(181 days)
Not Found
Yes
The intended use and device description explicitly state the use of "machine learning techniques" and "deep learning algorithms".
No
The device is described as a "computer-assisted detection (CADe) software device" that assists radiologists in identifying suspicious regions. It explicitly states, "DeepTek CXR Analyzer does not make treatment recommendations or provide a diagnosis." This indicates it is a diagnostic aid, not a device that directly treats or prevents a condition.
Yes
Explanation: The device is a "computer-assisted detection (CADe) software device that analyzes chest radiograph studies using machine learning techniques to identify, categorize, and highlight suspicious ROIs." This function directly supports the diagnostic process by assisting radiologists in interpreting medical images to detect potential abnormalities.
Yes
The device description explicitly states it is a "computer-assisted detection (CADe) software device" and details its function as analyzing images and providing annotations, without mentioning any accompanying hardware components that are part of the medical device itself. It interacts with existing PACS systems via software protocols.
Based on the provided information, the DeepTek CXR Analyzer v1.0 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- DeepTek CXR Analyzer's Function: The DeepTek CXR Analyzer analyzes medical images (chest radiographs), not biological specimens. It processes image data to identify potential areas of interest for a radiologist.
Therefore, while it is a medical device that aids in diagnosis, it does not fit the definition of an In Vitro Diagnostic device.
No
The letter does not mention that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The "Control Plan Authorized (PCCP) and relevant text" section explicitly states "Not Found".
Intended Use / Indications for Use
DeepTek CXR Analyzer v1.0 is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies using machine learning techniques to identify, categorize, and highlight suspicious ROIs in one of the following categories: Lungs, Pleura, Cardiac, and Hardware. The device is intended for use as a concurrent reading aid for radiologists. DeepTek CXR Analyzer v1.0 is indicated for adults and transitional adolescents (18 to
§ 892.2070 Medical image analyzer.
(a)
Identification. Medical image analyzers, including computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, is a prescription device that is intended to identify, mark, highlight, or in any other manner direct the clinicians' attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. This device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. This device is not intended to replace the review by a qualified radiologist, and is not intended to be used for triage, or to recommend diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the image analysis algorithms including a description of the algorithm inputs and outputs, each major component or block, and algorithm limitations.
(ii) A detailed description of pre-specified performance testing methods and dataset(s) used to assess whether the device will improve reader performance as intended and to characterize the standalone device performance. Performance testing includes one or more standalone tests, side-by-side comparisons, or a reader study, as applicable.
(iii) Results from performance testing that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures (
e.g., receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain a sufficient number of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.(iv) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results; and cybersecurity).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use.
(ii) A detailed description of the intended reading protocol.
(iii) A detailed description of the intended user and user training that addresses appropriate reading protocols for the device.
(iv) A detailed description of the device inputs and outputs.
(v) A detailed description of compatible imaging hardware and imaging protocols.
(vi) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality or for certain subpopulations), as applicable.(vii) Device operating instructions.
(viii) A detailed summary of the performance testing, including: test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 5, 2023
DeepTek Medical Imaging Pvt Ltd % Carrillo Rory Quality & Regulatory Consultant 3rd Floor, Ideas to Impact, Pallod Farms 3 Behind Vijay Sales, Baner Pune. Maharashtra 411405 INDIA
Re: K231001
Trade/Device Name: DeepTek CXR Analyzer v1.0 Regulation Number: 21 CFR 892.2070 Regulation Name: Medical Image Analyzer Regulatory Class: Class II Product Code: MYN Dated: September 8, 2023 Received: September 8, 2023
Dear Carrillo Rory:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
DeepTek CXR Analyzer v1.0
Indications for Use (Describe)
DeepTek CXR Analyzer v1.0 is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies using machine learning techniques to identify, categorize, and highlight suspicious ROIs in one of the following categories: Lungs, Pleura, Cardiac, and Hardware. The device is intended for use as a concurrent reading aid for radiologists. DeepTek CXR Analyzer v1.0 is indicated for adults and transitional adolescents (18 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."
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Image /page/3/Picture/0 description: The image shows the logo for DEEPTEK. The word "DEEPTEK" is written in blue and orange letters. Behind the word, there are four blue circles that are partially overlapping each other.
K231001
510(k) Summary
1. General Information
| 510(k) Sponsor | DeepTek Medical Imaging Pvt Ltd |
|---|---|
| Address | 3rd Floor, Ideas to Impact, Pallod Farms 3 |
| Behind Vijay Sales, Baner | |
| Pune, India, Maharashtra 411405 | |
| Correspondence Person | Rory A. Carrillo |
| Regulatory Consultant | |
| Cosm | |
| Contact Information | Email: rory@cosmhq.com |
| Phone: 415-580-0916 | |
| Date Prepared | April 07, 2023 |
2. Proposed Device
| Proprietary Name | DeepTek CXR Analyzer v1.0 |
|---|---|
| Common Name | CXR Analyzer |
| Classification Name | Medical image analyzer |
| Regulation Number | 892.2070 |
| Regulation Name | Medical image analyzer |
| Product Code | MYN |
| Regulatory Class | II |
3. Predicate Device
| Proprietary Name | Chest-CAD |
|---|---|
| Premarket Notification | K210666 |
| Classification Name | Medical image analyzer |
| Regulation Number | 892.2070 |
| Regulation Name | Medical image analyzer |
| Product Code | MYN |
| Regulatory Class | II |
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Image /page/4/Picture/0 description: The image shows the logo for DeepTek. The logo has the word "DEEPTEK" in blue and orange letters. The letters "DEEP" are in blue, and the letters "TEK" are in orange. To the right of the word are four semi-transparent blue circles that are layered on top of each other.
