(149 days)
No reference devices were used in this submission.
No
The summary describes a mechanical spinal fixation system and its components, with no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is intended to treat acute and chronic instabilities or deformities of the spine through stabilization and fusion, which is a therapeutic purpose.
No
This device is a spinal fixation system, which is an implant used to stabilize spinal segments as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists physical components such as pedicle screws, rods, and hooks, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for stabilizing the spine in skeletally mature patients with various spinal conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a system of screws, rods, and hooks designed to create a structural frame on the spine. This is consistent with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Performance Studies: The performance studies focus on mechanical testing and biocompatibility, which are relevant for surgical implants, not IVDs.
In summary, the device is a spinal fixation system, which is a type of medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
Spinal fixation system is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization 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, kyphosis, 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)
MNH, KWP, MNI
Device Description
Spinal fixation system is mainly constituted by pedicle screw, reduction pedicle screw, Set screw, Spine Hook, Rod and Transverse linking pole assembly. Through using the assembly of the screws, rods and/or poles, there will be established a firm frame structure on the Spinal (conforming to the bio-mechanics principle). The components of the system include: pedicle screw, reduction pedicle screw, set screw, spine hook, rod and transverse linking pole assembly and so on. According to the different specification of the rod's diameter and the different usage on the spinal segments, the system is classified: J2X03, J2X04, J2X07.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior spine, Spinal segments, T8
Indicated Patient Age Range
skeletally mature patients
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)
Mechanical testing: According to the ASTM F1717, the following tests were carried out:
- Static compression bending test
- Dynamic compression bending test
- Static torsion test
Biocompatibility testing: The Spinal fixation system has permanent contact (>30 days) with bone and tissu. The Spinal fixation system is made of Ti-6Al-4V. According to the ASTM F136, the materials have been employed successfully in human implant applications in contact with soft tissue and bone for over a decade. Due to the well-characterized level of biological response exhibited by this alloy, it has been used as a control material in Practice F 981. There is no Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.
Animal and clinical study: The subject of this premarket submission, Spinal fixation system, does not require clinical studies to support substantial equivalence.
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.
No reference devices were used in this submission.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
Canwell Medical Co., Ltd. % Mr. Mike Gu Regulatory Affairs Manager Osmunda Medical Device Consulting Co., Ltd Level 7. Jin Gui Business Center 982 Congyun Road, Baiyun District, Guangzhou, Guangdong 510420 CHINA
Re: K161151
Trade/Device Name: Spinal fixation system Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, KWP, MNI Dated: September 9, 2016 Received: September 13, 2016
Dear Mr. Gu:
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
1
(21 CFR Part 807); labeling (21 CFR Parts 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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" (21CFR 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.
Vincent J. Devlin -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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Indications for Use
510(k) Number (if known) K161151
Device Name Spinal fixation system
Indications for Use (Describe)
Spinal fixation system is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization 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, kyphosis, 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.
| 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) |
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Image /page/3/Picture/0 description: The image shows the text 'K161151 - Page 1 of 5' at the top. Below this text is the logo for 'CANWELL MEDICAL LTD.' The logo consists of a stylized graphic on the left and the company name in bold, sans-serif font on the right. The graphic appears to be a cluster of interconnected circles or spheres in a blue color.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
- l. SUBMITTER
CANWELL MEDICAL CO., LTD.
No.466 South Xianhua Street, HighTech Industrial
Zone, Jinhua, Zhejiang Province, 321016, P.R. of China
Primary Contact Person: Mike Gu
Regulatory Affairs Manager
OSMUNDA Medical Device Consulting Co., Ltd
21 CFR 888.3070 Pedicle screw spinal system, 21 CFR 888.3050 Spinal
Tel: (+86) 20-6232 1333
Fax: (+86) 20-8633 0253
Secondary Contact Person: Chen Hui
CANWELL MEDICAL CO., LTD.
Tel: 86-(0)579-8911-9235
Fax: 86-(0)579-8223-9558
interlaminal fixation orthosis
- Date Prepared: April 12, 2016
II. DEVICE
Name of Device: Spinal fixation system
Common/Usual Name: Pedicle screw spinal system
ll
Classification Names:
Regulation Class:
Product Code: MNH, MNI, KWP
III. PREDICATE DEVICE
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Primary predicate: Devine Spinal System K111690;
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
Spinal fixation system is mainly constituted by pedicle screw, reduction pedicle screw, Set screw, Spine Hook, Rod and Transverse linking pole assembly. Through using the assembly of the screws, rods and/or poles, there will be established a firm frame structure on the Spinal (conforming to the bio-mechanics principle). The components of the system include: pedicle screw, reduction pedicle screw, set screw, spine hook, rod and transverse linking pole assembly and so on. According to the different specification of the rod's diameter and the different usage on the spinal segments, the system is classified: J2X03, J2X04, J2X07..
