(182 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The technology described is standard image-guided navigation using optical tracking and image registration.
No.
The device is described as a "planning and intraoperative guidance system" that helps surgeons with precise positioning of instruments and implants, rather than directly treating a condition or restoring function itself.
No
Explanation: The device is described as a surgical navigation and guidance system, not a device used to diagnose medical conditions or diseases. Its purpose is to aid surgeons during procedures by providing real-time positioning and guidance, based on pre-existing or intraoperative images.
No
The device description explicitly states that the system is comprised of a platform, clinical software, surgical instruments, and a referencing system, and mentions testing for electrical safety and electromagnetic compatibility, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "precise positioning of surgical instruments or spinal implants during general spinal surgery." This describes a device used during a surgical procedure to guide the surgeon, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description reinforces this by stating it's an "Image Guided System" that "helps guide surgeons during spine procedures."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), providing diagnostic results, or being used for screening, diagnosis, or monitoring of diseases based on in vitro analysis.
The device is a surgical navigation system, which is a type of medical device used to assist surgeons during procedures.
N/A
Intended Use / Indications for Use
The Remex Spine Surgery Navigation System II, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery by means of registering intraoperative 2D fluoroscopic projections to pre-operative 3D CT imagery.
Example procedures include:
Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Remex Spine Surgery Navigation System II, also known as an Image Guided System, is comprised of a platform, clinical software, surgical instruments, and a referencing system. The system uses wireless optical tracking technology to track the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The system helps guide surgeons during spine procedures such as spinal fusion. The software functionality in terms of its feature sets are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic or CT imagery, intraoperative 2D fluoroscopic projections, pre-operative 3D CT imagery
Anatomical Site
rigid anatomical structure, such as the vertebra, lumbar region
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Software is verified and validated in accordance with FDA guidance for the content of premarket submissions for software contained in medical devices issued on May 11, 2005 and IEC 62304.
Electrical safety of the system is complied with the requirements of ANSI/AAMI ES60601-1:2015/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.
Electromagnetic compatibility of the system is complied with the requirements of IEC 60601-1-2:2014 and IEC/TR 60601-4-2.
Positional accuracy of the system is evaluated in accordance with ASTM F2554-18.
The effectiveness of all risk control measures is verified in accordance with ISO 14971:2007.
The design output fulfills all design input requirements.
All existing predicate data previously provided in the predicate 510(k) submission is still applicable, except for the risk assessment and design verification require to re-evaluate. However, the newly added image calibrator and assembly kit share the same testing method as the predicate device and the results of the testing are all pass. Furthermore, the modification of the hardware does not change the operation process of the system as per the User Manual. Therefore, REMEX believes design verification testing demonstrated that the subject devices are substantially equivalent to the predicate devices. Design validation has also been performed and demonstrated that the subject devices performed as intended.
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).
0
May 1, 2024
Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Remex Medical Corp. Wang Cheng-Hsiung Quality Representative 4F., No. 9, Jingke Road, Nantun Dist. Taichung, 408209 Taiwan
Re: K233513
Trade/Device Name: Remex Spine Surgery Navigation System II Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 1, 2024 Received: April 1, 2024
Dear Wang Cheng-Hsiung:
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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Remex Spine Surgery Navigation System II
Indications for Use (Describe)
The Remex Spine Surgery Navigation System II, is indicated for precise positioning of surgical instruments or spinal implants during general spinal surgery when reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a patient's fluoroscopic or CT imagery. It is intended as a planning and intraoperative quidance system to enable open or percutaneous image quided surgery by means of registering intraoperative 2D fluoroscopic projections to preoperative 3D CT imagery.
Example procedures include:
Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the word "REMEX" in a light gray color. The letter "R" has a green accent mark on the bottom left side. The letters are in a sans-serif font and are slightly blurred, giving the image a soft focus. The background is plain white.
