(115 days)
No
The description focuses on stereotaxic surgical instruments, inertial sensors, and computer-assisted tracking for alignment, without mentioning AI or ML algorithms for decision-making, image analysis, or predictive modeling. The software testing is described in terms of standard medical device software lifecycle processes (IEC 62304), not AI/ML specific validation.
No
The device is a surgical instrument system intended to assist the surgeon during total knee arthroplasty by providing positional information for cutting planes and component placement. It is an intraoperative aid, not a device used for treating a disease or condition itself.
No
The device is described as a computer-assisted stereotaxic surgical instrument system intended to assist the surgeon in preparing bone surfaces for orthopedic implant placement, not for diagnosing conditions.
No
The device description explicitly states that the iASSIST Knee System consists of Pods (tracking sensors), a computer system, software, and surgical instruments. This indicates the presence of hardware components beyond just 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 that the iASSIST Knee System is a "computer assisted stereotaxic surgical instrument system intended to assist the surgeon in preparing the bone surfaces for the positioning of orthopedic implant system components intra-operatively." This describes a surgical guidance and assistance system used during surgery on a patient.
- Device Description: The description details surgical instruments, sensors, a computer system, and software used to provide positional information and orient cutting planes during knee replacement surgery.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's health status.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on assisting a surgical procedure directly on the patient's body.
N/A
Intended Use / Indications for Use
The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system intended to assist the surgeon in preparing the bone surfaces for the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and inertial sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and cut guides relative to these axes.
The present iASSIST Knee System is designed for Total Knee Arthroplasty.
Product codes
OLO
Device Description
As in the predicates, the iASSIST Knee System consists of Pods (tracking sensors), 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. The computer system and software components control and sequence the functions of the Pods per the applicable knee surgery steps via wireless communication.
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
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:
Verification and Validation Testing for iASSIST Knee System was conducted with the following aspects:
- Physical/Performance Tests- to ensure the performance of the implemented features and verify related design inputs
- Engineering Analysis- to ensure the performance of the implemented features and verify related design inputs
- Usability Engineering- addressed user interactions with the iASSIST Knee System
- Validation Lab- performed to validate that using the iASSIST Knee System is safe and effective and that the performances of the iASSIST Knee System are acceptable under full simulated use on cadaveric specimens
Software Verification and Validation Testing:
Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software is considered a "moderate" level of concern, a malfunction in the device could lead to a minor injury. The testing demonstrates that the iASSIST Knee System does not raise any new issues of safety and effectiveness as compared to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
January 14, 2022
Orthosoft d/b/a Zimmer CAS Paul Hardy Regulatory Affairs Associate Director 75 Queen Street, Suite 3300 Montreal, Quebec H3C 2N6 Canada
Re: K213033
Trade/Device Name: iASSIST Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 20, 2021 Received: September 21, 2021
Dear Paul Hardy:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213033
Device Name iASSIST® Knee System
Indications for Use (Describe)
The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system intended to assist the surgeon in preparing the bone surfaces for the positioning of orthopedic implants intra-operatively. It involves surgical instruments and inertial sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and cut guides relative to these axes.
The present iASSIST Knee System is designed for Total Knee Arthroplasty.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
In accordance with 21 CFR $807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the iASSIST® Knee System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.
| Sponsor: | Orthosoft, Inc d/b/a. Zimmer CAS | |
|---|---|---|
| 75 Queen St., Suite 3300 | ||
| Montreal, QC, CANADA H3C 2N6 | ||
| Establishment Registration Number: 9617840 | ||
| Contact Person: | Paul Hardy | |
| Regulatory Affairs Associate Director | ||
| Telephone: 574-453-6739 | ||
| Paul.Hardy@zimmerbiomet.com | ||
| Date: | January 5, 2022 | |
| Subject Device: | Trade Name: iASSIST® Knee System | |
| Common Name: iASSIST® Knee System | ||
| Classification Name: | ||
| • OLO- Orthopedic Stereotaxic Instrument (21 CFR |
- 882.4560)
Primary Predicate Device:
| Manufacturer | Device Name | 510(k)
Number |
|--------------|---------------------|------------------|
| Zimmer CAS | iASSIST Knee System | K192080 |
Reference Devices:
| Manufacturer | Device Name | 510(k)
Number |
|--------------|------------------------|------------------|
| Zimmer CAS | iASSIST Knee System | K141601 |
| Zimmer CAS | SmartTools Knee System | K122326 |
Purpose and Device Description:
As in the predicates, the iASSIST Knee System consists of Pods (tracking sensors), 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
4
which the cutting planes are set. The computer system and software components control and sequence the functions of the Pods per the applicable knee surgery steps via wireless communication.
Indications for Use:
The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system intended to assist the surgeon in preparing the bone surfaces for the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and inertial sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and cut guides relative to these axes.
The present iASSIST Knee System is designed for Total Knee Arthroplasty.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- The subject and predicate devices are intended to assist the surgeon in ● providing software defined spatial boundaries for orientation
- The subject and predicate devices assist in intraoperative navigation of the patient's anatomy and are utilized to facilitate implant positioning.
- . The subject and predicate device consists of the same major components including Pods, Surgical Instruments, iASSIST V2 Tablet and software components.
- The software and iASSIST V2 Tablet of the subject and predicate devices are intended to sequence and to control the Pods and their user interface functions via wireless communication.
- The software algorithm and instrument features of the subject and ● predicate devices are intended to determine and track the alignment axes to reference the cutting planes.
- The instrument features and functions of the subject and predicate devices are intended to allow assembly of the sensors, to attach the subject bones, to register or digitize the applicable landmarks, and to adjust the alignment of provided saw guides.
Summary of Performance Data (Nonclinical and/or Clinical):
The iASSIST® Knee System has been evaluated through the following nonclinical testing in support of the substantial equivalence determination:
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Device Performance Testing:
Verification and Validation Testing for iASSIST Knee System was conducted with the following aspects:
- Physical/Performance Tests- to ensure the performance of the implemented features and verify related design inputs
- Engineering Analysis- to ensure the performance of the implemented ● features and verify related design inputs
- Usability Engineering- addressed user interactions with the iASSIST Knee System
- . Validation Lab- performed to validate that using the iASSIST Knee System is safe and effective and that the performances of the iASSIST Knee System are acceptable under full simulated use on cadaveric specimens
Software Verification and Validation Testing:
Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software is considered a "moderate" level of concern, a malfunction in the device could lead to a minor injury. The testing demonstrates that the iASSIST Knee System does not raise any new issues of safety and effectiveness as compared to the predicate devices.
Substantial Equivalence Conclusion:
In summary, the subject and predicate devices have similar indications for use, the same intended use, the same principle of operation as well as similar technological characteristics. Furthermore, the information provided herein demonstrates that:
- Any differences do not raise new questions of safety and effectiveness;
- Verification and Validation activities demonstrate that the subject device ● is at least as safe and effective as the legally marketed predicate devices.