(116 days)
Yes
The device description explicitly states that HYPER AiR "incorporates pre-trained neural networks" and "Convolutional neural network is able to distinguish the noise component and the image details". Neural networks are a core component of machine learning and artificial intelligence.
No
The device is an image processing function that reduces noise and improves contrast of PET images for diagnostic purposes. It is not intended to treat or prevent a disease or condition.
No
Explanation: The device is an image processing function that reduces noise and improves contrast of existing PET images. It is used to enhance images for radiologists and nuclear medicine physicians, but it does not make a diagnosis itself. The device serves as an alternative to existing image reconstruction algorithms.
Yes
The device description explicitly states "HYPER AiR is a software-only device." It is intended to be implemented on previously cleared PET/CT devices, indicating it is a software add-on or alternative reconstruction algorithm, not a new hardware component.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro).
- HYPER AiR's Function: HYPER AiR is a software that processes images generated by a PET/CT scanner. It works with the output of the imaging device, not with biological specimens.
- Intended Use: The intended use is to improve the quality of PET images for interpretation by radiologists and nuclear medicine physicians. This is a function related to medical imaging, not laboratory testing of biological samples.
Therefore, HYPER AiR falls under the category of medical imaging software, not In Vitro Diagnostics.
No
The provided input explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found," indicating no mention of PCCP authorization.
Intended Use / Indications for Use
HYPER AiR is an image processing function intended to be used by radiologists and nuclear medicine physicians to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images.
Product codes
KPS
Device Description
HYPER AiR is a software-only device. HYPER AiR is an image reconstruction technique which incorporates pre-trained neural networks in the iteration reconstruction process to control image noise and contrast. It is intended to be implemented on previously cleared PET/CT devices uMI 550 (K193241) and uMI 780 (K172143). HYPER AiR serves as an alternative to the existing image reconstruction algorithm that are available on the predicate devices.
Mentions image processing
HYPER AiR is an image processing function intended to be used by radiologists and nuclear medicine physicians to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images.
Mentions AI, DNN, or ML
HYPER AiR is an image reconstruction technique which incorporates pre-trained neural networks in the iteration reconstruction process to control image noise and contrast.
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists and nuclear medicine physicians / Onsite on the facility PET/CT reconstruction computer.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Engineering bench testing was performed to support substantial equivalence and the product performance claims. The evaluation and analysis used the identical raw datasets obtained on UH's uMI 780 and uMI 550, and then applies both HYPER AiR and OSEM to do image reconstruction. The resultant images were then compared for:
- Performance on noise reduction
- Performance on image contrast
- Performance on contrast to noise ratio
Performance tests have been conducted to show that HYPER AiR can improve image contrast while suppressing background noise.
The clinical image evaluation was performed by comparing HYPER AiR with OSEM. Each image was read by three board-certified nuclear medicine physicians who provided an assessment of image contrast, image noise and image quality. The results of the evaluation indicated that HYPER AiR produces images with better image contrast and lower image noise than OSEM while the image quality was sufficient for clinical diagnosis.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Shanghai United Imaging Healthcare Co., Ltd. % Xin GAO Regulatory Affairs Manager No. 2258 Chengbei Road Shanghai, Shanghai 201807 CHINA
Re: K210001
Trade/Device Name: HYPER AiR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS Dated: March 27, 2021 Received: March 30, 2021
Dear Xin GAO:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
April 30, 2021
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210001
Device Name HYPER AiR
Indications for Use (Describe)
HYPER AiR is an image processing function intended to be used by radiologists and nuclear medicine physicians to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images.
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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510 (k) SUMMARY
1. Date of Preparation
March 26, 2021
2. Sponsor Identification
Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Xin GAO Position: Regulatory Affairs Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device
Trade Name: HYPER AiR Common Name: Emission Computed Tomography System Model(s): HYPER AiR
Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS Review Panel: Radiology
4. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K193241 Device Name: Emission Computed Tomography System Model(s): uMI 550
Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK Review Panel: Radiology
5. Device Description:
HYPER AiR is a software-only device. HYPER AiR is an image reconstruction technique which incorporates pre-trained neural networks in the iteration reconstruction process to control image noise and contrast. It is intended to be
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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, with a white line running horizontally through the middle of the "U". The color of the text and the "U" shape is a dark gray.
implemented on previously cleared PET/CT devices uMI 550 (K193241) and uMI 780 (K172143). HYPER AiR serves as an alternative to the existing image reconstruction algorithm that are available on the predicate devices.
