(134 days)
The Premier is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): 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; and failed previous fusion (pseudoarthrosis).
The purpose of this 510(k) is to make modifications to the previously cleared Premier Spinal System (K160320). The changes include modifications to the implants, surgical instruments, indications and labeling. The Premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, iliac screw, domino connector, lateral connector and hooks.
It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Allov for Surgical Implant Applications, which are widely used for surgical implants with wellknown biocompatibility.
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.
The provided text does not describe an AI medical device or a study proving its acceptance criteria. Instead, it is an FDA 510(k) clearance letter for a Premier Thoracolumbosacral pedicle screw system, which is a physical orthopedic device used in spinal surgeries.
Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth related to an AI device. The document focuses on regulatory clearance for a medical implant and mentions conformance to ASTM standards and ISO guidelines for sterilization, not AI performance metrics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Shandong Weigao Orthopaedic Device Co., Ltd. % Mr. Justin Eggleton Senior Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers. LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
August 4, 2017
Re: K170861
Trade/Device Name: Premier Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP Dated: July 5, 2017 Received: July 6, 2017
Dear Mr. Eggleton:
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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
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.
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) K170861
Device Name Premier
Indications for Use (Describe)
The Premier is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): 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; and failed previous fusion (pseudoarthrosis).
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)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Device Trade Name: | Premier |
|---|---|
| Manufacturer: | Shandong Weigao Orthopaedic Device Co., Ltd.No. 26 Xiangjiang Road, Tourist ResortsWeihai, Shandong China 264203+86-631-5788966 |
| Contact: | Han WangR&D Vice DirectorShandong Weigao Orthopaedic Device Co., Ltd.No. 26 Xiangjiang Road, Tourist ResortsWeihai, Shandong China 264203 |
| Prepared by: | Mr. Justin EggletonSenior Director, Spine Regulatory AffairsMusculoskeletal Clinical Regulatory Advisers, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: (202) 552-5800jeggleton@mcra.com |
| Date Prepared: | July 5, 2017 |
| Classification: | 21 CFR §888.3070, Thoracolumbosacral pedicle screw system |
| Class: | II |
| Product Codes: | NKB, KWP |
| Predicate Device: | Weigao Orthopaedic Premier (K160320) |
| Additional PredicateDevices: | EXPEDIUM® Spine System (K101070)Vitality® Spinal Fixation System (K150896) |
Indications for Use:
The Premier is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): 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, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).
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Device Description:
The purpose of this 510(k) is to make modifications to the previously cleared Premier Spinal System (K160320). The changes include modifications to the implants, surgical instruments, indications and labeling. The Premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, iliac screw, domino connector, lateral connector and hooks.
It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Allov for Surgical Implant Applications, which are widely used for surgical implants with wellknown biocompatibility.
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.
Predicate Device:
The subject Premier is substantially equivalent to the primary predicate device Premier (K160320) and additional predicate devices EXPEDIUM® Spine System (K101070) and Vitality@ Spinal Fixation System (K150896) with respect to indications, design, materials, function, and performance.
Performance Testing:
The performance of the subject Premier System was determined based on a series of engineering rationales compared to the predicate devices cited in the previous section
Substantial Equivalence:
The subject Premier System is substantially equivalent to the primary predicate device Premier (K160320) and additional predicate devices EXPEDIUM® Spine System (K101070) and Vitality® Spinal Fixation System (K150896) with respect to indications, design, materials, function, and performance.
N/A