Intellijoint HIP(tm) System

K151364 · Intellijoint Surgical, Inc. · OLO · Dec 28, 2015 · Neurology

Device Facts

• Record ID: K151364
• Device Name: Intellijoint HIP(tm) System
• Applicant: Intellijoint Surgical, Inc.
• Product Code: OLO · Neurology
• Decision Date: Dec 28, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Intellijoint HIP™ is a computer-controlled, optical localizer intended to provide intraoperative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors. Intellijoint HIP™ is indicated for patients undergoing orthopaedic surgery, and where the use of stereotactic surgery is considered safe and effective. The system aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning. Example orthopaedic surgical procedures include, but are not limited to: Total Hip Arthroplasty - Minimally Invasive Hip Arthroplasty

Device Story

Imageless optical navigation system for orthopaedic surgery; provides intra-operative assessment of leg length, offset, anterior-posterior change, hip center-of-rotation change, and acetabular cup angle. Inputs: infrared tracking data from optical camera and trackers attached to bone/instruments. Processing: system calculates spatial relationships between tracked anatomical structures and surgical instruments. Output: real-time measurements displayed to surgeon on workstation. Used in OR by orthopaedic surgeons. Benefits: aids accurate implant positioning and limb alignment during Total Hip Arthroplasty; improves surgical precision.

Clinical Evidence

No clinical data. Evidence consists of bench testing and simulated use validation. Tracking accuracy verified per ASTM F2554-10. Simulated use testing performed on bone phantoms by orthopaedic surgeons to validate clinical accuracy requirements against ground truth values. Electrical safety/EMC compliance per ANSI/AAMI/IEC 60601-1:2005; biocompatibility per ISO 10993-1:2009.

Technological Characteristics

Imageless optical navigation system; infrared camera, trackers, computer workstation, and bone fixation hardware. Biocompatibility per ISO 10993-1. Accuracy testing per ASTM F2554-10. Electrical safety per ANSI/AAMI/IEC 60601-1. Software-based measurement and calculation system.

Indications for Use

Indicated for patients undergoing orthopaedic surgery (e.g., Total Hip Arthroplasty, Minimally Invasive Hip Arthroplasty) where stereotactic surgery is safe and effective and a rigid anatomical reference can be identified.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Intellijoint HIP™ System (K133759)
• Navitrack™ System – Total Hip Replacement CT-Free (K041369)

Submission Summary (Full Text)

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

December 28, 2015

Intellijoint Surgical, Incorporated Mr. Brandon Gingrich Ouality and Regulatory Affairs Manager 60 Bathurst Drive, Unit 1 Waterloo. Ontario Canada N2V 2A9

Re: K151364

Trade/Device Name: Intellijoint HIP™ System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: November 16, 2015 Received: November 17, 2015

Dear Mr. Gingrich:

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 Parts 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K151364

Device Name Intellijoint HIP™ SYSTEM

#### Indications for Use (Describe)

Intellijoint HIP is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors.

Intellijoint HIP is indicated for patients undergoing orthopaedic surgery, and where the use of stereotactic surgery is considered safe and effective. The system aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning.

Example orthopaedic surgical procedures include, but are not limited to:

- Total Hip Arthroplasty

- Minimally Invasive 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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Image /page/3/Picture/2 description: The image contains the logo for "Intellijoint Surgical". The logo consists of a blue triangle shape on the left, with the word "intellijoint" in gray text to the right of the triangle. Below the word "intellijoint" is the word "surgical" in a smaller, lighter gray font.

# 510(k) Summary

# 1. Submitter Information

| Submitter: | Intellijoint Surgical Inc. |
|----------------|-----------------------------------------------------------|
| Address: | 60 Bathurst Dr., Unit 1<br>Waterloo, ON<br>Canada N2V 2A9 |
| Telephone: | (519) 342 – 3178 |
| Fax: | (226) 317 – 0471 |
| Contact: | Brandon Gingrich |
| Date Prepared: | December 28th 2015 |

# 2. Device Information

| Trade Name: | Intellijoint HIPTM System |
|----------------------|------------------------------------|
| Common Name: | Orthopaedic Stereotaxic Instrument |
| Classification: | Class II per 21 CFR 882.4560 |
| Classification Name: | Orthopaedic Stereotaxic Instrument |
| Product Code: | OLO |

#### 3. Purpose of Submission

The purpose of this submission is to gain clearance for updates to a previously cleared Computer-Assisted Orthopaedic Surgery System.

# 4. Predicate Device Information

The intellijoint HIP™ System described in this submission is substantially equivalent to the following predicates:

| Predicate Device | Manufacturer | 510(k) No. |
|-------------------------------------------------------|-----------------------------|------------|
| intellijoint HIPTM System | Intellijoint Surgical, Inc. | K133759 |
| NavitrackTM System – Total Hip Replacement<br>CT-Free | ORTHOsoft, Inc. | K041369 |

# 5. Device Description

The intellijoint HIP™ System is an imageless optical navigation system intended for use in orthopaedic surgery. The device provides intra-operative assessment of patient leg length, offset, anterior-posterior change, hip center of rotation change, and acetabular cup angle during Total Hip Arthroplasty (THA) procedures. The system is composed of an infrared Camera, Tracker, computer workstation, software, and bone fixation instruments/hardware.

