(181 days)
Not Found
Unknown
The summary explicitly mentions "Mentions AI, DNN, or ML: Yes", but the detailed description of the device and performance studies does not provide any information about how AI/ML is used or evaluated. Without further details, it's impossible to confirm its integration.
No.
The device is described as a medical imaging system for processing, reviewing, analyzing, and communicating augmented reality images for preoperative surgical planning, not for delivering therapy.
Yes
The device is intended as a medical imaging system that allows the processing, review, analysis, and communication of augmented reality images acquired from CT scans and MRIs for preoperative surgical planning, which aligns with diagnostic purposes.
Yes
The device is described as an "Augmented Reality Application" and its description focuses entirely on software functionalities for processing, viewing, and manipulating 3D models from medical imaging data. While it utilizes a Head Mounted Display (HMD), the submission describes the application itself and its software-based features, not the HMD hardware. The performance studies mentioned are software verification and validation, and human factors testing related to the software's usability.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Sira Medical Augmented Reality Application processes and displays medical images (CT and MRI scans) for preoperative surgical planning. It does not analyze biological samples from the patient's body.
- Intended Use: The intended use is for surgical planning based on existing imaging data, not for diagnostic testing of biological specimens.
Therefore, while it is a medical device that processes medical imaging, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Sira Medical Augmented Reality Application is intended as a medical imaging system that allows the processing, review, analysis, and communication of augmented reality images acquired from the same data used to generate conventional CT scans and MRIs. Sira Medical software is designed for preoperative surgical planning and intended to be used by trained and qualified clinicians who are responsible for making patient management decisions.
Product codes
LLZ
Device Description
The Sira Medical Augmented Reality Application is used for viewing and manipulating 3D models created by the Sira 3D Image Preparation Service from customer-supplied anonymized (de-identified) imaging in Augmented Reality (AR) on a Head Mounted Display (HMD). The application allows the user to manipulate one or more 3D models in real time in an Augmented Reality (AR) environment. The user can view the model, adjust the orientation, scale, rotate and position the models within the AR visual space. Models can be sliced to create separate objects or merged together to create a single object. These models are used for preoperative surgical planning but are not used intraoperatively (during surgical procedures).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes (in relation to the predicate device)
Input Imaging Modality
conventional CT scans and MRIs (DICOM format)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended Users: Health care professionals
Intended Use Environment: Healthcare facilities such as hospitals and clinics
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
Bench / Performance Testing:
- Software verification and validation testing were conducted as required by IEC 62304. and documentation was provided as recommended by FDA Guidance "Content of Premarket Submissions for Software Contained in Medical Devices".
- Human factors testing was conducted in compliance with the requirements of IEC 62366-1 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices". Test participants representing the intended users of the device were included in the human factors validation testing. Observational data as well as interview data were recorded. The observation of participant performance and the assessment of their understanding of essential information through the interview confirmed that the design of the device is safe and effective for the intended users, uses and use environments.
Key Results: The results demonstrated that the Sira Medical, Inc. Augmented Reality Application performs according to its specifications and functions as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Sira Medical, Inc. % Richelle Helman Senior Director MEDIcept. INC, 200 Homer Avenue ASHLAND, MASSACHUSETTS 01721
February 1, 2024
Re: K232339
Trade/Device Name: Augmented Reality Application Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: August 4, 2023 Received: January 11, 2024
Dear Richelle Helman:
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 OS 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 medical devices and radiation-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,
Jessica Lamb
Jessica Lamb Assistant Director DHT8B: Division of Radiologic 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
510(k) Number (if known) K232339
Device Name Augmented Reality Application
Indications for Use (Describe)
Sira Medical Augmented Reality Application is intended as a medical imaging system that allows the processing, review, analysis, and communication of augmented reality images acquired from the same data used to generate conventional CT scans and MRIs. Sira Medical software is designed for preoperative surgical planning and intended to be used by trained and qualified clinicians who are responsible for making patient management decisions.
| 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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Image /page/3/Picture/0 description: The image shows the logo for SIRA MEDICAL. The logo consists of a blue cube on the left, followed by the text "SIRA MEDICAL" in blue and black. The "SIRA" part of the text is in blue, while the "MEDICAL" part is in black.
| Date: | 31-January-2024 |
|---|---|
| Company: | Sira Medical, Inc. |
| 14 Stanford Heights Avenue | |
| San Francisco, CA 94127 | |
| Phone: (917) 864-5083 | |
| Official Contact: | Richelle Helman |
| Senior Director, Regulatory | |
| rhelman@medicept.com | |
| Proprietary or Trade Name: | Augmented Reality Application |
| Regulation Name: | Medical Image Management and Processing System |
| Classification Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050, Class II |
| Classification Product Code: LLZ |
Device Description:
The Sira Medical Augmented Reality Application is used for viewing and manipulating 3D models created by the Sira 3D Image Preparation Service from customer-supplied anonymized (de-identified) imaging in Augmented Reality (AR) on a Head Mounted Display (HMD). The application allows the user to manipulate one or more 3D models in real time in an Augmented Reality (AR) environment. The user can view the model, adjust the orientation, scale, rotate and position the models within the AR visual space. Models can be sliced to create separate objects or merged together to create a single object. These models are used for preoperative surgical planning but are not used intraoperatively (during surgical procedures).
