(95 days)
No
The description focuses on computer-assisted surgical navigation using sensors and a computer module to calculate and display angles and positions. There is no mention of AI, ML, deep learning, or any algorithms that learn from data or adapt over time. The system appears to be based on pre-programmed calculations and measurements.
No.
The device assists the surgeon in determining reference alignment axes and positioning implants/instrumentation during surgical procedures, rather than directly treating a medical condition itself.
No
The device is described as a "computer controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures." It facilitates "the accurate positioning of implants and instrumentation." It is a "computer assisted surgical navigation system" that "detect[s], measure[s], and display[s] angular measurement changes" and "generate[s] positional information." This functionality is for guiding surgical procedures and positioning, not for diagnosing a medical condition.
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. The performance studies also include "System hardware verification/validation testing."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- KneeAlign® 2 System Function: The KneeAlign® 2 System is a surgical navigation system used during orthopedic surgical procedures (specifically knee arthroplasty). It assists the surgeon in determining anatomical alignment and positioning instruments and implants.
- No Specimen Analysis: The device does not analyze any specimens taken from the patient's body. It works by tracking the position and orientation of anatomical structures and surgical instruments in real-time during the surgery.
Therefore, the KneeAlign® 2 System falls under the category of surgical navigation or computer-assisted surgery devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The KneeAlign® 2 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign® 2 System facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to:
. Total Knee Arthroplasty
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The KneeAlign® 2 System is an innovative non-invasive computer assisted surgical navigation system for use in knee arthroplasty procedures. The KneeAlign® System is configured to detect, measure, and display angular measurement changes in a triaxial format.
The KneeAlign® 2 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 angle and the flexion/extension angle of the cutting block relative to femur.
- . Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to tibia.
The KneeAlign® 2 System comprises a single use computer module and reusable instrumentation.
The KneeAlign® 2 System comprises a single use computer module, a reusable reference sensor, a reusable femoral jig and a reusable tibial iig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical representation of instruments and anatomy on the user display screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical procedures
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 KneeAlign® 2 System can be used according to its intended use. The KneeAlign® 2 System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing included:
- Software verification and validation .
- System hardware verification/validation testing .
- Electrical safety and electromagnetic compatibility testing .
- . System accuracy testing
- . Simulated use testing
This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate devices, for its intended use in facilitating the accurate positioning of implants and instrumentation, relative to reference alignment axes.
A technological comparison and bench, and cadaver testing demonstrate the substantial equivalence of the KneeAlign® 2 System to the predicate devices.
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.
KneeAlign System with Reference Sensor (K093998), Navitrack System- S&N Image Free Knee (K043536)
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
APR - 4 2011
| This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c). |
|---|
| --------------------------------------------------------------------------------------------------------------- |
| APPLICANT | OrthAlign, Inc.
120 Columbia
Suite 500
Aliso Viejo, CA 92656
Tel: (949) 715-2424
Fax: (949) 831-9500 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Amy Walters
AWE, Inc.
338 Vista Madera
Newport Beach, CA 92660
amy@orthalign.com
Tel: (949) 923-9400
Fax: (949) 831-9500 |
| TRADE NAME | KneeAlign® 2 System |
| COMMON NAME | Stereotaxic Instrument |
| DEVICE
CLASSIFICATION | Class II, 21 CFR §882.4560 |
| PRODUCT CODES | OLO: Orthopedic Stereotaxic Instrument |
| PREDICATE
DEVICES | KneeAlign System with Reference Sensor (K093998)
Navitrack System- S&N Image Free Knee (K043536) |
12103899
SUBSTANTIALLY EQUIVALENT TO:
The KneeAlign® 2 System is substantially equivalent to the previously cleared KneeAlign System with Reference Sensor (K093998) and Navitrack System-S&N Image Free Knee (K043536).
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The KneeAlign® 2 System is an innovative non-invasive computer assisted surgical navigation system for use in knee arthroplasty procedures. The KneeAlign® System is configured to detect, measure, and display angular measurement changes in a triaxial format.
The current standard of care for knee arthroplasty procedures has the physician estimating these changes either by visual observation and tactile feedback or with
1
assistance of computer assisted surgery devices. The KneeAlign® 2 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 angle and the flexion/extension angle of the cutting block relative to femur.
- . Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to tibia.
The KneeAlign® 2 System comprises a single use computer module and reusable instrumentation.
INDICATIONS FOR USE:
The KneeAlign®2 System has the same indications for use as the previously cleared KneeAlign™ System with Reference Sensor (K093998). Additional functionality has been added to the predicate device to enable femoral navigation. Also, Indications for Use are common to the Navitrack System-S&N Image Free Knee (K043536). Thus, the Indications for Use are as follows:
The KneeAlign® 2 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign® 2 System facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to:
- . Total Knee Arthroplasty
TECHNICAL CHARACTERISTICS:
The KneeAlign® 2 System comprises a single use computer module, a reusable reference sensor, a reusable femoral jig and a reusable tibial iig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical representation of instruments and anatomy on the user display screen.
PERFORMANCE DATA:
Device performance testing confirms that the KneeAlign® 2 System can be used according to its intended use. The KneeAlign® 2 System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing included:
- Software verification and validation .
- System hardware verification/validation testing .
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- Electrical safety and electromagnetic compatibility testing .
- . System accuracy testing
- . Simulated use testing
This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate devices, for its intended use in facilitating the accurate positioning of implants and instrumentation, relative to reference alignment axes.
The information provided by OrthAlign in this 510(k) application was found to be substantially equivalent to predicate devices such as the KneeAlign® System with Reference Sensor (K093998), and Navitrack System- S&N Image Free Knee (K043536).
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
A technological comparison and bench, and cadaver testing demonstrate the substantial equivalence of the KneeAlign® 2 System to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a series of flowing lines. The symbol is black, and the text is also black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OrthAlign, Inc. % AWE, Inc. Ms. Amy Walters 338 Vista Madera Newport Beach, California 92660
APR - 4 2011
Re: K103829
Trade/Device Name: KneeAlign® 2 System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: March 23, 2011 Received: March 24, 2011
Dear Ms. Walters:
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
4
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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Kc. Robert Thomas
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4.
- INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K103829
Device Name: KneeAlign® 2 System
Indications for Use:
The KneeAlign® 2 System is a computer controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical structures during stereotactic orthopedic surgical procedures. The KneeAlign® 2 System facilitates the accurate positioning of implants and instrumentation, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to:
. Total Knee Arthroplasty
Prescription Use x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RP Ogler farman
(Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103829
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