Caduceus S

K220554 · Taiwan Main Orthopaedic Biotechnology Co., Ltd. · SBF · Dec 16, 2022 · Neurology

Device Facts

• Record ID: K220554
• Device Name: Caduceus S
• Applicant: Taiwan Main Orthopaedic Biotechnology Co., Ltd.
• Product Code: SBF · Neurology
• Decision Date: Dec 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Caduceus S is intended as an intraoperative guidance system to enable minimally invasive surgery. Intraoperatively registered surgical Instruments are tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data. Caduceus S enables image-guide navigation of medical image data, which can either be acquired preoperatively CT or intraoperatively C-arm by an appropriate image acquisition system. Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments. Caduceus S is indicated for L5~T6 spine surgery where reference to a rigid anatomical structure can be identified relative to the acquired patient imagery (CT or C-arm). The headset (Surglasses) of the Caduceus S system is an optional heads up display that projects the 2D stereotaxic screens of the system's display.

Device Story

Caduceus S is an optical surgical navigation system for spine surgery; tracks surgical instruments and patient anatomy using passive marker sensors; registers instruments to preoperative CT or intraoperative C-arm images. System components include navigation cart, touch screen, and optional 'Surglasses' head-mounted display (HMD) for augmented reality visualization. Operates in the OR; used by surgeons to plan and navigate pedicle screw placement. Inputs include patient image data and real-time optical tracking signals; transforms inputs via software to display instrument position and trajectory relative to anatomy on HMD or monitor. Provides visual guidance to assist in accurate screw placement; potentially improves surgical precision and reduces invasiveness.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via phantom and cadaver studies (L5-T6 spine). Accuracy metrics: CT mode mean positional error 1.91mm (99% UBL 2.07mm), angular error 1.59° (99% UBL 1.71°); C-arm mode mean positional error 1.80mm (99% UBL 2.06mm), angular error 1.65° (99% UBL 1.80°). All results statistically significantly lower than 3mm/3° thresholds.

Technological Characteristics

Optical tracking system using two infrared cameras (1.3-2m range). 6-DOF tracking via passive reflective spheres. Components: navigation cart, touch screen, HMD (Surglasses), disposable/reusable tools. Connectivity: DICOM import via CD/DVD/USB. Power: Li-ion battery for HMD. Software: Spine Navigation Software. Sterilization: EO for surgical instruments. Standards: ISO 14971, ISO 11135, ISO 10993, IEC 62304, IEC 60601-1.

Indications for Use

Indicated for L5~T6 spine surgery in patients where reference to a rigid anatomical structure can be identified relative to acquired CT or C-arm imagery for minimally invasive surgery.

Regulatory Classification

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.

Predicate Devices

• Spine & Trauma Navigation (K183605)

Reference Devices

• xvision Spine system (XVS) (K190929)

Submission Summary (Full Text)

{0}------------------------------------------------

December 16, 2022

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 letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Taiwan Main Orthopaedic Biotechnology Co., Ltd. Min-Liang Wang, CEO 1F., No. 46, Keya Rd., Daya Dist. Taichung City, 42881 Tw

### Re: K220554

Trade/Device Name: Caduceus S Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: November 30, 2022 Received: November 30, 2022

### Dear Min-Liang Wang:

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 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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Jesse Muir -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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

K220554

Device Name Caduceus S

### Indications for Use (Describe)

Caduceus S is intended as an intraoperative gudance system to enable minimally invasive surgery. Intraoperatively registered surgical Instruments are tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.

Caduceus S enables image-guide navigation of medical image data, which can either be acquired preoperatively CT or intraoperatively C-arm by an appropriate image acquisition system.

Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments.

Caduceus S is indicated for L5~T6 spine surgery where reference to a rigid anatomical structure can be identified relative to the acquired patient imagery (CT or C-arm).

The headset (Surglasses) of the Caduceus S system is an optional heads up display that projects the 2D stereotaxic screens of the system's display.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X 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 [e-mail]

"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."

