Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray

K172849 · Intellijoint Surgical, Inc. · OLO · Nov 16, 2017 · Neurology

Device Facts

• Record ID: K172849
• Device Name: Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray
• Applicant: Intellijoint Surgical, Inc.
• Product Code: OLO · Neurology
• Decision Date: Nov 16, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Intellijoint HIP Generation 2C System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic 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 Generation 2C System is indicated for patients undergoing orthopedic 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 orthopedic surgical procedures include, but are not limited to: - Total Hip Arthroplasty - Minimally Invasive Hip Arthroplasty

Device Story

Imageless optical navigation system for orthopedic surgery; provides intra-operative assessment of leg length, offset, anterior-posterior change, hip center of rotation, and acetabular cup angle. System components include infrared camera, tracker, computer workstation, software, and bone fixation hardware. Used in OR by surgeons to guide implant positioning. Inputs include optical signals from trackers attached to rigid anatomical structures; system processes these to calculate spatial measurements. Output displayed to surgeon to assist in component selection and positioning. Benefits include improved accuracy of implant placement during hip arthroplasty.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included manufacturing cleaning process verification, cytotoxicity analysis, packaging integrity (physical/climatic stress), sterilization validation (gamma irradiation), shelf-life/aging studies (5-year real-time), and pyrogenicity (LAL) testing. All acceptance criteria met.

Technological Characteristics

Imageless optical navigation system. Components: infrared camera, tracker, computer workstation, software, bone fixation instruments. Sterile barrier materials: Tyvek® 1073B and clear barrier film (48GA PET/281b LDPE). Sterilization: Gamma irradiation. Connectivity: Workstation-based. Software: Computer-controlled optical localization.

Indications for Use

Indicated for patients undergoing orthopedic surgery (e.g., Total Hip Arthroplasty, Minimally Invasive Hip Arthroplasty) where stereotactic surgery is considered safe and effective.

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® Generation 2 System (K151364)
• Intellijoint HIP® Generation 2A System (K162364)

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: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.

November 16, 2017

Intellijoint Surgical Inc. Brandon Gingrich Quality and Regulatory Affairs Manager 60 Bathurst Drive, Unit 6 Waterloo, ON Canada N2V 2A9

Re: K172849

Trade/Device Name: Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 31, 2017 Received: November 1, 2017

Dear Brandon 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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manufacturing practice requirements as set forth in 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.

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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark N. Melkerson -S

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)

#### K172849

Device Name Intellijoint HIP Generation 2C System

#### Indications for Use (Describe)

The Intellijoint HIP Generation 2C System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon

to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified. The system is only compatible with straight acetabular cup impactors.

The Intellijoint HIP Generation 2C System is indicated for patients undergoing orthopedic 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 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)

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# 510(k) Summary

K172849

| 1. | Submitter Information | | |
|----|------------------------|----------------------------------------------------------------------------------------|--|
| | Submitter:<br>Address: | Intellijoint Surgical Inc<br>60 Bathurst Dr., Unit 6<br>Waterloo, ON<br>Canada N2V 2A9 | |
| | Telephone:<br>Fax: | (519) 342—3178<br>[phone] | |
| | Contact: | Brandon Gingrich | |
| | Date Prepared: | September 19, 2017 | |

#### 2. Device Information

| Trade Name: | Intellijoint HIP® Generation 2C 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 updates to the sterilization and packaging processes as included in a previously cleared Computer-Assisted Orthopedic Surgery System.

## 4. Predicate Device Information

| 510(k) No. | Device | Manufacturer |
|-------------------------------------|-------------------------------------------|----------------------------|
| K151364<br>Concurrence: 28-Dec-2015 | Intellijoint HIP®<br>Generation 2 System | Intellijoint Surgical Inc. |
| K162364<br>Concurrence: 2-Mar-2017 | Intellijoint HIP®<br>Generation 2A System | Intellijoint Surgical Inc. |

## 5. Device Description

The Intellijoint HIP® Generation 2C System is an imageless optical navigation system intended for use in orthopedic 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 procedures. The system is composed of an infrared Camera, Tracker, computer workstation, software, and bone fixation instruments/hardware.

