Optimized Positioning System (OPS) Insight

K192656 · Corin USA · LLZ · May 1, 2020 · Radiology

Device Facts

• Record ID: K192656
• Device Name: Optimized Positioning System (OPS) Insight
• Applicant: Corin USA
• Product Code: LLZ · Radiology
• Decision Date: May 1, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

OPS™ Insight is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

Device Story

OPS™ Insight is interactive preoperative surgical planning software for total hip arthroplasty. Input: 2D and 3D patient-specific radiographic imaging. Operation: software uses patient anatomy and controlled implant database to enable 3D sizing/placement of implants; calculates biomechanical measurements (leg length, offset, femoral version); performs functional analysis (pelvic parameters, cup orientation during flexion/extension, prosthetic impingement detection). Output: surgical plan for component selection/placement. Used in clinical settings by orthopaedic surgeons. Surgeons interact with software to actively alter/change the pre-plan. Benefits: aids surgeons in optimizing implant positioning and sizing to improve surgical outcomes.

Clinical Evidence

No clinical data. Bench testing only. Software verification and validation testing conducted per ISO 62304 and FDA software guidance.

Technological Characteristics

Preoperative surgical planning software. Inputs: 2D/3D radiographic imaging. Outputs: 3D implant sizing/placement, biomechanical measurements, functional analysis. Closed platform. No patient contact.

Indications for Use

Indicated for orthopaedic surgeons performing preoperative surgical planning for primary total hip arthroplasty.

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

• OneFIT Medical hipEOS (K173390)
• Corin OPS™ Plan (K171847, K183038)
• Corin OPS™ FHA (K190834)

Reference Devices

• Trinity acetabular system (K093472, K103120, K110087, K111481, K122305, K130343, K170359)
• MetaFix (K082525, K121439, K130634, K131952, K15338, K162942)
• TriFit TS (K153772, K121563)
• TriFit CF (K173880)
• TaperFit (K153725, K142761)
• MiniHip (K131986, K11046, K083312)
• Paragon (K123782)
• MobiliT Cup (K191831)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an eagle emblem, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" in a larger font size and a blue square behind it.

May 1, 2020

Corin USA % Ms. Martina Cecconi Regulatory and Clinical Affairs Team Leader Corin (Australia) 17 Bridge Street Sydney, New South Wales 2073 AUSTRALIA

# Re: K192656

Trade/Device Name: Optimized Positioning System (OPS™) Insight Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, LZO, MEH, PLW, LWJ Dated: March 30, 2020 Received: March 31, 2020

#### Dear Ms. Cecconi:

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. 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 located 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality 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: 06/30/2020 See PRA Statement below.

#### 510(k) Number (if known)

K192656

Device Name

Optimized Positioning System (OPSTM) Insight

Indications for Use (Describe)

OPS™ Insight is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY

| 1. Applicant/Sponsor: | Corin USA Limited |
|-----------------------|-------------------------------------------------------------|
| Distributor | 12750 Citrus Park Lane<br>Suite 120<br>Tampa, Florida 33625 |
| | Establishment Registration No.: 1056629 |
| 2. Manufacturer: | Optimized Ortho Pty Ltd |
| | 17 Bridge Street |
| | Pymble NSW |
| | 2073 Australia |
| | Establishment Registration No: 3012916784 |
| 3. Contact Person: | Crissy Tomarelli |
| | Regulatory and Quality Director |
| | Corin Australia |
| | 1 61 2 94977400 |
| | [e-mail] |
| | Lucinda Gerber |
| | Global Regulatory Affairs Manager |
| | Corin USA Limited |

- 4. Date: 30th March 2020
- 5. Trade Name: Optimized Positioning System (OPSTM) Insight

1 [phone]

[e-mail]

- 6. Common Name: OPS™ Insight
- 7. Classification Product Code(s): LLZ

#### 8. Classification Name:

21 CFR 892.2050 – Picture archiving and communications

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## 9. Substantially Equivalent (predicate) device(s):

- OneFIT Medical hipEOS (K173390) .
- . Corin OPS™ Plan (K171847, K183038)
- Corin OPS™ FHA (K190834) .

# 10. De vice Description:

OPS™ Insight is an interactive software for preoperative planning of Total Hip Arthroplasty. It enables 3D sizing and placement of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on landmarks and anatomical models derived from patient-specific radiographic imaging and the templated implants. The biomechanical measurements include measurements relating to leg length, offset and femoral version, and the functional analysis includes determination of pelvic parameters, cup orientation calculation during flexion and extension, and prosthetic impingement detection.

The software uses 2D and 3D patient-specific radiographic data. The implant data required by the software is contained within a controlled database. OPS™ Insight is a closed platform. Please refer to the Instructions for Use for compatible implant systems.

## 11. Indications for Use / Intended Purpose:

OPS™ Insight is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

# 12. Summary of Technologies/Substantial Equivalence:

The device comparison showed that the subject device is substantially equivalent to the predicate OneFIT Medical hipEOS (K173390), Corin OPS™ Plan (K171847, K183038) and Corin OPS™ FHA (K190834). The subject device and predicate devices. OneFIT Medical hipEOS (K173390), Corin OPS™ Plan (K171847, K183038)and Corin OPS™ FHA (K190834) have similar indications for use, technological characteristics and principles of operation, with all utilizing imaging scans to generate an end plan. The predicate OneFIT Medical hipEOS (K173390) outputs similar biomechanical measurements including those relating to leg length,

offset and femoral version, cup orientation (cup inclination & anteversion)

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to the subject device. The predicate Corin OPS™ Plan (K171847, K183038) provide the same biomechanical measurements including those relating to leg length, offset and femoral version and the predicate and the subject device, and the Corin OPS™ FHA (K190834) performs the same functional analysis of the pelvic parameters and cup orientation calculation during flexion and extension as the subject device.

The end user for the subject and all predicate devices are trained medical professionals and the subject and predicate devices do not have contact with the patient.

The subject device differs from the predicate OneFIT Medical hipEOS (K173390) in the input imaging used and in that the subject device is used for total hip replacement while the predicate can be used for pre-operative planning for lower limb (including hip) and spine. The predicate device does not provide a functional analysis of the pelvic parameters or cup orientation calculation during flexion and extension,

The subject device differs from the predicates OPS™ Plan (K171847, K183038) and Corin OPS™ FHA (K190834) in that, for the predicate devices, the Surgeon cannot actively interact with, alter or change the surgical pre-plan.

The differences between the subject device and its predicate devices raise no new issues in terms of safety or effectiveness. Therefore, based on these similarities, Corin believes that the OPSTM Insight is substantially equivalent to the predicate devices.

#### Compatible Devices

OPS™ Insight can be used with the following implant systems:

Trinity acetabular system (K093472, K103120, K110087 (K111481, K122305, K130343, K170359) MetaFix (K082525, K121439, K130634, K131952, K15338, K162942) TriFit TS (K153772, K121563) TriFit CF (K173880) TaperFit (K153725, K142761) MiniHip, ( K131986, K11046,K083312) Paragon (K123782) MobiliT Cup (K191831)

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## 13. Non-Clinical Testing:

Non-clinical testing was performed to assess the usability and performance of OPS™ Insight software device to demonstrate that the device functions as intended. Software verification and validation testing was conducted according ISO 62304 and documentation provided as recommended by FDA's Guidance for the Industry: 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'

## 14. Clinical Testing:

Clinical testing was not necessary for this Traditional 510(k).

#### Conclusion: 15.

The subject device has similar intended uses, technological characteristics, and principles of operation as its predicate devices. The differences between the subject device and its predicates raise no new issues in terms of safety or effectiveness.