(15 days)
Not Found
No
The device description focuses solely on the mechanical components of a spinal fixation system (rods, screws, setscrews) and their materials. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies mentioned are mechanical tests, not related to algorithmic performance.
Yes.
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various acute and chronic instabilities or deformities, which is a therapeutic purpose.
No
The ProMIS™ Fixation System is a surgical implant designed to provide immobilization and stabilization of spinal segments, acting as an adjunct to fusion. It is used for acute and chronic instabilities or deformities, not for diagnosing them.
No
The device description explicitly lists physical, implanted components (rods, screws, setscrews) made of Ti6Al4V, which are hardware. There is no mention of software as a component of this system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The ProMIS™ Fixation System is described as a system of implanted parts (rods, screws, setscrew) made of titanium. These are physical devices intended to be surgically placed within the body to stabilize the spine.
- Intended Use: The intended use is to provide immobilization of spinal segments as an adjunct to fusion in various spinal conditions. This is a therapeutic and structural function, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant used for spinal fixation, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The ProMIS™ Fixation System 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: 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 (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 minimal invasive (MIS) instrumentation.
Product codes
NKB
Device Description
The ProMIS™ Fixation System consists of 3 main single use implanted parts:
-
- ProMIS™ Fusion Rods: a straight or bent rod of various lengths.
-
- Polyaxial Pedicle Screws: cannulated and non- cannulated screw bodies with self-tapping flutes and rounded or self-drilling tips, available in three diameters (5.5mm, 6.5mm, with length ranging from 25 to 60, in increments of 5mm.
-
- Setscrew.
All components are manufactured from Ti6Al4V per ASTM F136
Rods up to 100mm in length and the Pedicle Screws are provided sterile (gamma irradiated).
Rods exceeding 100mm are supplied non-sterile (steam/autoclave sterilization by the end user).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The ProMIS™ Fixation System was subjected to static torsion and dynamic compression testing per ASTM F1717.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Pre-determined 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.
0
July 7, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Premia Spine Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market St., 23rd Floor Philadelphia, Pennsylvania 19103
Re: K231844
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: June 22, 2023 Received: June 22, 2023
Dear Janice 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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,
Eileen
Digitally signed
by Eileen Cadel
-S
Cadel - Date:
S for
2023.07.07
14:41:37 -04'00'
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
2
Indications for Use
510(k) Number (if known) K231844
Device Name ProMIS™ Fixation System
Indications for Use (Describe)
The ProMIS™ Fixation System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in 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 (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 minimal invasive (MIS) instrumentation.
| 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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K231844 Page 1 of 3
510(k) SUMMARY
Premia Spine Ltd's ProMIS™ Fixation System
Submitter:
Premia Spine Ltd. Giborey Israel 7 Ramat Poleg, Netanya, 4250407, Israel Phone: +972-54-8080130 Facsimile: +972-7222-81203
Contact Person: Dr. Dorit Winitz
Date Prepared:
Trade Name: ProMIS™ Fixation System
21 C.F.R 888.3070 Thoracolumbosacral pedicle screw system NKB - Class II
Primary Predicate Device
ProMIS™ Fixation System by Premia Spine Ltd (K150380)
Purpose of the Special 510(k) notice.
The ProMIS™ Fixation System is a modification to the previously cleared ProMIS™ Fixation System by Premia Spine Ltd (K150380). The changes being made in the submission include:
- Expanding the pedicle screws line to include additional screws with the following features: .
- increased polyaxiality O
- decreased tulip's profile, O
- cannulated and non-cannulated pedicle screw bodies with self-tapping flutes and o tapered and rounded or self-drilling tips
- Addition of fusion rods of different lengths and tip designs ●
- Addition/minor modifications to Class I instruments ●
Indications for Use
The ProMIS™ 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
4
history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, 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 minimal invasive (MIS) instrumentation.
Device Description
The ProMIS™ Fixation System consists of 3 main single use implanted parts:
-
- ProMIS™ Fusion Rods: a straight or bent rod of various lengths.
-
- Polyaxial Pedicle Screws: cannulated and non- cannulated screw bodies with self-tapping flutes and rounded or self-drilling tips, available in three diameters (5.5mm, 6.5mm, with length ranging from 25 to 60, in increments of 5mm.
-
- Setscrew.
All components are manufactured from Ti6Al4V per ASTM F136
Rods up to 100mm in length and the Pedicle Screws are provided sterile (gamma irradiated).
Rods exceeding 100mm are supplied non-sterile (steam/autoclave sterilization by the end user).
Performance Data
The ProMIS™ Fixation System was subjected to static torsion and dynamic compression testing per ASTM F1717.
Substantial Equivalence
The cleared and modified ProMIS Fixation Systems share indications for use and principles of operation and the same components, materials, manufacturing processes and sterilization methods. They also share very similar design features, with the exception of the minor modifications that do not raise different questions of safety and efficacy.
The additional screw designs were added to address different surgeons' preferences for pedicle preparation and screw insertion techniques and to enhance manufacturability. The design modifications included increased polyaxiality, decreased tulip's profile, non-cannulated and cannulated pedicle screw bodies with self-tapping flute and tapered rounded or self-drilling tip design, and additional minor changes to enhance manufacturability. The functionality and mechanical performance of the modified pedicle screws were verified in functionality and mechanical testing, demonstrating substantial equivalent performance.
A few fusion rods of different lengths and tip designs were added to the product matrix, with different combinations of standard hex, bullet and blunt tips. The added longer rods do not represent a worstcase in terms of mechanical performance. Therefore, this modification does not raise different questions of safety or effectiveness.
5
Conclusions
The subject ProMIS™ Fixation System is substantially equivalent to the cleared ProMIS™ Fixation System. The subject system has the same intended uses and similar indications, technological 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.