V. INDICATIONS FOR USE
Spinal fixation system is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization 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, kyphosis, 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Spinal fixation system employs the same technology as its predicate device K111690. Both have the same indication for use and are made of same raw materials; the bench tests were conducted to verify that the proposed device met all design specifications as was substantially equivalent to the predicate device.
| Specification | Predicate Device | Proposed Device |
|---|---|---|
| Devine Spinal System K111690 | Spinal fixation system | |
| Manufacturer | Changzhou Orthmed Medical | |
| Instrument Co., Ltd | CANWELL MEDICAL | |
| CO., LTD. |
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Image /page/5/Picture/0 description: The image shows the text "K161151 - Page 3 of 5" at the top. Below this text is the logo for "CANWELL MEDICAL LTD.". The logo consists of the word "CANWELL" in bold, black letters, with the words "MEDICAL LTD." in a smaller, lighter font below it. To the left of the text is a blue graphic consisting of a circle with three curved lines inside it, and five smaller circles below it.
| Class | II |
|---|---|
| Product Code | MNH, MNI, KWP |
| Regulation Number | 21 CFR 888.3070, 21 CFR 888.3050 |
| Intended Use | The proposed devices of Spinal fixation systems intended |
| for posterior pedicle screw fixation of the non-cervical | |
| posterior spine in skeletally mature patients. | |
| Indications for Use | The deivce 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, kyphosis, 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. | |
| Patient Population | The device is to be used in skeletally mature patients |
| Prescription/OTC Use | Prescription use |
| Static compression bending: yield load | Similar, the testing results show no statistically significant |
| difference between two samples groups | |
| Static compression bending: stiffness | Similar, the testing results show no statistically significant |
| difference between two samples groups | |
| Dynamic compression bending | Similar, the testing results show no statistically significant |
| difference between two samples groups | |
| Static tension bending: yield load | Similar, the testing results show no statistically significant |
| difference between two samples groups | |
| Static tension bending: stiffness | Similar, the testing results show no statistically significant |
| difference between two samples groups | |
| Static torsion: yield torque | Similar, the testing results show no statistically significant |
| difference between two samples groups | |
| Static torsion: torsional stiffness | Similar, the testing results show no statistically significant |
| difference between two samples groups |
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Image /page/6/Picture/0 description: The image shows the logo for Canwell Medical LTD. The logo consists of a blue circular design on the left and the company name in bold, black letters on the right. The circular design features a series of interconnected circles, while the company name is written in two lines, with "CANWELL" on the top line and "MEDICAL LTD." on the bottom line.
| Materials | Titanium alloy (Ti-Al-4V) which
conforms to ASTM F136 | Titanium alloy (Ti-Al-
4V) which conforms
to ASTM F136 |
|------------------|----------------------------------------------------------|---------------------------------------------------------------------------|
| Biocompatibility | Titanium alloy (Ti-Al-4V) which
conforms to ASTM F136 | Titanium alloy (Ti-Al-
4V) which conforms
to ASTM F136 |
| Sterility | Provided as non-sterile, needs
autoclave prior to use | Provided as non-
sterile, needs steam
sterilization prior to
use |
The following technological differences exist between the subject and predicate device:
- . Size of components should be chosen based on patient's body size. The size difference between the proposed device and its predicate does not affect their clinical performance.
- The testing results of the static compression bending test, dynamic compression ● bending test and static torsion test are similar ,however no statistically significant difference between two samples groups
- VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
Mechanical testing
According to the ASTM F1717, the following tests were carried out:
- Static compression bending test
- Dynamic compression bending test
- Static torsion test
Biocompatibility testing:
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Image /page/7/Picture/0 description: The image shows the logo for Canwell Medical LTD. The logo consists of a blue graphic on the left, resembling a cluster of interconnected circles. To the right of the graphic, the word "CANWELL" is written in bold, black letters. Below "CANWELL", the words "MEDICAL LTD." are written in a smaller, lighter font.
The Spinal fixation system has permanent contact (>30 days) with bone and tissu
The Spinal fixation system is made of Ti-6Al-4V. According to the ASTM F136, the materials have been employed successfully in human implant applications in contact with soft tissue and bone for over a decade. Due to the well-characterized level of biological response exhibited by this alloy, it has been used as a control material in Practice F 981.
There is no Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.
Animal and clinical study
The subject of this premarket submission, Spinal fixation system, does not require clinical studies to support substantial equivalence.
VIII. CONCLUSIONS
The non-clinical data support the safety of the device and the performance testing report demonstrate that the Spinal fixation system should perform as intended in the specified use conditions. CANWELL MEDICAL CO., LTD. considers the Pedicle screw spinal system does not raise any new issues of safety or effectiveness.