(87 days)
Not Found
No
The description focuses on traditional navigation system functionality using anatomical landmarks and software algorithms for coordinate processing, without mentioning AI/ML terms or concepts.
No.
The device is a surgical navigation system designed to assist surgeons during Total Knee Arthroplasty (TKA) procedures by providing guidance for cutting planes and anatomical alignment. It does not directly provide therapy to the patient.
No
The device is a surgical navigation system that assists in guiding the surgeon during total knee replacement procedures by providing real-time information to locate and orient cutting planes. It does not diagnose medical conditions.
No
The device description explicitly states that Knee+ includes "surgical instruments" and "reusable surgical instruments" in addition to the software and Head Mounted Device (HMD). This indicates the device is not solely 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 Knee+ is a stereotaxic system intended for primary Total Knee Replacement to assist the surgeon in determining reference alignment axes and positioning cutting planes. This is a surgical navigation and guidance system used during a surgical procedure.
- Device Description: The description reinforces that it's a navigation system dedicated to orthopedic knee procedures, providing information to help locate and orientate cutting planes. It uses surgical instruments and software to track and guide the surgeon.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. The description of Knee+ does not involve any testing of biological samples.
Therefore, Knee+ is a surgical navigation and guidance system, not an In Vitro Diagnostic device.
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
SBF
Device Description
Knee+ is a navigation system dedicated to orthopaedic 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 planes as required during 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 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, a computer and displays intraoperative information to the user. A near-eye display allows the HMD screen 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, intraoperatively
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)
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. Human factors data were provided, in compliance with the requirements of IEC 62366-1 and FDA guidance "Applying Human 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 Device Software Functions". Cleaning and sterilization process of the reusable instruments was validated to SAL 10-6. Validation was performed in accordance with AAM ST98 and AAM TIR 12 guidances, and for sterilization, in compliance with the half-cycle validation approach outlined in ISO 17665-1, in accordance with the requirements of ISO 17664-1 and FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". Biocompatibility testing (cytotoxicity, sensitisty, acute systemic toxicity and iritation) have been performed according to ISO 10993 standard series following instrument modification and confirmed that the patient-contacting materials do not introduce new risks and that the KneeTools instruments were safe and biocompatible. 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)
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2025
Pixee Medical François Beaumont Regulatory Affairs engineer 18 rue Alain Savary Besançon, 25000 France
Re: K243975
Trade/Device Name: Knee+ Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: SBF Dated: December 20, 2024 Received: December 23, 2024
Dear François Beaumont:
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.
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"
1
(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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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
2
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243975
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Prepared on: 2025-01-24
Contact Details
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(5)
| Applicant Name | Pixee Medical |
|---|---|
| Applicant Address | 18 rue Alain Savary Besançon 25000 France |
| Applicant Contact Telephone | +33458101365 |
| Applicant Contact | Mr. François BEAUMONT |
| Applicant Contact Email | francois.beaumont@pixee-medical.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | Knee+ |
|---|---|
| Common Name | Stereotaxic instrument |
| Classification Name | Orthopedic Augmented Reality |
| Regulation Number | 882.4560 |
| Product Code(s) | SBF |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K233899 | Knee+ | OLO |
Device Description Summary 21 CFR 807.92(a)(4)Knee+ is a navigation system dedicated to orthopaedic 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 planes as required during 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 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, a computer and displays intraoperative information to the user. A near-eye display allows the HMD screen when needed.
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.
Indications for Use Comparison
There is no difference between Knee+ and the predicate device with respect to indications and intended purpose as
5
well as clinical performances and ben modified compared to its previous version. Precision and accuracy of the device remain unchanged compared to previous version when measured according to the same methods.
Technological Comparison
21 CFR 807.92(a)(6)
The device subject of this Premarket Notification from the device legally authorized under K233899, also manufactured by Pixee Medical.
Knee+ is substantially equivalent to its previous version cleared under K233899 with the main modifications being:
-
the reintroduction of the possibility to perform mechanical resection level measurement as it was possible in previous version K220104,
-
the modification of two instruments (Orientation mechanism and Cutting guide adaptor from K233899 including the addition of a new material and a new anodization process for the wheels),
-
the addition of voice command as an optional alternative to button selection through accelerometer,
-
the possibility to optionally connect the device to a connectivity module,
-
the addition of a user profile and its associated information (protocol preferences, surgery cases),
-
the redesign of the visual interface
-
the modification of the hip center acquisition constraint (from 10 to 5 acquisitions needed)
-
Flyte surgical helmet (K060713) compatibility of Knee+ with a new reference of surgical helmet and hoods available in the operating room (K200493 Stryker T7)
The main changes as well as other minor changes were assessed through risk management activities, including relevant verification and validation information, produced under design controls procedures. The results 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 (K233899):
-
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.
-
Human factors data were provided, in compliance with the requirements of IEC 62366-1 and FDA guidance "Applying Human 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 Device Software Functions".
-
Cleaning and sterilization process of the reusable instruments was validated to SAL 10-6. Validation was performed in accordance with AAM ST98 and AAM TIR 12 guidances, and for sterilization, in compliance with the half-cycle validation approach outlined in ISO 17665-1, in accordance with the requirements of ISO 17664-1 and FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
-
Biocompatibility testing (cytotoxicity, sensitisty, acute systemic toxicity and iritation) have been performed according to ISO 10993 standard series following instrument modification and confirmed that the patient-contacting materials do not introduce new risks and that the KneeTools instruments were safe and biocompatible.
All performance testing demonstrates that Knee+ performs according to its specifications and functions as intended.
Clinical testing is not applicable.
Knee+ has the same intended use and indications for use that its predicate device (i.e., the most recent cleared version K233899). The prior mentioned modifications do not raise new questions on effectiveness as non-clinical testing performed demonstrated the performance of the device were unchanged and substantially equivalent to its predicate (K233899).