(90 days)
Not Found
No
The summary describes an image-guided navigation system using optical tracking and displaying pre-acquired images and tracking information. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on image registration, tracking, and display for surgical guidance.
No.
The device is an image-guided navigation system intended to assist surgeons in precisely locating anatomical structures and placing pedicle screws. It does not directly treat a medical condition but rather aids in surgical procedures.
No
Explanation: The Caduceus S is a surgical navigation system that assists in precisely locating anatomical structures and guiding surgical instruments during percutaneous spine procedures. It provides visual guidance for treatment and does not diagnose medical conditions.
No
The device description explicitly lists multiple hardware components including a Navigation Cart, Navi Tracker, Headset, Minimally Invasive Spine Surgery Instruments, Disposable Passive Spheres, and other disposable surgical consumables. The performance studies also include testing related to hardware aspects like electrical safety, EMC, sterilization, and biological evaluation of materials.
Based on the provided information, the Caduceus S device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Caduceus S Function: The Caduceus S is an image-guided navigation system used during surgical procedures to assist surgeons in precisely locating anatomical structures and guiding instruments. It uses imaging data (CT, C-arm) and optical tracking to provide real-time guidance on the patient's anatomy.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. Its function is entirely focused on providing visual and positional guidance during surgery based on imaging and tracking.
Therefore, the Caduceus S falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Caduceus S is intended as an aid for precisely locating anatomical structures in percutaneous spine procedures. It is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, when reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT or 2D/3D C-arm images of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and lumbosacral spine. Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments. The Headset of the Caduceus S displays 2D stereotaxic screens and a 3D anatomy model (floating). The displayed stereotaxic screens are indicated for correlating the tracked instrument location to the patient registered imagery to assist in percutaneous visualization and trajectory planning.
Product codes
SBF
Device Description
The Caduceus S system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Navigation Cart, Navi Tracker, Headset, Minimally Invasive Spine Surgery Instruments, Disposable Passive Spheres, and other disposable surgical consumables. It uses optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' eyes using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or 2D/3D C-arm images
Anatomical Site
Spine, pelvis, thoracic and lumbosacral spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons, percutaneous computer-assisted spinal surgery.
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 device:
- Performance of the Headset display was demonstrated by verifying the following elements: Resolution, luminance, transmission, distortion, contrast ratio and latency.
- Electrical safety was tested in accordance with IEC 60601-1:2012+A2:2020 and EN 60601-1:2006+A 11:2011+A1:2013 +A 12:2014+A2:2021 - Medical electrical equipments for basic safety and essential performance.
- Electromagnetic Compatibility (EMC) was tested in accordance with IEC 60601-1-2:2014+AMD 1:2020 - Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
- Sterilization validation for the single use conducted in accordance with the ANSI AAM ISO 11135:2014/A1:2018. Additionally, shelf ife and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
- Cleaning and sterilization process of the reusable in SAL 10-6. For steam sterilization, in compliance with the half-cycle validation approach outlined in ISO 17665-1, in accordance with the requirements of ISO 17664 and FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
- Biological evaluation was provided in order to contacting materials do not introduce new risks. The modified instruments are still covered by the testing done according to ISO 10993 series.
- Repeatability and accuracy were tested according to ASTM F2554.
- The system's accuracy was validated in three cadaver studies, in which screws were positioned in the positional and trajectory errors were calculated as the difference between the actual and virtual screw tip position, and the difference between the screw orientation and its recorded virtual trajectory. Additionally, clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing the post-op scans.
- Human factors data were provided. Test participants representing the intended users of the human factor validation testing. Observational data as well as interview data were recorded. The observation of participant performance and the assessment of their understanding of essential interview confirmed that the design of 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 was conducted as required by IEC 62304 and FDA guidance on general principles of software validation, January 11, 2002.
All performance testing demonstrates that the Caduceus S performs according to 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
October 30, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Taiwan Main Orthopaedic Biotechnology Co., Ltd. Jacky Fan Regulatory Affairs Manager 2F., No. 41, Keya Rd., Daya Dist Taichung City, 428015 Taiwan
Re: K242271
Trade/Device Name: Caduceus S Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: SBF Dated: May 2, 2024 Received: August 1, 2024
Dear Jacky Fan:
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" (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).
1
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.
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-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 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).
2
Sincerely,
Tejen D. Soni -S
For
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
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Indications for Use
Submission Number (if known)
K242271
Device Name
Caduceus S
Indications for Use (Describe)
Caduceus S is intended as an aid for precisely locating anatomical structures in percutaneous spine procedures. It is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, when reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT or 2D/3D C-arm images of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and lumbosacral spine. Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments. The Headset of the Caduceus S displays 2D stereotaxic screens and a 3D anatomy model (floating). The displayed stereotaxic screens are indicated for correlating the tracked instrument location to the patient registered imagery to assist in percutaneous visualization and trajectory planning.
