(112 days)
Not Found
No
The description explicitly states the software is "rules-based" and "semi-automated," and there is no mention of AI, ML, or related concepts like training or test sets for algorithms.
No.
The device is a surgical planning software that generates plans and 3D models of spinal corrections for review by a surgeon; it does not directly treat a patient.
No
The device is described as a surgical planning software that processes a 3D spine model and inputs from healthcare professionals to produce 3D models of spinal corrections and anatomical measurements, and generates a surgical plan. It primarily aids in planning surgical interventions rather than diagnosing conditions.
Yes
The device description explicitly states it is "surgical planning software" and the outputs are a "surgical plan and 3D spinal correction assets," which are digital. There is no mention of any hardware component being part of the device itself.
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 aprevo® Digital Planning software is a surgical planning tool. It processes 3D spine models derived from imaging (DICOM) and surgeon input to create surgical plans and 3D models of spinal corrections. It does not analyze biological samples from the patient.
- Intended Use: The intended use is to generate surgical plans for skeletally mature patients, not to diagnose or monitor a condition based on biological samples.
- Device Description: The description focuses on software processing of anatomical models and surgeon input, not on the analysis of biological specimens.
Therefore, the aprevo® Digital Planning software falls under the category of medical device software used for surgical planning, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The aprevo® Digital Planning software is intended to be used by trained, medically knowledgeable design personnel to generate surgical plans for skeletally mature patients. The device processes a 3D spine model in conjunction with inputs from healthcare professionals to produce 3D models of spinal corrections and anatomical measurements.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The aprevo® Digital Planning, is a rules-based, semi-automated surgical planning software that, based on surgeon input, measures the 3D spine model and results in a spinal correction plan. The outputs consist of a surgical plan and 3D spinal correction assets, which are then reviewed by the surgeon. The device is operated by trained, medically knowledgeable Carlsmed design personnel.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM
Anatomical Site
Spine
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Trained, medically knowledgeable design personnel / Internal Carlsmed personnel only
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The surgical plans generated by aprevo® Digital Planning were shown to be substantially equivalent, with 90% confidence and reliability, to plans manually created by medically knowledgeable operators. In addition, the software development, verification and validation procedures ensure that the device performs according to specifications, user requirements, and the FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
Carlsmed, Inc. Karen Liu VP Quality and Regulatory 1800 Aston Ave. Suite 100 Carlsbad, CA 92008
December 20, 2024
Re: K242599
Trade/Device Name: aprevo® Digital Planning Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 22, 2024 Received: November 25, 2024
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/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"
1
(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).
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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
2
assistance/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, Ph.D 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
3
Indications for Use
Submission Number (if known)
Device Name
aprevo® Digital Planning
Indications for Use (Describe)
The aprevo® Digital Planning software is intended to be used by trained, medically knowledgeable design personnel to generate surgical plans for skeletally mature patients. The device processes a 3D spine model in conjunction with inputs from healthcare professionals to produce 3D models of spinal corrections and anatomical measurements.
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
Applicant Contact Information
| Company Name | Carlsmed, Inc. |
|---|---|
| Company Address | 1800 Aston Ave, Ste 100 |
| Carlsbad, CA 92008 | |
| Company Telephone | 760-766-1926 |
| Contact Person | Karen Liu, VP Quality and Regulatory |
| Carlsmed, Inc. | |
| 1800 Aston Ave, Ste 100 | |
| Carlsbad, CA 92008 | |
| Phone: 760-766-1926 | |
| Email: regulatory@carlsmed.com | |
| Date Prepared | November 22, 2024 |
Device Name
| Trade or proprietary
| name | aprevo® Digital Planning |
|---|---|
| Device classification | |
| regulation | §892.2050 |
| Common name | Image processing system |
| Classification | Class II |
| Product code | LLZ |
| Classification panel | Radiology |
Predicate Device
| 510(k) number | Product code | Trade name | Manufacturer |
|---|---|---|---|
| K222195 | LLZ | aprevo® Digital | |
| Workflow | Carlsmed, Inc. |
Description of the Device
The aprevo® Digital Planning, is a rules-based, semi-automated surgical planning software that, based on surgeon input, measures the 3D spine model and results in a spinal correction plan. The outputs consist of a surgical plan and 3D spinal correction assets, which are then reviewed by the surgeon. The device is operated by trained, medically knowledgeable Carlsmed design personnel.
Indications for Use
The aprevo® Digital Planning software is intended to be used by trained, medically knowledgeable design personnel to generate surgical plans for skeletally mature patients. The device processes a 3D spine model in conjunction with inputs from healthcare professionals to produce 3D models of spinal corrections and anatomical measurements.
5
Technological Characteristics
The aprevo® Digital Planning software offers the option to semi-automatically place landmarking points and apply a series of correctional operations. The aprevo® Digital Planning software is substantially equivalent to the predicate devices through a comparison including the intended use, design, technological characteristics, and functionality.
Substantial Equivalence
The software functionality is equivalent to the predicate device (K222195) based on the intended use and technological characteristics and does not raise any new question of safety and effectiveness. The table below includes details on a comparison between the subject and predicate devices.
| Characteristic | Subject Device | Primary Predicate Device | Substantial
Equivalence? |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Name | aprevo® Digital Planning | aprevo® Digital Workflow | |
| Clearance
Number | K242599 | K222195 | |
| Regulation
Number | 892.2050 | 892.2050 | Identical |
| Device Class | II | II | Identical |
| Product Code | LLZ | LLZ | Identical |
| Intended Use
and Indications
for Use | The aprevo® Digital Planning
software is intended to be used by
trained, medically knowledgeable
design personnel to generate
surgical plans for skeletally mature
patients. The device processes a 3D
spine model in conjunction with
inputs from healthcare professionals
to produce 3D models of spinal
corrections and anatomical
measurements. | 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. | Substantially
Equivalent |
| | | Technological Characteristics | |
| Algorithms | ●
Landmark determination
algorithm
●
Surgical plan generation
algorithm | ● Landmarking and correction plan
generation is manually conducted by
operators | Substantially
Equivalent |
| Compatible Input
File Types | DICOM | DICOM | Identical |
| Process
Functionality | Semi-automatic landmark and
surgical plan generation | Manual landmark and surgical plan
generation | Substantially
Equivalent |
| User Interaction | User interaction is that the operator
provides the surgical inputs, then
initiates the landmarking and
surgical plan generation algorithms | User interaction is that the operator must
manually place landmarking points and
perform a series of operations to create a
surgical plan | Substantially
Equivalent |
| Export Outputs | Surgical plan | Surgical plan | Identical |
| Intended User
Population | Internal Carlsmed personnel only | Internal Carlsmed personnel only | Identical |
6
Non-clinical Testing
The aprevo® Digital Planning software has been evaluated in accordance with internal software specifications and applicable performance standards. The surgical plans generated by aprevo® Digital Planning were shown to be substantially equivalent, with 90% confidence and reliability, to plans manually created by medically knowledgeable operators. In addition, the software development, verification and validation procedures ensure that the device performs according to specifications, user requirements, and the FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Conclusion
Based on the intended use, indications for use, functions, technological characteristics, performance testing, and comparison to the predicate device, the subject aprevo® Digital Planning device has been shown to be substantially equivalent to the predicate.