(291 days)
No
The summary describes a traditional image-guided navigation system based on optical tracking and registration, with no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an intraoperative guidance system that assists surgeons in navigation during spine surgery. It tracks instruments and registers them with patient images to provide guidance but does not directly treat or diagnose a disease state.
No
The device is described as an "intraoperative guidance system" and a "surgical navigation system" used to enable minimally invasive surgery by tracking instruments in relation to patient imagery. This functionality supports surgical procedures rather than diagnosing medical conditions.
No
The device description explicitly lists numerous hardware components (Navi Tracker, Surglasses, Navigation Cart, Touch Screen, Router, Control System, Connection System, disposable and reusable tools) in addition to the software.
Based on the provided information, the Caduceus S device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Caduceus S is an "intraoperative guidance system to enable minimally invasive surgery." It tracks surgical instruments and provides navigation based on medical images. This is a surgical guidance system, not a diagnostic test performed on samples from the human body.
- Device Description: The description details hardware and software for tracking and navigation during surgery. It does not mention any components or processes related to analyzing biological samples (blood, tissue, etc.) for diagnostic purposes.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The Caduceus S does not perform any such analysis.
The Caduceus S is a surgical navigation system, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / 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.
Product codes
OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or intraoperatively C-arm
Anatomical Site
rigid bone structures, L5~T6 spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
System's accuracy: The System Level Accuracy was also validated in a cadaver study, in which pedicle screws were positioned percutaneously in L5~T6 spine, using the Navi Clamp Kit as the rigid reference point. The positional error was calculated as the difference between the actual screw tip position, derived from the post-op scan, and its virtual tip, as recorded by the Caduceus S system. The trajectory error was calculated as the difference between the screw orientation and its recorded virtual trajectory. An overall mean positional error of 1.91mm (99% UBL = 2.07 mm) and angular error of 1.59 (99% UBL = 1.71) was measured under CT mode and overall mean positional error of 1.80mm (99% UBL = 2.06 mm) and angular error of 1.65 (99% UBL = 1.80) was measured under C-arm mode. Thus, the system has demonstrated performance in 3D positional accuracy with a mean error statistically significantly lower than 3mm and in trajectory angle accuracy with a mean error statistically significantly lower than 3 degrees, both in phantom and cadaver studies.
Key Metrics
System Level Accuracy with a mean positional error of 2.0 mm and mean trajectory error of 2°.
An overall mean positional error of 1.91mm (99% UBL = 2.07 mm) and angular error of 1.59 (99% UBL = 1.71) was measured under CT mode and overall mean positional error of 1.80mm (99% UBL = 2.06 mm) and angular error of 1.65 (99% UBL = 1.80) was measured under C-arm mode.
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
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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Indications for Use
510(k) Number (if known)
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)
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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 | |
| (R.O.C.) | ||
| Phone: | +886-4-3707-3159 | |
| Fax: | +886-4-2565-3330 | |
| 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 |
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| 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
Determination |
|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | Caduceus S | Spine & Trauma Navigation | xvision Spine system (XVS) | |
| 510(k) No. | | K183605 | K190929 | |
| 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 | Spine & Trauma 3D is intended as an
intraoperative image-guided
localization system to enable
minimally invasive surgery. It links a
freehand probe, tracked by a passive
marker sensor system to virtual
computer image space on a patient's
preoperative or Intraoperative 2D or
3D image data.
Spine & Trauma 3D enables computer-
assisted navigation of medical image
data, which can either be acquired
preoperatively or inter-operatively by
an appropriate image acquisition
system.
The software offers screw implant size
planning and navigation on rigid
bone structures with precalibrated and | The xvision Spine System, with
xvision Spine System Software, is
intended as an aid for precisely
locating anatomical structures in
either open or percutaneous spine
procedures. Their use is indicated
for any medical condition in which
the use of stereotactic surgery may
be appropriate, and where
reference to a rigid anatomical
structure, such as the spine, can be
identified relative to CT imagery
of the anatomy. This can include the
spinal implant procedures, such as
Posterior Pedicle Screw Placement
in the thoracic and sacro-lumbar
region.
