IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of cranio-maxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.

Device Description

The IPS CaseDesigner software is a tool for the virtual planning of orthognathic surgery. The user is a (oral and maxillofacial) surgeon who needs to plan an orthognathic surgery, and will use the software to plan the osteotomy (bone cutting). This allows the surgeon to re-position the digitally cut pieces in the desired alignment and allows the visualization of how the patient aspect will look like, through soft tissue simulation. The software supports various types of osteotomy procedures (Le Fort I, Sagittal Split, Ramus and Chin).The selection of the appropriate osteotomy procedure for each patient case is at the discretion of the clinician.

The IPS CaseDesigner is a 3D image-based environment that allows the clinician to visualize a patient's anatomy. The creation of the 3D augmented patient model is derived from CBCT (Cone-Beam CT) data (DICOM). This allows the clinician virtually plan and simulate a craniomaxillofacial surgery. The IPS CaseDesigner software has the capability to save a surgical splint file that the clinician can send to the manufacturing facility for surgical splint creation based on the CBCT Data. The software does not have any functionality for designing.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "IPS CaseDesigner" device (K161634). However, it does not contain detailed information about specific acceptance criteria and the results of a study proving the device meets those criteria.

The document states:

"Performance Data VII. The following performance data were provided or relied upon in support of the substantial equivalence determination."
"Software Validation: Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"."

This indicates that performance data and software validation were submitted to the FDA, but the details of these tests, including specific acceptance criteria, sample sizes, ground truth establishment, or clinical study results (like MRMC studies or standalone performance), are not present in the provided excerpt.

Therefore, I cannot provide a table of acceptance criteria and reported performance, nor can I answer questions about sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details. That information would typically be found in the detailed performance data or a separate study report, which is not included in this FDA 510(k) summary.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 10, 2016

Nobel Biocare Ab % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K161634

Trade/Device Name: IPS CaseDesigner Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: October 19, 2016 Received: October 20, 2016

Dear Charlemagne Chua:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 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 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,

Robert Oals

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

510(k) Number (if known)	K161634
Device Name	IPS CaseDesigner
Indications for Use (Describe)	IPS CaseDesigner is indicated for use as a software and image segmentation system for the transfer of imaging information from a scanner such as a CT scanner. It is also indicated to support the diagnostic and treatment planning process of cranio-maxillofacial procedures. IPS CaseDesigner facilitates the service offering of individualized surgical aids.
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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)	Page 1 of 1
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1. 510(k) Summary

I. Submitter

Submitted by: Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x7830 Fax: (714) 998-9348

Submitted for: Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Date Prepared : October 19, 2016

II. Device

Name of Device: IPS CaseDesigner Common or Usual Name: Picture Archiving and Communications System Classification Name: System, Image Processing, Radiological (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary Predicate

Maxilim, Medicim NV, K052424 ●
Additional Predicates
Surgicase Orthognathic Software Wizard, Materialise N.V., K111641 ●

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IV. Device Description

V. Indications for Use

Discussion

The Indications for Use statement between the subject and predicate devices are equivalent; minor differences in wording do not alter the intended therapeutic use of the subject device nor do they affect the safety and effectiveness of the subject device relative to the predicate. Both the subject and predicate devices are software devices intended for the transfer of medical images and to support diagnostics and treatment planning of cranio-maxillofacial procedures.

VI. Comparison of Technological Characteristics

The subject and predicate devices are software based surgical planning tools which allow for transfer of medical images, and creation of 3D models.

A comparison of the subject and predicate devices is provided in the table below.

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	SUBJECT DEVICE	PRIMARY PREDICATE	ADDITIONALPREDICATE
	IPS CaseDesigner	Maxilim(K052424)	SurgiCase, SurgiCase CMF,ProPlan CMF(K111641)
Indicationsfor UseStatement	IPS CaseDesigner isindicated for use as asoftware and imagesegmentation system for thetransfer of imaginginformation from a scannersuch as a CT scanner. It isalso indicated to support thediagnostic and treatmentplanning process of cranio-maxillofacial procedures.IPS CaseDesigner facilitatesthe service offering ofindividualized surgical aids.	Maxilim is indicated for useas a software interface andimage segmentation systemfor the transfer of imaginginformation from a medicalscanner such as a CTscanner. It is also indicatedfor use as a planning andsimulation software forsurgical treatment,specifically maxillofacialprocedures.	SurgiCase contains softwaremodule for pre-operativesimulation of orthognathicsurgical treatment options,based on imaginginformation from a medicalscanner such as a CT scanneror a Magnetic ResonanceImaging (MRI) scanner.
Intended use	IPS CaseDesigner is asoftware for the transfer andvisualization of imaginginformation from equipmentsuch as a CT scanner tosupport the diagnostic andtreatment planning processin cranio-maxillofacialregions. IPS CaseDesignerfacilitates the serviceoffering of individualisedsurgical aids.	Maxilim is indicated for useas a software interface andimage segmentation systemfor the transfer of imaginginformation from a medicalscanner such as a CTscanner. It is also indicatedfor use as a planning andsimulation software forsurgical treatment,specifically maxillofacialprocedures.	Information not available
Clinical Use	Cranio-maxillofacial andorthognathic treatment	Maxillofacial treatment	Cranio-maxillofacial andOrthognathic treatment
Image Import	DICOM data format fromCT/ CBCT scanner3D models in generic openfile format (STL)	DICOM data format fromCT/ CBCT scanner	CT/CBCT or MRI scan data
SoftwareFunctions	2D and 3D VisualizationMeasuring tool,Distance and angle	2D and 3D VisualizationMeasuring tool,Distance and angle	2D and 3D VisualizationMeasuring tool
	SUBJECT DEVICE	PRIMARY PREDICATE	ADDITIONALPREDICATE
	IPS CaseDesigner	Maxilim(K052424)	SurgiCase, SurgiCase CMF,ProPlan CMF(K111641)
	Bone fragments can bemoved in the 3D space(translations and rotations) inorder to plan the ideal post-operative position of eachfragment.	Bone fragments can bemoved in the 3D space(translations and rotations) inorder to plan the desiredpost-operative position ofeach fragment.	Information not available
	3D Surgical Model creation	3D Surgical Model creation	3D objects from medicalimage data
	Soft tissue simulation	Soft tissue simulation and3D photo mapping	Soft tissue simulation and3D photo mapping
	Based on the createdorthognathic plan the usercan export surgical splintorder files. These files canbe used to calculate andproduce orthognathic splintsin the production backend	No	Patient-specific surgicalsplints can be generated totransfer the planned dentalocclusion to surgery.
ComputerSystemRequirements	Windows 64bit,Mac	Windows 32 or 64 bit.	Windows 64 bit.

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Performance Data VII.

The following performance data were provided or relied upon in support of the substantial equivalence determination.

Software Validation

Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

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VIII. Conclusion

Although there are minor differences in the indications for use statements and technological features of the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the subject device is substantially equivalent to the cited predicate devices.

Regulation Number and Section

§ 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).