(224 days)
Not Found
No
The description focuses on an "imageless optical navigation system" that uses an infrared sensor and tracked markers to provide intra-operative measurements. There is no mention of AI, ML, or related concepts like training/test sets, which are typically associated with AI/ML-powered devices. The performance studies focus on accuracy and robustness of the tracking system and measurements, not on the performance of an AI/ML algorithm.
No.
The device is an imageless optical navigation system that provides intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implants. It does not directly treat or cure a disease but rather assists in a surgical procedure.
No.
The device provides intra-operative measurements to aid in surgical procedures, specifically for selected and positioning orthopedic implants and controlling leg length and offset. It does not diagnose a disease or condition.
No
The device description explicitly states the system is composed of an infrared sensor, a tracked reflective marker assembly (beacon), a computer workstation, software, and bone fixation components, indicating it includes significant hardware components beyond just software.
Based on the provided information, the Intellijoint HIP™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "infrared, computer-controlled localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implants, relative to anatomical structures and reference axes." This describes a surgical navigation and measurement tool used during a surgical procedure on a patient.
- Device Description: The description reinforces this by detailing an "imageless optical navigation system" that provides "intra-operative assessment of patient leg length and offset during Total Hip Arthroplasty (THA) procedures." It involves attaching components to the patient's bones.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The Intellijoint HIP™ does not perform any such tests on biological samples. It interacts directly with the patient's anatomy during surgery.
Therefore, the Intellijoint HIP™ falls under the category of a surgical navigation or measurement device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intellijoint HIP™ is an infrared, computer-controlled localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implants, relative to anatomical structures and reference axes.
Intellijoint HIP™ is indicated for patients undergoing orthopedic surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies.
Example orthopedic 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 orthopedic surgery. The Intellijoint HIPTM System provides intra-operative assessment of patient leg length and offset during Total Hip Arthroplasty (THA) procedures. The system is composed of an infrared sensor, a tracked reflective marker assembly (beacon), a computer workstation, software, and bone fixation components. The infrared sensor is affixed to the patient's pelvis and the beacon is attached to the patient's femur. The system records the position and orientation of the femur relative to the pelvis prior to hip dislocations. This baseline information can then be used to track the change in leg length and leg offset during the joint replacement procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis, femur, hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, orthopedic surgery, THA workflow, OR environment
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
The Intellijoint HIP™ System's accuracy was verified using the Intellijoint HIP™ software application according to the methodology in ASTM F2554-10 - Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.
Result: All accuracy specifications were met.
Verification - Benchtop Accuracy and Robustness
Verified clinical accuracy requirements using calibrated benchtop test fixtures while simulating normal use, a variety of worse-case use scenarios and realistic tracking disturbances.
Result: All accuracy and robustness requirements were met.
Verification - 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.
Verification - Software Functional and Unit Tests
Verified that the software application satisfies functional requirements and performs as intended. Algorithms and measurement calculations were verified in these tests.
Result: Software satisfied all requirements and specifications.
Verification - Electrical Safety and EMC
Compliance with ANSI/AAMI ES60601-1:2005/(R)2012 for medical electrical equipment: Part 1: General requirements for basic safety and essential performance Part 1-2: General requirements for basic safety and essential performance collateral standard-Electromagnetic compatibility - requirements and tests
Result: Compliance with the requirements of the standards demonstrated.
Verification - Biocompatibility Evaluation
Evaluation against the applicable requirements of ANSI/AAMI/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.
Validation - Sawbones Simulated Use and Accuracy
Non-clinical simulated use testing was performed on bone models (sawbones) by orthopedic surgeons in a simulated THA procedure following a typical THA workflow. This test validated that the Intellijoint HIPTM 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.
Validation - Cadaver Simulated Use and Accuracy
Pre-clinical simulated use testing was performed in a cadaver lab. This test validated that the Intellijoint HIPTM system satisfies clinical use/accuracy requirements and performs as intended when:
- Operated by a surgeon
- Used on human specimens
- Used in a realistic OR environment
Result: All clinical use and accuracy requirements were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
0
SECTION 5 - 510(k) Summary
510(k) Summary Intellijoint HIPTM System
1. Submitter Information
| Submitter:
Address: | Intellijoint Surgical Inc.
