(57 days)
Not Found
No
The summary describes an optical navigation system providing intra-operative measurements. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The updates described are related to sterilization of bone screws, not changes to the core technology.
No
The device provides intra-operative measurements to aid the surgeon during orthopedic surgery. It does not directly treat a disease or condition.
No
Explanation: The device is described as an "imageless optical navigation system" intended to provide "intra-operative measurements" to aid surgeons in "selection and positioning of orthopedic implant system components." It does not provide a diagnosis of a patient's condition or disease, but rather assists in the surgical procedure itself.
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 the system is for providing intra-operative measurements to a surgeon to aid in the selection and positioning of orthopedic implant components. This is a surgical navigation and measurement tool used during a surgical procedure.
- Device Description: The description reinforces that it's an "imageless optical navigation system intended for use in orthopedic surgery."
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
The device is a surgical aid used directly on the patient during surgery, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
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
Product codes
OLO
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.
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, patients undergoing 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
| Test | Brief Description | Result |
|---|---|---|
| Manufacturing Cleaning Process | Verified the cleaning process used during the manufacture of the Intellijoint HIP Pelvic and Femur Screws. | All gravimetric residue acceptance criteria were met. |
| Biocompatibility Analysis | Cytotoxicity analysis was used to evaluate the cytotoxicity level of samples following manufacturing, cleaning, and sterilization. | All acceptance criteria met with no deviations. |
| Packaging Integrity Testing | Physical and Climatic stress testing of packaging system, including visual integrity, seal integrity and strength testing. | All packaging system design and integrity requirements were met. |
| Sterilization Validation Testing | Substantiated gamma irradiation sterilization dose for the terminal sterilization of the Intellijoint HIP Pelvic and Femur Screws. | All sterility requirements were met. |
| Sterile Barrier System Integrity Tests | Sterile barrier system integrity evaluated by visual inspection of seals and pouches for anomalies. Seal width measurements, bubble leak test, and seal strength were also evaluated. | All acceptance criteria were met with no deviations. |
| Shelf-life/Aging Tests | Real-time 5-year sterile barrier system integrity of the QSEAL® Tyvek pouch assessed by contract packager. Accelerated aging studies were used to assess the performance of the clear barrier film (48GA PET/281b LDPE) and Tyvek® 1073B used in the IJH2C System sterile Screw pouches. | No degradation to sterile barrier system over a five-year period. |
| Pyrogenicity Testing | Limulus amebocyte lysate (LAL) testing was performed to quantify bacterial endotoxin levels and confirm endotoxin limits are met. | Bacterial endotoxin limits were met. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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.
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
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: | |||
| 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: | 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 |
|---|---|---|
| K151364 | ||
| Concurrence: 28-Dec-2015 | Intellijoint HIP® | |
| Generation 2 System | Intellijoint Surgical Inc. | |
| K162364 | ||
| Concurrence: 2-Mar-2017 | Intellijoint HIP® | |
| Generation 2A System | Intellijoint Surgical Inc. |
5. 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.
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 |
|---|---|---|
| Manufacturing | ||
| Cleaning Process | Verified the cleaning process used during the | |
| manufacture of the Intellijoint HIP Pelvic and | ||
| Femur Screws. | All gravimetric | |
| residue | ||
| acceptance | ||
| criteria were met. | ||
| Biocompatibility | ||
| Analysis | Cytotoxicity analysis was used to evaluate | |
| the cytotoxicity level of samples following | ||
| manufacturing, cleaning, and sterilization. | All acceptance | |
| criteria met with | ||
| no deviations. | ||
| Packaging | ||
| Integrity Testing | Physical and Climatic stress testing of | |
| packaging system, including visual integrity, | ||
| seal integrity and strength testing. | All packaging | |
| system design and | ||
| integrity | ||
| requirements | ||
| were met. | ||
| Sterilization | ||
| Validation | ||
| Testing | Substantiated gamma irradiation sterilization | |
| dose for the terminal sterilization of the | ||
| Intellijoint HIP Pelvic and Femur Screws. | All sterility | |
| requirements | ||
| were 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 Barrier
System Integrity
Tests | Sterile barrier system integrity evaluated by
visual inspection of seals and pouches for
anomalies. Seal width measurements, bubble
leak test, and seal strength were also
evaluated. | All acceptance
criteria were met
with no
deviations. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Shelf-life/Aging
Tests | Real-time 5-year sterile barrier system
integrity of the QSEAL® Tyvek pouch
assessed by contract packager. Accelerated
aging studies were used to assess the
performance of the clear barrier film (48GA
PET/281b LDPE) and Tyvek® 1073B used in
the IJH2C System sterile Screw pouches. | No degradation to
sterile barrier
system over a
five-year period. |
| Pyrogenicity
Testing | Limulus amebocyte lysate (LAL) testing was
performed to quantify bacterial endotoxin
levels and confirm endotoxin limits are met. | Bacterial
endotoxin limits
were 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.