The Headset of the xvision Spine | Equivalent
Both the subject and
predicate devices are an
intraoperative image-guided
localization system to enable
minimally invasive surgery
and the subject device is
focus on spine surgery.
Both the subject and
reference devices display the
image by a headset and a
screen.
Although there are some
technical differences among
these devices, the subject
device is tested and |
| | intraoperatively
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,
monitor and tracking cameras | • Platform including cart, computer,
monitor and tracking cameras | • Headset with near eye
see-through display | Equivalent |
| Main Component | • Headset with near eye see-through | • Software application | • tracking camera | subject device is
composed of headset as the |
| | display
Navi tracker
Software application
Reflective markers - Spheres
Instrument universal adaptors | Reflective markers - Spheres
Accessories (Instrument adaptors,
referencing system) | Software application
Reflective markers - Flat
Instrument universal adaptors
Reference point | reference device does, and
the rest components are
similar with that of the
predicate device.
Although the main
component is slightly
different among these
devices, the subject device is |
| | Patient Preparation
System Set-up | Patient Preparation
System Set-up | Patient Preparation
System Set-up | tested and validated so that
the difference does not raise
new issues of SE.
Equivalent |
| Modes of
Operation | Intraoperative scan
Scan Import
Planning
Patient Registration
Navigation | Intraoperative scan
Scan Import
Planning
Patient Registration
Navigation | Intraoperative scan
Scan Import
Patient Registration
Navigation | The modes of operation are
the same between subject
and predicate devices. |
| Localization
Technology | Optical | Optical | Optical | Same |
| Optical Tracker | Two infrared cameras, positioned 1.3 ~
2 m away from tracked objects | Two infrared cameras, positioned 2 ~
3 m away from tracked objects | Single infrared camera, positioned
0.5m above tracked objects | Equivalent
The number of tracking
cameras is the same between
subject and predicate |
| | | | | |
| | | | | devices.
Although the positioning
distance is slightly different
among these devices, the
subject device is tested and
validated so that the
difference does not raise
new issues of SE. |
| Tracking of
Rotational Motion | 6 degrees of freedom (DOF) | 6 degrees of freedom (DOF) | 6 degrees of freedom (DOF) | Same |
| | | | | Equivalent |
| | Triangulation | Triangulation | Perspective N-point | The tracking algorithm is the |
| | | | | same between subject and |
| | | | | predicate devices, and it is |
| Tracking
Algorithm | | | | compared on the headset
between subject and
reference devices. |
| | | | | The difference does not raise
new issues of SE. |
| System Accuracy
Requirement | System Level Accuracy with a mean
positional error of 2.0 mm and mean
trajectory error of 2° | System Level Accuracy with a mean
positional error of 2.0 mm and mean
trajectory error of 2° | System Level Accuracy with a
mean positional error of 2.0 mm
and mean trajectory error of 2° | Same |
| Imaging Modality | X-Ray Based Imaging | X-Ray Based Imaging | X-Ray Based Imaging | Same |
| Item | Subject Device | Predicate Device | Reference Device | Substantial Equivalence
Determination |
| Proprietary Name | Caduceus S | Spine & Trauma Navigation | xvision Spine system (XVS) | |
| 510(k) No. | | K183605 | K190929 | |
| Display Features | 2D images: axial and sagittal
3D model
Trajectories
Trajectory guidance
Instrument's tip view
3D transparent
3D OFF (only 2D)
3D follow instrument movement | Look Sideways 3D
Anatomic Orthogonal
Trajectory 1 and 2
Trajectory Guidance
Look Ahead
Probe's Eye
AP and Lateral
Synthetic AP and Lateral
Maximum Intensity
