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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the "KeYi Spinal Fixation System," a medical device. This document details the process and data used to demonstrate the device's substantial equivalence to predicate devices, focusing on non-clinical testing.

Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are established by demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. The performance is assessed against established ASTM standards for spinal implants.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
Compliance with ASTM F 1717-15 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including:	"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;"
- Static compression bending test parameters	Passed
- Dynamic compression bending test parameters	Passed
- Static torsion test parameters	Passed
Performance of proposed device not inferior to that of predicate devices, even with minor differences (e.g., additional screw types).	"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."
Sterilization validation (S.A.L. of 10-6 via autoclave) per ISO 17665-1:2006.	"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. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify the exact sample size (number of constructs or tests performed) for the non-clinical tests (ASTM F1717). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
Data Provenance: The data comes from non-clinical testing, specifically mechanical bench testing performed to established ASTM standards. The location of the testing is not explicitly stated, but the company is based in Beijing, China. This data is part of a premarket notification (510(k)) submission to the U.S. FDA, indicating it's intended for regulatory review in the US. The timeframe is from April 2019. It is not retrospective or prospective clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not Applicable. For this type of mechanical device, "ground truth" is established through engineering specifications and standardized test methods (like ASTM F1717). There are no human experts in the traditional sense involved in establishing "ground truth" for the performance of the non-clinical tests themselves, beyond the engineers and technicians conducting and analyzing the tests according to the standard protocols.

4. Adjudication Method for the Test Set:

Not Applicable. As this is non-clinical mechanical testing against a standard, there is no "adjudication method" in the sense of reconciling divergent human expert opinions. The determination of whether a test result meets the standard is objective based on the protocol.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document explicitly states: "No clinical study is included in this submission." Therefore, an MRMC comparative effectiveness study was not performed as part of this particular submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study:

Not Applicable. This is a physical spinal fixation system, not a software algorithm or AI-based device. Performance is assessed through mechanical testing and comparison to predicate physical devices.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical testing is based on established engineering standards and material specifications (e.g., ASTM F1717-15 for mechanical performance, ASTM F136-13 for Titanium Alloy, ASTM F1537-11 for CoCrMo, and ISO 17665-1:2006 for sterilization). The performance of the device is assessed against these quantifiable, objective criteria.

8. The Sample Size for the Training Set:

Not Applicable. This is a traditional medical device (spinal implant), not an AI/ML-based device that requires a training set. The performance is based on the inherent properties of the manufactured components and their assembly.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name of the agency is "U.S. Food & Drug Administration".

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

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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.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

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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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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

1. Date of Preparation: 04/23/2019
1. 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 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.

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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;
1. Clinical Test Conclusion

No clinical study is included in this submission.

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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 isintended for posterior, non-cervical fixation asan adjunct to fusion in skeletally maturepatients for the following indications:degenerative disc disease (defined as back painof discogenic origin with degeneration of thedisc confirmed by history and radiographicstudies); spondylolisthesis; trauma (i.e.,fracture or dislocation); spinal stenosis;curvatures (i.e., scoliosis, kyphosis and/orlordosis); tumor; pseudarthritis; and/or failedprevious fusion.	The Synergy Spinal System implants areintended to be used as a temporaryconstruct that assists normal healing andare not intended to replace normal bodystructures. They are intended to stabilizethe spinal operative site during fusionprocedures and should be removed afterfusion.The implants are attached to the spineposteriorly by means of hooks and/orscrews joined with rods and anteriorly bymeans of vertebral screws joined with rods.As a pedicle screw system, the SynergySpinal System is intended only for patients:(a) having severe spondylolisthesis (Grades3 and 4) of the fifth lumbar-first sacral(L5-S1) vertebral joint; (b) who are havingthe screws fixed or attached to the lumbarand sacral spine; (c) who are receivingfusions using autogenous bone graft only;	When used as a pedicle screwfixation system of the non-cervicalposterior spine in skeletally maturepatients using allograft and/orautograft, the TSRH Spinal system isindicated as an adjust to fusion forone or more of the following: (1)degenerative disc disease (defined asback pain of discogenic origin withdegeneration of the disc confirmedby patient history and radiographicstudies), (2) degenerativespondylolisthesis with objectiveevidence of neurologic impairment,(3) fracture, (4) dislocation, (5)scoliosis, (6) kyphosis, (7) spinaltumor, and/or (8) failed previousfusion (pseudarthrosis).In addition, when used as a pediclescrew fixation system, the TSRH

Table 1 Comparison of Proposed Device and Predicated Device

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510(k) Summary

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 removedafter the development of a solid fusionmass. The levels of screw fixation are L3 toS/Ilium.In addition, the pedicle screw system mayalso be used to provide immobilization andstabilization of spinal segments, inskeletally mature patients as an adjunct tofusion in the treatment of the followingacute and chronic instabilities ordeformities of the thoracic, lumbar, andsacral spine: degenerative spondylolisthesiswith objective evidence of neurologicimpairment, fracture, dislocation, scoliosis,kyphosis, spinal tumor, and failed previousfusion (pseudarthrosis).	Spinal System is indicated as anadjunct to fusion for skeletallymature patients using allograft and/orautograft: (1) having severespondylolisthesis (Grades 3 and 4) ofthe fifth lumbar-first sacral (L5-S1)vertebral joint: (2) who are receivingfusions using autogenous bone graftonly:(3) who are having the devicefixed or attached to the lumbar andsacral spine(L3 and below): and (4)who are having the device removedafter the development of a solidfusion 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.

Regulation Number and Section

§ 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.