This submission is an update to the intellijoint HIP™ System previously cleared in 510(k) K133759. The updates include an acetabular cup alignment feature, modifications to the method of patient registration, and other minor design and aesthetic improvements.

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Image /page/4/Picture/2 description: The image contains the logo for "IntelliJoint Surgical". The logo consists of a blue triangle on the left, with a smaller gray triangle overlapping the bottom portion of the blue triangle. To the right of the triangles is the word "IntelliJoint" in gray, with the word "surgical" in a smaller font size below it.

# 6. Intended Use

Intellijoint HIP™ is a computer-controlled, optical localizer intended to provide intraoperative measurements to a surgeon to aid in selection and positioning of orthopaedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors.

Intellijoint HIP™ is indicated for patients undergoing orthopaedic surgery, and where the use of stereotactic surgery is considered safe and effective. The system aids the surgeon in performing intra-operative measurements including measurements of limb position, joint center-of-rotation, and implant component positioning.

Example orthopaedic surgical procedures include, but are not limited to:

- Total Hip Arthroplasty -
- -Minimally Invasive Hip Arthroplasty

# 7. Comparison of Technological Characteristics

The substantial equivalence of the intellijoint HIP™ System to the predicates is shown by similarity in intended use, indications for use, materials, and performance.

# 8. Performance Data

The following tests were performed to demonstrate the substantial equivalence of the intellijoint HIP™ System to its predicate devices:

| Verification | | |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Test | Brief Summary | Result |
| Tracking System<br>Accuracy and<br>Robustness | The intellijoint HIPT™ System's accuracy was<br>verified according to the methodology in<br>ASTM F2554-10 - Standard Practice for<br>Measurement of Positional Accuracy of<br>Computer Assisted Surgical Systems. Testing<br>simulated normal conditions, and a variety of<br>worst-case use scenarios and realistic tracking<br>disturbances. | All accuracy<br>specifications<br>and robustness<br>requirements<br>were met. |
| Benchtop Accuracy | Verified clinical accuracy requirements using<br>calibrated benchtop test fixtures. | All accuracy<br>requirements<br>were met. |
| Bone Fixation<br>Performance | Verified bone fixation performance<br>requirements including functional tests,<br>robustness, rigidity of fixation and<br>repeatability. | All functional<br>and performance<br>requirements<br>were met. |
| Software Functional<br>and Unit Tests | Verified that the software application satisfies<br>functional requirements and performs as<br>intended. Algorithms and measurement<br>calculations were also verified in these tests. | Software<br>satisfied all<br>requirements and<br>specifications. |

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Image /page/5/Picture/1 description: The image contains the logo for "intelliJoint surgical". The logo consists of a geometric shape on the left, resembling a stylized joint or bone structure, rendered in shades of blue and gray. To the right of the geometric shape is the word "intelliJoint" in gray, with the word "surgical" in a smaller font size underneath.

| Electrical Safety and<br>EMC | Compliance with ANSI / AAMI / IEC 60601-<br>1:2005 for medical electrical equipment:<br>- Part 1: General requirements for basic<br>safety and essential performance<br>- Part 1-2: Collateral standard—<br>Electromagnetic compatibility –<br>requirements and tests<br>- Part 1-6: Collateral Standard: Usability | Compliance with<br>the requirements<br>of the standards<br>demonstrated. |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Biocompatibility<br>Evaluation | Evaluation against the applicable<br>requirements of ISO 10993-1:2009 –<br>Biological evaluation of medical devices<br>- Part 1: Evaluation and testing within a risk<br>management process<br>- Part 5: Tests for in vitro cytotoxicity<br>- Part 10: Tests for irritation and skin<br>sensitization<br>- Part 11: Tests for systemic toxicity | Compliance with<br>the requirements<br>of the standards<br>demonstrated. |
| Validation | | |
| Test | Brief Summary | Result |
| Anatomical<br>Phantom Simulated<br>Use and Clinical<br>Accuracy | Simulated use testing was performed on bone<br>models by orthopaedic surgeons in a<br>simulated THA procedure following a typical<br>workflow. This test validated that the<br>intellijoint HIP™ System satisfies user needs,<br>intended use and clinical accuracy<br>requirements. Accuracy was assessed by<br>comparing simulated use measurements with<br>ground truth values. | All user needs<br>and clinical<br>accuracy<br>requirements<br>were met. |

The testing demonstrated that the intellijoint HIP™ System is substantially equivalent to the legally marketed predicate devices for its intended use in facilitating the accurate positioning of orthopaedic implants where a reference to rigid anatomical structures can be identified relative to the anatomy.

# 9. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate devices, the intellijoint HIP™ System has been shown to be substantially equivalent to the legally marketed predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.