(221 days)
Not Found
No
The summary describes an optical navigation system that provides intraoperative measurements based on tracking and calculations, without mentioning any AI or ML components. The performance studies focus on accuracy and functional verification, not on training or testing of AI/ML models.
No
The device is an imageless optical navigation system intended to provide intraoperative measurements to aid in surgical procedures, not to provide therapy.
No
The device is an intraoperative measurement tool that aids surgeons in positioning orthopedic implants. It does not diagnose diseases or conditions in patients.
No
The device description explicitly states that the system is composed of hardware components including an infrared Camera, Tracker, computer workstation, and bone fixation instruments/hardware, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing intraoperative measurements to a surgeon to aid in the selection and positioning of orthopaedic implant system components during surgery. This is a surgical navigation and guidance system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details an "imageless optical navigation system" composed of hardware and software used during surgery. This aligns with a surgical tool, not an IVD.
- Performance Studies: The performance studies focus on accuracy of tracking, benchtop accuracy, bone fixation, software functionality, electrical safety, biocompatibility, and simulated use in a surgical setting. These are all relevant to a surgical device, not an IVD.
- Key Metrics: The key metric mentioned is accuracy, which is crucial for a surgical navigation system to ensure correct positioning of implants. IVDs typically report metrics like sensitivity, specificity, PPV, and NPV, which relate to the performance of a diagnostic test.
In summary, the Intellijoint HIP™ System is a surgical navigation device used during a surgical procedure to assist the surgeon, not a device used to perform tests on biological samples in vitro for diagnostic purposes.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Orthopaedic surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tracking System Accuracy and Robustness
The intellijoint HIPT™ System's accuracy was verified according to the methodology in ASTM F2554-10 - Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. Testing simulated normal conditions, and a variety of worst-case use scenarios and realistic tracking disturbances. Result: All accuracy specifications and robustness requirements were met.
Benchtop Accuracy
Verified clinical accuracy requirements using calibrated benchtop test fixtures. Result: All accuracy requirements were met.
Bone Fixation Performance
Verified bone fixation performance requirements including functional tests, robustness, rigidity of fixation and repeatability. Result: All functional and performance requirements were met.
Software Functional and Unit Tests
Verified that the software application satisfies functional requirements and performs as intended. Algorithms and measurement calculations were also verified in these tests. Result: Software satisfied all requirements and specifications.
Electrical Safety and EMC
Compliance with ANSI / AAMI / IEC 60601-1:2005 for medical electrical equipment: - Part 1: General requirements for basic safety and essential performance - Part 1-2: Collateral standard—Electromagnetic compatibility – requirements and tests - Part 1-6: Collateral Standard: Usability. Result: Compliance with the requirements of the standards demonstrated.
Biocompatibility Evaluation
Evaluation against the applicable requirements of ISO 10993-1:2009 – Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - Part 5: Tests for in vitro cytotoxicity - Part 10: Tests for irritation and skin sensitization - Part 11: Tests for systemic toxicity. Result: Compliance with the requirements of the standards demonstrated.
Anatomical Phantom Simulated Use and Clinical Accuracy
Simulated use testing was performed on bone models by orthopaedic surgeons in a simulated THA procedure following a typical workflow. This test validated that the intellijoint HIP™ System satisfies user needs, intended use and clinical accuracy requirements. Accuracy was assessed by comparing simulated use measurements with ground truth values. Result: All user needs and clinical accuracy requirements were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The profiles are stacked on top of each other, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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 |
| Waterloo, ON | |
| 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 | ||
| 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.
4
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 | ||
| Accuracy and | ||
| Robustness | The intellijoint HIPT™ System's accuracy was | |
| verified according to the methodology in | ||
| ASTM F2554-10 - Standard Practice for | ||
| Measurement of Positional Accuracy of | ||
| Computer Assisted Surgical Systems. Testing | ||
| simulated normal conditions, and a variety of | ||
| worst-case use scenarios and realistic tracking | ||
| disturbances. | All accuracy | |
| specifications | ||
| and robustness | ||
| requirements | ||
| were met. | ||
| Benchtop Accuracy | Verified clinical accuracy requirements using | |
| calibrated benchtop test fixtures. | All accuracy | |
| requirements | ||
| were met. | ||
| Bone Fixation | ||
| Performance | Verified bone fixation performance | |
| requirements including functional tests, | ||
| robustness, rigidity of fixation and | ||
| repeatability. | All functional | |
| and performance | ||
| requirements | ||
| were met. | ||
| Software Functional | ||
| and Unit Tests | Verified that the software application satisfies | |
| functional requirements and performs as | ||
| intended. Algorithms and measurement | ||
| calculations were also verified in these tests. | Software | |
| satisfied all | ||
| requirements and | ||
| specifications. |
5
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
EMC | Compliance with ANSI / AAMI / IEC 60601-
1:2005 for medical electrical equipment:
- Part 1: General requirements for basic
safety and essential performance - Part 1-2: Collateral standard—
Electromagnetic compatibility –
requirements and tests - Part 1-6: Collateral Standard: Usability | Compliance with
the requirements
of the standards
demonstrated. |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Biocompatibility
Evaluation | Evaluation against the applicable
requirements of ISO 10993-1:2009 –
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process - Part 5: Tests for in vitro cytotoxicity
- Part 10: Tests for irritation and skin
sensitization - Part 11: Tests for systemic toxicity | Compliance with
the requirements
of the standards
demonstrated. |
| Validation | | |
| Test | Brief Summary | Result |
| Anatomical
Phantom Simulated
Use and Clinical
Accuracy | Simulated use testing was performed on bone
models by orthopaedic surgeons in a
simulated THA procedure following a typical
workflow. This test validated that the
intellijoint HIP™ System satisfies user needs,
intended use and clinical accuracy
requirements. Accuracy was assessed by
comparing simulated use measurements with
ground truth values. | All user needs
and clinical
accuracy
requirements
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.