60 Bathurst Dr., Unit 1
Waterloo, ON
Canada N2V 2A9 |
|------------------------|-----------------------------------------------------------------------------------------|
| Telephone: | 519.342.3178 |
| Contact: | Brandon Gingrich |
| Date Prepared: | July 21st, 2014 |
2. Device Information
| Trade Name: | Intellijoint HIPTM 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 a new Computer-Assisted Orthopedic 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. |
|---|---|---|
| DASH Hip System | BrainLAB AG | K110021 |
| StealthStation Imageless Hip Module | Medtronic | K052623 |
5. Device Description
The Intellijoint HIP™ System is an imageless optical navigation system intended for orthopedic surgery. The Intellijoint HIPTM System provides intra-operative assessment of patient leg length and offset during Total Hip Arthroplasty (THA) procedures. The system is composed of an infrared sensor, a tracked reflective
1
marker assembly (beacon), a computer workstation, software, and bone fixation components. The infrared sensor is affixed to the patient's pelvis and the beacon is attached to the patient's femur. The system records the position and orientation of the femur relative to the pelvis prior to hip dislocations. This baseline information can then be used to track the change in leg length and leg offset during the joint replacement procedure.
6. Intended Use
Intellijoint HIP™ is an infrared, computer-controlled localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, relative to anatomical structures and reference axes.
Intellijoint HIP™ is indicated for patients undergoing orthopedic surgery where the use of stereotactic surgery is considered safe and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies.
Example orthopedic 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.
2
8. Performance Data
The following tests were performed to demonstrate the substantial equivalence of the Intellijoint HIP™ System to its predicate devices:
| Test | Brief Summary | Result |
|---|---|---|
| Verification | ||
| Tracking System | ||
| Accuracy | The Intellijoint HIP™ System's | |
| accuracy was verified using the | ||
| Intellijoint HIP™ software application | ||
| according to the methodology in | ||
| ASTM F2554-10 - Standard Practice | ||
| for Measurement of Positional | ||
| Accuracy of Computer Assisted | ||
| Surgical Systems. | All accuracy | |
| specifications | ||
| were met. | ||
| Benchtop Accuracy | ||
| and Robustness | Verified clinical accuracy requirements | |
| using calibrated benchtop test fixtures | ||
| while simulating normal use, a variety | ||
| of worse-case use scenarios and | ||
| realistic tracking disturbances. | All accuracy | |
| and robustness | ||
| 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 verified | ||
| in these tests. | Software | |
| satisfied all | ||
| requirements | ||
| and | ||
| specifications. | ||
| Electrical Safety and | ||
| EMC | Compliance with ANSI/AAMI | |
| ES60601-1:2005/(R)2012 for medical | ||
| electrical equipment: | ||
| Part 1: General requirements for | ||
| basic safety and essential | ||
| performance | ||
| Part 1-2: General requirements for | ||
| basic safety and essential | ||
| performance - collateral | ||
| standard-Electromagnetic | ||
| compatibility - requirements and | ||
| tests | Compliance | |
| with the | ||
| requirements of | ||
| the standards | ||
| demonstrated. | ||
| Biocompatibility | ||
| Evaluation | Evaluation against the applicable | |
| requirements of ANSI/AAMI/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 | | |
| Sawbones Simulated
Use and Accuracy | Non-clinical simulated use testing was
performed on bone models (sawbones)
by orthopedic surgeons in a simulated
THA procedure following a typical
THA workflow. This test validated that
the Intellijoint HIPTM 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 and Accuracy | Pre-clinical simulated use testing was
performed in a cadaver lab. This test
validated that the Intellijoint HIPTM
system satisfies clinical use/accuracy
requirements and performs as intended
when: - Operated by a surgeon
- Used on human specimens
- Used in a realistic OR environment | All clinical use
and accuracy
requirements
were met. |
3
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 orthopedic 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.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The logo is simple and monochromatic, with a focus on conveying a sense of national service and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2014
Intellijoint Surgical, Incorporated Mr. Brandon Gingrich Quality and Regulatory Affairs Manager 60 Bathurst Drive, Unit 1 Waterloo, Ontario N2V 2A9 Canada
Re: K133759
Trade/Device Name: Intellijoint HIPTM Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Product Code: OLO Regulatory Class: Class II Dated: June 25, 2014 Received: June 26, 2014
Dear Mr. Gingrich:
This letter corrects our substantially equivalent letter of July 23, 2014.
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. Iisting 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
5
Page 2 - Mr. Brandon Gingrich
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.
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.
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133759
Device Name Intellijoint НІРТм
Indications for Use (Describe)
Intellijoint HIP™ is an infrared. computer-controlled localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implants, relative to anatomical structures and reference axes.
Intellijoint HIP™ is indicated for patients undergoing orthopedic surgery where the use of stereotactic safe and effective, and where a reference to a rigid anatomical structure, such as a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Casey L. Hanley, Ph.D.