(26 days)
Not Found
No
The description focuses on computer-assisted surgical navigation using sensors and pre-defined steps for anatomical registration and instrument positioning, without mentioning AI/ML algorithms for analysis or decision support.
No
The device is a computer-assisted surgical navigation system that aids the surgeon in determining reference alignment and positioning implants, rather than directly treating a disease or condition.
No
The device is described as a computer-assisted surgical navigation system that aids the surgeon in determining reference alignment axes and positioning implants, but it does not diagnose a medical condition or disease.
No
The device description explicitly states that the system comprises a "palm-sized computer module and reference sensor" and "reusable instrumentation," indicating the presence of hardware components beyond just software.
Based on the provided information, the OrthAlign Plus® System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for assisting the surgeon during stereotactic orthopedic surgical procedures to determine reference alignment axes and facilitate implant positioning. This is an intraoperative surgical aid, not a diagnostic test performed on biological samples in vitro.
- Device Description: The description reinforces that it's a "non-invasive computer assisted surgical navigation system." It measures and displays positional changes in vivo during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions, or providing diagnostic information based on in vitro testing.
Therefore, the OrthAlign Plus® 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 OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instructures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty.
Example orthopedic surgical procedures include but are not limited to:
- Total Knee Arthroplasty
- Total Hip Arthroplasty: Anterior/Posterior
- Unicompartmental Knee Arthroplasty: Tibial transverse resection
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.
In knee arthroplasty procedures, the device assists the surgeon in:
- Establishing the mechanical axis of the femur. determining the varus/valgus and . the flexion/extension angle of the cutting block relative to the femur.
- Establishing the mechanical axis of the tibia, determining the varus/valgus angle and ● the posterior slope angle of the cutting block relative to the tibia.
In hip arthroplasty procedures, the device assists the surgeon in:
- . Establishing the orientation of the anterior pelvic plane and determining the inclination angle and the anteversion angle of the shell impactor relative to the anterior pelvic plane, or to the anterior pelvic plane adjusted for pelvic tilt.
- Measuring the intraoperative change in leg length and offset.
In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:
- Establishing the mechanical axis of the tibia, determining the varus/valgus angle and ● the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur, tibia, hip/pelvic plane
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical setting.
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)
Device performance testing confirms that the OrthAlign Plus® System can be used according to its intended use. The OrthAlign Plus® System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing addressed the new functionality and surgical procedure steps. Performance testing included:
- Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences.
- Customer requirements validation with an advising surgeon to validate the system meets design input requirements for its functions in a simulated use environment.
- System accuracy testing: bench testing with mechanical fixtures and foam models to verify leg length and offset and updated scale reader measurement accuracy.
This testing regime demonstrates that the subject device is as effective, and performs as well as the predicate device. This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device, for its intended use in facilitating the accurate measurement of intraoperative change in leg length and offset and navigation of the acetabular shell impactor relative to the anterior pelvic plane established by the table reference frame, in THA, posterior approach.
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2017
OrthAlign, Inc. David Vancelette Sr. Director OA/RA 120 Columbia. Suite 500 Aliso Viejo, California 92656
Re: K171780
Trade/Device Name: OrthAlign Plus System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 14, 2017 Received: June 15, 2017
Dear David Vancelette:
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 device
1
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,
Image /page/1/Picture/9 description: The image shows the name "Vincent J. Devlin -S" in a clear, sans-serif font. The text is horizontally oriented and appears to be a title or heading. The background is plain, ensuring the text is easily readable.
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)
K171780
Device Name OrthAlign Plus System
Indications for Use (Describe)
The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instructures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty.
Example orthopedic surgical procedures include but are not limited to:
- Total Knee Arthroplasty
- · Total Hip Arthroplasty: Anterior/Posterior
- · Unicompartmental Knee Arthroplasty: Tibial transverse resection
| Type of Use (Select one or both, as applicable) |
|---|
| Registration Under Part 21 CFR 801, Subpart D |
| Custom Use, Under 21 CFR 801, Subpart C |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
1. 510(K) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).
| DATE | June 14, 2017 |
|---|---|
| APPLICANT | OrthAlign, Inc. |
| 120 Columbia, Suite 500 | |
| Aliso Viejo, CA 92656 | |
| Tel: (949) 715-2424 | |
| Fax: (949) 831-9500 | |
| OFFICIAL | |
| CORRESPONDENT | David Vancelette |
| OrthAlign, Inc. | |
| 120 Columbia, | |
| Suite 500 | |
| Aliso Viejo, CA 92656 | |
| dvancelette@orthalign.com | |
| Tel: (858) 692-0335 | |
| Fax: (949) 831-9500 | |
| TRADE NAME | OrthAlign Plus® System |
| COMMON NAME | Stereotaxic Instrument |
| DEVICE | |
| CLASSIFICATION | Class II, 21 CFR §882.4560 |
| PRODUCT CODES | OLO: Orthopedic Stereotaxic Instrument |
| PREDICATE DEVICE | OrthAlign Plus® System (K162962) |
| SUBMISSION TYPE | Special 510(k): Device Modification. The subject |
| device is a modification to the previously cleared | |
| OrthAlign Plus® System (K162962). |
SUBSTANTIALLY EQUIVALENT TO:
The OrthAlign Plus® System is substantially equivalent to the previously cleared OrthAlign Plus® System (K162962).
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for
4
registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.
In knee arthroplasty procedures, the device assists the surgeon in:
- Establishing the mechanical axis of the femur. determining the varus/valgus and . the flexion/extension angle of the cutting block relative to the femur.
- Establishing the mechanical axis of the tibia, determining the varus/valgus angle and ● the posterior slope angle of the cutting block relative to the tibia.
