(126 days)
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.
The QuantumCam is a general purpose dual detector gamma camera system comprised of a mechanical gantry allowing the Detectors to be positioned and moved in close proximity to the patient for scanning. The Gantry provides for positioning of the detectors in location(s) suitable for patient to be brought in position for tomographic, whole body scanning as well as planar scanning in sitting or standing position.
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.
Here's a breakdown of the acceptance criteria and study information for the QuantumCam 9SYS2070-B02, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on NEMA (National Electrical Manufacturers Association) tests for gamma camera systems. The performance reported is for the new High Energy General Purpose (HEGP) collimator, which is the main addition that expands the device's energy range.
| Feature / Performance Metric | Acceptance Criteria (Specification) | Reported Device Performance (NEMA Test Result) |
|---|---|---|
| HEGP Collimator Hole Properties: | ||
| Shape | HEX | HEX (Measured and compared to Unicorn drawings) |
| Size | 3.0 mm | 3.0 mm (Measured and compared to Unicorn drawings) |
| Septa | 1.75 mm | 1.75 mm (Measured and compared to Unicorn drawings) |
| Length | 43 mm | 43 mm (Measured and compared to Unicorn drawings) |
| Device Performance with HEGP Collimator (NEMA Tests): | ||
| Sensitivity | 183 cpm/uCi | Not explicitly stated as a pass/fail. The value 183 cpm/uCi is given but not compared against a specific pass/fail threshold. |
| Spatial Resolution @ 10cm, HEGP Collimator | < 16.5 mm (less than 16.5 mm) | Not explicitly stated whether the result meets the criteria. The value is not provided. |
| Septal Penetration (Calculated) | 39.8 % | Not explicitly stated whether the result meets the criteria. The value 39.8% is given, with the note that the official specification is based on septa thickness and |
| calculated based on lead absorption (4.8%). This suggests 39.8% is the calculated value, not a measured one, and 4.8% might be the acceptable absorption. | ||
| Detector Shielding (I-131 Source (364 keV)): | ||
| Li | Not specified | 6.4% |
| LFi | Not specified | 1.4% |
| LSi | Not specified | 20% |
Important Note: The document focuses on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" presented are primarily the physical specifications of the HEGP collimator and results from standard NEMA tests. However, for "Spatial Resolution @ 10cm" and "Septal Penetration", the actual test result that directly compares to the specified criteria is not explicitly provided in the table. The statements indicate that these were NEMA tested, but not the explicit numerical outcome for direct comparison to the "less than 16.5 mm" or the 39.8% calculated value (which seems to be the expected performance rather than an acceptance threshold).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "NEMA test on a QuantumCam system" and measurements of collimator hole properties. This suggests a single or very small number of physical devices/collimators were tested.
- Data Provenance: The tests were conducted internally by DDD-Diagnostic A/S as part of their quality system procedures. The country of origin for the data is implicitly Denmark, where DDD-Diagnostic A/S is located. The study is retrospective in the sense that it's a verification of a product design feature rather than a clinical trial with patients over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated. The document mentions "conducted and reported by qualified experts." No specific number or qualifications are provided beyond "qualified experts."
- Qualifications: "Qualified experts" is the only description given. No specific details like "radiologist with 10 years of experience" are provided.
4. Adjudication Method for the Test Set
- The document does not describe any adjudication method. The testing appears to be objective, physical measurements and NEMA standard tests, rather than subjective interpretation requiring adjudication among multiple readers.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. The submission is for a device modification (expanded energy range with a new collimator) based on substantial equivalence, not a clinical effectiveness study to compare diagnostic accuracy or reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, the tests described are standalone performance tests of the gamma camera system itself (e.g., sensitivity, spatial resolution, septal penetration), without human involvement in interpreting images or making diagnoses. This is an objective measurement of the device's physical imaging capabilities.
