(82 days)
Not Found
No
The summary describes software for surgical planning based on measurements and geometric parameters, without mentioning AI, ML, or related concepts.
Yes
The device is a surgical planning software that assists healthcare professionals in planning lumbar spinal fusion surgeries, which is a therapeutic intervention.
No
The device is described as "surgical planning software" that "assists healthcare professionals in planning lumbar spinal fusion surgeries." It "allows service providers to plan surgical procedures," including assessing anatomical components for implant placement and estimating post-operative alignment. This functionality positions it as a tool for pre-surgical planning rather than for diagnosing a disease or condition.
Yes
The device description explicitly states "The Ortho Kinematics OKI Surgical Planning Software is a software only accessory".
No, 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 for diagnosis, monitoring, or screening.
- Device Function: The OKI Surgical Planning Software works with medical images (DICOM compliant images from a PACS) to assist in planning surgical procedures. It analyzes anatomical structures and helps with implant placement planning.
- Lack of Specimen Analysis: The software does not analyze any biological specimens taken from the patient. Its input is image data, not biological samples.
Therefore, based on the provided information, the OKI Surgical Planning Software falls under the category of medical devices used for surgical planning and image analysis, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OKI 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 OKI Surgical Planning Software is a software only accessory to a picture archiving and communications system. It is designed to be used 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, spinal
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): 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.
Nemaris, Inc.'s Surgimap 2.0 (K141669)
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and three human profiles. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2017
Ortho Kinematics, Inc. % John Smith, M.D., J.D. Regulatory Counsel Hogan Lovells US LLP 555 13th Street. NW WASHINGTON DC 20004
Re: K171617
Trade/Device Name: OKI Surgical Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 11, 2017 Received: August 11, 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K171617
Device Name
OKI Surgical Planning Software
Indications for Use (Describe)
The OKI 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)
� Prescription Use (Part 21 CFR 801 Subpart D)
[ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY (K171617)
Ortho Kinematics, Inc.'s OKI Surgical Planning Software
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: August 11, 2017
Name of Device: OKI Surgical Planning Software
Classification Name: Picture archiving and communications system (21 C.F.R. 892.2050)
Regulatory Class: Class II
Product Code: LLZ
Predicate Device: Nemaris, Inc.'s Surgimap 2.0 (K141669)
Device Description
The Ortho Kinematics OKI Surgical Planning Software is a software only accessory to a picture archiving and communications system. It is designed to be used 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 OKI 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:
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| Feature | OKI Surgical Panning
Software | Surgimap 2.0 |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------|
| 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 | Local + PACS connectivity |
| Runs on Server | Optional | Yes |
| Generic measurements | Yes | Yes |
| Spine measurements | Yes | Yes |
| Pre-operative planning | Yes | Yes |
| Custom implants | No | Yes |
| Database of implants | Yes | Yes |
| Case sharing | No | Yes |
| 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 OKI Surgical Planning Software is as safe and effective as the predicate device. The subject device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended therapeutic use of the device and do not affect its safety and effectiveness when used as labeled. In addition, 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.