(161 days)
K060950, 3MATIC by MATERIALISE
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No
The summary describes software for visualizing and measuring 3D spine models based on user input, with no mention of AI or ML algorithms for analysis, planning, or prediction.
No.
The explanation clearly states that the software visualizes surgical plans and measures 3D spine models for surgical planning purposes. It does not directly treat or diagnose a disease or condition. The output is used by healthcare professionals for placement of surgical implants, but the software itself isn't a therapeutic device.
No
The device is used to visualize surgical plans and assist in the placement of surgical implants, not to diagnose medical conditions or diseases.
Yes
The device description explicitly states it is a "proprietary software tool" and describes its function solely in terms of software operations (viewing, storing, manipulating, measuring, exporting 3D models). There is no mention of accompanying hardware components that are part of the regulated device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for visualizing surgical plans for spinal alignment, manipulating 3-D models of the spine, and producing 3-D models of spinal correction and anatomical measurements. These activities are related to surgical planning and visualization, not to the examination of specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease or impairment.
- Device Description: The description reinforces that the software visualizes and provides measurements of a healthcare professional's surgical plan. It focuses on the manipulation and visualization of a 3D spine model.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory tests.
The device falls under the category of medical software used for surgical planning and visualization, which is distinct from In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
aprevo® Digital Workflow software is intended to view, store, and manipulate 3-D models to visualize surgical plans for spinal alignment. The device inputs a 3-D spine model which is used by trained, medically knowledgeable design personnel in conjunction with inputs from healthcare professionals to produce 3-D models of spinal correction and anatomical measurements. The device outputs are used by healthcare professionals for placement of surgical implants.
Product codes
LLZ
Device Description
The aprevo® Digital Workflow is a proprietary software tool that visualizes and provides measurements of a healthcare professional's surgical plan for a spinal alignment. The software is used to input the patient's spine model, then view, store and measure the 3D spine model to create a visual representation of the desired surgical plan. The software is used to export the visualization of the surgical plan along with associated measurements. The Subject Device is operated by trained, medically knowledgeable Carlsmed design personnel while the output is reviewed and approved by a healthcare professional.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
spinal alignment, spine
Indicated Patient Age Range
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Intended User / Care Setting
The device inputs a 3-D spine model which is used by trained, medically knowledgeable design personnel in conjunction with inputs from healthcare professionals to produce 3-D models of spinal correction and anatomical measurements. The device outputs are used by healthcare professionals for placement of surgical implants.
The Subject Device is operated by trained, medically knowledgeable Carlsmed design personnel while the output is reviewed and approved by a healthcare professional.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The Subject Device 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 and Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions.
In addition, the measuring function of the Subject Device was evaluated in bench testing using in-silico phantoms with known values.
Key Metrics
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Predicate Device(s)
K060950, 3MATIC by MATERIALISE
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 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.
Carlsmed, Inc. Karen Liu VP Quality and Regualtory 1800 Aston Ave., Ste 100 Carlsbad, California 92008
Re: K222195
December 30, 2022
Trade/Device Name: aprevo® Digital Workflow Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 29, 2022 Received: November 30, 2022
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 (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
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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.
Jessica Lamb
Jessica Lamb, PhD Assistant Director Imaging Software 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
Enclosure
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Indications for Use
510(k) Number (if known) K222195
Device Name aprevo® Digital Workflow
Indications for Use (Describe)
aprevo® Digital Workflow software is intended to view, store, and manipulate 3-D models to visualize surgical plans for spinal alignment. The device inputs a 3-D spine model which is used by trained, medically knowledgeable design personnel in conjunction with inputs from healthcare professionals to produce 3-D models of spinal correction and anatomical measurements. The device outputs are used by healthcare professionals for placement of surgical implants.
| 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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K222195 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: | 11/29/2022 |
| Trade or Proprietary Name: | aprevo® Digital Workflow |
| Predicate Clearance Numbers | |
| and Name | K060950, 3MATIC by MATERIALISE |
| Common or Usual Name: | System, image processing, radiological |
| Classification: | Class II per 21 CFR §892.2050 |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The aprevo® Digital Workflow is a proprietary software tool that visualizes and provides measurements of a healthcare professional's surgical plan for a spinal alignment. The software is used to input the patient's spine model, then view, store and measure the 3D spine model to create a visual representation of the desired surgical plan. The software is used to export the visualization of the surgical plan along with associated measurements. The Subject Device is operated by trained, medically knowledgeable Carlsmed design personnel while the output is reviewed and approved by a healthcare professional.
INDICATIONS FOR USE
aprevo® Digital Workflow software is intended to view, store, and manipulate 3-D models to visualize surgical plans for spinal alignment. The device inputs a 3-D spine model which is used by trained, medically knowledgeable design personnel in conjunction with inputs from healthcare professionals to produce 3-D models of spinal correction and anatomical measurements. The device outputs are used by healthcare professionals for placement of surgical implants.
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TECHNOLOGICAL CHARACTERISTICS
The aprevo® Digital Workflow will replace 510(k) cleared software in the implant design workflow to perform 3D model based surgical planning. The software functionality is equivalent to the predicate device (3Matics, K060950) based on the intended use and technological characteristics, and does not raise any new question of safety and effectiveness.
PERFORMANCE DATA
The Subject Device 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 and Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions.
In addition, the measuring function of the Subject Device was evaluated in bench testing using in-silico phantoms with known values.
CONCLUSION
The overall indications for use and technology characteristics of the aprevo® Digital workflow are similar to the primary predicate device. This leads to the conclusion that the proposed aprevo® Digital workflow is substantially equivalent to its primary predicate from the safety and effectiveness perspective.