(76 days)
No
The device description focuses on mechanical components for spinal fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The change described is related to sterilization.
No.
The device is a spinal fixation system, intended to stabilize the spine as an adjunct to fusion, which is a structural and mechanical function rather than a therapeutic one (i.e. treating a disease or condition).
No
The device is a surgical fixation system (pedicle screws, rods, interconnecting devices) used to stabilize the spine as an adjunct to fusion, not to diagnose a condition.
No
The device description explicitly states it is a system made up of physical components (pedicle screws, rods, interconnecting devices) manufactured from titanium alloy, which are implanted in the body. This is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Sterile Posterior Spinal Fixation System is a surgical implant used to stabilize the spine. It is physically implanted into the patient's body.
- Intended Use: The intended use is for posterior, non-cervical fixation as an adjunct to fusion for various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a specimen.
The device is a surgical implant, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Sterile Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenc 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
NKB
Device Description
The Sterile Posterior Spinal Fixation System is a single-use system for surgical fixation of the spine. It is made up of pedicle screws, rods, and interconnecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implantable devices are manufactured from titanium alloy and are provided sterile.
The Sterile Posterior Spinal Fixation System includes the following sets:
- RS8 LEGEND (designed for open surgery)
- RS8 LONG (designed for minimally invasive surgery)
Each set comprises of different rods, screws, set screws, and accessory parts, including various lengths and diameters of reduction screws. Both sets are designed for internal posterior thoracolumbar fixation of the spine. Patient diagnosis and individual conditions should be taken into consideration when selecting the surgical option.
Surgical instruments are provided with the subject device and predicate device.
The subject of this submission is a design change to Posterior Spinal Fixation System(K201737). The Posterior Spinal Fixation System(K201737) is provided non-sterile and the subject device is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical fixation
Indicated Patient Age Range
Not Found
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
The evaluation of biocompatibility, sterility, pyrogenicity, package integrity, and shelf-life were performed in support of the proposed change.
No additional pre-clinical or clinical data is required to support the substantial equivalence determination for this change.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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August 31, 2022
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Shanghai REACH Medical Instrument Co., Ltd. % Huifang Zhao Consultant Sinow Medical AS Hoyteknologisenteret, Thormohlens gate 55 Bergen, 5006 Norway
Re: K221745
Trade/Device Name: Sterile Posterior Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: August 19, 2022 Received: August 24, 2022
Dear Huifang Zhao:
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,
for
Colin O'Neill, M.B.E. 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
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Indications for Use
510(k) Number (if known) K221745
Device Name
Sterile Posterior Spinal Fixation System
Indications for Use (Describe)
The Sterile Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenc 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
K221745
1. Contact Information
1.1. Applicant
Date prepared: Aug.19,2022 Applicant: Shanghai REACH Medical Instrument Co., Ltd Address: Building 13, No.999 Jiangyue Road, Minhang District, 201114 Shanghai, PEOPLE'S REPUBLIC OF CHINA Contact Person: Mingsha Ye Title: Registration Manager Telephone: (86) 021-54840582 E-mail: yems(@reach-med.com 1.2. Consultant Company: Sinow Medical AS Address: Høyteknologisenteret, Thormøhlens gate 55, 5006 Bergen, Norway Contact Person: Huifang Zhao Telephone: +47 41412078 Email: huifang.zhao@sinowmedical.no
2. Device information
Trade Name: Sterile Posterior Spinal Fixation System Common Name: Thoracolumbosacral Pedicle Screw System Regulation Number: 21 CFR 888.3070 Classification Name: Thoracolumbosacral Pedicle Screw System Classification: II Product Code: NKB Review Panel: Orthopedic
3. Legally Marketed Primary Predicate Device
Posterior Spinal Fixation System (K201737)
4. Indications for use
The Sterile Posterior Spinal Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and
4
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.
5. Device Description
The Sterile Posterior Spinal Fixation System is a single-use system for surgical fixation of the spine. It is made up of pedicle screws, rods, and interconnecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implantable devices are manufactured from titanium alloy and are provided sterile.
The Sterile Posterior Spinal Fixation System includes the following sets:
- RS8 LEGEND (designed for open surgery)
- RS8 LONG (designed for minimally invasive surgery)
Each set comprises of different rods, screws, set screws, and accessory parts, including various lengths and diameters of reduction screws. Both sets are designed for internal posterior thoracolumbar fixation of the spine. Patient diagnosis and individual conditions should be taken into consideration when selecting the surgical option.
Surgical instruments are provided with the subject device and predicate device.
The subject of this submission is a design change to Posterior Spinal Fixation System(K201737). The Posterior Spinal Fixation System(K201737) is provided non-sterile and the subject device is provided sterile.
6. Substantially Equivalent (SE) Comparison
The subject device has the same indications for use/intended use, design, and materials as the primary predicate device. The only change proposed in this submission is the method used to sterilize the subject device.
7. Description of the change
The modification has been made only to sterilization method of the implants. The predicate device provides non-sterile implants and surgical instruments which must be cleaned and sterilized by the end user prior to use. For the subject device the implants are sterilized with gamma sterilization by manufacture and the sterilization process was validated according to ISO 11137-1:2006 and AAMI TIR29:2012. The implants will provide a sterility assurance level (SAL) of 10-6.
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8. Performance data
The evaluation of biocompatibility, sterility, pyrogenicity, package integrity, and shelf-life were performed in support of the proposed change.
No additional pre-clinical or clinical data is required to support the substantial equivalence determination for this change.
9. Conclusion
The information presented in this 510(k) submission establishes that the subject device is substantially equivalent to the primary predicate device.