(191 days)
Not Found
No
The summary describes an imageless optical navigation system that provides intra-operative measurements based on tracking and calculations, with no mention of AI or ML terms or methodologies.
No
The device is an intra-operative navigation system that aids the surgeon in measurements and positioning; it does not directly treat or cure a condition.
No.
The device provides intra-operative measurements and aids in the selection and positioning of orthopaedic implant system components during surgery; it does not diagnose a medical condition.
No
The device description explicitly states that the system is composed of an infrared Camera, Tracker, computer workstation, software, and bone fixation instruments/hardware, indicating it includes hardware components in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Intellijoint HIP Generation 2A System is an optical navigation system used during orthopaedic surgery. It provides real-time measurements to the surgeon to aid in the positioning of implants. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for providing intra-operative measurements to a surgeon to aid in the selection and positioning of orthopaedic implant system components. This is a surgical aid, not a diagnostic test performed on a specimen.
Therefore, the Intellijoint HIP Generation 2A System falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intellijoint HIP Generation 2A System 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.
The Intellijoint HIP Generation 2A System 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, 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® Generation 2A System is an imageless optical navigation system intended for use in orthopaedic surgery. The device provides intra-operative assessment of patient leg length, offset, 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.
The intellijoint HIP® Generation 2A System is an update to the intellijoint HIP® System previously cleared in 510(k) K151364. The updates include revised software to support THA procedures performed using the Direct Anterior Approach, modified methods of patient registration, and leg position measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, orthopaedic surgery
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)
Verification:
- Tracking System Accuracy and Robustness: The intellijoint HIP® Generation 2A 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.
- 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.
Validation:
- 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® Generation 2A 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.
- Cadaver Simulated Use: Simulated use testing was also performed in a cadaver lab. This test validated that the intellijoint HIP® Generation 2A System satisfies clinical use requirements and performs as intended when: - Operated by a surgeon - Used on human specimens - Used in a realistic OR environment. Result: All clinical use requirements were met.
The testing demonstrated that the intellijoint HIP® Generation 2A 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (qualitative assessment of accuracy specifications and requirements being met).
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
Intellijoint Surgical Inc. Brandon Gingrich Quality And Regulatory Affairs Manager 60 Bathurst Drive, Unit 6 Waterloo, Ontario N2V 2A9 Canada
Re: K162364
Trade/Device Name: Intellijoint HIP Generation 2A System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 27, 2017 Received: January 30, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
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,
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) K162364
Device Name Intellijoint HIP Generation 2A System
Indications for Use (Describe)
The Intellijoint HIP Generation 2A System 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.
The Intellijoint HIP Generation 2A System 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, and implant component positioning.
Example orthopaedic surgical procedures include, but are not limited to:
- Total Hip Arthroplasty
- Minimally Invasive Hip Arthroplasty
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/1 description: The image contains the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left, resembling a stylized joint, with the company name to the right. The geometric shape is composed of blue and gray triangles, while the company name is written in gray, with the word "surgical" in a smaller font size below "intellijoint".
K162364
510(k) Summary
1. Submitter Information
| Submitter:
Address: | Intellijoint Surgical Inc.
60 Bathurst Dr., Unit 6
Waterloo, ON
Canada N2V 2A9 |
|------------------------|-----------------------------------------------------------------------------------------|
| Telephone:
Fax: | (519) 342 - 3178
(226) 317 - 0471 |
| Contact: | Brandon Gingrich |
| Date Prepared: | January 27th, 2016 |
| Trade Name: | intellijoint HIP® Generation 2A 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® Generation 2A System described in this submission is substantially equivalent to the following predicates:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| intellijoint HIP® Generation 2 System | Intellijoint Surgical Inc. | K151364 |
| Navitrack™ System – Total Hip Replacement | ||
| CT-Free | ORTHOsoft, Inc. | K041369 |
5. Device Description
The intellijoint HIP® Generation 2A System is an imageless optical navigation system intended for use in orthopaedic surgery. The device provides intra-operative assessment of patient leg length, offset, 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.
4
Image /page/4/Picture/1 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of three triangles, one blue, one light blue, and one gray. The company name is written in a sans-serif font, with the word "Intellijoint" in a larger font than the word "Surgical".
The intellijoint HIP® Generation 2A System is an update to the intellijoint HIP® System previously cleared in 510(k) K151364. The updates include revised software to support THA procedures performed using the Direct Anterior Approach, modified methods of patient registration, and leg position measurement.
6. Intended Use
The Intellijoint HIP Generation 2A System 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.
The Intellijoint HIP Generation 2A System 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® Generation 2A System to the predicates is shown by similarity in intended use, indications for use, and performance.
8. Performance Data
This submission is for updates to the intellijoint HIP® Generation 2 System cleared in 510(k) K151364. The following tests were performed to demonstrate the substantial equivalence of the updated intellijoint HIP® Generation 2A System to its predicate devices:
| Test | Brief Summary | Result |
|---|---|---|
| Verification | ||
| Tracking System Accuracy and Robustness | The intellijoint HIP® Generation 2A 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. |
5
Image /page/5/Picture/1 description: The image shows the logo for "Intellijoint Surgical". The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of a blue triangle on top, a light blue curved shape in the middle, and a gray triangle pointing downwards at the bottom. The company name is written in a sans-serif font, with "Intellijoint" in a larger font size and "Surgical" in a smaller font size below it.
| 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. |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Validation | | |
| 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® Generation 2A 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. |
| Cadaver Simulated
Use | Simulated use testing was also performed in
a cadaver lab. This test validated that the
intellijoint HIP® Generation 2A System
satisfies clinical use requirements and
performs as intended when:
- Operated by a surgeon
- Used on human specimens
- Used in a realistic OR environment | All clinical use
requirements
were met. |
The testing demonstrated that the intellijoint HIP® Generation 2A 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® Generation 2A 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.