(63 days)
Not Found
No
The summary describes a mechanical spinal fixation system made of metal components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical testing, not algorithmic performance.
Yes
The device is described as an "adjunct to fusion" for various spinal conditions, including degenerative disc disease, spondylolisthesis, and trauma, all of which are medical conditions that the device aims to treat or alleviate.
No
Explanation: The device, the KeYi Spinal Fixation System, is described as an implantable system of rods, screws, and cross-connectors used for posterior spinal fixation as an adjunct to fusion. Its purpose is to physically stabilize the spine, not to diagnose conditions.
No
The device description explicitly states it consists of physical components (rods, screws, cross-connectors) made of Titanium Alloy and CoCrMo, which are hardware implants.
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, or tissue) to provide information about a person's health.
- Device Description: The KeYi Spinal Fixation System is a collection of implants (rods, screws, cross-connectors) made of metal alloys. These are surgically implanted into the body to stabilize the spine.
- Intended Use: The intended use is for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for various spinal conditions. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
The information provided clearly describes a surgical implant system, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The proposed KeYi Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The KeYi Spinal Fixation System implant consists of a variety of shapes and sizes of rods, screws and cross-connectors which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The proposed device is made of Titanium Alloy (Ti6Al4V) which meets ASTM F136-13 and CoCrMo which meets ASTM F1537-11.
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
posterior, non-cervical 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 standards:
ASTM F 1717-15, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items
- A Static compression bending test;
-
Dynamic compression bending test;
- A Static torsion test;
No clinical study is included in this submission.
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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Beijing KeYi Medical Device Technology Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 CN
Re: K190567
Trade/Device Name: Ke Yi Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: February 22, 2019 Received: March 6, 2019
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. 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
1
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.htm); 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 medical devices and radiation-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.
for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190567
Device Name KeYi Spinal Fixation System
Indications for Use (Describe)
The proposed KeYi Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and/ or failed previous fusion.
| 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
Tab 7 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K190567
-
- Date of Preparation: 04/23/2019
-
- Sponsor Identification
Beijing KeYi Medical Device Technology Co., Ltd. Building 1, 30 Yongchang South Road, Beijing Economic Technological Development Area, 100176 Beijing, China
Establishment Registration Number: Not yet registered.
Contact Person: Jenny Jiang Position: RA Supervisor Tel: +86-10-67853877 Fax: +86-10-67853877 ext. 8117 Email: jiangli@keyibangen.com
3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: KeYi Spinal Fixation System Common Name: Pedicle Screw Spinal System
Regulatory Information Classification Name: Thoracolumbosacral Pedicle Screw System Classification: II Product Code: NKB Regulation Number: 21 CFR 888.3070 Review Panel: Orthopedic
Indications for Use:
The proposed Ke Yi Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
Device Description
The KeYi Spinal Fixation System implant consists of a variety of shapes and sizes of rods, screws and cross-connectors which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The proposed device is made of Titanium Alloy (Ti6Al4V) which meets ASTM F136-13 and CoCrMo which meets ASTM F1537-11.
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.
- న్. Identification of Predicate Device
Primary Predicate Device 510(k) Number: K012871 Product Name: SYNERGY TI INTEGRAL OPEN SCREWS Manufacturer: INTERPORE CROSS INTL.
5
Additional Predicate Device 510(k) Number: K111942 Product Name: TSRH Manufacturer: Medtronic
- Non-Clinical Test Conclusion 6.
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 standards:
ASTM F 1717-15, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including the following items
- A Static compression bending test;
-
Dynamic compression bending test;
- A Static torsion test;
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
510(k) Summary
Substantially Equivalent (SE) Comparison 8.
