Ideal® pedicle screw 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); turnor; 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.

Device Description

The spinal system consists of pedicle screws, fixed screws, bars and crosslink rod etc. It is made of titanium alloy (Ti6Al4V ELI), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1 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

This document is a 510(k) premarket notification for a medical device called the "Ideal® Pedicle Screw Spinal System." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a clinical study. Therefore, the information requested in your prompt (acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, etc.) is not applicable or present in this document.

Here's why and what information is available:

No acceptance criteria or device performance report: This document focuses on demonstrating that the new device (Ideal® Pedicle Screw Spinal System) is "substantially equivalent" to an existing, legally marketed device (Kangli® pedicle screw spinal system). This is typically achieved through design comparisons, material specifications, and bench testing rather than clinical studies with explicit acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader improvement.
No clinical study: The document explicitly states: "Bench tests were conducted to verify that proposed device meet all design specifications as was Substantially Equivalent (SE) to the predicate device." This means the evaluation was limited to non-clinical, laboratory-based tests.
No test set, training set, or ground truth information: These concepts relate to clinical studies involving AI/ML algorithms or human interpretation of data, which are not part of this 510(k) submission.

Information that is available from the document:

Device Name: Ideal® Pedicle Screw Spinal System
Predicate Device: K140053 Kangli® pedicle screw spinal system
Non-Clinical Testing Standards:
- ASTM F1717-14, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, including:
  - Static compression bending test
  - Dynamic compression bending test
  - Static torsion test
Materials: Titanium alloy (Ti6Al4V ELI) meeting ASTM F136.
Sterilization: Non-sterile, required to be sterilized by autoclave to a SAL of 10^-6, validated per ISO 17665-1.
Intended Use/Indications: Posterior, non-cervical, pedicle fixation for severe spondylolisthesis (grade 3 or 4) of L5-S1; trauma; spinal stenosis; curvatures (scoliosis, kyphosis, lordosis); tumor; pseudoarthrosis; and failed previous fusion. Used in skeletally mature patients as an adjunct to fusion with bone graft at levels T8-S1.

In summary, this 510(k) premarket notification describes a device that showed substantial equivalence to a predicate device through bench testing, not through a clinical study with performance acceptance criteria, test/training sets, or expert ground truth adjudication.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Jiangsu Ideal Medical Science & Technology Company, Limited % Ms. Alice Gong Shanghai Yarui Consultant Company, Limited 503 Room, 8 Building, 600 Liu Zhou Road 200233 Shanghai China

January 30, 2015

Re: K142957

Trade/Device Name: Ideal® Pedicle Screw Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: October 21, 2014 Received: November 4, 2014

Dear Ms. Gong:

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

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Page 2 - Ms. Alice Gong

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/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/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142957

Device Name Ideal® pedicle screw spinal system

Ideal® pedicle screw spinal system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-Sl vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); turnor; 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)

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)

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江苏艾迪尔医疗科技股份有限公司

Section 5 of Traditional 510(K) Submission:

510 (K) Summary

This 510(K) Summary of safety and effectiveness information is being submitted in accordance with requirement of 21 CFR807.92

1. Date of Submission: Oct. 8, 2014
1. Submitter / 510(K) Holder

Jiangsu Ideal Medical Science & Technology Co., Ltd. East Area, Jinfeng Industry Park Zhangjiagang City Jiangsu Province, China 215625

Contact Person: Miss Alice Gong Tel: (86) 0512-58550488 Fax: (86) 0512-58550988 E-mail: chinafda@hotmail.com

3. Proposed Device Name

Trade name: Ideal® Pedicle Screw Spinal system Common name: Pedicle screw spinal system

Classification Name: Pedicle screw spinal system Device Class: Class II Classification Panel: Orthopedic Panel Product Code: MNI, MNH Regulation Number: 21 CFR part 888.3070

4. Predicate Devices

510 (k) Number: K140053 Product Name: Kangli® pedicle screw spinal system Submitter: Suzhou Kangli Orthopaedics Instrument Co., Ltd.,

5. Device Description

The spinal system consists of pedicle screws, fixed screws, bars and crosslink rod etc.

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It is made of titanium alloy (Ti6Al4V ELI), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10° by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1 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. Indication for Use/Intended Use

Ideal® pedicle screw spinal system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); turnor; 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.

7. Non-Clinical Testing

Bench tests were conducted to verify that proposed device meet all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that proposed device complies with the following standards:

ASTM F1717-14, 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.

8. Substantially Equivalent Conclusion

The Ideal® pedicle screw spinal system has same intended use than the predicate device and similar technological characteristics as the predicate device, the Ideal® pedicle screw spinal system, is determined to be Substantially Equivalent (SE) to the predicate device, K140053 Kangli® pedicle screw spinal system.

Regulation Number and Section

N/A