(90 days)
Not Found
No
The description focuses on computer-controlled navigation and infrared tracking, with no mention of AI or ML terms or concepts.
No
The device aids surgeons in implant positioning and intra-operative measurements during knee surgeries; it does not directly treat a disease or condition itself.
No
This device is a surgical navigation system that assists with implant positioning and guiding surgical instruments, rather than diagnosing a condition or disease.
No
The device description explicitly states it consists of a "navigation unit" which includes an "infrared stereo camera" and measures the position and orientation of "NAVItags." These are hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Naviswiss Knee Navigation System is a surgical navigation system used during surgery to assist the surgeon in positioning orthopedic implants. It uses an infrared camera to track the position and orientation of instruments and anatomical structures.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples from the patient. The system operates by tracking physical objects in the surgical field.
- Intended Use: The intended use clearly states that the system is intended to "assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components." This is a surgical assistance tool, not a diagnostic test performed on a biological sample.
Therefore, the Naviswiss Knee Navigation System falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Naviswiss Knee Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system aids the surgeon in performing intra-operative measurements of femoral and tibial alignment axes to assist in executing the distal femoral and proximal tibial resections. The equipment is intended for use by trained surgeons in operating theaters.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Naviswiss Knee is a surgical navigation system which assists the orthopaedic surgeon during the implantation of an artificial knee joint. It consists of a navigation unit which is first used to register the patient's anatomy. Subsequently the navigation system supports the surgeon in guiding the surgical instruments with the implant according to the pre-operative planning.
The navigation unit includes an infrared stereo camera which measures the position and orientation of small NAVItags
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, femoral, tibial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained surgeons in operating theaters.
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
Benchtop Accuracy: The Naviswiss Knee's accuracy was verified using calibrated test fixtures.
Anatomical Phantom Simulated Use and Clinical Accuracy: Simulated use testing was performed on a metallic bone simulator by orthopedic surgeons in THA procedures following a typical workflow. This was assessed by comparing the measurements obtained in the simulated use with known values.
Cadaver Simulated Use: Simulated use testing was performed in multiple cadaver wet labs to validate the Naviswiss Knee Navigation System satisfies clinical use requirements and performed as intended on human specimans when used in an OR environment by trained surgeons.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Benchtop Accuracy: All requirements were met.
Anatomical Phantom Simulated Use and Clinical Accuracy: The test validated that the Navigation System satisfies user needs, intended use, and clinical accuracy requirements.
Cadaver Simulated Use: The system satisfied clinical use requirements and performed as intended.
Clinical Testing: Not Applicable.
Key Results: The testing demonstrated that the Naviswiss Knee is substantially equivalent to the legally marketed predicate devices for its intended use.
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.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.
January 31, 2023
Naviswiss AG % Frederike Bruhschwein-Mandic Senior Consultant confinis AG Hauptstrasse 16 Dudingen, 3186 Switzerland
Re: K223351
Trade/Device Name: Naviswiss Knee Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 2, 2022 Received: November 2, 2022
Dear Frederike Bruhschwein-Mandic:
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.
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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 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-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223351
Device Name Naviswiss Knee
Indications for Use (Describe)
The Naviswiss Knee Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system aids the surgeon in performing intra-operative measurements of femoral and tibial alignment axes to assist in executing the distal femoral and proximal tibial resections. The equipment is intended for use by trained surgeons in operating theaters.
| 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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| Prepared on: 2023-01-31 | |
|---|---|
| ------------------------- | -- |
510(k) Summary Contact Details 21 CFR 807.92(a)(1) Naviswiss AG Applicant Name Applicant Address Stahlrain 2 Brugg 5200 Switzerland Applicant Contact Telephone +41617618537 Applicant Contact Mr. Domenico Romeo Applicant Contact Email domenico.romeo@naviswiss.eu Correspondent Name confinis AG Correspondent Address Hauptstrasse 16 Dudingen 3186 Switzerland +4915201892430 Correspondent Contact Telephone Correspondent Contact Mrs. Frederike Bruhschwein-Mandic Correspondent Contact Email frederike.bruehschwein@confinis.com Device Name 21 CFR 807.92(a)(2) Device Trade Name Naviswiss Knee Common Name Orthopedic stereotaxic instrument Classification Name 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 K193094 Naviswiss Hip OLO K191507 Intellijoint Navigation System OLO Device Description Summary 21 CFR 807.92(a)(4) The Naviswiss Knee is a surgical navigation system which assists the orthopaedic surgeon during the implantation of an artificial knee joint. It consists of a navigation unit which is first used to register the patient's anatomy. Subsequently the navigation system supports the surgeon in guiding the surgical instruments with the implant according to the pre-operative planning.
The navigation unit includes an infrared stereo camera which measures the position and orientation of small NAVItags
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Naviswiss Knee Navigation System is a computer-controlled system intended to assist the surgeon in determining reference
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alignment axes to aid in the positioning of orthopedic implants where a reference to a rigid anatomical structure can be identified. The system aids the surgeon intra-operative measurements of femoral and tibial alignment axes to assist in executing the distal femoral and proximal tibial resections. The equipment is intended for use on in operating theaters.
Indications for Use Comparison
The indications for use are similar in comparison to the primary predicate.
Technological Comparison
The Naviswiss Knee is using the same principle of operation compared to the reference device: using imagefree surgical navigation with a camera and either NAVItags for the Naviswiss devices or Bone Tracker for the reference device. The accuracy of measurement is as accuracte as the primary predicate Naviswiss Hip.
The possibility of a connection to an external monitor via a Wifi module to display the same information as on the navigation unit has been introduced to the Naviswiss Knee. In addition, a tablet can now be used with the Naviswiss Knee to display the same information as on the navigation unit.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Benchtop Accuracy
The Naviswiss Knee's accuracy was verified using calibrated test fixtures. All requirements were met.
Anatomical Phantom Simulated Use and Clinical Accuracy
Simulated use testing was performed on a metallic bone simulator by orthopedic surgeons in THA procedures following a typical workflow. The test validated that the Navigation System satisfies user needs, intended use, and clinical accuracy requirements. This was assessed by comparing the measurements obtained in the simulated use with known values.
Cadaver Simulated Use
Simulated use testing was performed in multiple cadaver wet labs to validate the Naviswiss Knee Navigation System satisfies clinical use requirements and performed as intended on human specimans when used in an OR environment by trained surgeons.
Clinical Testing
Not Applicable.
The testing demonstrated that the Naviswiss Knee is substantially equivalent to the legally marketed predicate devices for its intended use.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
i