7. The Type of Ground Truth Used
- The ground truth for the device performance tests (sensitivity, spatial resolution, septal penetration) is based on NEMA standards and physical measurements. For the collimator specifications (shape, size, septa, length), the ground truth is the Unicorn drawings (presumably engineering or design drawings) that define the intended specifications, against which the manufactured collimator was measured.
8. The Sample Size for the Training Set
- Not applicable. This device is hardware (gamma camera system), not a machine learning or AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this hardware device.
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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.
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
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)
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FORM FDA 3881 (8/14)
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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/SDr. Neergaards Vej 5E2970 Horsholm, DenmarkTel: +45 45 768888Fax: + 45 45 164659 |
|---|---|---|
| Contact person: | Niels SørensenTel: + 45 45 768888Fax: + 45 45 164659E-mail: niels.sorensen@ddd-diagnostic.dk | |
| Preparation date: | 02 May 2016 | |
| 2 | Device Trade Name: | QuantumCam (Commercial name) 9SYS2070-B02(BodyMD is the development name) |
| Common Name: | Gamma Camera System | |
| Classification name: | Emission computed tomography system | |
| 3 | Predicate Device: | QuantumCam 9SYS2070-A01,DDD-Diagnostic A/S |
| 510(k) Number: | K140206 | |
| 4 | Device description: | The QuantumCam is a general purpose dual detector gamma camerasystem comprised of a mechanical gantry allowing the Detectors tobe positioned and moved in close proximity to the patient forscanning. The Gantry provides for positioning of the detectors inlocation(s) suitable for patient to be brought in position fortomographic, whole body scanning as well as planar scanning insitting or standing position |
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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.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:
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1PMN3099-A01
| Submitted device:QuantumCam, 9SYS2070-B02 | Predicate device:QuantumCam, 9SYS2070-A01 | |
|---|---|---|
| Design: | The QuantumCam is an opengantry design supported on anopen base frame. The completesystem is comprised of: a gantrybase, detector tower, detectorgear box and two imagingdetectors, collimator cart, PC,and electronics including a mainPSU. | The QuantumCam is an opengantry design supported on anopen base frame. The completesystem is comprised of: a gantrybase, detector tower, detectorgear box and two imagingdetectors, collimator cart, PC, andelectronics including a main PSU. |
| Material: | The QuantumCam employsdetector of scintillation crystalsin a traditional Anger design. Thegantry and patient table employssteel and anodized aluminum,steel plate and aluminum covers. | The QuantumCam employsdetector of scintillation crystals ina traditional Anger design. Thegantry and patient table employssteel and anodized aluminum,steel plate and aluminum covers. |
| Energy source: | Mains supply.200VAC - 240VAC | Mains supply.200VAC - 240VAC |
| Detector: | The QuantumCam has twoseparate detectors. Eachdetector casting is supported bymeans of a U-shaped detectorarm in a balanced designenabling manual tilt of thedetector. The complete detectoris comprised of: a detectorcasting, a Nal detector crystal,PM tubes, collimators andelectronics for data processing. | The QuantumCam has twoseparate detectors. Each detectorcasting is supported by means of aU-shaped detector arm in abalanced design enabling manualtilt of the detector. The completedetector is comprised of: adetector casting, a Nal detectorcrystal, PM tubes, collimators andelectronics for data processing. |
| Energy range: | 40 - 400 keV | 40 - 300 keV |
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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:Shape = HEXSize = 3.0 mmSepta = 1,75 mmLength = 43 mm | Measured and compared to Unicorn drawings. |
|---|---|---|
| Sensitivity:183 cpm/uCi | NEMA test on a QuantumCam system. | |
| Spatial Resolution @10cm, HEGP collimator:< 16.5 mm | NEMA test on a QuantumCam system. | |
| Septal Penetration:39,8 % | NEMA test on a QuantumCam system. Theofficial specification is based on septa thicknessand is caluculated based on the absorptioncharacteristics of lead (4,8%). |
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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.
§ 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.