K Number
K231498
Device Name
TraumaCad Neo
Manufacturer
Date Cleared
2023-11-20

(180 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones.
Device Description
TraumaCad Neo allows surgeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitates the film-less orthopedic practice. TraumaCad Neo allows post-operative review of images obtained after the surgical procedure. The program features an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad Neo supports DICOM and is integrated to communicate with Quentry®, a proprietary web-based cloud service from Brainlab. It is through Quentry®, where the medical staff can upload images to plan their expected results prior to the procedure to create a smooth surgical workflow from start to finish.
More Information

Not Found

No
The document describes a software for orthopedic planning and image analysis using measurements and templates, with no mention of AI or ML capabilities.

No
The device is described as software that assists healthcare professionals in analyzing orthopedic conditions and planning procedures by overlaying visual information on radiological images. It is not intended for primary radiological image interpretation or appraisal, and it does not directly treat or diagnose a disease or condition. Its function is to aid in planning and evaluation, rather than providing therapy.

No

Explanation: The device is described as assisting healthcare professionals in analyzing orthopedic conditions and planning procedures by overlaying visual information on radiological images. It is explicitly stated that it is "not intended for primary radiological image interpretation or radiological appraisal," which indicates it is not performing a diagnostic function itself. Its purpose is for pre-operative planning and evaluation, not the initial identification or diagnosis of a disease.

Yes

The device description explicitly states it is a "software application" and focuses on image analysis, planning, and measurement functionalities performed on digital images. There is no mention of accompanying hardware components that are part of the regulated 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 devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
  • TraumaCad Neo's Function: TraumaCad Neo is a software application that assists healthcare professionals in analyzing radiological images and planning orthopedic procedures. It works with images of the body, not with specimens taken from the body.
  • Intended Use: The intended use clearly states it's for analyzing orthopedic conditions and planning procedures by overlaying information on radiological images. It does not mention analyzing biological samples.

Therefore, TraumaCad Neo falls under the category of medical imaging software or surgical planning software, not In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones.

Product codes

LLZ

Device Description

TraumaCad Neo allows surgeons to evaluate digital images while performing various pre-operative surgical planning and evaluation of images. This software application enables surgeons to plan operations on screen, execute measurements, and facilitates the film-less orthopedic practice. TraumaCad Neo allows post-operative review of images obtained after the surgical procedure. The program features an extensive regularly updated library of digital templates from leading manufacturers. TraumaCad Neo supports DICOM and is integrated to communicate with Quentry®, a proprietary web-based cloud service from Brainlab. It is through Quentry®, where the medical staff can upload images to plan their expected results prior to the procedure to create a smooth surgical workflow from start to finish.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Can receive digital images from Quentry®

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals

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 Performance Evaluation of TraumaCad Neo was based upon well-established test methods which demonstrated conformity to the intended use. These test methods were the same which were used to demonstrate the substantial equivalence of the predicate device TraumaCad Mobile 2.0. The performance tests have been completed and successfully confirm the performance of the device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K160001

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).

0

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.

Brainlab Ltd. % Yael Guttentag QM & RA Senior Manager 35 Efal Street Petach-Tikva, 4951132 Israel

Re: K231498

November 20, 2023

Trade/Device Name: TraumaCad Neo Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 18, 2023 Received: October 18, 2023

Dear Yael Guttentag:

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).

1

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).

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

2

Indications for Use

510(k) Number (if known) K231498

Device Name TraumaCad Neo

Indications for Use (Describe)

TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates. Clinical judgment and experience are required to properly use the software is not intended for primary radiological image interpretation or radiological appraisal. Device is not intended for use on mobile phones.

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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Æ BRAINLAB 510(k) Summary

K231498

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

| 1. (a) | Submitter
Address: | Brainlab Ltd
35 Efal Street
Petach-Tikva, Israel 4951132 |
|--------|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. (b) | Manufacturer
Address: | Brainlab Ltd
35 Efal Street
Petach-Tikva, Israel 4951132 |
| | Mfg. Phone: | Tel.: +972-3-929-0929 |
| | Contact Person: | Mrs. Yael Guttentag |
| | Date: | May 22, 2023 |
| 2. | Device &
Classification
Name: | Radiological Image Processing System -
classified as Class 2 LLZ, Regulation Number 21 CFR 892.2050
TraumaCad Neo |
| 3. | Predicate Device: | TraumaCad Mobile 2.0 (K160001) |
| 4. | Description: | TraumaCad Neo allows surgeons to evaluate digital images while
performing various pre-operative surgical planning and evaluation of
images. This software application enables surgeons to plan operations on
screen, execute measurements, and facilitates the film-less orthopedic
practice. TraumaCad Neo allows post-operative review of images
obtained after the surgical procedure. The program features an extensive
regularly updated library of digital templates from leading manufacturers.
TraumaCad Neo supports DICOM and is integrated to communicate with
Quentry®, a proprietary web-based cloud service from Brainlab. It is through
Quentry®, where the medical staff can upload images to plan their expected
results prior to the procedure to create a smooth surgical workflow from start
to finish. |
| 5. | Indications for
Use: | TraumaCad Neo is indicated for assisting healthcare professionals to
analyze orthopedic conditions and to plan orthopedic procedures by
overlaying on relevant radiological images visual information such as
measurements and prosthesis templates. Clinical judgment and experience
are required to properly use the software. The software is not intended for
primary radiological image interpretation or radiological appraisal. Device is
not intended for use on mobile phones. |