Remex Medical Corporation 4F, No. 9, Jingke Road, Nantun District, Taichung City408209, Taiwan
Submitted By REMEX MEDICAL CORP. 4F., No.9 Jingke Rd., Nantun District, Taichung, TW 408209 Tel. +886-4-23595336 Fax.+886-4-23598875 Contact Person Chegn-Hsiung Wang Kevin816@mail.intai.com.tw Date Prepared May 1, 2024 Device Name Remex Spine Surgery Navigation System II Classification Name Stereotaxic instrument Regulation Number 882.4560 Product Codes OLO Device Class Class II Predicate Devices K230738, Anatase Spine Surgery Navigation System (primary) Information K220348, Anatase Spine Surgery Navigation System K180523, INTAI Surgery Navigation System
510(k) Summary
| Device Description | The Remex Spine Surgery Navigation System II, also known as an Image Guided
System, is comprised of a platform, clinical software, surgical instruments, and
a referencing system. The system uses wireless optical tracking technology to
track the position of instruments in relation to the surgical anatomy and
identifies this position on diagnostic or intraoperative images of a patient. The
system helps guide surgeons during spine procedures such as spinal fusion. The
software functionality in terms of its feature sets are categorized as imaging
modalities, registration, planning, interfaces with medical devices, and views. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Remex Spine Surgery Navigation System II, is indicated for precise
positioning of surgical instruments or spinal implants during general spinal
surgery when reference to a rigid anatomical structure, such as the vertebra,
can be identified relative to a patient's fluoroscopic or CT imagery. It is
intended as a planning and intraoperative guidance system to enable open or
percutaneous image guided surgery by means of registering intraoperative 2D
fluoroscopic projections to pre-operative 3D CT imagery.
Example procedures include:
Posterior-approach spinal implant procedures, such as pedicle screw
placement, within the lumbar region. |
| Technological
Characteristics | The subject devices have the same intended use, indications for use, materials,
similar design, fundamental technology, sterilization, and surgical technique as
the predicate device, Anatase Spine Surgery Navigation System(K230783).
The difference between the subject device and the predicate device is the |
4
Image /page/4/Picture/0 description: The image shows the logo for REMEX. The logo is in gray, with a green accent on the left side of the "R". The text is bold and sans-serif. The logo is simple and modern.
Remex Medical Corporation 4F, No. 9, Jingke Road, Nantun District, Taichung City408209, Taiwan
upgrade of the system version, and new instruments for corresponding compatible devices. However, these modifications share same function and fundamental technology with predicate device.
Performance Data Verification and validation activities have been completed to provide sufficient assurance that the subject device meets the performance requirements under its indications for use conditions. Below is a summary of all performance tests which should carried out on the subject device to demonstrated that the subject device performs as safely and effectively as the predicate device.
| Test | Description |
|---|---|
| Software | Software is verified and validated in accordance with |
| FDA guidance for the content of premarket submissions | |
| for software contained in medical devices issued on May | |
| 11, 2005 and IEC 62304. | |
| Electrical Safety | Electrical safety of the system is complied with the |
| requirements of ANSI/AAMI ES60601-1:2015/(R)2012 | |
| and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012. | |
| Electromagnetic | |
| Compatibility | Electromagnetic compatibility of the system is complied |
| with the requirements of IEC 60601-1-2:2014 and IEC | |
| /TR 60601-4-2. | |
| Accuracy | Positional accuracy of the system is evaluated in |
| accordance with ASTM F2554-18. | |
| Risk Assessment | The effectiveness of all risk control measures is verified |
| in accordance with ISO 14971:2007 | |
| Design | |
| Verification | The design output fulfills all design input requirements. |
All existing predicate data previously provided in the predicate 510(k) submission is still applicable, except for the risk assessment and design verification require to re-evaluate. However, the newly added image calibrator and assembly kit share the same testing method as the predicate device and the results of the testing are all pass. Furthermore, the modification of the hardware does not change the operation process of the system as per the User Manual. Therefore, REMEX believes design verification testing demonstrated that the subject devices are substantially equivalent to the predicate devices. Design validation has also been performed and demonstrated that the subject devices performed as intended.
Conclusion The subject device has been compared to the predicate device with respect to intended use, materials, design features, and performance data. The technological characteristics of the subject device do not raise new type of questions regarding safety and effectiveness. These comparison demonstrate that the Remex Surgery Navigation System II is substantially equivalence to the predicate device.