(88 days)
No
The summary describes a stereotaxic navigation system that uses software algorithms to process anatomical references and instrument tracking data for surgical guidance. It does not mention or imply the use of AI or ML techniques for tasks like image analysis, predictive modeling, or automated decision-making. The algorithms described appear to be based on traditional geometric calculations and tracking.
No.
Explanation: This device is a surgical navigation system that assists in Total Knee Replacement procedures by providing guidance and information to the surgeon. It does not directly provide therapy or treatment to the patient. Its function is to facilitate the surgical procedure itself.
No
Explanation: The device is a navigation system intended to assist surgeons in primary Total Knee Replacement procedures by providing guidance for surgical cutting, not for diagnosing a condition. It helps in the treatment phase by assisting with tool placement and orientation.
No
The device description explicitly states that Knee+ includes both "KneePlus software and KneeTools reusable surgical instruments." It also mentions the use of "surgical instruments which include markers" and validation of the "cleaning and sterilization process of the reusable instruments." This indicates the device is a system comprising both software and hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Knee+ is to assist a surgeon during primary Total Knee Replacement surgery by providing navigation and guidance for positioning cutting planes. This is an in vivo application, meaning it is used directly on or within the patient's body during a surgical procedure.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro).
- Device Description: The device description clearly outlines a surgical navigation system that uses instruments and a head-mounted display to guide the surgeon during the operation. This is consistent with an in vivo surgical tool, not an in vitro diagnostic test.
The information provided about the device's function, intended use, and how it interacts with the patient during surgery all point to it being a surgical navigation system, which is a type of medical device used in vivo.
N/A
Intended Use / Indications for Use
Knee+ is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. Knee+ is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting computed mechanical axis. The Knee+ includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.
Product codes
OLO
Device Description
Knee+ is a navigation system dedicated to orthopaedic knee surgery. It includes KneePlus software and KneeTools reusable surgical instruments.
The main purpose of Knee+ is to assist the surgeon during primary Total Knee Arthroplasty (TKA) interventions.
Knee+ provides information to help locate and orientate the main femoral and tibial cutting TKA. Knee+ allows the surgeon to adjust the orientation of the cutting plane orientation and the level of resection by collecting anatomical references during the TKA procedure using surgical instruments. The software locates in a 3D reference frame the instruments which include markers. All collected coordinates are treated by software algorithms to provide the surgeon with relevant orientation and location of the tracked cutting guide. Knee+ software is installed on a wearable Head Mounted Device (HMD) which includes a camera and displays intraonerative information to the user. A near-eye display allows the HMD screen or the field of view when needed.
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)
The following testing was conducted to evaluate the Knee+ device, subject of this premarket submission, in order to confirm that Knee+ performs as intended and is as safe as its previously marketed version (K230789):
• Bench testing was conducted in order to demonstrate that Knee+ performs according to its requirements and specifications. In particular, repeatability and accuracy were tested according to ASTM F2554.
• Cleaning and sterilization process of the reusable instruments was validation was performed in accordance with AAMI TIR30 guidance, and for steam sterilization, in compliance with the half-cycle validation approach outlined in ISO 17665-1, in accordance with the requirements of ISO 1764 and FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
• Biological evaluation was provided in order to contient-contacting materials do not introduce new risks. The modified instruments are still covered by the testing done according to ISO 10993 series.
• Human factors data were provided, in compliance with the requirements of IEC 62366-1 and FDA guidance factors and usability engineering to medical devices". Test participants representing the intended in the human factor validation testing. Observational data were recorded. The observation of participant performance and the assessment of their understanding of essential information through the interview confirmed that the device, including the additional features of the latest version, is safe and effective for the intended users, uses and use environments.
• Software verification and validation testing were conducted as required by IEC 62304 and documentation was provided as
recommended by FDA Guidance "Content of Premarket Submissions for Software in Medical Devices".
All performance testing demonstrates that Knee+ performs according to its specifications and functions as intended.
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).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
March 8, 2024
Pixee Medical Lucie Pecheur Regulatory Affairs Manager 18 rue Alain Savary Besancon, 25000 France
Re: K233899
Trade/Device Name: Knee+ Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 6, 2023 Received: December 11, 2023
Dear Lucie Pecheur:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Tejen D. Soni -S
For Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair
2
and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233899
Device Name Knee+
Indications for Use (Describe)
Knee+ is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. Knee+ is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting computed mechanical axis. The Knee+ includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.
| 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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4
K233899 510(k) Summary Prepared on: 2024-03-08
21 CFR 807.92(a)(1)
| Applicant Name | PIXEE MEDICAL | |||
|---|---|---|---|---|
| Applicant Address | 18 rue Alain Savary BESANCON 25000 France | |||
| Applicant Contact Telephone | +33458101365 | |||
| Applicant Contact | Mrs. Lucie Pecheur | |||
| Applicant Contact Email | lucie.pecheur@pixee-medical.com | |||
| Device Name | 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Knee+ | |||
| Common Name | Stereotaxic instrument | |||
| Classification Name | Orthopedic Stereotaxic Instrument | |||
| Regulation Number | 882.4560 | |||
| Product Code | OLO | |||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K230789 | Knee+ | OLO | ||
| K110054 | Navitrack® System - OS Knee Universal | OLO | ||
| Device Description Summary | 21 CFR 807.92(a)(4 |
Knee+ is a navigation system dedicated to orthopaedic knee surgery. It includes KneePlus software and KneeTools reusable surgical instruments.
