(89 days)
Not Found
No
The device description focuses on the mechanical components and materials of a spinal fixation system, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies described are non-clinical mechanical tests.
Yes
The device is used for fixation and stabilization of the spine as an adjunct to fusion for treating various instabilities and deformities, indicating a therapeutic purpose.
No
The General Spinal System is a surgical implant designed for stabilization and immobilization of spinal segments, as an adjunct to fusion. It does not perform any diagnostic function.
No
The device description explicitly lists physical components made of titanium alloy (screws, hooks, rods, etc.), indicating it is a hardware-based medical device.
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 is done outside of the body (in vitro).
- Device Description: The provided description clearly states that the General Spinal System is a collection of implants (screws, rods, hooks, etc.) made of Titanium Alloy. These are surgically implanted into the body to stabilize the spine.
- Intended Use: The intended use describes the surgical application of these implants for posterior pedicle screw fixation of the spine. This is a surgical procedure performed on the body.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The General Spinal System is intended for posterior pedicle screw fixation of the non-cervical 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 deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, 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
MNI, MNH
Device Description
The General Spinal System consists of Fixed-Angle Screws, Fix-Angle Reduction Screws, Hooks, Rods, Cross Link and Set Screws.
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) Allov 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 10 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 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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed. device complies with the following standard:
ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items:
- Static compression bending test;
- Dynamic compression bending test;
- Static torsion test.
Differences in physical specification and performance between the proposed and predicate device have been discussed and address. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and effectiveness.
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.
0
K140229 Page 1 of 4
APR 2 9 2014
Section 3 510(k) Summary
This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K140229
-
Date of Submission: 01/27/2014
-
Sponsor Identification
.
Tianjin Walkman Biomaterial Co., Ltd No. 19 Technology Road, Tianyu Technology Development Zone, East of Jinghai, Tianjin, 301609. China
Establishment Registration Number: Not yet registered
Contact Person: Ms. Fengmei Ren Position: Management Representative Tel: +86-22-68660780 Fax: +86-22-68660776 Email: wm-rfm@126.com
Submission Correspondent 3.
Ms. Diana Hong& Mr. Lee Fu 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
1
Proposed Device Identification 4.
Common Name: Pedicle Screw Spinal System Proposed Device Name: General Spinal System Classification Name: Pedicle screw spinal system Product Code: MNI, MNH Regulation Number: 21 CFR part 888.3070 Review Panel: Orthopedic
Intended Use Statement:
The General Spinal System is intended for posterior pedicle screw fixation of the non-cervical 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 deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, 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.
-
- Predicate Device Identification
510(k) Number: K082617 Product Name: Trauson General Spinal System (GSS) Manufacturer: Trauson (Jiangsu) Medical Instrument Co., Ltd.
- Predicate Device Identification
Device Description 6.
The General Spinal System consists of Fixed-Angle Screws, Fix-Angle Reduction Screws, Hooks, Rods, Cross Link and Set Screws.
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) Allov 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 10 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
2
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed. device complies with the following standard:
ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items:
- Static compression bending test;
- Dynamic compression bending test;
- Static torsion test.
-
- Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
| Item | Proposed Device | Predicate Device |
|---|---|---|
| K082617 | ||
| Product Code | MNH | MNH |
| MNI | MNI | |
| Regulation | ||
| Number | 21 CFR 888.3070 | 21 CFR 888.3070 |
| Intended Use | The General Spinal System is intended for | |
| posterior pedicle screw fixation of the | ||
| non-cervical 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 | ||
| 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. | Trauson General Spinal System (GSS) is | |
| intended for posterior pedicle screw fixation | ||
| (GSS-VII can be applied for anterior or | ||
| anterolateral fixation) of the non-cervical | ||
| 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 deformities. |
When used as a posterior spine
thoracic/lumbar system, Trauson General Spinal
System (GSS) is indicated for one or more of the
following: (1) trauma (i.e. fracture or |
| | | |
Table 3-1 Comparison of Technology Characteristics
3
| | | dislocation), (2) curvatures (scoliosis, kyphosis,
and/or lordosis), (3) spinal tumor, (4) failed
previous fusion, (5) pseudarthrosis, (6) spinal
stenosis. |
|--------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Trauson General Spinal (GSS) is not
intended for pedicle screw fixation about T8. |
| Assembly | Fixed-Angle Screws, Fix-Angle Reduction
Screws, Cross Link, Rod and Set Screws | Fix-Angle Reduction_Screws, Cross Link, Rod
and Set Screws |
| Material | Titanium alloy | Titanium alloy |
| How supplied | Non-Sterile | Non-Sterile |
| Single Use | Yes | Yes |
| Sterile | Subject to steam sterilized prior to use. | Subject to steam sterilized prior to use. |
| Performance | ASTM F 1717-04 Standard Test Methods for
Spinal Implant Constructs in a Vertebrectomy
Model | ASTM F 1717-04 Standard Test Methods for
Spinal Implant Constructs in a Vertebrectomy
Model |
Differences in physical specification and performance between the proposed and predicate device have been discussed and address. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and effectiveness.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2014 ·
Tianjin Walkman Biomaterial Company, Limited % Mid-Link Consulting Company, Limited Ms. Diana Hong P.O. Box 120-119 Shanghai, 200120, CHINA -
Re: K140229
Trade/Device Name: General Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: January 27, 2014 Received: January 30, 2014
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 (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.
5
Page 2 - Ms. Diana Hong
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/ResourcesforYou/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/Safetv/ReportalProblem/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.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140229
Device Name
General Spinal System
Indications for Use (Describe)
The General Spinal System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature paients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities deformities: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, kyphosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion, (5) spinal stenosis. It is not intended for pedicle screw fixation above T8.
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)
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)
James P. Bertram -S 2014.04.29 12:31:40 -04
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