{3}------------------------------------------------

Traditional 510(k) Summary

# K220554 510(k) SUMMARY

| 5.1 | Type of Submission: | Traditional |
|-----|---------------------|--------------------------------------------------------------------------|
| 5.2 | Date of Summary: | February 25, 2022 |
| 5.3 | Submitter: | Taiwan Main Orthopaedic Biotechnology Co., Ltd. |
| | Address: | 1F., No. 46, Keya Rd., Daya Dist., Taichung City 428, Taiwan<br>(R.O.C.) |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | Contact: | Jacky Fan (Regulatory Affair) |

#### 5.4 Identification of the Device:

| Proprietary/Trade name: | Caduceus S |
|------------------------------|------------------------|
| Classification Product Code: | OLO |
| Regulation Number: | 882.4560 |
| Regulation Description: | Stereotaxic instrument |
| Review Panel: | Orthopedic |
| Device Class: | II |
| Basis for the Submission: | New Device |

#### ર્ રંડ Identificationof the Predicate Device:

| Predicate Device Name: | Spine & Trauma Navigation |
|------------------------------|---------------------------|
| Submitter: | Brainlab AG |
| Classification Product Code: | OLO |
| Regulation number: | 882.4560 |
| Device Class: | II |
| 510(k) Number: | K183605 |

#### 5.6 Identificationof the Reference Device:

| Reference Device Name: | xvision Spine system (XVS) |
|------------------------------|----------------------------|
| Submitter: | Augmedics Ltd. |
| Classification Product Code: | OLO |

{4}------------------------------------------------

| Regulation number: | 882.4560 |
|--------------------|----------|
| Device Class: | II |
| 510(k) Number: | K190929 |

### 5.7 Indications for Use

Caduceus S is intended as an intraoperative guidance system to enable minimally invasive surgery. Intraoperatively registered surgical Instruments are tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.

Caduceus S enables image-guide navigation of medical image data, which can either be acquired preoperatively CT or intraoperatively C-arm by an appropriate image acquisition system.

Caduceus S offers pedicle screw implant size planning and navigation on rigid bone structures with intraoperatively registered surgical Instruments.

Caduceus S is indicated for L5~T6 spine surgery where reference to a rigid anatomical structure can be identified relative to the acquired patient imagery (CT or C-arm).

The headset (Surglasses) of the Caduceus S system is an optional heads up display that projects the 2D stereotaxic screens of the system's display.

### 5.8 Device Description

Caduceus S surgical navigation system is an image guidance system, which is composed of Navi Tracker, Surglasses, other hardware (Navigation Cart with an arm, Touch Screen, Router, Control System, Connection System), disposable tools (Disposable Passive Sphere, Straight Guide Pin, Navi Clamp Kit, Instrument Adapter Type A&B, Calibration Plate, Registration Kit, Correction Tool), reusable tools (Calibration Board, Instrument Holder), and Spine Navigation Software. Caduceus S is an optical tracking and guiding system for spine surgery. It can track the marks on the surgical instruments and patient's anatomical structure with marks, and register with the preoperative or intraoperative images of the patients. During the surgery, it can be displayed on the Touch Screen and the head mounted display Surglasses to provide the navigation for the surgical instruments.

{5}------------------------------------------------

### Traditional 510(k) Summary

# 5.9 Substantial Equivalence Determination

Equivalence, same and difference among the subject, predicate and reference devices are cited as below.

