(123 days)
Yes
The device description explicitly states that the software will utilize an "AI-based algorithm" for segmentation.
No
The software is used to create 3D models from medical images for design and segmentation purposes, not to provide therapy or treatment to a patient.
No
Explanation: The device is intended for digital image segmentation and 3D model creation of the spine, primarily lumbar anatomy, for trained design personnel. It processes DICOM images to output a 3D model. While it uses an AI-based algorithm and mentions performance metrics like accuracy, sensitivity, and specificity in the context of segmentation performance, its stated purpose is to "perform digital image segmentation" and "render a 3D model," not to diagnose a disease or condition. It is a tool for image processing and modeling, not a diagnostic decision-making tool for clinicians.
Yes
The device description explicitly states "The device is a software medical device". The inputs are DICOM images and the output is a 3D model, both of which are digital formats. There is no mention of any accompanying hardware components that are part of the regulated device itself.
Based on the provided information, the aprevo® Digital Segmentation software 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 (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- aprevo® Digital Segmentation's Function: This software processes medical images (DICOM files) of the spine. It performs segmentation and creates a 3D model. This process is based on analyzing images of the body, not on analyzing specimens taken from the body.
- Intended Use: The intended use clearly states it's for performing digital image segmentation of the spine. This is an image processing and modeling function, not a diagnostic test performed on biological samples.
While the software is a medical device and uses AI for image processing, its function falls under the category of medical image analysis and modeling, not in vitro diagnostics.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
aprevo® Digital Segmentation software is intended to be used by trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy. The device inputs DICOM images and outputs a 3-D model of the spine.
Product codes
QIH
Device Description
The device is a software medical device that will use DICOM images as input and provide 3D model of the spine structure. Pre-processing will be performed on the uploaded DICOM files to filter soft tissue and identifying spine. Upon removal of soft tissue and identification of spine structure, the software will utilize an AI-based algorithm to segment the structure and render a 3D model as an output.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
DICOM
Anatomical Site
spine, primarily lumbar anatomy.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained, medically knowledgeable design personnel
Description of the training set, sample size, data source, and annotation protocol
Independent training and validation datasets were selected to ensure model performance would reflect real clinical performance.
Description of the test set, sample size, data source, and annotation protocol
Validation datasets represented diversity in populations and equipment.
Summary of Performance Studies
The software performance was evaluated using an IOU (intersection over union) score for segmentation which exceeded the acceptance criteria of 80%. It was also evaluated for accuracy of vertebral body labeling which exceeded the acceptance criteria of 90% overall, with sensitivity and specificity exceeding 80% each. Additionally, the performance was evaluated across key cohorts.
Key Metrics
IOU (intersection over union) score for segmentation >= 80%.
Accuracy of vertebral body labeling >= 90% overall, with sensitivity and specificity >= 80% each.
Predicate Device(s)
K183105, Mimics Medical
Reference Device(s)
K202034 aprevo™ Intervertebral Body Fusion Device, K201232 Limbus Contour
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 & 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.
Carlsmed, Inc. Karen Liu VP Quality and Regulatory 1800 Aston Ave. Suite 100 SAN DIEGO, CALIFORNIA 92008
Re: K231955
November 3, 2023
Trade/Device Name: aprevo® Digital Segmentation Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: September 28, 2023 Received: October 5, 2023
Dear Karen Liu:
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/cdrb/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).
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
ements, the Quality System (QS) regulation (21 CFR Part
Page 2
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 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).
Sincerelv.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Submission Number (if known)
Device Name
aprevo® Digital Segmentation
Indications for Use (Describe)
aprevo® Digital Segmentation software is intended to be used by trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy. The device inputs DICOM images and outputs a 3-D model of the spine.
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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K231955 510(K) SUMMARY
| Submitter's Name: | Carlsmed, Inc. |
|---|---|
| Submitter's Address: | 1800 Aston Ave, Ste 100 |
| Carlsbad, CA 92008 | |
| Submitter's Telephone: | 760-766-1926 |
| Contact Person: | Karen Liu, VP Quality and Regulatory |
| Carlsmed, Inc. | |
| 1800 Aston Avenue Suite 100 | |
| Carlsbad, CA 92008 | |
| 760-766-1926 | |
| regulatory@carlsmed.com | |
| Date Summary was Prepared: | October 31, 2023 |
| Trade or Proprietary Name: | aprevo® Digital Segmentation |
| Predicate Clearance Numbers | |
| and Name | K183105, Mimics Medical |
| Reference Device Number | |
| and Name | K202034 aprevo™ Intervertebral Body Fusion Device |
| K201232 Limbus Contour | |
| Common or Usual Name: | Medical Image Management and Processing System |
| Classification: | Class II per 21 CFR §892.2050 |
| Product Code: | QIH |
| Classification Panel: | Radiology |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The device is a software medical device that will use DICOM images as input and provide 3D model of the spine structure. Pre-processing will be performed on the uploaded DICOM files to filter soft tissue and identifying spine. Upon removal of soft tissue and identification of spine structure, the software will utilize an AI-based algorithm to segment the structure and render a 3D model as an output.
INDICATIONS FOR USE
aprevo® Digital Segmentation software is intended to be used by trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy. The device inputs DICOM images and outputs a 3-D model of the spine.
