(89 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for treating various spinal instabilities and conditions, indicating its therapeutic purpose in supporting the healing and recovery of spinal issues.
No.
The device is described as an implant system (polyaxial screws, hooks, rods, etc.) intended to provide immobilization and stability for spinal segments, not to diagnose medical conditions.
No
The device description explicitly lists physical components such as screws, hooks, rods, and plates, indicating it is a hardware-based spinal implant system.
Based on the provided text, the ANAX™ OCT Spinal System is not an IVD (In Vitro Diagnostic) device.
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 about a person's health.
- ANAX™ OCT Spinal System Function: The description clearly states that the ANAX™ OCT Spinal System is a spinal implant system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion. It is a physical device implanted into the body.
- No Mention of Specimen Analysis: The text does not mention any analysis of biological specimens or providing diagnostic information based on such analysis.
Therefore, the ANAX™ OCT Spinal System falls under the category of a surgical implant or medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ANAX ™ OCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. ANAX™ OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, ANAX™ OCT Spinal System may be connected to Perfix™ Spinal System and ANAXIN 5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™ OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.
Product codes (comma separated list FDA assigned to the subject device)
NKG, KWP
Device Description
ANAX™ OCT Spinal System is manufactured by U&I corporation. ANAX™ OCT Spinal System is for fixation the Cervicocranium (Occiput/C2), the true subaxial region (C3/C6), and the cervicothoracic junction (C7 to T2) by one system. The ANAX™ OCT Spinal System consists of polyaxial screws, polyaxial shank screws, hooks, rods, set screws, transverse(cross) links and occipital plate. Connectors are also provided for surgical convenience. ANAX™OCT Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The singleuse ANAX™ OCT Spinal System components are supplied as non- sterile and are fabricated from medical grade titanium alloy (ASTM F136). All polyaxial screws have self-tapping function in the ANAX™ OCT Spinal System. Specialized instruments made from surqical instrument grade stainless steel are available for the application and removal of the ANAX™ OCT Spinal System implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniocervical junction, the cervical spine (C1 to C7), thoracic spine from T1-T3, Cervicocranium (Occiput/C2), the true subaxial region (C3/C6), and the cervicothoracic junction (C7 to T2)
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)
The mechanical performance of ANAX™ OCT Spinal System met the acceptance criteria which have been established from the predicate device.
ANAX™ OCT Spinal System was tested in a non-clinical setting (bench testing) to assess that no new safety and efficiency issues were raised with this device. All tests met all acceptance criteria and that verifies performance of the ANAX™ OCT Spinal System is substantially equivalent to predicate devices.
The following tests were performed:
- Worst case constructs of the occipito-cervical portion of ANAX™ OCT Spinal System were tested per ASTM F2706.
Static compression bending test
Static torsion test
Axial compression fatigue test
Axial torsion fatigue test - Worst case constructs of the thoracic portion of the ANAX™ OCT Spinal System were tested per ASTM F1717.
Static compression bending test
Static torsion test
Axial compression fatigue test
Axial torsion fatigue test - Worst case of subassembly of the ANAX™ OCT Spinal System were tested per ASTM F1798.
Axial gripping capacity test
Axial torque gripping capacity test
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.
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
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2015
U & I Corporation Mr. Young-Geun Kim Regulatory Affairs Specialist 20. Sandan-ro 76beon-gil (Road) Uijeongbu-si. Gyeonggi-do Republic of Korea 480-859
Re: K150570
Trade/Device Name: ANAX™ OCT Spinal System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: March 2, 2015 Received: March 6, 2015
Dear Mr. Kim:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Young-Geun Kim
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150570
Device Name ANAXTM OCT Spinal System
Indications for Use (Describe)
ANAX "MOCT Spinal System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. ANAX™ OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, ANAX™ OCT Spinal System may be connected to Perfix™ Spinal System and ANAXIN 5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™ OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.
| 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
6. 510(k) Summary
| Manufacturer: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
Korea, 480-859 |
|------------------------------|-------------------------------------------------------------------------------------------------|
| Sponsor: | U & I Corporation
20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,
Korea, 480-859 |
| Sponsor Contact: | Young-Geun Kim, Regulatory Affairs Specialist
+82 31 852 0102 (ext.619)
ygkim@youic.com |
| Date Prepared: | June 02, 2015 |
| Device Name: | ANAX™ OCT Spinal System |
| Classification Name: | Unclassified |
| Common Name: | Occipito-cervico-thoracic spinal fixation system |
| Product Code: | NKG, KWP |
| Primary Predicate
Device: | VERTEX ® Reconstruction System (K143471) |
| Reference Devices: | VERTEX SELECT® Reconstruction System (K123656,
K110522)
Synapse System (K133698) |
Description of Device:
ANAX™ OCT Spinal System is manufactured by U&I corporation. ANAX™ OCT Spinal System is for fixation the Cervicocranium (Occiput/C2), the true subaxial region (C3/C6), and the cervicothoracic junction (C7 to T2) by one system. The ANAX™ OCT Spinal System consists of polyaxial screws, polyaxial shank screws, hooks, rods, set screws, transverse(cross) links and occipital plate. Connectors are also provided for surgical convenience. ANAX™OCT Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The singleuse ANAX™ OCT Spinal System components are supplied as non- sterile and are
4
fabricated from medical grade titanium alloy (ASTM F136). All polyaxial screws have self-tapping function in the ANAX™ OCT Spinal System. Specialized instruments made from surqical instrument grade stainless steel are available for the application and removal of the ANAX™ OCT Spinal System implants.
Indications for Use:
ANAX™OCT Spinal System is intended to provide immobilization of spinal segments as an adiunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine(C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g.pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. ANAX™OCT Spinal System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, ANAX™OCT Spinal System may be connected to Perfix™ Spinal System and ANAX™5.5 Spinal System rods with the rod connectors. Transition rods with differing diameters may also be used to connect ANAX™OCT Spinal System to Perfix™ Spinal System and ANAX™ 5.5 Spinal System.
Substantial Equivalence:
ANAX™ OCT Spinal System is substantially equivalent to VERTEX® Reconstruction System (K143471) in design, material, mechanical performance, function and intended use.
Comparison Technological Characteristics
The predicate and proposed device has the similar intended use, basic fundamental scientific technology, and the following similarities;
- The similar indications for use ●
- Similar design features
- Incorporate the same or similar materials
- The equivalent mechanical performance
Summary of Performance Data:
The mechanical performance of ANAX™ OCT Spinal System met the acceptance criteria which have been established from the predicate device.
5
Performance Testing
ANAX™ OCT Spinal System was tested in a non-clinical setting (bench testing) to assess that no new safety and efficiency issues were raised with this device. All tests met all acceptance criteria and that verifies performance of the ANAX™ OCT Spinal System is substantially equivalent to predicate devices.
The following tests were performed:
-
- Worst case constructs of the occipito-cervical portion of ANAX™ OCT Spinal System were tested per ASTM F2706.
- . Static compression bending test
- . Static torsion test
- Axial compression fatique test
- Axial torsion fatigue test
-
- Worst case constructs of the thoracic portion of the ANAX™ OCT Spinal System were tested per ASTM F1717.
- Static compression bending test .
- . Static torsion test
- Axial compression fatique test
- Axial torsion fatique test
-
- Worst case of subassembly of the ANAX™ OCT Spinal System were tested per ASTM F1798.
- Axial gripping capacity test ●
- . Axial torque gripping capacity test
Conclusion:
The mechanical testing and published literature support the conclusion that the ANAX™ OCT Spinal System is substantially equivalent to predicate device with respect to indications for use and technological characteristics.