Indications for Use:
Sira Medical Augmented Reality Application is intended as a medical imaging system that allows the processing, review, analysis, and communication of augmented reality images acquired from the same data used to generate conventional CT scans and MRIs. Sira Medical software is designed for preoperative surgical planning and intended to be used by trained and qualified clinicians who are responsible for making patient management decisions.
Substantial Equivalence:
The Sira Medical, Inc. Augmented Reality Application is substantially equivalent to the predicate device, the Albolit Technologies, LLC, Aibolit 3D+ (510(k) K211443). The table below presents the similarities and differences between the products for substantial equivalence purposes. The differences between the subject device and the predicate device do not raise any new issues of safety and effectiveness. Performance data are available to support substantial equivalence.
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Image /page/4/Picture/0 description: The image shows the logo for SIRA MEDICAL. The logo consists of a blue cube on the left and the text "SIRA MEDICAL" on the right. The letters "SI" and "RA" are in blue, while the rest of the letters are in black.
| Characteristic | Subject Device: | Predicate Device: |
|---|---|---|
| Augmented Reality Application | Aibolit 3D+ | |
| Indications for Use | Sira Medical Augmented Reality | |
| Application is intended as a | ||
| medical imaging system that | ||
| allows the processing, review, | ||
| analysis, and communication of | ||
| augmented reality images | ||
| acquired from the | ||
| same data used to generate | ||
| conventional CT scans and MRIs. | ||
| Sira Medical software is designed | ||
| for preoperative surgical planning | ||
| and intended to be used by trained | ||
| and qualified clinicians who are | ||
| responsible for making patient | ||
| management decisions. | [510(k) K211443] | |
| Aibolit 3D+ is intended as a medical | ||
| imaging system that allows the | ||
| processing, review, analysis, | ||
| communication and media | ||
| interchange of multidimensional | ||
| digital images acquired from CT | ||
| imaging devices. It is also intended | ||
| as software for preoperative surgical | ||
| planning, training, patient | ||
| information and as software for the | ||
| intraoperative display of the | ||
| multidimensional digital images. | ||
| Aibolit 3D+ is designed for use by | ||
| health care professionals and is | ||
| intended to assist the clinician who | ||
| is responsible for making all final | ||
| patient management decisions. | ||
| Intended Use | Provides one or more capabilities | |
| relating to the review and digital | ||
| processing of medical images for | ||
| the purposes of interpretation by a | ||
| trained practitioner of disease | ||
| detection, diagnosis or patient | ||
| management. The software | ||
| components may provide | ||
| advanced or complex imaging | ||
| processing functions for image | ||
| manipulation, enhancement, or | ||
| quantification that are intended for | ||
| use in the interpretation and | ||
| analysis of medical images. | ||
| Advanced image manipulation | ||
| functions may include 3D | ||
| visualization. | Provides one or more capabilities | |
| relating to the review and digital | ||
| processing of medical images for | ||
| the purposes of interpretation by a | ||
| trained practitioner of disease | ||
| detection, diagnosis or patient | ||
| management. The software | ||
| components may provide advanced | ||
| or complex imaging processing | ||
| functions for image manipulation, | ||
| enhancement, or quantification that | ||
| are intended for use in the | ||
| interpretation and analysis of | ||
| medical images. Advanced image | ||
| manipulation functions may include | ||
| 3D visualization. | ||
| Mechanism of Action | Capture and enhancement of | |
| (DICOM) digital images via | ||
| software-based conversion to 2-D | ||
| and 3-D anatomical structure | ||
| images that can be manipulated | ||
| for viewing | Capture and enhancement of | |
| (DICOM) digital images via | ||
| software-based conversion to 2-D | ||
| and 3-D anatomical structure | ||
| images that can be manipulated for | ||
| viewing | ||
| Intended Users | Health care professionals | Health care professionals |
| Intended Use Environment | Healthcare facilities such as | |
| hospitals and clinics | Healthcare facilities such as | |
| hospitals and clinics | ||
| Format of Captured Images | DICOM | DICOM |
| Security | Data coded and HIPAA compliant | Data coded and HIPAA compliant |
| Characteristic | Subject Device: | Predicate Device: |
| Augmented Reality Application | Aibolit 3D+ | |
| [510(k) K211443] | ||
| Form of Device | Sira Medical is a software only device that permits electronic image uploads, provides image conversion and allows viewing on a head mounted device. | Aibolit 3D+ is a software only device that permits electronic image uploads, provides image conversion and allows viewing on a mobile device or standard computer monitor. |
| Image processing | High-definition digital images | High-definition digital images |
| Functions | Generation of 2D and 3D images from DICOM data Organ segmentation and structure identification Dimensional and volume references Multi-axis image rotation Organ transparency | Generation of 2D and 3D images from DICOM data Organ segmentation and structure identification Dimensional and volume references Multi-axis image rotation Organ transparency Organ retraction animation |
| Body contact | None | None |
| User Interface and System Work-Flow | Physician uploads DICOM images and specifies desired anatomical segments of interest | |