In hip arthroplasty procedures, the device assists the surgeon in:
- . Establishing the orientation of the anterior pelvic plane and determining the inclination angle and the anteversion angle of the shell impactor relative to the anterior pelvic plane, or to the anterior pelvic plane adjusted for pelvic tilt.
- Measuring the intraoperative change in leg length and offset.
In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:
- Establishing the mechanical axis of the tibia, determining the varus/valgus angle and ● the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.
INDICATIONS FOR USE:
The OrthAlign Plus System has the same indications for use as the previously cleared OrthAlign Plus® System (K162962).
The Indications for Use are as follows:
OrthAlign Plus® System:
The OrthAlign Plus® System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty.
Example orthopedic surgical procedures include but are not limited to:
- Total Knee Arthroplasty ●
- Total Hip Arthroplasty: Anterior/Posterior ●
- Unicompartmental Knee Arthroplasty: Tibial transverse resection
TECHNICAL CHARACTERISTICS (COMPARED TO PREDICATE):
The OrthAlign Plus® System was cleared under K162962. The OrthAlign Plus® System
5
comprises a single use computer module, a reusable reference sensor, a reusable laser module, a reusable femoral jig, a reusable tibial jig, a reusable posterior hip jig and a reusable anterior hip jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and anatomy on the user display screen.
The OrthAlign Plus® System is being updated for the total hip arthroplasty: posterior approach to include navigation of the shell impactor to the table (or coronal) reference plane, and to enable the measurement of intraoperative change in leg length and offset using a laser to guide repositioning of the leg as in the previously cleared predicate device OrthAlign Plus® System (K162962) when used for total hip arthroplasty: anterior approach. All other features and principles of operation remain unchanged.
PERFORMANCE DATA:
Device performance testing confirms that the OrthAlign Plus® System can be used according to its intended use. The OrthAlign Plus® System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing addressed the new functionality and surgical procedure steps. Performance testing included:
- . Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences.
- . Customer requirements validation with an advising surgeon to validate the system meets design input requirements for its functions in a simulated use environment.
- . System accuracy testing: bench testing with mechanical fixtures and foam models to verify leg length and offset and updated scale reader measurement accuracy.
This testing regime demonstrates that the subject device is as effective, and performs as well as the predicate device. This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate device, for its intended use in facilitating the accurate measurement of intraoperative change in leg length and offset and navigation of the acetabular shell impactor relative to the anterior pelvic plane established by the table reference frame, in THA, posterior approach.
The information provided by OrthAlign in this 510(k) application confirms that the modified OrthAlign Plus® System is substantially equivalent to predicate device, the OrthAlign Plus® System (K162962).
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
A technological comparison and bench testing demonstrate the substantial equivalence of the OrthAlign Plus® System to the predicate device.
The subject device is identical to the predicate OrthAlign Plus® System (K162962), with the following exceptions:
6
- The subject device allows for the navigation of the acetabular shell impactor relative to ● the anterior pelvic plane established by the table reference frame, in THA, posterior approach.
- . The subject device uses a laser to facilitate repositioning of the leg and single point femur registration for the measurement of intraoperative changes in leg length and joint offset in THA, posterior approach.
The table below summarizes the main features of the subject device as compared to the predicate device.
| Feature or Principle | Modified
Device | Predicate OrthAlign Plus System (K162962) |
|-------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Identical | • 17-4 PH Stainless Steel H900
• 316L Stainless Steel
• 455 Stainless Steel
• 455 Stainless Steel
• 300 Series Stainless Steels
• Nitronic 60
• Solvay Radel R-5000
• Solvay Radel R-5100
• Solvay Radel R-5500
• POM C Acetal Copolymer
• Polyester, Autoflex-EBA
• Lexan HP1-7H8D330
• Internal electronics |
| Control Mechanism -
shell impactor navigation | Identical | • Computer measurement of the shell impactor's orientation
during acetabular shell implantation. |
| | Identical | • Computer displayed anteversion and abduction angles for the
shell impactor. |
| Control Mechanism - leg
length & offset change
measurements | Identical | • Computer displayed length (superior-inferior) and offset
(medial-lateral) changes. |
| | Identical | • Computer calculation of the intraoperative change in position
of the femur. |
| Operating Principles | | |
| Computer generation
of positional
information | Identical | Uses inertial sensors, microcontroller and digital signal
processor to generate positional information, based on physical
positions of registration instruments. |
| Feature or Principle | Modified
Device | Predicate OrthAlign Plus System (K162962) |
| Registration of
anatomy | Identical | Electronics attached to movable instruments, placed in specified
procedural positions for recording sensor data. |
| Femur registration | Identical to
the predicate's
anterior
approach | • Physically registers a fiduciary plate: instrument temporarily
attaches to the femur.
• Anterior approach: physically registers a fiduciary point:
instrument attached to the femur. |
| Leg positioning | Identical to
the predicate's
anterior
approach | • Posterior approach: visual positioning and registration of a
reference plane used to locate leg.
• Anterior approach: Laser crosshair pattern used to locate leg. |
| Main System
Components | Identical
Identical
Identical
Identical
Identical | • Single-use computer unit
• Navigation software
• Reusable instrument set
• Registration instruments
• Acetabular Shell Impactor |
| User Interface | Identical | Integrated graphical user interface, on single-use unit that
attaches to instrumentation. |
| Energy Type | Identical | • Navigation unit, reference sensor and laser module: DC
battery power.
• Instruments: manual positioning and manipulation. |
| Sterilization | Identical | Navigation unit: EO sterilization.
Instruments: autoclave sterilization |
| Biocompatibility | Identical | Per ISO 10993-1, External Communicating Device,
Tissue/Bone/Dentin Communicating, with subsystems that have
direct and potential indirect contact for a limited contact duration
(