(481 days)
Not Found
No
The device description and intended use focus on the mechanical components and materials of a spinal fixation system, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is a Spinal Fixation System, which is used for posterior, non-cervical, pedicle fixation with indications such as severe spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and failed previous fusion, all of which aim to treat or alleviate a disease or injury.
No
The device is a Spinal Fixation System, which is an implant used for stabilizing the spine as an adjunct to fusion. Its purpose is to physically support and stabilize the skeletal structure, not to diagnose medical conditions.
No
The device description explicitly lists physical components (screws, rods, transverse bar assembly, set screws) made of titanium alloy, 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 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 provided text clearly describes a surgical implant used for spinal fixation. It is a physical device implanted into the body to stabilize the spine.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is purely mechanical support and stabilization.
The information provided aligns with a Class II or Class III medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
The Spinal 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 of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Spinal Fixation System consists of screws, rods, transverse bar assembly, set screws.
It is made of titanium Alloy (Ti6AI4VELI), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Vanadium 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 10th 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
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)
The Spinal Fixation System of Shandong Kangsheng Medical Devices Co., Ltd. has taken the sterility and performance testing into concern in accordance to Food and Drug Administration related guidance and recognized international standards. Test data and report information are included in this submission.
Test Items:
Static Compression Bending Test
Static Torsion Test
Dynamic Compression Bending Test
Test Standard: ASTM F1717-15
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 16, 2020
Shangdong Kangsheng Medical Devices Co., Ltd. % Jonathan Hu Technical Manager Medwheat (Shanghai) Medical Technology Co. Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No. 33 Room 303 Shanghai, 200082 China
Re: K190408
Trade/Device Name: Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: June 2, 2020 Received: June 12, 2020
Dear Mr. Hu:
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. 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 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190408
Device Name Spinal Fixation System
Indications for Use (Describe)
The Spinal 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 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
Image /page/3/Picture/2 description: The image shows the logo for Cansun. The logo features the word "CANSUN" in bold, black letters. Below the word, there are smaller Chinese characters. Above the word, there is a symbol that looks like a person with their arms raised, with a green arch above them.
Date Prepared: Jun 16th, 2020
510(k) Summary
[As required by 21 CFR 807.92]
1. Submitter's Information
| Name of Sponsor: | Shandong Kangsheng Medical Devices Co., Ltd. |
|---|---|
| Address: | North of industrial park, Dawenkou Gypsum, 271000, Tai |
| an, China | |
| Contact Name: | Wenxing Dong |
| Telephone No.: | +86 0538-8161819 |
| Fax No.: | +86 0538-8168500 |
| Email Address: | dwx@sansun.cn |
2. Correspondent's Information
| Company Name: | Medwheat Shanghai |
|---|---|
| Correspondent Name: | Jonathan Hu |
| Telephone No.: | 86-021-65181421 |
| Email Address: | Jonathan.hu@medwheat.com |
3. Trade Name, Common Name, Classification
| Trade / Device Name: | Spinal Fixation System |
|---|---|
| Common Name: | Pedicle Screw Spinal System |
| Mode Name: | SF I , DF II |
| Regulation Classification: | 21 CFR 888.3070 - Thoracolumbosacral pedicle screw |
| Product Code: | system, NKB |
| Classification Panel: | Orthopedic |
| Device Class: | II |
4
Image /page/4/Picture/1 description: The image shows the logo for Cansun. The logo features a stylized symbol in blue and green above the word "CANSUN" in bold, sans-serif font. Below "CANSUN" are Chinese characters, presumably the company's name in Chinese. The symbol above the name appears to be an abstract representation of people or growth, with the green portion on top and the blue portion below.
510(k) Submission
4. Identification of Predicate Device(s)
The identified primary predicate within this submission is as follows:
The General Spinal System has been cleared by FDA through 510(k) No. K122994 (Decision Date -- April 12, 2013).
5. Description of the Device
The Spinal Fixation System consists of screws, rods, transverse bar assembly, set screws.
It is made of titanium Alloy (Ti6AI4VELI), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Vanadium 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 10th 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.
6. Intended Use/Indication for Use
The Spinal 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.
5
Image /page/5/Picture/1 description: The image contains the logo for Cansun. The logo features a stylized graphic above the word "CANSUN" in bold, sans-serif font. Below "CANSUN" are smaller Chinese characters. The graphic consists of a blue figure with arms raised, topped by a green arch. The overall design is clean and modern.
510(k) Submission
7. Technological Characteristics
| Technological
Characteristics | Subject Device
Spinal Fixation System | Predicate Device
General Spinal System
K122994 | Discussion |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | NKB | MNI MNH KWP | Same* |
| Regulation | 21 CFR 888.3070 | 21 CFR 888.3050
21 CFR 888.3070 | Same |
| Intended Use | The Spinal
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. | 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; 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. | Same |
| Material | Ti6Al4V ELI conforms
to ASTM F136-13 | Ti6Al4V ELI conforms
to ASTM F136 | Same |
| Technological
Characteristics | Subject Device
Spinal Fixation System | Predicate Device
General Spinal System
K122994 | Discussion |
| Test Items | Static Compression
Bending Test | Static Compression
Bending Test | Same |
| | Static Torsion Test | Static Torsion Test | |
| | Dynamic Compression
Bending Test | Dynamic Compression
Bending Test | |
| Test Standard | ASTM F1717-15 | ASTM F1717-04 | Same |
| How Supplied | Non-sterile | Non-sterile | Same |
| Sterilization
Method | Method: Autoclave | Method: Autoclave | Same |
| Single Use | Yes | Yes | Same |
| Prescription /
OTC Use | Prescription Use | Prescription Use | Same |
| *Product Code is consolidated. | | | |
6
Image /page/6/Picture/1 description: The image contains a logo for a company called Cansun. The logo features the word "CANSUN" in bold, black letters, with the Chinese characters for "Kang Sheng Medical" written below it in a smaller font. Above the word "CANSUN" is a stylized graphic of a person with outstretched arms, with the head of the person being a circle. The person is blue, and the arms are green.
510(k) Submission
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
The Spinal Fixation System of Shandong Kangsheng Medical Devices Co., Ltd. has taken the sterility and performance testing into concern in accordance to Food and Drug Administration related guidance and recognized international standards. Test data and report information are included in this submission.
7
Image /page/7/Picture/1 description: The image shows the logo for Cansun. The logo features a stylized graphic above the word "CANSUN" in bold, sans-serif font. Below "CANSUN" are Chinese characters. The graphic consists of a blue figure with arms raised, topped by a green arching shape.
9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Shandong Kangsheng Medical Devices Co., Ltd. concludes that Spinal Fixation System is substantially equivalent to predicate devices with regard to safety and effectiveness.