(101 days)
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, 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.
Functional description:
The Detectors are standard Nal (Sodium lodide) / 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. 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 summary of the acceptance criteria and the study details for the QuantumCam device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Specification | Acceptance Criteria (NEMA Standard NU 1:2007) | Reported Device Performance (from NEMA testing) |
|---|---|---|
| Intrinsic Spatial Resolution, FWHM, UFOV @ surface | ≤ ± 3.9 mm | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Spatial Resolution, FWHM, LEGP collimator @ 10cm, Tc-99m | < 9.1 mm | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Energy Resolution, @ Tc-99m | ≤ 9.6 % | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Spatial Linearity, UFOV, Diff. | < ± 0.2 mm | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Flood Field Uniformity, UFOV Intrinsic, Diff. | < ± 2.55 % | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Maximum Count rate with scatter | > 320 kcps | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Count rate Sensitivity, @ 20% loss | > 225 kcps | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
| Detector shielding Sensitivity, @ 184 keV | < 2.0 % | Not explicitly stated as a single value, but compliance with NEMA standard implies meeting this. |
Important Note: The document states that the "test equipment used, test setup and all calculations have all been performed according to the NEMA Standard NU 1:2007 in a 20% energy." This implies that the device met the specifications outlined in the NEMA standard, even if explicit performance values are not listed next to each criterion. For the detector shielding sensitivity, it is specifically mentioned that the test was performed according to NEMA Standard NU 1:2007.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing conducted according to NEMA Standard NU 1:2007. This standard outlines procedures for measuring the performance of gamma cameras.
- Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases. Instead, it refers to testing of the physical device components (detectors, collimators) using standard phantoms and calibrated sources as per NEMA guidelines. Therefore, there isn't a "test set" in the traditional sense of patient data.
- Data Provenance: The testing was "performed according to DDD quality system procedures as investigations performed according to standards... conducted and reported by qualified experts." This indicates the testing was done by the manufacturer (DDD-Diagnostic A/S) in Denmark. It is a prospective test in the sense that the device was actively tested against the NEMA standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this was a non-clinical, performance-based test against a technical standard (NEMA NU 1:2007), there was no "ground truth" established by human experts in a diagnostic sense (e.g., radiologists interpreting images). The "ground truth" was the objective measurement values obtained by following the NEMA standard, which are then compared to the specified acceptance criteria of the standard itself.
The document mentions "qualified experts" conducted and reported the investigations, but their specific number or qualifications (e.g., "radiologist with 10 years of experience") are not provided. These "experts" would likely be engineers or physicists specializing in nuclear medicine imaging system performance.
4. Adjudication Method for the Test Set
Not applicable. As described above, this was a non-clinical, objective performance test against a standard, not a subjective interpretation task requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating the device's technical performance and substantial equivalence to a predicate device, not on how human readers perform with or without AI assistance. The QuantumCam is a gamma camera system, not an AI-assisted interpretation tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The QuantumCam is a physical gamma camera system (hardware) that acquires data. It is not an algorithm that provides standalone diagnostic interpretations. While it uses software for acquisition and control, the "performance" described is about the quality of the raw data acquisition, not an automated diagnostic output from an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this study was the objective measurements obtained by following the specific protocols outlined in the NEMA Standard NU 1:2007. This standard provides a framework for quantitatively assessing the physical performance characteristics of gamma cameras. The device's performance was compared directly to the numerical acceptance criteria defined by this standard.
8. The Sample Size for the Training Set
Not applicable. This is a medical device (gamma camera) performance study, not an AI algorithm development study. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned or implied by the document.
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K140206
Page 1 of 5
MAY 0 8 2014
510(k) Submission, QuantumCam
1PMN2618-A03
Diagnostic
25 November 2013
| 5. | 510(k) Summary or 510(k) Statement | |
|---|---|---|
| 5.1 | 510(k) SummaryRef. to 21 CFR 807.92 | |
| 1 | Submitted by: | DDD-Diagnostic A/SDr. Neergaards Vej 5E2970 Horsholm, DenmarkTel: + 45 45 768888Fax: + 45 45 164659Contact person: Trine OlesenTel: +45 45 768888Fax: + 45 45 164659E-mail: trine.olesen@ddd-diagnostic.dkPreparation date: November 25, 2013 |
| 2 | Device Trade Name: | QuantumCam (Commercial name)(BodyMD is the development name) |
| Common Name: | Gamma Camera System | |
| Classification name: | Emission computed tomography system | |
| 3 | Predicate Device: | UNICORN MODEL SYS0630 (later renamed as Meridian),DDD-Diagnostic A/S |
| 510(k) Number: | K001888 | |
| 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. |
| 510(k) Submission, QuantumCam | ||
| 1PMN2618-A03 | 25 November 2013 | |
| Functional description: | The Detectors are standard Nal (Sodium lodide) / Photomultiplierbased scintillation detectors designed following the Anger Cameraprinciples first described by Hal Oscar Anger. This detectortechnology has been used effectively in Nuclear Medicine fordecades. The Detectors are equipped with standard Collimatorsfollowing the principles known to the industry. The image data fromthe detectors are collected by hardware in the detector and the dataacquisition is controlled by software running on a standard personalcomputer with a suitable operating system. The data maysubsequently be transferred to a Nuclear Medicine Workstation forprocessing and interpretation. This Workstation is not part of theQuantumCam system. | |
