INTELLIJOINT HIP

K133759 · Intellijoint Surgical, Inc. · OLO · Jul 23, 2014 · Neurology

Device Facts

• Record ID: K133759
• Device Name: INTELLIJOINT HIP
• Applicant: Intellijoint Surgical, Inc.
• Product Code: OLO · Neurology
• Decision Date: Jul 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Intellijoint HIP™ is an infrared, computer-controlled localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes. Intellijoint HIP™ is indicated for patients undergoing orthopedic surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies. Example orthopedic surgical procedures include, but are not limited to: - Total Hip Arthroplasty - Minimally Invasive Hip Arthroplasty

Device Story

Intellijoint HIP is an imageless optical navigation system for orthopedic surgery; used in OR by surgeons. System inputs: infrared sensor data from pelvis-affixed sensor and femur-attached tracked reflective marker assembly (beacon). System transforms inputs via computer workstation software to calculate position/orientation of femur relative to pelvis. Outputs: real-time intra-operative measurements of leg length and offset. Surgeon uses output to guide selection and positioning of orthopedic implants; facilitates accurate joint replacement; reduces leg length/offset discrepancies; improves patient outcomes.

Clinical Evidence

No clinical data. Evidence consists of bench testing and non-clinical simulated use. Verification included tracking accuracy (ASTM F2554-10), benchtop accuracy/robustness, bone fixation performance, software functional/unit tests, electrical safety (ANSI/AAMI ES60601-1), and biocompatibility (ISO 10993). Validation included simulated use on bone models (sawbones) and cadaver lab testing by orthopedic surgeons to confirm clinical accuracy and user needs.

Technological Characteristics

Imageless optical navigation system. Components: infrared sensor, tracked reflective marker assembly (beacon), computer workstation, software, bone fixation components. Biocompatibility per ISO 10993. Electrical safety per ANSI/AAMI ES60601-1. Accuracy verified per ASTM F2554-10.

Indications for Use

Indicated for patients undergoing orthopedic surgery (e.g., Total Hip Arthroplasty, Minimally Invasive Hip Arthroplasty) where stereotactic surgery is safe and effective and a rigid anatomical reference (e.g., long bone) is identifiable. Aids in controlling leg length and offset discrepancies.

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

• DASH Hip System (K110021)
• StealthStation Imageless Hip Module (K052623)

Submission Summary (Full Text)

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## SECTION 5 - 510(k) Summary

## 510(k) Summary Intellijoint HIPTM System

## 1. Submitter Information

| Submitter:<br>Address: | Intellijoint Surgical Inc.<br>60 Bathurst Dr., Unit 1<br>Waterloo, ON<br>Canada N2V 2A9 |
|------------------------|-----------------------------------------------------------------------------------------|
| Telephone: | 519.342.3178 |
| Contact: | Brandon Gingrich |
| Date Prepared: | July 21st, 2014 |

## 2. Device Information

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

### 3. Purpose of Submission

The purpose of this submission is to gain clearance for a new Computer-Assisted Orthopedic 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. |
|-------------------------------------|--------------|------------|
| DASH Hip System | BrainLAB AG | K110021 |
| StealthStation Imageless Hip Module | Medtronic | K052623 |

## 5. Device Description

The Intellijoint HIP™ System is an imageless optical navigation system intended for orthopedic surgery. The Intellijoint HIPTM System provides intra-operative assessment of patient leg length and offset during Total Hip Arthroplasty (THA) procedures. The system is composed of an infrared sensor, a tracked reflective

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marker assembly (beacon), a computer workstation, software, and bone fixation components. The infrared sensor is affixed to the patient's pelvis and the beacon is attached to the patient's femur. The system records the position and orientation of the femur relative to the pelvis prior to hip dislocations. This baseline information can then be used to track the change in leg length and leg offset during the joint replacement procedure.

## 6. Intended Use

Intellijoint HIP™ is an infrared, computer-controlled localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes.

