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

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.

AI/ML Overview

The provided text describes a 510(k) submission for the Intellijoint HIP Generation 2C System, which is an update to a previously cleared computer-assisted orthopedic surgery system. The submission focuses on changes to the sterilization and packaging processes for bone screws, rather than a clinical performance study of the device's accuracy in intra-operative measurements.

Therefore, the acceptance criteria and study detailed below relate to manufacturing, sterilization, and packaging aspects of the bone screws included with the system, not the accuracy or clinical effectiveness of the Intellijoint HIP system itself. The document states "The intended use and fundamental scientific technology is unchanged, and remains substantially equivalent to the predicate device." and "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."

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied / Stated)	Reported Device Performance
Manufacturing Cleaning Process	All gravimetric residue acceptance criteria specified for the cleaning process.	All gravimetric residue acceptance criteria were met.
Biocompatibility Analysis	Cytotoxicity levels meet specified acceptance criteria.	All acceptance criteria met with no deviations.
Packaging Integrity Testing	Packaging system design and integrity requirements are met, including visual integrity, seal integrity, and strength testing under physical and climatic stress.	All packaging system design and integrity requirements were met.
Sterilization Validation Testing	All sterility requirements for gamma irradiation sterilization dose for terminal sterilization are met.	All sterility requirements were met.
Sterile Barrier System Integrity Tests	No anomalies in visual inspection of seals and pouches; seal width measurements, bubble leak test, and seal strength meet acceptance criteria.	All acceptance criteria were met with no deviations.
Shelf-life/Aging Tests	No degradation to the sterile barrier system over a five-year period for both real-time (QSEAL® Tyvek pouch) and accelerated aging (clear barrier film and Tyvek® 1073B).	No degradation to sterile barrier system over a five-year period.
Pyrogenicity Testing	Bacterial endotoxin levels are quantified and meet specified endotoxin limits.	Bacterial endotoxin limits were met.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for each test mentioned (e.g., number of screws tested for cleaning, biocompatibility, sterilization, or packaging). The tests listed are primarily laboratory-based or engineering tests on components/packaging rather than clinical studies with patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply in the context of these specific manufacturing and sterilization validation tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable to the types of tests described, as the ground truth is established through standardized laboratory testing procedures and specifications (e.g., gravimetric analysis for residue, cytotoxicity assays, bacterial endotoxin limits, physical testing for packaging integrity) rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical or image-based studies where human interpretation or consensus is required. These methods are not relevant to the engineering and analytical tests described for manufacturing, sterilization, and packaging validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The submission explicitly states it does not alter the device's fundamental scientific technology and the purpose is for updates to sterilization and packaging processes. Therefore, a clinical MRMC comparative effectiveness study, particularly one measuring human reader improvement with or without AI, was not conducted nor is it applicable to this type of regulatory submission. The device is an "imageless optical navigation system" and the current submission is about manufacturing/sterilization, not a new AI component requiring human reader evaluations.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. The tests described are related to the manufacturing, sterility, and packaging of physical components (bone screws) of the system, not a standalone algorithm's performance in a clinical or diagnostic context.

7. The Type of Ground Truth Used

For the tests described:

Manufacturing Cleaning Process: Measured gravimetric residue, compared against pre-defined acceptance criteria.
Biocompatibility Analysis: Cytotoxicity levels determined via standardized assays, compared against safety limits.
Packaging Integrity Testing: Physical measurements (e.g., seal width, strength), visual inspections, and performance under stress, compared against engineering specifications.
Sterilization Validation Testing: Sterility assurance levels (SAL) confirmed through gamma irradiation studies, adhering to regulatory standards for medical device sterility.
Sterile Barrier System Integrity Tests: Physical characteristics (seal width, strength), leak tests, visual inspection, compared against design specifications.
Shelf-life/Aging Tests: Observation of material degradation and integrity over time (real-time and accelerated), compared against expected performance.
Pyrogenicity Testing: Bacterial endotoxin levels quantified using LAL testing, compared against established endotoxin limits.

In essence, the ground truth for these tests is based on established scientific and engineering standards, validated laboratory methods, and regulatory limits applicable to medical device manufacturing and sterilization.

8. The Sample Size for the Training Set

This concept is not applicable here. The document describes validation tests for manufacturing and sterilization processes, not the development or training of an algorithm or AI model.

9. How the Ground Truth for the Training Set Was Established

This concept is not applicable as there is no training set for an AI/algorithm described in this submission.

Summary

{0}------------------------------------------------

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

510(k) Summary

K172849

1.	Submitter Information
	Submitter:Address:	Intellijoint Surgical Inc60 Bathurst Dr., Unit 6Waterloo, ONCanada N2V 2A9
	Telephone:Fax:	(519) 342—3178(226) 317-0471
	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
K151364Concurrence: 28-Dec-2015	Intellijoint HIP®Generation 2 System	Intellijoint Surgical Inc.
K162364Concurrence: 2-Mar-2017	Intellijoint HIP®Generation 2A System	Intellijoint Surgical Inc.

5. Device Description

{4}------------------------------------------------

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
ManufacturingCleaning Process	Verified the cleaning process used during themanufacture of the Intellijoint HIP Pelvic andFemur Screws.	All gravimetricresidueacceptancecriteria were met.
BiocompatibilityAnalysis	Cytotoxicity analysis was used to evaluatethe cytotoxicity level of samples followingmanufacturing, cleaning, and sterilization.	All acceptancecriteria met withno deviations.
PackagingIntegrity Testing	Physical and Climatic stress testing ofpackaging system, including visual integrity,seal integrity and strength testing.	All packagingsystem design andintegrityrequirementswere met.
SterilizationValidationTesting	Substantiated gamma irradiation sterilizationdose for the terminal sterilization of theIntellijoint HIP Pelvic and Femur Screws.	All sterilityrequirementswere met.

{5}------------------------------------------------

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 BarrierSystem IntegrityTests	Sterile barrier system integrity evaluated byvisual inspection of seals and pouches foranomalies. Seal width measurements, bubbleleak test, and seal strength were alsoevaluated.	All acceptancecriteria were metwith nodeviations.
Shelf-life/AgingTests	Real-time 5-year sterile barrier systemintegrity of the QSEAL® Tyvek pouchassessed by contract packager. Acceleratedaging studies were used to assess theperformance of the clear barrier film (48GAPET/281b LDPE) and Tyvek® 1073B used inthe IJH2C System sterile Screw pouches.	No degradation tosterile barriersystem over afive-year period.
PyrogenicityTesting	Limulus amebocyte lysate (LAL) testing wasperformed to quantify bacterial endotoxinlevels and confirm endotoxin limits are met.	Bacterialendotoxin limitswere 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.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
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.(b)
Classification. Class II (performance standards).