(417 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for the "stabilization and immobilization of the spine as an adjunct to fusion with bone graft," which directly treats conditions like "severe spondylolisthesis," "trauma," "spinal stenosis," "curvatures," "tumor," "pseudoarthrosis," and "failed previous fusion." These are all therapeutic indications.
No
The device is a spinal inner fixation system, which is a surgical implant designed for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists physical components made of titanium alloy (pedicle screws, rods, hooks, etc.), indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to stabilize the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The components listed (pedicle screws, rods, hooks, etc.) are all physical implants used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing and biocompatibility, which are relevant for implanted devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This spinal fixation system does not fit that description.
N/A
Intended Use / Indications for Use
Spinal inner fixation system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
Product codes
MNH, MNI, KWP
Device Description
Spinal inner fixation system consists of a variety of shapes and sizes of pedicle screws, rods, hooks, transverse linking pole assembly, and connecting components (side, domino, and axial), which can be rigidly locked into a variety of configurations. These components are made of titanium alloy per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (non-cervical), L5-S1 vertebrae, T8-S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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
Dissociation testing of screw head
Biocompatibility testing:
The Spinal inner fixation system has permanent contact (>30 days) with bone and tissue.
The Spinal inner 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 this Orthopedic Device.
Animal and clinical study:
The subject of this premarket submission, Spinal inner fixation system, does not require clinical studies to support substantial equivalence.
Key results:
- 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 torsion: 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
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
§ 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.
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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Changzhou Dingjian Medical Appliance Company, Limited % Mr. Mike Gu Regulatory Affairs Manager OSMUNDA Medical Device Consulting Company, Limited 7th Floor, Jingui Business Building, 982 Congyun Road Baiyun District, Guangzhou, Guangdong, 510420 CHINA
December 11, 2015
Re: K143013
Trade/Device Name: Spinal Inner Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: November 16, 2015 Received: November 24, 2015
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 (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 – Mr. Mike Gu
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" (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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143013
Device Name Spinal Inner Fixation System
Indications for Use (Describe)
Spinal inner fixation system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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."
4
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: l. SUBMITTER
Changzhou Dingjian Medical Appliance Co., Ltd.
No. 19 Juxiang Road
Wujin Economic Development Zone
Changzhou, Jiangsu Province, 213149, China
| Primary Contact Person: | Mike Gu |
|---|---|
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd | |
| Tel: (+86) 20-6232 1333 | |
| Fax: (+86) 20-8633 0253 |
| Secondary Contact Person: | Li Qingsong |
|---|---|
| Changzhou Dingjian Medical Appliance Co., Ltd. | |
| Tel: 0086-13584330156 | |
| Fax: 0086-519-89603573 |
| Date Prepared: | October 05, 2014 |
|---|---|
| II. DEVICE | |
| Name of Device: | Spinal Inner Fixation System |
Common/Usual Name: Pedicle screw spinal system
Classification Names: 21 CFR 888.3070 Pedicle screw spinal system, 21 CFR 888.3050 Spinal interlaminal fixation orthosis Regulation Class: ll
- Product Code: MNH, KWP, MNI
5
PREDICATE DEVICE III.
Primary predicate: General Spinal System K122994;
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
Spinal inner fixation system consists of a variety of shapes and sizes of pedicle screws, rods, hooks, transverse linking pole assembly, and connecting components (side, domino, and axial), which can be rigidly locked into a variety of configurations. These components are made of titanium alloy per ASTM F136.
> INDICATIONS FOR USE
Spinal inner fixation system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
The Spinal inner fixation system employs the same technology as its predicate device K122994. 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 |
|---|---|---|
| General Spinal System K122994 | Spinal inner fixation system |
6
| Manufacturer | Weigao Orthopaedic Device Co.,
Ltd. | Changzhou Dingjian
Medical Appliance
Co., Ltd. |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Class | II | |
| Product Code | MNH, KWP, MNI | |
| Regulation Number | 21 CFR 888.3070, 21 CFR 888.3050 | |
| Intended Use | Intended for posterior, non-cervical, pedicle fixation for the
following indications: severe spondylolisthesis (grade 3 or 4) of
the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal
stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
tumor; pseudoarthrosis; and failed previous fusion. The device
is to be used in skeletally mature patients, and for stabilization
and immobilization of the spine as an adjunct to fusion with
bone graft. The levels of fixation are T8 - S1. | |
| Indications for Use | The levels of fixation are T8 – S1 | |
| 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
torsion:
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 | |
| Materials | Titanium alloy (TiAl4V ELI) which
conforms to ASTM F136 | Titanium alloy
(TiAl4V ELI) which
conforms to ASTM
F16 |
| Biocompatibility | Titanium alloy (TiAl4V ELI) which
conforms to ASTM F136 | Titanium alloy
(TiAl4V ELI) 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 |
7
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
Dissociation testing of screw head
Biocompatibility testing:
The Spinal inner fixation system has permanent contact (>30 days) with bone and tissue.
The Spinal inner fixation system is made of Ti-6Al-4V. According to the ASTM F136, the
8
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 this Orthopedic Device.
Animal and clinical study
The subject of this premarket submission, Spinal inner fixation system, does not require clinical studies to support substantial equivalence.
VIII. CONCLUSIONS
The non-clinical data supports the substantial equivalence of the device and the performance testing report demonstrates that the Spinal inner fixation system should perform as intended in the specified use conditions. Changzhou Dingjian Medical Appliance Co., Ltd., Inc considers the Spinal inner fixation system does not raise any new issues of safety or effectiveness.