| Radiologist annotates sample (segments) images | ||
| Software facilitates annotation of available images under guidance and control by the Radiologist | ||
| Imaging technician generates multi-axis rotatable image and retraction model | ||
| Radiologist reviews images generated by imaging technician and returns output file to requesting physician | Physician uploads DICOM images and specifies desired anatomical segments of interest | |
| Radiologist annotates sample (segments) images | ||
| AI software facilitates annotation of available images under guidance and control by the Radiologist | ||
| Imaging technician generates multi-axis rotatable image and retraction model | ||
| Radiologist reviews images generated by imaging technician and returns output file to requesting physician | ||
| External / Internet Connections | Web-based software | Web-based software |
| Image Uploading | By requesting physician | By requesting physician |
| Other User Inputs | List of organ structures to be annotated and displayed, patient ID and demographics | List of organ structures to be annotated and displayed, patient ID and demographics |
| Characteristic | Subject Device: | Predicate Device: |
| Image Segmentation | By Radiologist (MD) - Manual annotation is done for all image data | Aibolit 3D+ |
| [510(k) K211443] | ||
| By Radiologist (MD) - Manual annotation is done for all CT slices with optional use of AI/ML algorithms as determined by Radiologist and with Radiologist's approval | ||
| Organ Identification | By Radiologist | By Radiologist |
| 3D Image generation | 3D image file generated by 3rd party software (Osirix MD) following Radiologist review and approval of annotation | 3D image file generated by 3rd party software (3D Slicer) following Radiologist review and approval of annotation |
| Organ structure identification | Proprietary software assigns color coding to each structure identified by Radiologist and displays color-coded image | Proprietary software assigns color coding to each structure identified by Radiologist and displays color-coded image with labeled key to color/structure identity |
| Image editing permission | Only the radiologist can alter or edit images following review - User physicians cannot edit images - Physicians have option to show or hide organs on display | Only the radiologist can alter or edit images following review - User physicians cannot edit images - Physicians have option to show or hide organs on display |
| Device Output Devices | 3D image can be displayed on augmented reality 3D headset | 3D image can be displayed on standard monitor |
| Supplemental outputs | Organ structure dimensions, volume, organ labels, patient ID, CT date and demographics | Organ structure dimensions, volume, organ labels, patient ID, CT date and demographics |
| Output image manipulation by user | Physician user can show or hide individual organ structures, zoom capability, rotational capability and transparency capability | Physician user can show or hide individual organ structures, zoom capability, rotational capability and transparency capability |
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Image /page/5/Picture/0 description: The image shows the logo for SIRA MEDICAL. The logo consists of a blue cube-like shape on the left, followed by the text "SIRA MEDICAL" in blue and black. The "SIRA" part of the text is in blue, while the "MEDICAL" part is in black.
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Image /page/6/Picture/0 description: The image shows the logo for SIRA MEDICAL. The logo consists of a blue cube on the left, followed by the text "SIRA MEDICAL" in blue and black. The "SIRA" part of the text is in blue, while the "MEDICAL" part is in black.
From the comparison form above, the subject device and predicate device have the same intended use and the same operating principle as a medical imaging system for the display of multidimensional digital images. The minor differences in the devices do not raise different questions of safety or effectiveness.
Non-clinical performance testing:
Bench / Performance Testing -
- Software verification and validation testing were conducted as required by IEC 62304 . and documentation was provided as recommended by FDA Guidance "Content of Premarket Submissions for Software Contained in Medical Devices".
- . Human factors testing was conducted in compliance with the requirements of IEC 62366-1 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices". Test participants representing the intended users of the device were included in the human factors validation testing. Observational data as well as interview
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Image /page/7/Picture/0 description: The image shows the logo for SIRA MEDICAL. The logo consists of a blue cube-like shape on the left, followed by the text "SIRA MEDICAL" in blue and black. The "SIRA" part of the text is in blue, while the "MEDICAL" part is in black.
data were recorded. The observation of participant performance and the assessment of their understanding of essential information through the interview confirmed that the design of the device is safe and effective for the intended users, uses and use environments.
The results demonstrated that the Sira Medical, Inc. Augmented Reality Application performs according to its specifications and functions as intended.
Substantial Equivalence Conclusion
The Sira Medical, Inc. Augmented Reality Application has the same intended use and the same operating principle as the predicate device. The performance testing demonstrated that the subject device can perform the same intended use as safely and effectively as the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.