling. A dedicated S/W package for Graphic User Interface (GUI) - S/W package for acquisition setup and gantry/detector motion control. The package also includes means for data transmission via an external network. | The QuantumCam acquisition station is based on a PC architecture with Windows 7 64bit operating system and Microsoft SQL for database handling. A dedicated S/W package for Graphic User Interface (GUI) - S/W package for acquisition setup and gantry/detector motion control. The package also includes means for data transmission via an external network. | 6 b Description of how the non clinical test results have been collected: Non clinical data has been obtained according to DDD quality system procedures. The HEGP Collimator is a late addition to the range of collimators for QuantumCam and verification is done according to standards as listed below, conducted and reported by qualified experts: | Specifications: | Collimator hole:<br>Shape = HEX<br>Size = 3.0 mm<br>Septa = 1,75 mm<br>Length = 43 mm | Measured and compared to Unicorn drawings. | |-------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sensitivity:<br>183 cpm/uCi | | NEMA test on a QuantumCam system. | | Spatial Resolution @<br>10cm, HEGP collimator:<br>< 16.5 mm | | NEMA test on a QuantumCam system. | | Septal Penetration:<br>39,8 % | | NEMA test on a QuantumCam system. The<br>official specification is based on septa thickness<br>and is caluculated based on the absorption<br>characteristics of lead (4,8%). | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for DDD Diagnostic. The logo consists of three capital "D" letters. The first two "D" letters are black, and the third "D" letter is purple. Below the three "D" letters, the word "Diagnostic" is written in purple. 510(k) Submission QuantumCam | Detector shielding: | The QuantumCam detector was mounted with a | |---------------------|------------------------------------------------| | Li = 6,4% | High Energy General Purpose collimator (HEGP). | | LFi = 1,4% | A I-131 source (364 keV) in source holder. | | LSi = 20% | NEMA test on a QuantumCam system. | Rationale for substantial Energy Range is expanded for the submitted device to be able to use equivalence: high energy isotopes such as I-131. For this purpose a HEGP collimator is added to the range of existing collimators for QuantumCam. They all have similar characteristics and the choice of which collimator to use is the users, based on guidelines from professional societies. Adding the HEGP collimator still fulfill the intended use of the QuantumCam system. The two devices are therefore considered substantial equivalent. Conclusion: The submitted device has been evaluated for effectiveness, electrical and mechanical safety, and has been found in compliance with applicable medical device standards, as referred to in Appendix 2. Based on this DDD considers the submitted device, QuantumCam (expanded energy range) 9SYS2070-B02 to be substantially equivalent in terms of safety and effectiveness to the predicate device, QuantumCam 9SYS2070-A01.