(33 days)
No
The summary describes standard surgical planning software based on measurements and geometric parameters, with no mention of AI/ML terms or capabilities.
No
The device is described as "Surgical Planning Software" and "assists healthcare professionals in planning lumbar spinal fusion surgeries." It assesses measurements and plans procedures. It does not directly provide therapy or interact with the patient for therapeutic effect.
No
The device is described as "Surgical Planning Software" that assists healthcare professionals in planning surgical procedures. It helps with measurements and estimating post-operative alignment, but it does not diagnose a condition or disease.
Yes
The device description explicitly states "The Ortho Kinematics Surgical Planning Software is a software only accessory". It also clarifies that it operates on data from a cleared PACS device, indicating it does not include its own hardware for image acquisition or processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this software assists healthcare professionals in planning surgical procedures based on measurements from medical images (DICOM compliant images from a PACS). It does not perform tests on biological samples.
- Intended Use: The intended use is for surgical planning, not for diagnosing or detecting conditions through analysis of biological samples.
Therefore, this device falls under the category of surgical planning software, which is distinct from In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Surgical Planning Software assists healthcare professionals in planning lumbar spinal fusion surgeries. The device allows service providers to plan surgical procedures, including tools for assessing anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.
Product codes
LLZ
Device Description
The Ortho Kinematics Surgical Planning Software is a software only accessory to a picture archiving and communications system. It is designed to assess measurements from DICOM compliant images in a cleared PACS device and plan surgical spinal procedures. It offers the ability to plan certain surgical procedures, such as lumbar spine fusion. It offers tools for viewing data, and the ability to facilitate the estimation of a potential post-operative alignment and correction, based on pre-operative measurements, as well as the geometric parameters associated with specific lumbar interbody implant devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
No image input; measurements from DICOM compliant images inputted from cleared PACS
Anatomical Site
lumbar spinal fusion surgeries
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)
Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ortho Kinematics, Inc.'s Surgical Planning Software version 1.1 (K171617)
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 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2017
Ortho Kinematics, Inc. % John Smith, M.D., J.D. Regulatory Counsel Hogan Lovells US LLP 553 13th Street, NW WASHINGTON DC 20004
Re: K173247
Trade/Device Name: Surgical Planning Software version 1.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 6, 2017 Received: October 6, 2017
Dear Dr. Smith:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Oaks
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
Surgical Planning Software version 1.1
Indications for Use (Describe)
The Surgical Planning Software assists healthcare professionals in planning lumbar spinal fusion surgeries. The device allows service providers to plan surgical procedures, including tools for assessing anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.
| Type of Use (Select one or both, as applicable) | |
|---|---|
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510(k) SUMMARY
K173247
Ortho Kinematic, Inc.'s Surgical Planning Software version 1.1
Submitter
Ortho Kinematics, Inc. 110 Wild Basin Road, Suite #250 Austin, Texas 78746 Phone: (512) 334-5490 Facsimile: (512) 334-5500 Contact Person: Adam Deitz, Chief Technology Officer
Date Prepared: November 6, 2017
Name of Device: Surgical Planning Software version 1.1
Classification Name: Picture archiving and communications system (21 C.F.R. 892.2050)
Regulatory Class: Class II
Product Code: LLZ
Predicate Device: Ortho Kinematics, Inc.'s Surgical Planning Software version 1.1 (K171617)
Device Description
The Ortho Kinematics Surgical Planning Software is a software only accessory to a picture archiving and communications system. It is designed to assess measurements from DICOM compliant images in a cleared PACS device and plan surgical spinal procedures. It offers the ability to plan certain surgical procedures, such as lumbar spine fusion. It offers tools for viewing data, and the ability to facilitate the estimation of a potential post-operative alignment and correction, based on pre-operative measurements, as well as the geometric parameters associated with specific lumbar interbody implant devices.
Intended Use / Indications for Use
The Surgical Planning Software assists healthcare professionals in planning lumbar spinal fusion surgeries. The device allows service providers to plan surgical procedures, including tools for assessing anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software
Comparison of Technological Characteristics
The following table provides a comparison of technological characteristics to the predicate device:
4
| Feature | Surgical Planning Software
version 1.1 | Surgical Planning Software
version 1.0 |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Computer | PC Compatible | PC Compatible |
| Operating System | Windows + MAC | Windows + MAC |
| Image Input | No image input; measurements
from DICOM compliant images
inputted from cleared PACS | No image input; measurements from
DICOM compliant images inputted
from cleared PACS |
| Runs on Server | Optional | Optional |
| Generic measurements | Yes | Yes |
| Spine measurements | Yes | Yes |
| Display of geometric and
measurement data | Graphical and Textual | Textual |
| Pre-operative planning | Yes | Yes |
| Custom implants | No | No |
| Database of implants | Yes | Yes |
| Case sharing | No | No |
| Access to VMA report
PDF and associated data | Yes | No |
| Output file formats | JSON and PDF file output | JSON file output |
| Human Intervention for
interpretation and
manipulation of images | Required | Required |
Performance Data
Software verification and validation testing was completed for the subject device. The software functioned as intended and all results observed were as expected.
Conclusions
The Surgical Planning Software is as safe and effective as the predicate device. The subject device has the same intended use and indications for use with similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the subject device and its predicate device raise no different questions of safety or effectiveness. Software verification and validation testing demonstrates that the device performs as intended. Thus, the Surgical Planning Software is substantially equivalent.