(387 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural components of a spinal fixation system, with no mention of AI or ML technologies.
No.
The device is a spinal implant system used for stabilization of spinal segments as an adjunct to fusion, rather than actively providing therapy.
No
The device is described as a spinal fixation system, which is a surgical implant used to stabilize the spine as an adjunct to fusion. Its function is to provide mechanical support, not to diagnose a condition.
No
The device description explicitly states it is a "combination of pedicle screws, pedicle hooks, rods, set screws, connectors, and cross links," which are physical hardware components.
Based on the provided information, 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 and Intended Use: The description clearly states that the Cellent Spinal System is a combination of implants (screws, rods, etc.) intended for surgical fixation of the spine. It is a physical implant used within the body, not a device used to analyze samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing laboratory tests, or providing diagnostic information based on such tests.
Therefore, the Cellent Spinal System falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cellent Spinal Systems are intended for posterior pedicle screw fixation of the non-cervical posterior spine in sketally 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.
Cellent Spinal Systems are not intended for pedicle screw fixation above T8.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
Cellent Spinal System is a combination of pedicle screws, pedicle hooks, rods, set screws, connectors, and cross links, which can fix the vertebral body through pedicle or lamina.
It is made of Titanium Alloy (Ti-6AL-41V ELI), which meet ASTM F136-13, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical posterior spine
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)
Performance testing: Comparative performance tests (static and dynamic compression bending and static torsion) were conducted between Cellent Spinal System and the predicate device, according to ASTM F1717-15 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, and static axial and torsional gripping capacity testing per ASTM F1798-13 Standard Guide For Evaluating The Static And Fatigue Properties Of Interconnection Mechanisms And Subassemblies Used In Spinal Arthrodesis Implants. The performance differences between proposed device and predicate device will not affect the safety and effectiveness of the proposed device. It demonstrates substantial equivalences to the predicate device.
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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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
October 10, 2018
Jiangsu Trauhui Medical Instrument Co.,Ltd. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co.,Ltd. 8-9Th Floor, R&D Building, No.26 Qinglan Street Panyu District Guangzhou. 510006 CN
Re: K172826
Trade/Device Name: Cellent Spinal Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw Systems Regulatory Class: Class II Product Code: NKB Dated: August 28, 2018 Received: August 27, 2018
Dear Mike Gu:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Colin O'neill -S for MNM
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) K172826
Device Name Cellent Spinal Systems
Indications for Use (Describe)
Cellent Spinal Systems are intended for posterior pedicle screw fixation of the non-cervical posterior spine in sketally 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.
Cellent Spinal Systems are not intended for pedicle screw fixation above T8.
| 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)
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Image /page/3/Picture/0 description: The image shows the word "TRAUHUI" in blue, block letters. The letters are all capitalized and evenly spaced. The font is sans-serif and appears to be bolded. The background is white.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. SUBMITTER
Jiangsu Trauhui Medical Instrument Co., Ltd No.2 Longqing Road, Wujin Hi-Tech Industrial Zone, Changzhou, Jiangsu, China Tel: (+86) 519-88769966 Fax: (+86) 519-88738899
| Primary Contact | Mike Gu |
|---|---|
| Person: | Regulatory Affairs Manager |
| Guangzhou Osmunda Medical Device Technical Service | |
| Co., Ltd. | |
| Tel: (+86)-20-6231 6262 | |
| Fax: (+86) -20-8633 0253 | |
| Secondary Contact | Zhou Yu |
| Person: | Quality Manager |
| Jiangsu Trauhui Medical Instrument Co., Ltd | |
| Tel: (+86) 519-88769966 | |
| Fax: (+86) 519-88738899 | |
| Date prepared | Sep 20, 2018 |
| 2. DEVICE | |
| Device Name: | Cellent Spinal Systems |
| Common/Usual Name: | Cellent Spinal Systems |
| Regulation number | 21 CFR 888.3070 |
Regulation Name Thoracolumbosacral Pedicle Screw System Regulation Class: ll Product Code: NKB
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3. PREDICATE DEVICES
Primary predicate device: K161151, Spinal fixation system Additional predicate device: K082617, Trauson General Spinal System (GSS)
4. DEVICE DESCRIPTION
Cellent Spinal System is a combination of pedicle screws, pedicle hooks, rods, set screws, connectors, and cross links, which can fix the vertebral body through pedicle or lamina.
It is made of Titanium Alloy (Ti-6AL-41V ELI), which meet ASTM F136-13, Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants.
INDICATIONS FOR USE 5.
Cellent Spinal Systems are intended for posterior pedicle screw fixation of the noncervical posterior spine in skeletally mature patients. It 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.
Cellent Spinal Systems are not intended for pedicle screw fixation above T8.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Cellent Spinal System is substantially equivalent to the cleared primary predicate device, the Spinal fixation system (K161151) because it has same indications for use, is composed of the same materials, and has similar technological characteristics. Differences between the subject and predicate devices include sizes of pedicles and screws. The differences in technological characteristics do not raise different questions of safety and effectiveness. In addition, Cellent Spinal System meets or exceeds the performance of the predicate devices in ASTM F1717 and ASTM F1798 bench tests.
- NON-CLINICAL DATA 7.
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The following non-clinical data were provided in support of the substantial equivalence determination.
Performance testing
Comparative performance tests (static and dynamic compression bending and static torsion) were conducted between Cellent Spinal System and the predicate device, according to ASTM F1717-15 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, and static axial and torsional gripping capacity testing per ASTM F1798-13 Standard Guide For Evaluating The Static And Fatigue Properties Of Interconnection Mechanisms And Subassemblies Used In Spinal Arthrodesis Implants. The performance differences between proposed device and predicate device will not affect the safety and effectiveness of the proposed device. It demonstrates substantial equivalences to the predicate device.
Animal Study
The subject of this premarket submission, Cellent Spinal System, does not require animal studies to support substantial equivalence.
CLINICAL DATA 8.
The subject of this premarket submission, Cellent Spinal System, did not require clinical studies to support substantial equivalence.
9. CONCLUSION
The differences between the Cellent Spinal System and its predicate devices do not raise different questions of safety and effectiveness. The non-clinical data support substantial equivalence of the device and the performance testing report demonstrate that the Cellent Spinal System should perform as intended in the specified use conditions.
From the results of non-clinical data including the performance testing and comparative performance testing described, Jiangsu Trauhui Medical Instrument Co., Ltd. concludes that the Cellent Spinal System is substantially equivalent to the predicate devices.