(27 days)
The ProMIS™ Fixation System is 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: degenerative disc disease (DDD; 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.
The ProMIS™ Fixation System consists of 3 main single use implanted parts:
- ProMIS™ Fusion Rods: a straight or bent rod with various lengths.
- Polyaxial Pedicle screws.
- Setscrew.
All components are manufactured from Ti6Al4V per ASTM F136.
This document describes a 510(k) premarket notification for the Premia Spine Ltd.'s ProMIS™ Fixation System, which is a thoracolumbosacral pedicle screw system. The purpose of this 510(k) is to modify the sterilization method of certain rods, add new rod lengths, and introduce a modified set screw and new instrumentation. The document asserts substantial equivalence to a previously cleared device (K150380).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Aspect | Description / Standard | Reported Device Performance |
|---|---|---|
| Sterilization Efficacy | Sterilization validation for gamma irradiation to achieve a Sterility Assurance Level (SAL) of $10^{-6}$. | Validated according to ISO 11137-2:2013 by the method of substantiation of 25kGy as a sterilization dose for SAL $10^{-6}$ (VDmax25). This applies to pedicle and set screws, and fusion rods up to 100mm. Fusion rods longer than 100mm are provided non-sterile for steam sterilization by the user. |
| Pyrogenicity | Bacterial endotoxin testing (BET) to achieve an Endotoxin limit of <20 EU/device. | Conducted as specified in USP <85> to achieve the Endotoxin limit of <20 EU/device. |
| Packaging Integrity | Validation of packaging integrity during transportation and shelf life. | Packaging validation conducted according to ASTM D4169-16 and AAMI/ISO 11607-1:2006 (R) 2010. Accelerated aging study and real-time (ongoing) study conducted according to ASTM F1980-07 (2011) and ISO 11607-1:2006 to verify integrity and assure product sterility (SAL $10^{-6}$) and safety. |
| Mechanical Performance (Set-Screw) | Verification of functionality and proper locking for the modified set-screw design. | The mechanical performance of the modified Set-Screw design was verified under a functionality test, demonstrating clear and smooth movements between parts and proper locking into position. |
| Mechanical Performance (Overall System) | Assessment of whether changes introduce a new worst-case scenario. | An engineering analysis was performed and demonstrated that the subject components (including changes in rod length and set-screw design) do not introduce a new worst case. Therefore, additional mechanical testing (of the overall system) was not performed. The basis for this is likely a comparison to the predicate device, which would have undergone its own mechanical testing. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not contain information about a "test set" in the context of clinical performance or diagnostic accuracy. The performance data presented are related to engineering and manufacturing validations (sterilization, pyrogenicity, packaging, mechanical functionality) for design changes to an existing device.
- Sample Size: Not applicable for a traditional test set as described in clinical studies. The sample sizes would be specific to each engineering validation (e.g., number of units tested for sterilization, packaging integrity, and set-screw functionality). These specific sample sizes are not detailed in the summary.
- Data Provenance: The document does not specify the country of origin for the validation data. The studies are stated to be conducted according to international standards (ISO, ASTM, AAMI, USP), suggesting a globally recognized methodology. The data is based on retrospective engineering validation and analysis for the device modifications, rather than prospective human clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission is for modifications to a spinal fixation system, focusing on engineering and manufacturing validation, not on diagnostic accuracy requiring expert interpretation of medical images or clinical outcomes. Ground truth in this context refers to established scientific and engineering principles for manufacturing and sterility.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" requiring adjudication by human experts in this type of device submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-based diagnostic devices where human reader performance is compared with and without AI assistance. The ProMIS™ Fixation System is a surgical implant, not a diagnostic AI device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone performance study (in the context of an algorithm's diagnostic accuracy without human involvement) was not done. The device is a physical surgical implant, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the various performance criteria is based on:
- Established scientific standards and regulatory requirements: For sterilization (ISO 11137-2), pyrogenicity (USP <85>), and packaging integrity (ASTM D4169-16, AAMI/ISO 11607-1, ASTM F1980-07).
- Engineering analysis and functional demonstration: For the mechanical performance of the modified set-screw and the overall system, demonstrating adherence to design specifications and non-deterioration of current worst-case scenarios.
8. Sample Size for the Training Set
Not applicable. There is no training set for an AI algorithm in this device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for an AI algorithm in this device submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 2, 2017
Premia Spine Ltd. % Ms. Janice M. Hogan Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K170061
Trade/Device Name: ProMISTM Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: January 6, 2017 Received: January 6, 2017
Dear Ms. Hogan:
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 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
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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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
Device Name
ProMIS™ Fixation System
Indications for Use (Describe)
The ProMlS™ Fixation System is intended to provide immobilization 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 disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): spondvlolisthesis: trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis); tumor; pseudoarthrosis; and failed previous fusion.