| 5 Intended use: | The intended use of the QuantumCam gamma camera system is toperform general nuclear medicine imaging procedures. This isintended to be accomplished by imaging the distribution of aradiopharmaceutical within the human body.Gamma rays emitted from the radiopharmaceutical are detected bythe gamma camera system and formed into images characterizingand showing the state of organs or structures in the form offunctional images. When QuantumCam is connected to a nuclearmedicine workstation, these images can be used in concert withother clinical data to assist in making clinical diagnoses by authorizedmedical personnel. | |
| Indications for use.The QuantumCam is a gamma camera system designed to acquiredata for whole body static, gated or dynamic and multi-slice images.The system is intended for use as diagnostic imaging device. Whenused with appropriate radio pharmaceuticals, images are producedrepresenting the internal distribution of radioactivity in head or body.The system allows you to acquire data for high resolution threedimensional, static, gated or dynamic images of biochemical andmetabolic processes using Tc-99m, TI-201, I-123, In-111, Ga-67, Co-57. | ||
| 6 a Summary of technologicalcharacteristics: | The submitted device has the same technological and functionalcharacteristics as the predicate device. However, the gantry withpatient support device is in design different. | |
| Submitted device:QuantumCam, 9SYS2070 | Predicate device:Unicorn model, SYS0630 | |
| 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. | Lightweight compact castedaluminum ring gantry supporting asingle detector in an unbalanceddesign. The complete gantry iscomprised of: a ring gantry, a detector, a patient table, acollimator cart, PC, and electronicsincluding 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 predicate device employs atraditional detector Anger designof scintillation crystals and PMtubes. The gantry employs castedand extruded aluminum, steelplate and fiberglass covers. |
| Energy source: | Mains supply.200VAC - 240VAC | Mains supply.100VAC - 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 detector is supported bymeans of 2 casted aluminumbrackets secured to the side of agantry bearing by means of 2linear bearings. The linearbearings enables radial detectorpositioning and detector tilt. Thedetector is a reinforced castedlead housing. |
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Image /page/2/Picture/0 description: The image shows the logo for DDD Diagnostic. The logo consists of three overlapping "D" letters. The word "Diagnostic" is written in a smaller font size below the three "D" letters.
1PMN2618-A03
510(k) Submission, QuantumCam
1 - 1 - 1 - 1 - 1 -
25 November 2013
5-3
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Image /page/3/Picture/0 description: The image shows the logo for DDD Diagnostic. The logo consists of three overlapping "D" letters in a bold, sans-serif font. Below the letters, the word "Diagnostic" is written in a smaller, simpler font.
510(k) Submission, QuantumCam
1PMN2618-A03
25 November 2013
| 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 predicate device acquisition station is based on a PC architecture with Windows NT 4.0, SP 6+ operating system. The system is controlled by a software package formed by a dedicated Software (S/W) package for Graphic User Interface (GUI) and a dedicated S/W package designed for the purpose of controlling system setup, gantry/table motions and acquisition and data transfer. |
- 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 as investigations performed according to standards as listed below, conducted and reported by qualified experts:
| Specifications: | ||
|---|---|---|
| Intrinsic SpatialResolution, FWHM, UFOV@ surface.$\leq \pm 3.9$ mm | Test equipment used, test setup and allcalculations have all been performed accordingto the NEMA Standard NU 1:2007 in a 20%energy. | |
| Spatial Resolution, FWHM,LEGP collimator @ 10cm,Tc-99m.$ < 9.1$ mm | Test equipment used, test setup and allcalculations have all been performed accordingto the NEMA Standard NU 1:2007 in a 20%energy. | |
| Energy Resolution, @Tc-99m.$\leq 9.6$ % | Test equipment used, test setup and allcalculations have all been performed accordingto the NEMA Standard NU 1:2007 in a 20%energy. | |
| Spatial Linearity, UFOV,Diff.$ < \pm 0.2$ mm | Test equipment used, test setup and allcalculations have all been performed accordingto the NEMA Standard NU 1:2007 in a 20%energy. |
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K140206
Page 5 of 5
Diagnostic
510(k) Submission, QuantumCam
1PMN2618-A03
25 November 2013
| Flood Field Uniformity,UFOV Intrinsic, Diff.< ± 2.55 % | Test equipment used, test setup and allcalculations have all been performed accordingto the NEMA Standard NU 1:2007 in a 20%energy. |
|---|---|
| Maximum Count ratewith scatter.> 320 kcps | Test equipment used, test setup and allcalculations have all been performed accordingto the NEMA Standard NU 1:2007 in a 20%energy. |
| Count rate Sensitivity, @20 % loss.> 225 kcps | Test equipment used, test setup and allcalculations have all been performed accordingto the NEMA Standard NU 1:2007 in a 20%energy. |
| Detector shieldingSensitivity, @ 184 keV.< 2.0 % | The QuantumCam detector was mounted with aMedium Energy General Purpose collimator(MEGP). A Ga-67 source (184 keV) in sourceholder. Has been performed according to theNEMA Standard NU 1:2007 in a 20% energy. |
Rationale for substantial equivalence:
The type of energy source applied is the same for the two devices. The QuantumCam has a limited power voltages range 200-240VAC whereas the predicated device has a range of 100-240VAC. This will in no way influence the safety or effectiveness of the QuantumCam system.
The two devices are therefore still 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 1. Based on this DDD considers the QuantumCam to be substantially equivalent in terms of safety and effectiveness to the predicate device, UNICORN MODEL SYS0630, K001888.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of movement or connection.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2014
DDD-Diagnostic A/S % Ms. Trine Olesen QA/RA Manager Dr. Neergaards Vej 5E 2970 Horsholm DENMARK
Re: K140206 Trade/Device Name: QuantumCam Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: April 22, 2014 Received: April 25, 2014
Dear Ms. Olesen:
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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Page 2-Ms. Olesen
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Michal D.
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K140206
Device Name: QuantumCam
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, In-111, Ga-67, Co-57.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
210(k) K140206
Page 1 of 1
§ 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.