Device Description 4.
DeepTek CXR Analyzer is a computer-assisted detection (CADe) software device developed to assist radiologists in identifying suspicious regions of interest (ROIs) in the following categories: Lungs, Pleura, Cardiac, and Hardware. DeepTek CXR Analyzer detects suspicious ROIs by analyzing adult frontal chest radiographs using deep learning algorithms and provides relevant annotations to assist radiologists with their interpretations.
The device has an authentication graphical user interface, which allows the user to authenticate themselves. The user can connect the PACS with the DeepTek CXR Analyzer using the configuration interface. The user can enter the PACS AE Title, IP address, Listener and Sender Port number to configure the device. Once the device is configured correctly, DeepTek CXR Analyzer receives chest radiographs from the configured PACS in DICOM format as input. DeepTek CXR Analyzer identifies suspicious ROIs in the following categories: Lungs, Pleura, Cardiac, and Hardware, and sends the secondary capture DICOM with AI output to the same PACS over the DICOM protocol. The output DICOM File Processing component creates a DICOM image containing the original radiograph with a message stating that the image was analyzed by DeepTek CXR Analyzer (with information containing manufacturer name, product name, product version, and a link to user manual) and color-coded bounding boxes containing suspected ROIs. If no suspicious ROIs are detected in the image, the output will not contain any bounding boxes and will have a message stating "No Suspicious ROI(s) Detected". In the event of any type of failure in the workflow, a human-readable error message representing the type of failure will be logged in the Logs interface.
DeepTek CXR Analyzer does not make treatment recommendations or provide a diagnosis. Radiologists should review images annotated by DeepTek CXR Analyzer concurrently with original, unannotated images before making the final decision on a case. DeepTek CXR Analyzer is an adjunct tool and does not replace the role of the radiologists. The CAD-generated output should not be used as the primary interpretation by radiologists.
DeepTek CXR Analyzer has been trained using a large and diverse dataset of more than 100,000 chest X-ray images sourced from 30 distinct sites from India, including medical imaging centers, data partners, and medical hospitals, and over 15 different modality manufacturers. The inclusion of such a diverse range of data ensures that the performance of the DeepTek CXR Analyzer generalizes to a wide variety of confounders.
DeepTek CXR Analyzer is not designed to detect conditions other than those classified under the following categories: Lung, Cardiac, Pleura, and Hardware. Radiologists should review original images for all suspected ROIs.
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Image /page/5/Picture/0 description: The image shows the logo for DeepTek. The logo has the word "DEEPTEK" in blue and orange letters. The letters "DEEP" are in blue, and the letters "TEK" are in orange. To the right of the word, there are four semi-transparent blue circles that are stacked on top of each other.
.. Indications For Use
The DeepTek CXR Analyzer V1.0 is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies using techniques to identify, categorize, and highlight suspicious ROIs in one of the following categories: Lungs, Pleura, Cardiac, and Hardware. The device is intended for use as a concurrent reading aid for radiologists. DeepTek CXR Analyzer V1.0 is indicated for adults and transitional adolescents (18 to 0
where wAFROC-FOMation-mean wAFROC-FOM for aided reads, and wAFROC FOM maided is the population-mean for unaided reads.
The test dataset consisted of 300 frontal chest radiographs obtained from 13 U.S. hospitals. 24 U.S. board-certified radiologists with varying levels of experience were enrolled in this study. The clinical performance assessment consisted of two independent reading sessions separated by a washout period of 30 days in order to mitigate memory bias. During the first reading session, the readers evaluated each scan in the test dataset while not being aided by the device (unaided reading). During the second reading session, the readers evaluated each scan again, but this time they were aided by the device (aided reading). The evaluation workflow for the unaided and aided readings was identical except that, during the aided reading, a secondary image containing device output markers was shown to the readers in addition to the original image.
DeepTek Medical Imaging Pvt Ltd, 510(k) Submission
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Image /page/10/Picture/0 description: The image shows the word "DEEPTEK" in blue and orange letters. The letters "DEEP" are in blue, while the letters "TEK" are in orange. To the right of the word is a series of four semi-transparent blue circles that are arranged in a row, with each circle being slightly smaller than the one before it. The circles appear to be overlapping each other.
The area under the weighted alternative free-response receiver operating characteristic curve as the figure of merit (wAFROC-FOM) was used for comparing the performance of the readers during the unaided reading sessions with their performance during the aided reading sessions.The wAFROC-FOM for aided readings was 0.893 [0.871-0.914], which was significantly higher (p