Type of Use (Select one or both, as applicable)
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
| 510(k) #: | K242271 | Prepared on: | 2024-08-01 | |
|---|---|---|---|---|
| ----------- | --------- | -- | -------------- | ------------ |
510(k) Summary
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Taiwan Main Orthopaedic Biotechnology Co., Ltd. |
| Applicant Address | 2F., No. 41, Keya Rd., Daya Dist., Taichung City 428015, Taiwan |
| (R.O.C.) Taichung City 428015 Taiwan | |
| Applicant Contact Telephone | +886-4-25652818 |
| Applicant Contact | Mr. Jacky Fan |
| Applicant Contact Email | tbk.jacky@surglasses.com |
Device Name
| 21 CFR 807.92(a)(2) | |
|---|---|
| Device Trade Name | Caduceus S |
| Common Name | Stereotaxic instrument |
| Classification Name | Orthopedic Stereotaxic Instrument |
| 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 |
| K183605 | Spine & Trauma Navigation | OLO |
Device Description Summary
| 21 CFR 807.92(a)(4) | |
|---|---|
| -- | --------------------- |
The Caduceus S system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately,
during percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Navigation Cart, Navi Tracker,
Headset, Minimally Invasive Spine Surgery Instruments, Disposable Passive Spheres, and other disposable surgical consumables. It uses
optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired
intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information,
are projected to the surgeons' eyes using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and
the navigation data at the same time.
Intended Use/Indications for Use
| 21 CFR 807.92(a)(5) | |
|---|---|
| -- | --------------------- |
Caduceus S is intended as an aid for precisely locating anatomical structures in percutaneous spine procedures. It is indicated for
medical conditions in which the use of stereotactic surgery may be appropriate, when reference to a rigid anatomical structure, such as
the spine or pelvis, can be identified relative to CT or 2D/3D C-arm images of the anatomy. This can include the spinal implant
procedures, such as Posterior Pedicle Screw Placement in the thoracic and lumbosacral spine. Caduceus S offers pedicle screw implant
size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments. The Headset of the
Caduceus S displays 2D stereotaxic screens and a 3D anatomy model (floating). The displayed stereotaxic screens are indicated for
correlating the tracked instrument location to the patient registered imagery to assist in percutaneous visualization and trajectory
planning
Indications for Use Comparison
| 21 CFR 807.92(a)(5) | |
|---|---|
| -- | --------------------- |
The subject device expanded indication for use for placing screws in additional spine segments.
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This change does not alter the intended use of the device for its use as an aid in localization during spine surgery. Therefore,Caduceus S System is substantially equivalent in terms of intended use / indications for use.
Technological Comparison
21 CFR 807.92(a)(6)
The modified Caduceus S System is similar in its technological features to its cleared Caduceus S System. Both systems include very similar hardware and software components: software, Headset with optical tracking camera, Disposable Passive Spheres point, and Instrument universal adaptors. The Headset in both systems is positioned on the surgeon's head and is designed to provide 2D and stereoscopic 3D augmented reality (AR) display with overlaid naviqation information, onto patient's anatomy. The software in both systems is designed for real time calculation and display of the spatial position of the tip of the surgical instruments relative to patient's anatomy. Although there should be some different specifications among these devices, the tests performed on subject device demonstrate equivalent safety and effectiveness.".Both systems follow similar fundamental principles of operation.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following testing was conducted to evaluate the device:
· Performance of the Headset display was demonstrated by verifying the following elements: Resolution, luminance, transmission, distortion, contrast ratio and latency.
-Electrical safety was tested in accordance with IEC 60601-1:2012+A2:2020 and EN 60601-1:2006+A 11:2011+A1:2013 +A 12:2014+A2:2021 - Medical electrical equipments for basic safety and essential performance.
· Electromagnetic Compatibility (EMC) was tested in accordance with IEC 60601-1-2:2014+AMD 1:2020 - Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
• Sterilization validation for the single use conducted in accordance with the ANSI AAM ISO 11135:2014/A1:2018. Additionally, shelf ife and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
· Cleaning and sterilization process of the reusable in SAL 10-6. For steam sterilization, in compliance with the half-cycle validation approach outlined in ISO 17665-1, in accordance with the requirements of ISO 17664 and FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
· Biological evaluation was provided in order to contacting materials do not introduce new risks. The modified instruments are still covered by the testing done according to ISO 10993 series.
·Repeatability and accuracy were tested according to ASTM F2554.
•The system's accuracy was validated in three cadaver studies, in which screws were positioned in the positional and trajectory errors were calculated as the difference between the actual and virtual screw tip position, and the difference between the screw orientation and its recorded virtual trajectory. Additionally, clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing the post-op scans.
• Human factors data were provided. Test participants representing the intended users of the human factor validation testing. Observational data as well as interview data were recorded. The observation of participant performance and the assessment of their understanding of essential interview confirmed that the design of 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 was conducted as required by IEC 62304 and FDA guidance on general principles of software validation, January 11, 2002.
All performance testing demonstrates that the Caduceus S performs according to specifications and functions as intended.
The Caduceus S is substantially equivalent to its predicate, the cleared Caduceus S. Both systems have intended use, technological characteristics, and principles of operation. The expanded indications do not alter the intended surgical use of the device and do not affect its safety and effectiveness when used as labeled. None of the minor differences in technology raise new types of safety or effectiveness questions. Performance data demonstrated that the Caduceus S functions as intended.