| Item | Proposed Device | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| K012871 | K111942 | ||
| Product Code | KWP | KWP | KWP |
| Regulation Number | 21 CFR 888.3050 | 21 CFR 888.3050 | 21 CFR 888.3050 |
| Class | II | II | II |
| Indications for Use | The proposed KeYi Spinal Fixation System is | ||
| intended for posterior, non-cervical fixation as | |||
| an adjunct to fusion in skeletally mature | |||
| patients for the following indications: | |||
| degenerative disc disease (defined as back pain | |||
| of discogenic origin with degeneration of the | |||
| disc confirmed by history and radiographic | |||
| studies); spondylolisthesis; trauma (i.e., | |||
| fracture or dislocation); spinal stenosis; | |||
| curvatures (i.e., scoliosis, kyphosis and/or | |||
| lordosis); tumor; pseudarthritis; and/or failed | |||
| previous fusion. | The Synergy Spinal System implants are | ||
| intended to be used as a temporary | |||
| construct that assists normal healing and | |||
| are not intended to replace normal body | |||
| structures. They are intended to stabilize | |||
| the spinal operative site during fusion | |||
| procedures and should be removed after | |||
| fusion. |
The implants are attached to the spine
posteriorly by means of hooks and/or
screws joined with rods and anteriorly by
means of vertebral screws joined with rods.
As a pedicle screw system, the Synergy
Spinal System is intended only for patients:
(a) having severe spondylolisthesis (Grades
3 and 4) of the fifth lumbar-first sacral
(L5-S1) vertebral joint; (b) who are having
the screws fixed or attached to the lumbar
and sacral spine; (c) who are receiving
fusions using autogenous bone graft only; | When used as a pedicle screw
fixation system of the non-cervical
posterior spine in skeletally mature
patients using allograft and/or
autograft, the TSRH Spinal system is
indicated as an adjust to fusion for
one or more of the following: (1)
degenerative disc disease (defined as
back pain of discogenic origin with
degeneration of the disc confirmed
by patient history and radiographic
studies), (2) degenerative
spondylolisthesis with objective
evidence of neurologic impairment,
(3) fracture, (4) dislocation, (5)
scoliosis, (6) kyphosis, (7) spinal
tumor, and/or (8) failed previous
fusion (pseudarthrosis).
In addition, when used as a pedicle
screw fixation system, the TSRH |
Table 1 Comparison of Proposed Device and Predicated Device
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510(k) Summary
| Components | Multi-axial screw | VLS Open Screw | Variable Angle Screw |
|---|---|---|---|
| Mono-axial screw | Close Screw | ||
| Multi-axial reduction screw | VLS Open Reduction Screw | ||
| Mono-axial reduction screw | Close Reduction Screw | ||
| Uni-planar reduction screw | Angled Closed Reduction Screw | ||
| Multi-axial cannulated reduction screw | / | Multi-axial cannulated reduction screw | |
| Mono-axial cannulated reduction screw | / | Mono-axial cannulated reduction screw | |
| Mono-axial cannulated reduction screw | / | Mono-axial cannulated reduction screw | |
| and (d) who are having the device removed | |||
| after the development of a solid fusion | |||
| mass. The levels of screw fixation are L3 to | |||
| S/Ilium. | |||
| In addition, the pedicle screw system may | |||
| also be used 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: degenerative spondylolisthesis | |||
| with objective evidence of neurologic | |||
| impairment, fracture, dislocation, scoliosis, | |||
| kyphosis, spinal tumor, and failed previous | |||
| fusion (pseudarthrosis). | Spinal System is indicated as an | ||
| adjunct to fusion for skeletally | |||
| mature patients using allograft and/or | |||
| autograft: (1) having severe | |||
| spondylolisthesis (Grades 3 and 4) of | |||
| the fifth lumbar-first sacral (L5-S1) | |||
| vertebral joint: (2) who are receiving | |||
| fusions using autogenous bone graft | |||
| only:(3) who are having the device | |||
| fixed or attached to the lumbar and | |||
| sacral spine(L3 and below): and (4) | |||
| who are having the device removed | |||
| after the development of a solid | |||
| fusion mass. |
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510(k) Summary
| Rod | Ti Rod | Ti Rod, CoCrMo Rod and SS Rod | |
|---|---|---|---|
| Set screw | Set screw | Lock screw | |
| Cross connector | Cross connector | Crosslink |
The proposed device has three more types of screws than are multi-axial camulated reduction screw, mono-axial cannulated reduction screw and cannulated Uni-planat reduction screw. The configuration of predicates can cover that of proposed device, and the performance of proposed device has been tested per ASTM F1717 and the test results shows the performance of proposed device is not inferior to that of predicate. Therefore, this difference is determined not to affect the Substantially Equivalency (SE) between the proce and predicate device concerning the safety and effectiveness of the medical device.
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.