4

    1. Comparison of With respect to technology and intended use, TraumaCad Neo is Technological substantially equivalent to its predicate device. Based upon the outcomes Characteristics: from the Risk Analysis and Performance Testing Evaluation, Brainlab Ltd believes that the modification of TraumaCad Mobile 2.0 (predicate device) which allows it to become TraumaCad Neo does not raise additional safety or efficacy concerns. The following comparison table depicts the changes.
Submitted DevicePredicate Device
Features/ CharacteristicsTraumaCad NeoTraumaCad Mobile
Release 2.0
Product CodeLLZLLZ
Indication for UseTraumaCad Neo is indicated
for assisting healthcare
professionals to analyze
orthopedic conditions and to
plan orthopedic procedures
by overlaying on relevant
radiological images visual
information such as
measurements and
prosthesis templates. Clinical
judgment and experience
are required to properly use
the software. The software is
not intended for primary
radiological image
interpretation or radiological
appraisal. Device is not
intended for use on mobile
phones.The TraumaCad Mobile
Release 2.0 program is
indicated for assisting
healthcare professionals in
preoperative planning of
orthopedic surgery. The
device allows for
overlaying of prosthesis
templates on radiological
images, and includes tools
for performing
measurements on the
image and for positioning
the template. Clinical
judgment and experience
are required to properly
use the software. The
software is not for primary
image interpretation. The
software is not for use on
mobile phones.
Operating SystemMicrosoft Windows 10 and
above
iOS 16.x and above
MAC OS 11 and above
Android 11 and aboveMS Windows 7,
8 or 10
iOS 7.x, 8.x or
9.x MAC OS X
Devices SupportedPC
MAC
iPads
Android tabletsPC/MAC
iPad 3, 4 and 5 (Air)
Browsers SupportedMicrosoft Edge
Firefox
Chrome
Safari (MAC/iOS)Minimum
requirements:
iOS based
browsers:
  • Safari 7
  • Chrome 30
    Mac based
    browsers:
  • Firefox 26
  • Safari 5
    Windows based
    browsers:
  • Chrome 30
  • Firefox 26
  • Safari 5
  • IE 11 |
    | Image Input | Can receive digital images
    from Quentry® | Can receive digital images
    from various sources |
    | Means of Collecting Data | Obtained from pre-obtained
    digital images via Quentry® | Obtained from pre-
    obtained digital images via
    PACS or via Quentry® |
    | Number of Images that can
    simultaneously viewed on
    the screen | Up to 3 | Up to 2 |
    | Runs on Server | yes | yes |
    | Hip Module | yes | yes |
    | Knee Module | yes | yes |
    | Foot and Ankle Module | yes | yes |
    | Upper Limb Module | yes | yes |
    | Digital Prosthetic
    Templates | yes | yes |
    | Interactive template
    positioning | yes | yes |
    | Automatic Scaling | yes | yes |
    | Template support from
    manufacturers | yes | yes |
    | Permits Template
    Rotation | yes | yes |
    | Pre-Operative Planning | yes | yes |
    | Post Operative Review | yes | no |
    | Patient Contacting | no | no |
    | Control of Life Sustaining
    Devices | no | no |
    | Healthcare professional
    intervention for
    interpretation of images | yes | yes |
    | 510(k) # | Pending | K160001 |

5

510k Notification: TraumaCad Neo

6

  • The Performance Evaluation of TraumaCad Neo was based upon well-7. Performance Evaluation: established test methods which demonstrated conformity to the intended use. These test methods were the same which were used to demonstrate the substantial equivalence of the predicate device TraumaCad Mobile 2.0.
    1. Conclusion: The intended use and the fundamental technological characteristics of TraumaCad Neo are the same as those in the TraumaCad Mobile 2.0, which is the predicate device. Any additions or differences do not affect the safety and effectiveness of the device. The performance tests have been completed and successfully confirm the performance of the device. Based upon this data, Brainlab Ltd believes that TraumaCad Neo is substantially equivalent to the predicate device.