(130 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to immobilize and stabilize spinal elements as an adjunct to fusion for treating various medical conditions like trauma, spinal stenosis, tumors, deformities, and pseudoarthrosis, indicating its use in treating or alleviating a disease or injury.
No
This device is a spinal fixation system, intended to provide immobilization and stabilization to facilitate fusion, not to diagnose a condition.
No
The device description explicitly states it consists of non-sterile rods, monoaxial and polyaxial pedicle screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The CB PROT II Posterior Spinal System is described as a system of rods and screws intended for surgical implantation to stabilize the spine. It is a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is to provide immobilization and stabilization for posterior spinal fusion, which is a surgical procedure.
The information provided clearly indicates this is a surgical implant device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CB PROT II Posterior Spinal System is intended to provide immobilization and stabilization for posterior, noncervical, pedicle fixation of the thoracic, lumbar and sacral spinal elements (T1-S1) as an adjunct to fusion for the following indications:
- Trauma (i.e. fracture or dislocation).
- Spinal stenosis.
- Vertebral tumors.
- Pseudoarthrosis and failed previous fusion in skeletally mature patients.
- Scoliosis, kyphosis and lordosis, and severe spondylolisthesis (grade 3 or 4) of the T1-S1 vertebra.
The system is intended to be used with autograft or allograft to facilitate fusion.
Product codes
MNH, MNI
Device Description
The CB PROT II Posterior Spinal System consists of non-sterile rods, monoaxial and polyaxial pedicle screws. The thoraco-lumbar rods are available in a variety of lengths (one diameter). Screws are available in various lengths and diameters according to practical requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spinal elements (T1-S1)
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
Mechanical testing including static/dynamic axial compression bending test and static torsion test were conducted referring to ASTM F1717 to demonstrate substantial equivalence to the predicate system. The results represented that the CB PROT II Posterior Spinal System performs as well as or better than the predicate device.
Key Metrics
Not Found
Predicate Device(s)
SmartLocTM spinal fixation system (K111883)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2015
Chin Bone Technique Corporation Mr. Cheng-Kung Cheng Number 165, Section 2, Xi'an Street, Beitou District Taipei, Taiwan 11274 CHINA
Re: K142655
Trade/Device Name: CB PROT II Posterior Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: December 26, 2014 Received: December 31, 2014
Dear Mr. Cheng:
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
1
Page 2 - Mr. Cheng-Kung Cheng
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
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Indications for Use
510(k) Number (if known) K142655
Device Name CB PROT II Posterior Spinal System
Indications for Use (Describe)
The CB PROT II Posterior Spinal System is intended to provide immobilization and stabilization for posterior, noncervical, pedicle fixation of the thoracic, lumbar and sacral spinal elements (T1-S1) as an adjunct to fusion for the following indications:
- Trauma (i.e. fracture or dislocation).
- Spinal stenosis.
- Vertebral tumors.
- Pseudoarthrosis and failed previous fusion in skeletally mature patients.
- Scoliosis, kyphosis and lordosis, and severe spondylolisthesis (grade 3 or 4) of the T1-S1 vertebra.
The system is intended to be used with autograft or allograft to facilitate fusion.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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510(K) SUMMARY
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92(c).
| Submitter Information: | Chin Bone Technique Corp.
No. 165, Sec. 2, Xi'an St., Beitou Dist.
Taipei 11274, Taiwan, R.O.C. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Prof. Cheng-Kung Cheng |
| | TEL: +886-2-2827-4262 |
| | Fax: +886-2-2822-8557 |
| | E-mail: ckcheng@chin-bone.com |
| Date prepared: | December 26, 2014 |
| Trade Name: | CB PROT II Posterior Spinal System |
| Device Class: | Class II |
| Produce Code: | MNI, MNH |
| Common Name: | Pedicle screw system |
| Classification Name: | Pedicle screw spinal system |
| Regulation Number: | 21 CFR 888.3070 |
| Predicate Devices: | SmartLocTM spinal fixation system (K111883) |
| Material: | The CB PROT II Posterior Spinal System components
are manufactured from medical grade titanium alloy
(Ti6Al4V) that meets ASTM F136 & ISO 5832-3 |
Device Description:
The CB PROT II Posterior Spinal System consists of non-sterile rods, monoaxial and polyaxial pedicle screws. The thoraco-lumbar rods are available in a variety of lengths (one diameter). Screws are available in various lengths and diameters according to practical requirements.
4
Indications for Use:
The CB PROT II Posterior Spinal System is intended to provide immobilization and stabilization for posterior, non-cervical, pedicle fixation of the thoracic, lumbar and sacral spinal elements (T1-S1) as an adjunct to fusion for the following indications:
- Trauma (i.e. fracture or dislocation). -
- Spinal stenosis. -
- Vertebral tumors. -
- Pseudoarthrosis and failed previous fusion in skeletally mature patients. -
- Scoliosis, kyphosis and lordosis, and severe spondylolisthesis (grade 3 or 4) of the T1-S1 vertebra.
The system is intended to be used with autograft or allograft to facilitate fusion.
Performance Data:
Mechanical testing including static/dynamic axial compression bending test and static torsion test were conducted referring to ASTM F1717 to demonstrate substantial equivalence to the predicate system. The results represented that the CB PROT II Posterior Spinal System performs as well as or better than the predicate device.
Conclusion of Substantial Equivalence:
The CB PROT II Posterior Spinal System has been demonstrated to be substantially equivalent to predicate system with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device.