The main purpose of Knee+ is to assist the surgeon during primary Total Knee Arthroplasty (TKA) interventions.
Knee+ provides information to help locate and orientate the main femoral and tibial cutting TKA. Knee+ allows the surgeon to adjust the orientation of the cutting plane orientation and the level of resection by collecting anatomical references during the TKA procedure using surgical instruments. The software locates in a 3D reference frame the instruments which include markers. All collected coordinates are treated by software algorithms to provide the surgeon with relevant orientation and location of the tracked cutting guide. Knee+ software is installed on a wearable Head Mounted Device (HMD) which includes a camera and displays intraonerative information to the user. A near-eye display allows the HMD screen or the field of view when needed.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Knee+ is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. Knee+ is intended for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting computed mechanical axis. The Knee+ includes smart glasses as a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The smart glasses should not be relied upon solely and should always be used in conjunction with traditional methods.
Indications for Use Comparison
5
There are no differences between the subject device and the predicate (K230789, previous version of the device) with respect to indications for use.
The indications for use were already found equivalent to the indications for use of the reference device, Navitrack® System - OS Knee Universal (K110054).
Therefore, Knee+ device is substantially equivalent in terms of intended use / indications for use.
Technological Comparison
21 CFR 807.92(a)(6)
The device subject of this Premarket Notification from the device legally authorized under K230789, also manufactured bv Pixee Medical.
The main difference is the resection level which is now provided numerically to the user instead of mechanically. The acuracy of the resection level remains the same as before and the numerical resection level is not a new feature was aready included in the following reference device: Navitrack® System - OS Knee Universal (K110054), which was the predicate of the first Knee+ cleared version.
The main change as well as other minor changes were assessed through risk management activities, including relevant verification and validation information, produced under design controls of the design controls activities were provided in the Premarket Notification.
Substantial equivalence was therefore supported by performance data which demonstrated that the modified is still safe and effective for its intended use. The differences from the previous version do not raise any concerns regarding the safety and effectiveness of the device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following testing was conducted to evaluate the Knee+ device, subject of this premarket submission, in order to confirm that Knee+ performs as intended and is as safe as its previously marketed version (K230789):
• Bench testing was conducted in order to demonstrate that Knee+ performs according to its requirements and specifications. In particular, repeatability and accuracy were tested according to ASTM F2554.
• Cleaning and sterilization process of the reusable instruments was validation was performed in accordance with AAMI TIR30 guidance, and for steam sterilization, in compliance with the half-cycle validation approach outlined in ISO 17665-1, in accordance with the requirements of ISO 1764 and FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
• Biological evaluation was provided in order to contient-contacting materials do not introduce new risks. The modified instruments are still covered by the testing done according to ISO 10993 series.
ı Human factors data were provided, in compliance with the requirements of IEC 62366-1 and FDA guidance factors and usability engineering to medical devices". Test participants representing the intended in the human factor validation testing. Observational data were recorded. The observation of participant performance and the assessment of their understanding of essential information through the interview confirmed that the device, including the additional features of the latest version, is safe and effective for the intended users, uses and use environments. • Software verification and validation testing were conducted as required by IEC 62304 and documentation was provided as
recommended by FDA Guidance "Content of Premarket Submissions for Software in Medical Devices".
All performance testing demonstrates that Knee+ performs according to its specifications and functions as intended.
Knee+ has the same intended use and indications for use that its predicate device (i.e., the most recent cleared version K230789). The fact that the resection level is now determined numerically and other minor modifications do not raise and effectiveness as it is already present in the reference device Navitrack® System - OS Knee Universal (K110054) and substantially equivalent to its predicate (K230789). Performance data demonstrated that Knee+ is as safe, as effective and performs as well as legally marketed devices.
Knee+ has the same intended use and indications for use that its predicate device (i.e., the most recent cleared version K230789). The fact that the resection level is now determined numerically and other minor modifications do not raise new questions of safety and effectiveness as it is already present in the reference device Navitrack® System - OS Knee Universal (K110054) and substantially equivalent to its predicate (K230789). Performance data demonstrated that Knee+ is as safe, as effective and performs as well as legally marketed devices.