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TECHNOLOGICAL CHARACTERISTICS
The aprevo® Digital Segmentation will allow the user to import, visualize and segment medical images, check and correct the segmentations, and create digital 3D models. The software functionality is equivalent to the predicate device (Mimics Medical, K183105) from intended use and technological characteristics, and does not raise any new question of safety and effectiveness.
SUBSTANTIAL EQUIVALENCE
The subject device, aprevo® Digital Segmentation is software intended to segment spine bony structure in an automated manner. The device has similar intended use and technological characteristics to its predicate device Mimics Medical. The table below includes detail on comparison between the subject device to its predicate device, Mimics Medical (K183105)
| Characteristic | Subject Device | Predicate Device | Differences |
|---|---|---|---|
| Name | aprevo® Digital | ||
| Segmentation | Mimics Medical | ||
| Clearance | |||
| Number | K231955 | K183105 | |
| Regulation | |||
| Number | 892.2050 | 892.2050 | Identical |
| Product Code | QIH | LLZ | Similar: both are Image |
| Processing Systems | |||
| Indications For | |||
| Use | aprevo® Digital | ||
| Segmentation software | |||
| is intended to be used | |||
| by trained, medically | |||
| knowledgeable design | |||
| personnel to perform | |||
| digital image | |||
| segmentation of the | |||
| spine, primarily | |||
| lumbar anatomy. The | |||
| device inputs DICOM | |||
| images and outputs a | |||
| 3-D model of the | |||
| spine. | Mimics Medical is | ||
| intended for use as a | |||
| software interface and | |||
| image segmentation system | |||
| for the transfer of medical | |||
| imaging information to an | |||
| output file. Mimics | |||
| Medical is also intended for | |||
| measuring and treatment | |||
| planning. | |||
| The Mimics Medical | |||
| output can be used for the | |||
| fabrication of physical | |||
| replicas of the output file | |||
| using traditional or additive | |||
| manufacturing methods. | |||
| The physical replica can be | |||
| used for diagnostic | |||
| purposes in the field of | |||
| orthopaedic, maxillofacial | |||
| and cardiovascular | |||
| applications. | |||
| Mimics Medical should be | |||
| used in conjunction with | |||
| expert clinical judgment. | Similar. The subject device | ||
| has a narrower indication for | |||
| use compared to the | |||
| predicate device. |
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| Characteristic | Subject Device | Predicate Device | Differences | |||
|---|---|---|---|---|---|---|
| Technical Characteristics | ||||||
| Compatible | ||||||
| Input File | ||||||
| Types | DICOM | DICOM and standard | ||||
| imaging formats (such as | ||||||
| RAW, TIFF, BMP and | ||||||
| jpeg format) | Similar. The subject device | |||||
| has narrower input file types. | ||||||
| Segmentation | ||||||
| Functionality | Automatic Spinal | |||||
| Algorithm | Manual tools, Semi- | |||||
| automatic tools, and | ||||||
| automatic algorithms | Similar. Both devices | |||||
| include automated spine | ||||||
| segmentation tool. | ||||||
| User | ||||||
| Interaction | User cannot review | |||||
| and edit segmentation | ||||||
| and 3D models | Contains tools to review | |||||
| and edit segmentation and | ||||||
| 3D models | Similar: The output of both | |||||
| devices can be reviewed by | ||||||
| the user. While the predicate | ||||||
| device has a viewer to | ||||||
| review and edit | ||||||
| segmentation outputs the | ||||||
| subject device output does | ||||||
| not include any viewer but | ||||||
| its outputs can be reviewed | ||||||
| as part of the entire | ||||||
| workflow utilizing 3rd party | ||||||
| software. | ||||||
| 3D Model | ||||||
| Generation | The subject device | |||||
| generates a 3D model | The predicate device | |||||
| generates a 3D model | Identical | |||||
| Export Outputs | The subject device | |||||
| generates an output | ||||||
| file. | The predicate device | |||||
| generates an output file. | Identical | |||||
| Intended User | ||||||
| Population | Trained Personnel, | |||||
| Knowledgeable in | ||||||
| Medicine | Trained personnel, | |||||
| knowledgeable in medicine | Identical |
NON-CLINICAL TESTING
The aprevo® Digital Segmentation has been evaluated in accordance with internal software specifications and applicable performance standards through the software development and verification and validation procedures to ensure performance according to specifications, user requirements, and the FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Independent training and validation datasets were selected to ensure model performance would reflect real clinical performance. Validation datasets represented diversity in populations and equipment.
The software performance was evaluated using an IOU (intersection over union) score for segmentation which exceeded the acceptance criteria of 80%. It was also evaluated for accuracy of vertebral body labeling which exceeded the acceptance criteria of 90% overall, with sensitivity and specificity exceeding 80% each. Additionally, the performance was evaluated across key cohorts.
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CLINICAL TESTING
Not applicable.
CONCLUSION
The overall indications for use and technology characteristics of the aprevo® Digital Segmentation are similar to the primary predicate device. This leads to the conclusion that the proposed aprevo® Digital Segmentation is substantially equivalent to its primary predicate from the safety and effectiveness perspective.