6. Indications for Use
HYPER AiR is an image processing function intended to be used by radiologists and nuclear medicine physicians to reduce noise and improve contrast of fluorodeoxyglucose (FDG) PET images.
7. Comparison of Technological Characteristics with the Predicate Devices
A comparison between the technological characteristics of proposed and predicate devices is provided as below.
| ITEM | Predicate Device
uMI 550 ( K193241) | Proposed Device
HYPER AIR | Remark |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image
Processing
Location | Onsite on the facility
PET/CT reconstruction
computer. | Onsite on the facility
PET/CT
reconstruction
computer. | Same |
| Operating
system | Windows | Windows | Same |
| Workflow | Support online & offline | Support online & offline | Same |
| Protocols | Standard scanner
protocols | Standard scanner
protocols | Same |
| Algorithm | OSEM included in uMI
550 uses maximum-
likelihood estimation
techniques by
maximizing the
probability to the given
counts represented by the
image corresponding to
the true activity
distribution in the source,
under a Poisson
probability model for the
positron emission. To
accelerate convergence
speed, it divides the
projection data into a
limited number of subsets
and accesses them in
order for iterative
calculation. | HYPER AIR is a
modification of
conventional OSEM
by incorporating the
pre-trained
convolutional neural
networks into the
iteration process. | OSEM included in uMI
550 uses maximum-
likelihood estimation
techniques. But HYPER
AIR incorporates
convolutional neural
networks into OSEM to
help to reconstruct PET
images. Convolutional
neural network is able to
distinguish the noise
component and the image
details, and removes the
noise component from the
image or enhances the
image details. So HYPER
AIR can produce lower
noise and higher contrast
PET images than OSEM.
Performance Evaluation
Report and Clinical Image |
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| Evaluation show that it's safe and effective. | ||
|---|---|---|
| -- | -- | ----------------------------------------------- |
HYPER AiR utilizes the same hardware with the predicate devices and does not introduce any new restrictions on use. The differences do not affect the safety and the effectiveness.
8. Performance Data
Non-Clinical Testing
Non-clinical testing including image performance tests and clinical image evaluation were concluded for the HYPER AiR during the product development. UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:
Software
- A NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine (DICOM)
-
IEC 62304: Medical Device Software - software life cycle process
- A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- A Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Other Standards and Guidance
-
ISO 14971: Medical Devices - Application of risk management to medical devices
- Code of Federal Regulations, Title 21, Part 820 Quality System Regulation A
Software Verification and Validation
Software documentation for a Moderate Level of Concern software per FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission. The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence. UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.
Performance Verification
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized symbol that resembles a "U" shape with a vertical line running through the center, creating a cross-like figure within the "U".
Engineering bench testing was performed to support substantial equivalence and the product performance claims. The evaluation and analysis used the identical raw datasets obtained on UH's uMI 780 and uMI 550, and then applies both HYPER AiR and OSEM to do image reconstruction. The resultant images were then compared for:
-
Performance on noise reduction
- A Performance on image contrast
-
Performance on contrast to noise ratio
Performance tests have been conducted to show that HYPER AiR can improve image contrast while suppressing background noise.
Clinical Image Evaluation
The clinical image evaluation was performed by comparing HYPER AiR with OSEM. Each image was read by three board-certified nuclear medicine physicians who provided an assessment of image contrast, image noise and image quality. The results of the evaluation indicated that HYPER AiR produces images with better image contrast and lower image noise than OSEM while the image quality was sufficient for clinical diagnosis.
9. Conclusions
Based on the comparison and analysis above, the proposed device has similar performance, equivalent safety and effectiveness as the predicate devices. The differences between the proposed device and predicate devices do not affect the indications for use, safety and effectiveness. And no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.