The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
区 Prescription Use (Part 21 CFR 801 Subpart D)
[ Over-The-Counter Use (21 CFR 801 Subpart C)
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K170061 Page 1 of 3
510(k) SUMMARY
Premia Spine Ltd.'s ProMIS™ Fixation System
Submitter:
Premia Spine Ltd. 7 Giborey Israel Street Ramat Poleg, 42504, Israel Phone: 972-54-4626602 Facsimile: 972-72-2281201 Contact Person: Vered Nitzan
Date Prepared: January 31, 2017
Trade Name: ProMIS™ Fixation System
21 C.F.R. 888.3070 Thoracolumbosacral pedicle screw system. NKB - Class II
Predicate Devices
ProMIS™ Fixation System by Premia Spine Ltd. (K150380)
Device Description
The ProMIS™ Fixation System consists of 3 main single use implanted parts:
-
- ProMIS™ Fusion Rods: a straight or bent rod with various lengths.
-
- Polyaxial Pedicle screws.
-
- Setscrew.
All components are manufactured from Ti6Al4V per ASTM F136.
Intended Use/Indications for Use
The ProMIS™ Fixation System is 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: degenerative disc disease (DDD; 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; deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with minimally invasive (MIS) instrumentation.
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Summary of Technological Characteristics
The subject and predicate systems are made from the same materials and are composed of the same components, including pedicle screws, fusion rods, and set screws.
The following technological differences exist between the subject and predicate devices:
- · The short rods (up to 100mm) in the subject system are provided sterile by gamma irradiation, while in the predicate system they are provided non sterile and should be steam sterilized by the user. Please note the package was not altered due to this modification.
- . The rods length range in the subject system is 35mm-180mm, while in the predicate system it is 40mm-180mm in length.
- . Minor design change to the set-screw
- · Addition of Instrumentation
Purpose of 510(k)
The purpose of this 510(k) is to modify the ProMIS™ Fixation System by the sterilization method of rods up to 100mm and to add rods with 35 mm lengths, a modified set screw, and Class I instrumentation.
Performance Data
Sterilization validation of the modified process was conducted according to ISO 11137-2:2013 by the method of substantiation of 25kGy as a sterilization dose for SAL 10° (VDmax25).
Bacterial endotoxin testing (BET) as specified in USP <85> is used for pyrogenicity testing to achieve the Endotoxin limit of <20EU/device.
Packaging validation according to ASTM D4169-16 and AAMI/ ISO 11607-1: 2006 (R) 2010, and accelerated aging study, and real time (ongoing) study, according to ASTM F1980-07 (2011) and ISO 11607-1:2006, were conducted in order to verify the integrity of the product packaging during their transportation and shelf life thus assuring product sterility (SAL 10°) and safety when the product is used.
The mechanical performance of the modified Set-Screw design was verified under functionality test demonstrating clear and smooth movements between parts and proper locking into position.
An engineering analysis was performed and demonstrated the subject components do not introduce a new worst case. Therefore, additional mechanical testing was not performed.
Conclusions
The subject ProMIS™ Fixation System is substantially equivalent to the cleared ProMIS™ Fixation The subject system has the same intended uses and similar indications, technological System. characteristics, and principles of operation as its predicate device. The minor technological differences raise no new issues of safety or effectiveness. Performance data demonstrate that the ProMIS™ Fixation System is substantially equivalent to the previously cleared ProMIS™ Fixation System.
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Table 3.1. Comparison Table between the subject and predicate systems:
| Subject ProMIST ™ Fixation System | Predicate ProMIST ™ Fixation System(K150380) | ||
|---|---|---|---|
| Intended Use/Indications for Use | The ProMIS ™ Fixation System is intended to provide immobilization and stabilization ofspinal segments in skeletally mature patients as an adjunct to fusion in the treatment ofthe following acute and chronic instabilities or deformities of the thoracic, lumbar, andsacral spine: degenerative disc disease (DDD; defined as back pain of discogenic originwith degeneration of the disc confirmed by history and radiographic studies);spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities orcurvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failedprevious fusion.The ProMIST ™ Fixation System can be used in an open approach or a posterior,percutaneous approach with minimally invasive (MIS) instrumentation. | ||
| User Population | Skeletally mature patients | ||
| Material | Pedicle and Set screws: Ti6Al4VFusion Rods: Ti6Al4V | ||
| Dimensions: | Pedicle screws:Diameter: 5.5mm-8.5mmLength: 25mm-60mmFusion Rods:Diameter: 6mmLength: 35mm-180mm | Pedicle screws:Diameter: 5.5mm-8.5mmLength: 25mm-60mmFusion Rods:Diameter: 6mmLength: 40mm-180mm | |
| DesignFeatures | Fusion Rods | Straight or bent with various lengths | |
| Pedicle Screws | Polyaxial pedicle screws consist of a self-drilling, cannulated, threaded portion, an insert, a pedicle screw head | ||
| Set Screw | Includes internal slots | Does not include internal slots | |
| Sterilization Process | Pedicle and set screws –provided sterile by gamma irradiation Fusion Rods up to 100mm - provided sterile by gamma irradiation Fusion Rods longer than 100mm – provided non sterile, to be steam sterilized by user | Pedicle and set screws –provided sterile by gamma irradiation Fusion Rods – provided non sterile, to be steam sterilized by user | |
| Single Use | Single use | ||
| Shelf Life | 5 years | Fusion Rods – not applicablePedicle and Set Screws – 5 years |
§ 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.