(30 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on traditional image-guided navigation techniques using optical tracking and registration of pre-operative and intraoperative images.
No.
The device is described as a navigation system and an image guided system used for precise positioning of surgical instruments or spinal implants and to help guide surgeons. It aids in the surgical procedure but does not directly treat or cure a disease or condition itself.
No.
The device is described as a surgical navigation system intended for precise positioning of surgical instruments or implants during spinal surgery. Its purpose is to guide surgeons intraoperatively rather than to diagnose medical conditions.
No
The device description explicitly states that the system is comprised of a platform, clinical software, surgical instruments, and a referencing system, and uses wireless optical tracking technology. This indicates the presence of hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Anatase Spine Surgery Navigation System is an image-guided surgical system. It uses medical images (fluoroscopic or CT) of the patient's anatomy to help surgeons navigate and position instruments or implants during surgery. It does not analyze biological specimens.
- Intended Use: The intended use clearly states its purpose is for "precise positioning of surgical instruments or spinal implants during general spinal surgery" and as a "planning and intraoperative guidance system." This is a surgical aid, not a diagnostic test performed on a sample.
The device's function and intended use fall squarely within the realm of surgical navigation and guidance, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Anatase Spine Surgery Navigation System 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 but are not limited to:
Posterior-approach spinal implant procedures, such as pedicle screw placement, within the lumbar region.
Product codes
OLO
Device Description
The Anatase Spine Surgery Navigation System, 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, CT
Anatomical Site
Spinal, 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)
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.
Sterilization: Moist heat sterilization of those reusable accessories is validated in accordance with ISO 17665-1:2006.
Repeated Reliability: Reliability of those reusable instruments after repeated reprocessing is validated throughout their use-life.
Biocompatibility: Biocompatilibity of those accessories that come into contact with patient 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" issued on June 16, 2016 and ISO 10993-1:2009.
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.
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.
Usability: Usability of the system is validated in accordance with ANSI/AAMI HE75:2009/(R)2013, IEC 62366-1:2015 and IEC 60601-1-6:2010+A1:2013.
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 14971:2019
Design Verification: The design output fulfills all design input requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
April 21, 2023
Remex Medical Corp. Wang Cheng-Hsiung Quality representative 4F., No. 9, Jingke Road, Nantun Dist. Taichung City, Taiwan 408209 Taiwan
Re: K230783
Trade/Device Name: Anatase Spine Surgery Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 20, 2023 Received: March 22, 2023
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 (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.
1
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 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 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
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Indications for Use
510(k) Number (if known) K230783
Device Name
Anatase Spine Surgery Navigation System
Indications for Use (Describe)
The Anatase Spine Surgery Navigation System 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 but are not limited to:
Posterior-approach spinal implant procedures, such as pedicle screw placement, within 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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3
| 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 | March 7th, 2023 |
| Device Name | Anatase Spine Surgery Navigation System |
| Classification Name | Stereotaxic instrument |
| Regulation Number | 882.4560 |
| Product Codes | OLO |
| Device Class | Class II |
| Predicate
Information | Devices K220348, Anatase Spine Surgery Navigation System, Model number:
SNS-Spine2-S, SNS-Spine2-V
K180523, INTAI Surgery Navigation System |
510(k) Summary
| Device Description | The Anatase Spine Surgery Navigation System, 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 Anatase Spine Surgery Navigation System 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 but are not limited to:
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, Model
number: SNS-Spine2-S, SNS-Spine2-V (K220348). |
4
The difference between the subject device and the predicate device is the 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. Description Test Sterilization Moist heat sterilization of those reusable accessories is validated in accordance with ISO 17665-1:2006. Repeated Reliability of those reusable instruments after repeated reprocessing is validated throughout their use-life. Reprocessing Biocompatibility Biocompatilibity of those accessories that come into contact with patient 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" issued on June 16, 2016 and ISO 10993-1:2009. Software is verified and validated in accordance with Software FDA guidance for the content of premarket submissions for software contained in medical devices issued on May 11, 2005. 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 Electromagnetic compatibility of the system is complied Compatibility with the requirements of IEC 60601-1-2:2014. Usability Usability of the system is validated in accordance with ANSI/AAMI HE75:2009/(R)2013, IEC 62366-1:2015 and IEC 60601-1-6:2010+A1:2013. Accuracy Positional accuracy of the system is evaluated in accordance with ASTM F2554-18. The effectiveness of all risk control measures is verified Risk Assessment in accordance with ISO 14971:2019 Design The design output fulfills all design input requirements. Verification
All existing predicate data previously provided in the predicate 510(k) submission is still applicable and not retested, except for the risk assessment and design verification require to re-evaluate. However, the newly added instruments share the same testing method as the predicate device. 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 Anatase Surgery Navigation System is substantially equivalence to the predicate device.