OKI Surgical Planning Software

K171617 · Ortho Kinematics, Inc. · LLZ · Aug 22, 2017 · Radiology

Device Facts

• Record ID: K171617
• Device Name: OKI Surgical Planning Software
• Applicant: Ortho Kinematics, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

Software-only accessory to PACS; processes DICOM-compliant images from cleared PACS devices. Enables assessment of anatomical components; facilitates estimation of post-operative alignment and correction based on pre-operative measurements; provides geometric parameters for specific lumbar interbody implants. Used by healthcare professionals in clinical settings to plan surgical procedures. Output consists of surgical planning data and implant placement assessments; used by surgeons to inform surgical strategy and implant selection. Benefits include improved surgical planning accuracy and procedural preparation.

Clinical Evidence

Bench testing only. Software verification and validation testing confirmed the device functions as intended with all results meeting expected performance criteria. No clinical data provided.

Technological Characteristics

Software-only PACS accessory; PC-compatible (Windows/MAC). Inputs DICOM images from cleared PACS. Features include generic and spine measurement tools, pre-operative planning, and an implant database. Does not perform image acquisition. Operates as a standalone or optional server-based application. Requires human intervention for image interpretation and manipulation.

Indications for Use

Indicated for healthcare professionals planning lumbar spinal fusion surgeries. Requires clinical judgment and experience for use.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Surgimap 2.0 (K141669)

Submission Summary (Full Text)

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Public Health Service

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Facsimile: [phone] 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<br>Software | Surgimap 2.0 |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------|
| Computer | PC Compatible | PC Compatible |
| Operating System | Windows + MAC | Windows + MAC |
| Image Input | No image input; measurements<br>from DICOM compliant images<br>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<br>interpretation and<br>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.