| Item | Subject Device | Predicate Device | Reference Device | Substantial Equivalence<br>Determination |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | Caduceus S | Spine & Trauma Navigation | xvision Spine system (XVS) | |
| 510(k) No. | | K183605 | K190929 | |
| Indications for<br>Use | Caduceus S is intended as an<br>intraoperative guidance system to<br>enable minimally invasive surgery.<br>Intraoperatively registered surgical<br>Instruments are tracked by a passive<br>marker sensor system to virtual<br>computer image space on a patient's<br>preoperative or intraoperative 2D or 3D<br>image data.<br>Caduceus S enables image-guide<br>navigation of medical image data,<br>which can either be acquired<br>preoperatively CT or intraoperatively<br>C-arm by an appropriate image<br>acquisition system.<br>Caduceus S offers pedicle screw<br>implant size planning and navigation<br>on rigid bone structures with | Spine & Trauma 3D is intended as an<br>intraoperative image-guided<br>localization system to enable<br>minimally invasive surgery. It links a<br>freehand probe, tracked by a passive<br>marker sensor system to virtual<br>computer image space on a patient's<br>preoperative or Intraoperative 2D or<br>3D image data.<br>Spine & Trauma 3D enables computer-<br>assisted navigation of medical image<br>data, which can either be acquired<br>preoperatively or inter-operatively by<br>an appropriate image acquisition<br>system.<br>The software offers screw implant size<br>planning and navigation on rigid<br>bone structures with precalibrated and | The xvision Spine System, with<br>xvision Spine System Software, is<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous spine<br>procedures. Their use is indicated<br>for any medical condition in which<br>the use of stereotactic surgery may<br>be appropriate, and where<br>reference to a rigid anatomical<br>structure, such as the spine, can be<br>identified relative to CT imagery<br>of the anatomy. This can include the<br>spinal implant procedures, such as<br>Posterior Pedicle Screw Placement<br>in the thoracic and sacro-lumbar<br>region.<br>The Headset of the xvision Spine | Equivalent<br>Both the subject and<br>predicate devices are an<br>intraoperative image-guided<br>localization system to enable<br>minimally invasive surgery<br>and the subject device is<br>focus on spine surgery.<br>Both the subject and<br>reference devices display the<br>image by a headset and a<br>screen.<br>Although there are some<br>technical differences among<br>these devices, the subject<br>device is tested and |
| | intraoperatively<br>registered surgical | additional | individually-calibrated System displays 2D stereotaxic | validated so that the |
| | Instruments. | surgical tools. The system is indicated | screens and a virtual anatomy | difference does not raise |
| | Caduceus S is indicated for L5~T6 for any medical condition in which the | | screen. The stereotaxic screen is | new issues of SE. |
| | spine surgery where reference to a rigid | use of stereotactic surgery may be | indicated for correlating the | |
| | anatomical structure can be identified | appropriate and where a reference to a | tracked instrument location to the | |
| | relative to the acquired patient imagery | rigid anatomical structure, such as the | registered patient imagery. The | |
| | (CT or C-arm). | skull, the pelvis, a long bone or | virtual screen is indicated for | |
| | The headset (Surglasses) of the | vertebra can be identified relative to | displaying the virtual instrument | |
| | Caduceus S system is an optional heads | the acquired image (CT, MR, 2D | location in relation to the virtual | |
| | up display that projects the 2D | fluoroscopic image or 3D fluoroscopic | anatomy to assist in percutaneous | |
| | stereotaxic screens of the system's | image reconstruction) and/or an image | visualization and trajectory | |
| | display. | data based model of the anatomy. | planning. | |
| | | | The virtual display should not be | |
| | | | relied upon solely for absolute | |
| | | | positional information and should | |
| | | | always be used in conjunction with | |
| | | | the displayed stereotaxic | |
| | | | information. | |
| Type of Use | Prescription Use | Prescription Use | Prescription Use | Same |
| Use Environment | Operating Room | Operating Room | Operating Room | Same |
| | • Platform including cart, computer,<br>monitor and tracking cameras | • Platform including cart, computer,<br>monitor and tracking cameras | • Headset with near eye<br>see-through display | Equivalent |
| Main Component | • Headset with near eye see-through | • Software application | • tracking camera | subject device is<br>composed of headset as the |
| | display<br>Navi tracker<br>Software application<br>Reflective markers - Spheres<br>Instrument universal adaptors | Reflective markers - Spheres<br>Accessories (Instrument adaptors,<br>referencing system) | Software application<br>Reflective markers - Flat<br>Instrument universal adaptors<br>Reference point | reference device does, and<br>the rest components are<br>similar with that of the<br>predicate device.<br>Although the main<br>component is slightly<br>different among these<br>devices, the subject device is |
| | Patient Preparation<br>System Set-up | Patient Preparation<br>System Set-up…