Projection
Video Input | 2D images: axial and sagittal
3D model
Trajectories
Trajectory guidance
Instrument's tip view
3D transparent
3D OFF (only 2D)
3D follow instrument movement | Equivalent
The display features are the
same between subject and
reference devices. |
| Software Interface
(GUI) | Black and gray style with procedure
task overview in a menu. Software
controls for images, instrument and
planned trajectory management are
contained in a left side bar. | Black and gray style with procedure
task overview in left menu option and
next/back task flow at bottom of the
screen. Software controls for images,
planning and instrument management
are contained in a right side bar. | Black and blue style with
procedure task overview in a menu
and next/back task flow. Software
controls for images, instrument and
planned trajectory
management. | Equivalent
Although the design of
software interface is slightly
different among these
devices, the subject device is
tested and validated so that
the difference does not raise
new issues of SE. |
| Display and | Augmented Reality using near eye | Data displayed on a monitor | Augmented Reality using near eye | Equivalent |
| Optics
Technology | see-through display; data displayed on patient's anatomy. | | see-through display; data displayed on patient's anatomy. | The display technology is the same between subject and reference devices. |
| Frame rate of
displayed images | 60 fps | (not revealed) | 60 fps | Equivalent
The frame rate is the same between subject and reference devices. |
| Headset power
source | Li-ion rechargeable battery | (no headset) | Li-ion rechargeable battery | Equivalent
The frame rate is the same between subject and reference devices. |
| Communication
between Scanner
and platform/
computer | CD 、DVD 、USB
DCIOM Import | Network Connectivity
CD 、DVD 、USB
DCIOM Import
DCIOM Export | USB & LAN connectivity using
DICOM | Equivalent
Although the communication way between scanner and computer is slightly different among these devices, the subject device is tested and validated so that the difference does not raise new issues of SE. |
| Communication
between Headset
and computer | Wireless, encrypted | (no headset) | Wireless, encrypted | Equivalent
The communication way between headset and |
| Caduceus S | | Traditional 510(k) Summary | | |
| Applications | C-arm Imaging System
CT Imaging System | (not revealed) | O-arm Imaging System
Ziehm Vision FD Vario 3D
C-Arm and RFD 3D Siemens
CIOS SPin
Airo system by Brainlab | computer is the same
between subject and
reference devices.
Equivalent
Although the application is
slightly different among
these devices, the subject
device is tested and
validated so that the
difference does not raise
new issues of SE. |
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11
Traditional 510(k) Summary
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
5.10 Similarity and Difference
The Caduceus S has been compared with predicate device "Spine & Trauma Navigation" and reference device "xvision Spine system". The subject device has same intended use, principle of operation and similar technological characteristics as the predicate and reference devices. The subject device has undergone safety and the results complied with the test requests.
Although there are some different specifications between these devices, the performance test has been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. Therefore, the difference among the subject, predicate and reference devices did not raise of substantial equivalence. The subject device is substantially equivalent to the predicate and reference devices in intended use, design and performance claims.
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5.11 Summary of Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, Caduceus S.
