(25 days)
Not Found
No
The summary describes surgical navigation instruments and their use with existing navigation systems. There is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on mechanical instruments and their compatibility with image-guided navigation.
No
The device is a set of instruments (Nav Awl, Nav Drill Guide, Nav Tap, Nav Screwdriver, Nav Handle) used to assist surgeons in precise positioning of surgical instruments or spinal implants during spine surgery, particularly for pedicle screw placement. These are tools for guidance and preparation, not devices that directly provide therapy.
No
The device is a surgical navigation instrument designed to assist in the precise positioning of surgical instruments or spinal implants during spine surgery. It is an intraoperative guidance system, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description explicitly lists physical instruments (Nav Awl, Nav Drill Guide, Nav Tap, Nav Screwdriver, Nav Handle) as components of the device. While it is used with navigation systems (which likely involve software), the device itself includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Remex Spine Surgery Navigation Instrument is a set of surgical tools (Awl, Drill Guide, Tap, Screwdriver, Handle) designed to be used during surgery to assist with the precise positioning of instruments and implants based on medical imaging.
- Intended Use: The intended use clearly states it's for "precise positioning of surgical instruments or spinal implants during general spine surgery" and acts as a "planning and intraoperative guidance system." This is an in vivo application (within the living body), not in vitro (outside the living body).
- No Sample Analysis: The description does not mention any analysis of biological samples.
Therefore, the Remex Spine Surgery Navigation Instrument is a surgical navigation system component used in vivo during spine surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Remex Spine Surgery Navigation instrument is designed for use with Anatase Spine Surgery Navigation System(K230783) and Remex Spine Surgery Navigation System II(K233513). The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine 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, with the lumbar region.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Remex Spine Surgery Navigation Instrument is designed for use with Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery Navigation System II (K233513). The Remex Spine Surgery Navigation Instrument consists of the Nav Awl, Nav Drill Guide, Nav Tap, Nav Screwdriver and Nav Handle.
- Nav Awl: The subject device is intended to support the surgeon to create an entry point before implanting the screw.
- Nav Drill Guide: The subject device is intended to assist in drilling holes to a desired depth and ensuring proper orientation.
- Nav Tap: The subject device is intended to create screw threads.
- Nav Screwdriver: The subject device is intended to driver the screw into the vertebra.
Nav Handle: The subject device is intended to connected with Nav Awl, Nav Tap or Nav Screwdriver for navigation tracking purpose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic, CT imagery
Anatomical Site
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)
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.
Software: Software is verified and validated in accordance with FDA guidance for the content of premarket submissions for software contained in medical devices and IEC 62304.
Risk Assessment: The effectiveness of all risk control measures is verified in accordance with ISO 14971.
Design Verification: The design output fulfills all design input requirements.
Biocompatibility Evaluation: The materials that contact with human tissue, blood or bone must be considered for biocompatibility to ensure no rejection, allergic and adverse reactions occur. The subject device is evaluated in accordance with FDA guidance for the use of international standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1.
The intended use and fundamental technology of the device are identical to the predicate device, and could share the same testing methods as the predicate devices. All the results are passed. Therefore, REMEX believes the testing demonstrated that the subject devices are as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2024
Remex Medical Corp. Cheng-Hsiung Wang Quality Representative I 4F, No.9, Jingke Road, Nantun District Taichung, 408209 Taiwan
Re: K243560
Trade/Device Name: Remex Spine Surgery Navigation Instrument Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 11, 2024 Received: November 18, 2024
Dear Cheng-Hsiung 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 (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"
1
(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).
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 OS 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-devices/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 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
2
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
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Indications for Use
510(k) Number (if known) K243560
Device Name Remex Spine Surgery Navigation Instrument
Indications for Use (Describe)
The Remex Spine Surgery Navigation instrument is designed for use with Anatase Spine Surgery Navigation System(K230783) and Remex Spine Surgery Navigation System II(K233513). The Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II are indicated for precise positioning of surgical instruments or spinal implants during general spine 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, with the lumbar region.
