(168 days)
Not Found
No
The summary describes a mechanical spinal fixation system made of titanium alloy. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is described as a "Spinal System" intended for "pedicle fixation" and "stabilization of the spine as an adjunct to fusion with bone graft" for various medical conditions, indicating its use in treating and managing patient health.
No
Explanation: The device is a spinal system intended for fixation and stabilization of the spine as an adjunct to fusion, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components made of Titanium Alloy (screws, rods, crosslink plates, set screws, and hooks), 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, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- YAHUA Spinal System Function: The YAHUA Spinal System is a surgical implant used for stabilizing the spine within the body (in vivo). It is a mechanical device used to provide structural support and aid in fusion.
The provided text clearly describes a surgical implant for spinal fixation, not a device for testing biological samples.
N/A
Intended Use / Indications for Use
The Y AHUA Spinal 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 of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
Product codes
MNI, MNH, KWP
Device Description
The spinal system consists of screws, rods, crosslink plates, set screws and hooks.
It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.
The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical, pedicle fixation, L5-S1 vertebrae, spine, T8 - S1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
hospital
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)
The proposed device and predicate device are tested together per the following standard, to evaluate the performance of the proposed device and the predicate device. The test results demonstrated that the mechanical performance of proposed device is similar as the predicate.
ASTM F1717-14, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items:
- A Static compression bending test;
- ≫ Dynamic compression bending test;
-
Static torsion test.
- No clinical study is included in this submission.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human face in profile, with three overlapping faces suggesting community and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
February 1, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Beijing Weigao Yahua Artificial Joint Development Company, Limited % Ms. Diana Hong Mid-Link Consulting Company, Limited P.O. Box 120-119 Shanghai 200120 CHINA
Re: K152324
Trade/Device Name: YAHUA Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: January 6, 2016 Received: January 11, 2016
Dear Ms. Hong:
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
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 yours,
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) K152324
Device Name YAHUA Spinal System
Indications for Use (Describe)
The Y AHUA Spinal 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 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
-
- Date of Preparation: 06/20/2015
-
- Sponsor Identification
Beijing Weigao Yahua Artificial Joint Development Co. Ltd. No.7, NiuHui Street, NiuLanShan Town ,ShunYi District ,Beijing, 101301, China
Establishment Registration Number: Not yet registered
Contact Person: Xinjian Lv Position: R&D Manager Tel: +86-10-69416956 Fax: +86-10-69416956 Email: lxj@wegojoint.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: YAHUA Spinal System
Regulatory Information
Classification Name: Pedicle screw spinal system Classification: Class II Product Code: MNI, MNH, KWP Regulation Number: 21 CFR part 888.3070, 21 CFR part 888.3050 Review Panel: Orthopedic
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The YAHUA Spinal 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 and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
Device Description
The spinal system consists of screws, rods, crosslink plates, set screws and hooks.
It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.
The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
Primary Predicate న్.
510(k) Number: K122994 Product Name: General Spinal System Manufacturer: Weigao Orthopaedic Device Co., Ltd
5
Non-Clinical Test Conclusion 6.
The proposed device and predicate device are tested together per the following standard, to evaluate the performance of the proposed device and the predicate device. The test results demonstrated that the mechanical performance of proposed device is similar as the predicate.
ASTM F1717-14, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items:
- A Static compression bending test;
- ≫ Dynamic compression bending test;
-
Static torsion test.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
Substantially Equivalent (SE) Comparison 8.
| Item | Proposed Device | Predicate Device |
|---|---|---|
| YAHUA Spinal System | General Spinal System | |
| Product Code | MNI, MNH, KWP | MNI, MNH, KWP |
| Regulation | ||
| Number | 888.3070 and 888.3050 | 888.3070 and 888.3050 |
| Intended Use | The YAHUA Spinal System is intended for | |
| posterior, non-cervical, pedicle fixation for the | ||
| following indications: | The General Spinal System is intended for | |
| posterior, non-cervical, pedicle fixation for the | ||
| following indications: | ||
| Severe spondylolisthesis (grade 3 or 4) of the L5-S1 | ||
| vertebrae | Severe spondylolisthesis (grade 3 or 4) of the | |
| L5-S1 vertebrae | ||
| Trauma (i.e. fracture or dislocation) | Trauma (i.e. fracture or dislocation) | |
| Spinal stenosis | Spinal stenosis | |
| Curvatures (i.e. scoliosis, kyphosis, and/or lordosis); | Curvatures (i.e., scoliosis, kyphosis and/or | |
| lordosis); | ||
| Tumor | Tumor | |
| Pseudoarthrosis; | Pseudoarthrosis; | |
| Failed previous fusion. | 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. | 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 | ||
| Configuration | Rods | Rods |
| Multi Axial Screws | Multi Axial Screws | |
| Multi-Axial Reduction Screws | Multi-Axial Reduction Screws | |
| Fixed Angle Screw | Fixed Angle Screw | |
| Fixed Angle Reduction Screws | Fixed Angle Reduction Screws | |
| Crosslink Plate | Crosslink Plate | |
| Set Screws (Non Break-off, Break-off) | Set Screws (Non Break-off, Break-off) | |
| Sterile | Provided Non-Sterile, required to be sterilized prior | |
| to operation. | Provided Non-Sterile, required to be sterilized | |
| prior to operation. | ||
| Method: Steam | Method: Steam | |
| SAL: 10-6 | SAL: 10-6 | |
| Single Use | Yes | Yes |
| Material | Titanium Alloy (Ti-6Al-4V ELI) | |
| Conforms to ASTM F136 | Titanium Alloy (Ti-6Al-4V ELI) | |
| Conforms to ASTM F136 | ||
| Implant |
Table 1 Comparison of Technology Characteristics
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| | instruments | Stainless Steel
Conforms to ASTM F138 | Stainless Steel
Conforms to ASTM F138 |
| -- | ------------- | ------------------------------------------ | ------------------------------------------ |
|---|
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.