(222 days)
Not Found
No
The device description focuses solely on the mechanical components and materials of a spinal fixation system. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is described as a "Thoracolumbar Fixation System" intended to provide "stabilization of spinal segments as an adjunct to fusion" for various conditions, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device description indicates it is a fixation system providing stabilization of spinal segments, and the intended use describes it as an adjunct to fusion for treating various instabilities or deformities. It is a therapy/treatment device, not one for diagnosing conditions.
No
The device description explicitly states it consists of physical components like pedicle screws, reduction screws, titanium rods, and transverse connectors, which are hardware.
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 Description: The IRENE Thoracolumbar Fixation System is a collection of implants (screws, rods, connectors) designed to be surgically implanted into the spine to provide stabilization.
- Intended Use: The intended use is to provide stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The information provided clearly describes a surgical implant system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
IRENE Thoracolumbar Fixation System provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: ( ) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The proposed device consists of pedicle screws, reduction screws, titanium rods and transverse connectors in various sizes, providing immobilization and stabilization of spinal segments through bridge connection between these components.
The proposed device is made of titanium alloy per ASTM F136, and is intended for single-use.
The proposed device includes three sub-systems, which are named as PLATINUM 5.5M Thoracolumbar Fixation System (NS2), TITANTM 5.5mm Thoracolumbar Fixation System and PLATINUM 6.35 Thoracolumbar Fixation System (NS3), all the devices use the same material and similar design principle, there are slight differences in design and parts size among these three sub-systems which does not raise different questions of safety and effectiveness. There is no surface modification or coating.
The proposed devices are supplied non-sterile. It is required to be sterilized via moist heat to reach a SAL of 106 prior to surgery. The sterilization method is presented in the instructions for use, which has been validated per ISO 17665-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal segments, T8
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)
Bench tests have been conducted to compare the mechanical properties of the proposed and predicate device according to:
ASTM F1717-15, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Three tests including static axial compression, dynamic axial compression, and static torsion were conducted according to the methods stipulated in above standard, results indicate that the mechanical properties of proposed device are no lower than that of the predicate device.
No clinical data is presented in this submission.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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March 6. 2018
Tianjin Zhengtian Medical Instrument Co., Ltd. Changli Ou Regulatory Affairs Specialist No. 318, Jingyi Road, Airport Economic Zone Tianjin, 300308 CHINA
Re: K172267
Trade/Device Name: IRENE Thoracolumbar Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: February 8, 2018 Received: February 8, 2018
Dear Changli Ou:
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 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);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
IRENE Thoracolumbar Fixation System
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
IRENE Thoracolumbar Fixation System provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: ( ) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| --------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ |
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See PRA Statement below.
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Section 7 - 510 (k) Summary
Date Prepared: Oct. 13th, 2017 A.
B. Submitter and Owner
Tianjin Zhengtian Medical Instrument Co., Ltd. No. 318, Jingyi Road, Airport Economic Zone, Tianjin, 300308, P. R. China Official Correspondent: Xiang Zhaojun, Regulatory Affairs Supervisor Tel: +86-10-82292929 E-mail: xiangzhaojun@naton.cn Submission Contact: Ou, Changli, Regulatory Affairs Specialist Tel: +86-10-82292929 Email: ouchangli(@naton.cn
Establishment Registration Number: 3010227982
C. Proposed Device
Propriety Name: IRENE Thoracolumbar Fixation System Common Name: Thoracolumbar Fixation System Classification: 21 CFR 888.3070 Thoracolumbosacral Pedicle Screw System, Class II Product Code: NKB
Predicate Device D.
Trade Name: Devine Spinal System 510(k) Number: K111690 Classification Regulation: 21 CFR 888.3070 Product Code: MNH. MNI Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd
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E. Indications for Use
IRENE Thoracolumbar Fixation System provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pseudarthrosis, (6) spinal stenosis. It is not intended for pedicle screw fixation above T8.
F. Device Description
The proposed device consists of pedicle screws, reduction screws, titanium rods and transverse connectors in various sizes, providing immobilization and stabilization of spinal segments through bridge connection between these components.
The proposed device is made of titanium alloy per ASTM F136, and is intended for single-use.
The proposed device includes three sub-systems, which are named as PLATINUM 5.5M Thoracolumbar Fixation System (NS2), TITANTM 5.5mm Thoracolumbar Fixation System and PLATINUM 6.35 Thoracolumbar Fixation System (NS3), all the devices use the same material and similar design principle, there are slight differences in design and parts size among these three sub-systems which does not raise different questions of safety and effectiveness. There is no surface modification or coating.
The proposed devices are supplied non-sterile. It is required to be sterilized via moist heat to reach a SAL of 106 prior to surgery. The sterilization method is presented in the instructions for use, which has been validated per ISO 17665-1.
G. Technological Characteristic Comparison
The Propose device is found to possess similar technological characteristics under the premises of sharing same intended use after comparing design, material, composition and other aspects, the detailed information is listed in Substantial Equivalence Discussion.
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H. Performance Data
Mechanical Testing
Bench tests have been conducted to compare the mechanical properties of the proposed and predicate device according to:
ASTM F1717-15, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Three tests including static axial compression, dynamic axial compression, and static torsion were conducted according to the methods stipulated in above standard, results indicate that the mechanical properties of proposed device are no lower than that of the predicate device.
Clinical Studies
No clinical data is presented in this submission
I. Conclusion
Based on the technological characteristics and non-clinical performance data, IRENE Thoracolumbar Fixation System is as safe and effective as the predicate device due to same intended use and similar technical characteristics.