Intellijoint HIP™ is indicated for patients undergoing orthopedic surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies.

Example orthopedic 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.

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## 8. Performance Data

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

| Test | Brief Summary | Result |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Verification | | |
| Tracking System<br>Accuracy | The Intellijoint HIP™ System's<br>accuracy was verified using the<br>Intellijoint HIP™ software application<br>according to the methodology in<br>ASTM F2554-10 - Standard Practice<br>for Measurement of Positional<br>Accuracy of Computer Assisted<br>Surgical Systems. | All accuracy<br>specifications<br>were met. |
| Benchtop Accuracy<br>and Robustness | Verified clinical accuracy requirements<br>using calibrated benchtop test fixtures<br>while simulating normal use, a variety<br>of worse-case use scenarios and<br>realistic tracking disturbances. | All accuracy<br>and robustness<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<br>performance<br>requirements<br>were met. |
| Software Functional<br>and Unit Tests | Verified that the software application<br>satisfies functional requirements and<br>performs as intended. Algorithms and<br>measurement calculations were verified<br>in these tests. | Software<br>satisfied all<br>requirements<br>and<br>specifications. |
| Electrical Safety and<br>EMC | Compliance with ANSI/AAMI<br>ES60601-1:2005/(R)2012 for medical<br>electrical equipment:<br>Part 1: General requirements for<br>basic safety and essential<br>performance<br>Part 1-2: General requirements for<br>basic safety and essential<br>performance - collateral<br>standard-Electromagnetic<br>compatibility - requirements and<br>tests | Compliance<br>with the<br>requirements of<br>the standards<br>demonstrated. |
| Biocompatibility<br>Evaluation | Evaluation against the applicable<br>requirements of ANSI/AAMI/ISO<br>10993-1:2009 - Biological evaluation<br>of medical devices<br>- Part 1: Evaluation and testing<br>within a risk management process<br>- Part 5: Tests for in vitro<br>cytotoxicity<br>- Part 10: Tests for irritation and<br>skin sensitization<br>- Part 11: Tests for systemic toxicity | Compliance<br>with the<br>requirements of<br>the standards<br>demonstrated. |
| Validation | | |
| Sawbones Simulated<br>Use and Accuracy | Non-clinical simulated use testing was<br>performed on bone models (sawbones)<br>by orthopedic surgeons in a simulated<br>THA procedure following a typical<br>THA workflow. This test validated that<br>the Intellijoint HIPTM system satisfies<br>user needs, intended use and clinical<br>accuracy requirements. Accuracy was<br>assessed by comparing simulated use<br>measurements with ground truth<br>values. | All user needs<br>and clinical<br>accuracy<br>requirements<br>were met. |
| Cadaver Simulated<br>Use and Accuracy | Pre-clinical simulated use testing was<br>performed in a cadaver lab. This test<br>validated that the Intellijoint HIPTM<br>system satisfies clinical use/accuracy<br>requirements and performs as intended<br>when:<br>- Operated by a surgeon<br>- Used on human specimens<br>- Used in a realistic OR environment | All clinical use<br>and accuracy<br>requirements<br>were met. |

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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 orthopedic 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.

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

July 29, 2014

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

Re: K133759

Trade/Device Name: Intellijoint HIPTM Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Product Code: OLO Regulatory Class: Class II Dated: June 25, 2014 Received: June 26, 2014

Dear Mr. Gingrich:

This letter corrects our substantially equivalent letter of July 23, 2014.

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. Iisting 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

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Page 2 - Mr. Brandon Gingrich

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 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.

# Lori A. Wiggins

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K133759

Device Name Intellijoint НІРТм

### Indications for Use (Describe)

Intellijoint HIP™ is an infrared. computer-controlled localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implants, relative to anatomical structures and reference axes.

Intellijoint HIP™ is indicated for patients undergoing orthopedic surgery where the use of stereotactic safe and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies.

Example orthopedic 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)

## 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)

Casey L. Hanley, Ph.D.

# Division of O