(158 days)
No
The description focuses on optical localization and measurement algorithms, with no mention of AI or ML terms or methodologies in the device description, intended use, or performance studies.
No.
The device is an optical localizer and navigation system used to provide intra-operative measurements. It aids the surgeon in component selection and positioning during orthopedic surgery for total hip arthroplasty procedures, but it does not directly treat or restore the patient's health.
No
Explanation: The device is an imageless optical navigation system used intra-operatively to provide measurements and aid in the selection and positioning of orthopedic implant components. It does not diagnose diseases or conditions.
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.
No, 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 intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant system components during surgery. This is an in-vivo application, meaning it's used within the living body during a surgical procedure.
- Device Description: The description reinforces that it's an "imageless optical navigation system intended for use in orthopedic surgery." It describes components used in the operating room environment and for bone fixation.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such tests on bodily samples.
The Intellijoint HIP Generation 2B System is a surgical navigation system, which is a type of medical device used to assist surgeons during procedures, but it is not an IVD.
N/A
Intended Use / Indications for Use
The Intellijoint HIP Generation 2B 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 Intellijoint HIP Generation 2B System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective. 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
-
Revision Hip Arthroplasty
Product codes
OLO
Device Description
The Intellijoint HIP® Generation 2B 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.
The Intellijoint HIP® Generation 2B System is an update to the Intellijoint HIP® System previously cleared in 510(k) K162364. This submission provides the addition of revision hip arthroplasty (RHA) procedures to the indications for use, and the use of either linear or non-linear acetabular cup impactors. Other minor modifications made to the device are also provided.
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, orthopedic 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
| Test | Summary | Result |
|---|---|---|
| Verification | ||
| Benchtop Accuracy | Verified clinical accuracy requirements using calibrated benchtop test fixtures. | 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. | Software satisfied all requirements and specifications. |
| Bone Fixation Functional and Performance Tests | Provides confirmation that new hardware (Femoral Disc and Femoral Rod) satisfy functional and performance requirements. | All functional and performance requirements met. |
| Validation | ||
| Anatomical Phantom Simulated Use and Clinical Accuracy | Simulated use testing was performed on bone models by orthopedic surgeons in a simulated THA procedure following a typical workflow. This test validated that the Intellijoint HIP® Generation 2B 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 2B System satisfies clinical use requirements and performs as intended when: - Operated by a surgeon - Used on human specimens - Used in a realistic operating room environment | All clinical use requirements were met. |
The testing demonstrated that the Intellijoint HIP® Generation 2B System is substantially equivalent to the legally marketed predicate devices for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
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October 30, 2017
Intellijoint Surgical Inc. Brandon Gingrich Quality and Regulatory Affairs Manager 60 Bathurst Drive. Unit 6 Waterloo, Ontario N2V 2A9 Canada
Re: K171525
Trade/Device Name: Intellijoint HIP Generation 2B System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 5, 2017 Received: October 6, 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 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
1
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 (DICE) 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 (DICE) 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) K171525
Device Name
Intellijoint HIP Generation 2B System
Indications for Use (Describe)
The Intellijoint HIP Generation 2B 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 Intellijoint HIP Generation 2B System is indicated for patients undergoing orthopedic surgery, and where the use of stereotactic surgery is considered safe and effective. 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
-
Revision 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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3
510(k) Summary
1. Submitter Information
| Submitter: | Intellijoint Surgical Inc. |
|---|---|
| Address: | 60 Bathurst Dr., Unit 6 |
| Waterloo, ON | |
| Canada N2V 2A9 | |
| Telephone: | (519) 342-3178 |
| Fax: | (226) 317-0471 |
| Contact: | Brandon Gingrich |
| Date Prepared: | May 23, 2017 |
2. Device Information
| Trade Name: | Intellijoint HIP® Generation 2B 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 indications for use for a previously cleared Computer-Assisted Orthopedic Surgery System.
4. Predicate Device Information
The Intellijoint HIP® Generation 2B System described in this submission is substantially equivalent to the following predicates:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| Intellijoint HIP® Generation 2A System | Intellijoint Surgical Inc. | K162364 |
| Stryker OrthoMap Versatile Hip System | Stryker Leibinger GmbH | K162937 |
5. Device Description
The Intellijoint HIP® Generation 2B 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.
The Intellijoint HIP® Generation 2B System is an update to the Intellijoint HIP® System previously cleared in 510(k) K162364. This submission provides the addition of revision hip arthroplasty (RHA) procedures to the indications for use, and the use of either linear
4
Image /page/4/Picture/2 description: The image shows the logo for Intellijoint Surgical. The logo consists of a blue geometric shape on the left and the word "intellijoint" in gray on the right. Below "intellijoint" is the word "surgical" in a smaller font size, also in gray. The geometric shape appears to be made up of three triangles.
or non-linear acetabular cup impactors. Other minor modifications made to the device are also provided.
6. Intended Use
The Intellijoint HIP Generation 2B 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 Intellijoint HIP Generation 2B 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
- Revision Hip Arthroplasty -
7. Comparison of Technological Characteristics
The substantial equivalence of the Intellijoint HIP® Generation 2B 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 2A System cleared in 510(k) K162364. The following tests were performed to demonstrate the substantial equivalence of the updated Intellijoint HIP® Generation 2B System to its predicate devices:
| Test | Summary | Result |
|---|---|---|
| Verification | ||
| Benchtop Accuracy | Verified clinical accuracy requirements using | |
| calibrated benchtop test fixtures. | 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. | Software | |
| satisfied all | ||
| requirements and | ||
| specifications. | ||
| Bone Fixation | ||
| Functional and | ||
| Performance Tests | Provides confirmation that new hardware | |
| (Femoral Disc and Femoral Rod) satisfy | ||
| functional and performance requirements. | All functional | |
| and performance | ||
| requirements | ||
| met. |
5
Image /page/5/Picture/2 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 in different shades of blue and gray. The company name is written in a sans-serif font, with the word "intellijoint" in bold and the word "surgical" in a smaller font below it.
| Validation | ||
|---|---|---|
| Anatomical Phantom | ||
| Simulated Use and | ||
| Clinical Accuracy | Simulated use testing was performed on bone | |
| models by orthopedic surgeons in a | ||
| simulated THA procedure following a typical | ||
| workflow. This test validated that the | ||
| Intellijoint HIP® Generation 2B 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 2B System | ||
| satisfies clinical use requirements and | ||
| performs as intended when: |
- Operated by a surgeon
- Used on human specimens
- Used in a realistic operating room
environment | All clinical use
requirements
were met. |
The testing demonstrated that the Intellijoint HIP® Generation 2B System is substantially equivalent to the legally marketed predicate devices for its intended use.
9. Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate devices, the Intellijoint HIP® Generation 2B System has been shown to be substantially equivalent to the legally marketed predicate devices identified in this submission, and does not present any changes to safety or effectiveness.