This submission describes updates implemented to provide terminally sterile bone screws to the user, which were previously only supplied non-sterile. The intended use and fundamental scientific technology is unchanged, and remains substantially equivalent to the predicate device.

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Image /page/4/Picture/2 description: The image shows the logo for "Intellijoint Surgical". The logo features a blue and gray triangular shape on the left side. To the right of the shape is the word "Intellijoint" in a sans-serif font, with the word "surgical" in a smaller font size underneath.

## 6. Intended Use

Intellijoint HIP Generation 2C System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic 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 Generation 2C System is indicated for patients undergoing orthopedic 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 centerof-rotation, and implant component positioning.

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

- Total Hip Arthroplasty

- Minimally Invasive Hip Arthroplasty

## 7. Comparison of Technological Characteristics

This modification does not alter the device's fundamental scientific technology in comparison to the predicate devices (K151364 and K162364) and therefore has the same technological characteristics.

#### 8. Performance Data

This submission is for updates to the Intellijoint HIP® Generation 2A System cleared in 510(k) K162364. The following tests were performed to demonstrate the substantial equivalence of the updated system to its predicates.

| Test | Brief Description | Result |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Manufacturing<br>Cleaning Process | Verified the cleaning process used during the<br>manufacture of the Intellijoint HIP Pelvic and<br>Femur Screws. | All gravimetric<br>residue<br>acceptance<br>criteria were met. |
| Biocompatibility<br>Analysis | Cytotoxicity analysis was used to evaluate<br>the cytotoxicity level of samples following<br>manufacturing, cleaning, and sterilization. | All acceptance<br>criteria met with<br>no deviations. |
| Packaging<br>Integrity Testing | Physical and Climatic stress testing of<br>packaging system, including visual integrity,<br>seal integrity and strength testing. | All packaging<br>system design and<br>integrity<br>requirements<br>were met. |
| Sterilization<br>Validation<br>Testing | Substantiated gamma irradiation sterilization<br>dose for the terminal sterilization of the<br>Intellijoint HIP Pelvic and Femur Screws. | All sterility<br>requirements<br>were met. |

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Intellijoint HIP® Generation 2C System

Image /page/5/Picture/2 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a blue triangle shape on the left, followed by the text "intellijoint" in a dark gray sans-serif font. Below "intellijoint" is the word "surgical" in a smaller, lighter gray font. The logo is simple and modern, with a focus on the company name.

| Sterile Barrier<br>System Integrity<br>Tests | Sterile barrier system integrity evaluated by<br>visual inspection of seals and pouches for<br>anomalies. Seal width measurements, bubble<br>leak test, and seal strength were also<br>evaluated. | All acceptance<br>criteria were met<br>with no<br>deviations. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Shelf-life/Aging<br>Tests | Real-time 5-year sterile barrier system<br>integrity of the QSEAL® Tyvek pouch<br>assessed by contract packager. Accelerated<br>aging studies were used to assess the<br>performance of the clear barrier film (48GA<br>PET/281b LDPE) and Tyvek® 1073B used in<br>the IJH2C System sterile Screw pouches. | No degradation to<br>sterile barrier<br>system over a<br>five-year period. |
| Pyrogenicity<br>Testing | Limulus amebocyte lysate (LAL) testing was<br>performed to quantify bacterial endotoxin<br>levels and confirm endotoxin limits are met. | Bacterial<br>endotoxin limits<br>were met. |

## 9. Conclusion

The changes proposed in this submission do not alter the intended use, operating principle, and technological characteristics in comparison to the approved legally marketed predicate devices (K151364 and K162364). The design development processes of the Intellijoint HIP® System conforms to currently valid standards, including applicable medical device safety and performance standards. The modifications proposed do not affect the safety and effectiveness of the device.