(87 days)
No
The description focuses on computer-assisted stereotaxic surgical instrumentation for positioning based on anatomical landmarks and alignment axes, without mentioning AI or ML algorithms for analysis, prediction, or decision support. The performance studies also focus on software functionality, performance under simulated conditions, and instrument robustness, not on the evaluation of AI/ML model performance.
No
The device is a surgical instrument system designed to assist surgeons in positioning orthopedic implant components, not to directly treat or cure a disease or condition.
No
Explanation: The device is described as a "computer assisted stereotaxic surgical instrument system" used "to assist the surgeon in the positioning of orthopedic implant system components intra-operatively." Its function is to "determine alignment axes in relation to anatomical landmarks and to precisely position alignments and implant components," not to diagnose a condition or disease.
No
The device description explicitly states that the system consists of "tracking sensors ('pods'), a computer system, software, and surgical instruments." This indicates the presence of hardware components beyond just software. The performance studies also include testing of hardware aspects like "hardware and user interfaces," "communication protocols," "use of pods and instruments," "response to temperature effects," "resistance of the pods to electro-static discharges," and "pod's battery expected lifetime."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the iASSIST Knee System is a "computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively." This describes a surgical guidance system used during a surgical procedure, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description focuses on surgical instruments, sensors, a computer system, and software used to determine alignment axes and position implant components. This aligns with a surgical assistance device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
Therefore, the iASSIST Knee System falls under the category of a surgical instrument or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignments and implant components relative to these axes.
Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.
Product codes
OLO
Device Description
As in the predicate, the iASSIST Knee System consists of tracking sensors ('pods'), a computer system, software, and surgical instruments designed to assist the surgeon in the placement of Total Knee Replacement components. The pods combined with the surgical instruments provide positional information to help orient and locate the main femoral and tibial cutting planes as required in knee replacement surgery. This includes means for the surgeon to determine and thereafter track each of the bones' alignment axes relative to which the cutting planes are set.
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, intra-operatively
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)
Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. The main tests included the following:
- Software system tests were performed to ensure that the required functionalities were maintained or correctly updated per the changes without the introduction of hazardous anomalies. They included the hardware and user interfaces, the communication protocols. the use of pods and instruments as applicable, the response to temperature effects, and the verification of fault conditions.
- Performance tests were performed under simulated bench test conditions and analyses to verify the implementation of the performance of the bone registration related functionalities.
- Bench test and analyses were performed to verify the robustness and compatibility of the added or modified instruments, to verify the resistance of the pods to electro-static discharges, and to verify the sufficiency the pod's battery expected lifetime as in the predicate.
- Full use simulations tests using sawbones were performed to verify and validate the overall system performance in terms of the system usage, surgical flow, and instrument ergonomics.
- Electrical certification test related to the certification update.
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2014
ZIMMER CAS Mr. Christopher Mclean Quality and regulatory Affairs Associate Director 75 QUEEN STREET, SUITE 3300 MONTREAL, Canada H3C 2N6
Re: K141601
Trade/Device Name: iASSIST™ Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 11, 2014 Received: August 12, 2014
Dear Mr. Mclean:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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/Resourcesfor You/Industry/default.htm. 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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Device Name iASSIST Knee System
Indications for Use (Describe)
The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignments and implant components relative to these axes.
Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS iASSIST™ KNEE SYSTEM
Applicant: Zimmer CAS 75 Queen Street, suite 3300 Montreal, Quebec Canada, H3C 2N6 Tel.: 514 861 4074 Fax: 514 866 2197
Contact Person: Christopher McLean
Date Summary Prepared: June 12, 2014
Device Trade Name: iASSIST™ Knee System
Device Classification Name: Orthopedic Stereotaxic Instrument (product code OLO): 21 CFR & 882.4560
Predicate Device:
i ASSIST Knee System, from Zimmer CAS, 510(k) # K122326, cleared Nov. 30th, 2012
Device Description:
As in the predicate, the iASSIST Knee System consists of tracking sensors ('pods'), a computer system, software, and surgical instruments designed to assist the surgeon in the placement of Total Knee Replacement components. The pods combined with the surgical instruments provide positional information to help orient and locate the main femoral and tibial cutting planes as required in knee replacement surgery. This includes means for the surgeon to determine and thereafter track each of the bones' alignment axes relative to which the cutting planes are set.
Indications for Use / Intended Use:
This is unchanged from the predicate:
The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system to assist the surgeon in the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and position sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignments and implant components relative to these axes.
Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.
Technological Comparisons to the Predicates:
The fundamental scientific technology of the predicate is unchanged including the operating principle and control mechanism.
The changes involved altering the system to allow for an alternate surgical flow requiring only 2 pods as compared to the predicate 4 pod method. This involved the introduction of a new 2 pod kit along with software adjustments to allow for the altered step sequence.
In addition, general system improvements and updates have been implemented in the predicate. These involved secondary engineering changes and improvements. They did not involve
4
changes to the intended and indication for use and did not raise any new issues of safety and effectiveness. These included the following:
- -Update of the pod electrical certification to latest IEC 60601-1:2005 electrical safety standard
- Removal of no longer used or redundant pod and instrument graphical symbols and mechanical interfaces
- The modification or addition instruments and methods to facilitate use and improve the compatibility with implant systems
- Improvements to the system software components to improve system usability, to increase the robustness of bone registration and wireless communication algorithms, to further increase the resistance to electro-static discharges, and to further ensure the pod's battery lifetime to accommodate the system changes.
Performance Data:
Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. The main tests included the following:
-
- Software system tests were performed to ensure that the required functionalities were maintained or correctly updated per the changes without the introduction of hazardous anomalies. They included the hardware and user interfaces, the communication protocols. the use of pods and instruments as applicable, the response to temperature effects, and the verification of fault conditions.
-
- Performance tests were performed under simulated bench test conditions and analyses to verify the implementation of the performance of the bone registration related functionalities.
-
- Bench test and analyses were performed to verify the robustness and compatibility of the added or modified instruments, to verify the resistance of the pods to electro-static discharges, and to verify the sufficiency the pod's battery expected lifetime as in the predicate.
-
- Full use simulations tests using sawbones were performed to verify and validate the overall system performance in terms of the system usage, surgical flow, and instrument ergonomics.
-
- Electrical certification test related to the certification update.
Conclusion:
The information and data provided in this 510(k) Premarket Notification established that the modified iASSIST Knee System is substantially equivalent to its predicate version.