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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Image /page/4/Picture/0 description: The image shows the word "REMEX" in a sans-serif font. The letters are gray, except for a green parallelogram in the lower-left corner of the "R". The letters are large and bold, taking up most of the image space. The background is white.
510(k) Summary
| 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 | Cheng-Hsiung Wang
Kevin816@mail.intai.com.tw | |
| Date Prepared | October 11th, 2024 | |
| Device Name | Remex Spine Surgery Navigation Instrument | |
| Classification Name | Stereotaxic instrument | |
| Regulation Number | 882.4560 | |
| Product Codes | OLO | |
| Device Class | Class II | |
| Predicate Devices
Information | K233513, Remex Spine Surgery Navigation System II (primary)
K230783, Anatase Spine Surgery Navigation System | |
| Device Description | The Remex Spine Surgery Navigation Instrument is designed for use with
Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery
Navigation System II (K233513).
The Remex Spine Surgery Navigation Instrument consists of the Nav Awl, Nav
Drill Guide, Nav Tap, Nav Screwdriver and Nav Handle.
- Nav Awl: The subject device is intended to support the surgeon to create an
entry point before implanting the screw. - Nav Drill Guide: The subject device is intended to assist in drilling holes to a
desired depth and ensuring proper orientation. - Nav Tap: The subject device is intended to create screw threads.
- Nav Screwdriver: The subject device is intended to driver the screw into the
vertebra.
Nav Handle: The subject device is intended to connected with Nav Awl, Nav Tap
or Nav Screwdriver for navigation tracking purpose. | |
| Indications for Use | The Remex Spine Surgery Navigation Instrument is designed for use with
Anatase Spine Surgery Navigation System (K230783) and Remex Spine Surgery
Navigation System II (K233513).
The Anatase Spine Surgery Navigation System and Remex Spine Surgery
Navigation System II, are 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, same indications for use, same
sterilization method, same fundamental technology, and similar materials, similar
design as the predicate devices, Anatase Spine Surgery Navigation System
(K230783) and Remex Spine Surgery Navigation System II (K233513). | |
| | The difference between the subject devices and the predicate devices are the
upgrade of the system software version, and new instruments for corresponding
compatible devices. However, these modifications share same function and
fundamental technology with the predicate devices. | |
| 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 and IEC 62304. |
| | Risk Assessment | The effectiveness of all risk control measures is verified in
accordance with ISO 14971. |
| | Design
Verification | The design output fulfills all design input requirements. |
| | Biocompatibility
Evaluation | The materials that contact with human tissue, blood or
bone must be considered for biocompatibility to ensure no
rejection, allergic and adverse reactions occur. The subject
device is evaluated in accordance with FDA guidance for
the use of international standard ISO 10993-1, "Biological
evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process" and ISO 10993- - |
| | The intended use and fundamental technology of the device are identical to the
predicate device, and could share the same testing methods as the predicate
devices. All the results are passed. Therefore, REMEX believes the testing
demonstrated that the subject devices are as safe and effective as the predicate
devices. | |
| Conclusion | The Remex Spine Surgery Navigation Instrument and the predicate devices have
the same intended use and have the same or similar technological characteristics.
Moreover, the information contained in this submission demonstrates that any
differences in their technological characteristics do not raise new issues of safety | |
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Image /page/5/Picture/0 description: The image shows the word "REMEX" in a sans-serif font. The letters are gray, except for a green leaf-like shape that replaces the bottom left portion of the "R". The word is presented in a clear and legible manner, with a modern and professional aesthetic.
Remex Medical Corporation 4F, No. 9, Jingke Road, Nantun District, Taichung City408209, Taiwan
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Image /page/6/Picture/0 description: The image shows the word "REMEX" in a sans-serif font. The letters are gray, except for a green leaf-like shape in the lower-left corner of the "R". The text is centered and appears to be a logo or brand name.
Remex Medical Corporation 4F, No. 9, Jingke Road, Nantun District, Taichung City408209, Taiwan
| or effectiveness. Hence, The Remex Spine Surgery Navigation Instrument is |
|---|
| substantially equivalent to the predicate devices. |