| Test | Conclusion | Main Reference |
|---|---|---|
| General design | ||
| requirements and risk | ||
| analysis | Verification of general design requirements is successful, | |
| and risk control measures are effective and mitigate the | ||
| associated risks. | ISO 14971 | |
| Sterilization Validation | ||
| for EO sterile surgical | ||
| instruments | The testing of device safety for sterilization as well as | |
| validation is successful, and all requirements are met. | ISO 11135; | |
| ISO 10993-7; | ||
| ISO 11737-1; | ||
| ISO 11737-2 | ||
| Reliability Test | ||
| for electrical hardware | The testing of general device function in critical | |
| environment is successful, and all requirements are met. | N/A | |
| Shelf Life Test for EO | ||
| sterile surgical instruments | The testing of device safety for shelf life of sterile | |
| package is successful, and all requirements are met. | ASTM F1980; | |
| ASTM F1886 / F1886M; | ||
| ASTM F1140 / F1140M; | ||
| ASTM F1929; | ||
| ASTM F88 / F88M | ||
| Biocompatibility Tests | ||
| for surgical instruments | The testing of device safety for biocompatibility is | |
| successful, and all requirements are met. | ISO 10993-1 and the | |
| subsequent standards; | ||
| FDA Guidance for Use of | ||
| International Standard ISO | ||
| 10993-1. | ||
| Software Validation | The testing of software validation is successful, including | |
| unit and integration tests, and all requirements are met. | IEC 62304; | |
| FDA Guidance for the Content | ||
| of Premarket Submissions for | ||
| Software Contained in Medical | ||
| Devices | ||
| Cybersecurity Evaluation | The evaluation of device demonstrates the positive | |
| cybersecurity under the expected using environment, and | ||
| all requirements are met. | FDA Guidance for the Content | |
| of Premarket Submissions for | ||
| Management of Cybersecurity in | ||
| Medical Devices | ||
| Test | Conclusion | Main Reference |
| Electromagnetic | ||
| Compatibility and | ||
| Electrical Safety Tests | ||
| for electrical hardware | The testing of device EMC & Electrical safety is | |
| successful, and all requirements are met. | IEC / EN 60601-1; | |
| IEC / EN 60601-1-2; | ||
| FDA Guidance for Information | ||
| to Support a Claim of | ||
| Electromagnetic Compatibility | ||
| (EMC) of Electrically-Powered | ||
| Medical Devices. | ||
| Wireless Coexistence | ||
| Evaluation | The evaluation of device demonstrates the positive | |
| wireless coexistence under the expected using | ||
| environment, and all requirements are met. | AAMI TIR 69; | |
| ANSI IEEE C63.27; | ||
| FDA Guidance for Radio | ||
| Frequency Wireless Technology | ||
| in Medical Devices. | ||
| Performance on the head | ||
| mounted display | The testing of device intended performance is | |
| successful, and all requirements are met. | Field of View(FOV),resolution, | |
| luminance, transmission, | ||
| distortion, contrast ratio, | ||
| latency | ||
| System's accuracy | The System Level Accuracy was also validated in a | |
| cadaver study, in which pedicle screws were positioned | ||
| percutaneously in L5~T6 spine, using the Navi Clamp | ||
| Kit as the rigid reference point. | IEC 63145-20-20; | |
| ASTM F2554; | ||
| IEC 62366-1; | ||
| Performance and Usability | ||
| of device intended use | The positional error was calculated as the difference | |
| between the actual screw tip position, derived from the | ||
| post-op scan, and its virtual tip, as recorded by the | ||
| Caduceus S system. The trajectory error was calculated | ||
| as the difference between the screw orientation and its | ||
| recorded virtual trajectory. | ||
| An overall mean positional error of 1.91mm (99% | ||
| UBL*= $2.07$ mm) and angular error of 1.59 (99% | ||
| UBL*= $1.71$ ) was measured under CT mode and overall | ||
| mean positional error of 1.80mm (99% | ||
| UBL*= $2.06$ mm) and angular error of 1.65 (99% | ||
| UBL*= $1.80$ ) was measured under C-arm mode. | ||
| Thus, the system has demonstrated performance in 3D | ||
| positional accuracy with a mean error statistically | FDA Guidance for Applying | |
| Human Factors and Usability | ||
| Engineering to Medical Devices. |
13
14
| Taiwan Main Orthopaedic Biotechnology Co., Ltd. | Traditional 510(k) Summary |
|---|---|
| Caduceus S | |
| significantly lower than 3mm and in trajectory angle | |
| accuracy with a mean error statistically significantly | |
| lower than 3 degrees, both in phantom and cadaver | |
| studies. |
All the test results demonstrate Caduceus S meets the requirements of its pre-defined acceptance criteria and intended use, and performs as safely and effectively as predicate and reference devices.
5.12 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
5.13 Conclusion
After comparing the devices and analyzing non-clinical safety & performance testing data, it can be concluded that the Caduceus S is substantially equivalent to the predicate and reference devices.