(42 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and functionality of spinal implants and surgical instruments. There is no mention of AI, ML, image processing, or data analysis capabilities.
Yes
The device is described as an "adjunct of fusion" to provide "immobilization of spinal segments" for conditions such as "degenerative disc disease," "spondylolisthesis," and "trauma," which are all therapeutic interventions for medical conditions.
No
The device is a system of screws and rods intended to provide immobilization of spinal segments as an adjunct to fusion, not to diagnose a condition.
No
The device description explicitly details physical components like screws, rods, and surgical instruments, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Sterispine™ PS system is for "immobilization of spinal segments in skeletally mature patients as an adjunct of fusion." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details surgical implants (screws and rods) and surgical instruments. These are used directly on the patient during surgery.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description. It does not analyze biological samples.
The information provided consistently points to a surgical implant system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sterispine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct of fusion. Sterispine™ PS system is intended for posterior non-cervical, pedicle and nonpedicle fixation for the following indications: 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 ; tumor ; pseudoarthrosis and failed previous fusion.
Product codes
NKB, KWQ
Device Description
The cleared range of Sterispine™ PS system includes multiaxial screws and cannulated multiaxial screws with or without extended head (Ø5.5, 6.5 and 7.5mm, lengths from 25 to 85mm) and straight and prebent rods (Ø5.5, 6.5 and 7.5mm, lengths from 30 to 380mm). Sterispine™ PS implants are supplied sterile with a sterile single-use set of surgical instruments supplied in kits. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior non-cervical
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 following non-clinical tests were conducted on the STERISPINE™ PS system Mechanical testing of fenestrated screw φ4.5 mm / with cross -connector where applicable):
- Axial Grip, Flexural Grip, Torsional Grip and Dynamic Flexion per ASTM F1798
- Static Compression Bending, Static Tension Bending, Static Torsion and Dynamic compression per ASTM F1717.
Results demonstrate that the Sterispine™ PS system meets or exceeds functional requirements and suitability for use. Additionally, the Sterispine™ PS system performs equivalent or better than predicates systems. - Functional evaluation of the cross-connector and associated surgical instrumentation
All tests met the acceptance criteria - Functional testing of the single-use surgical instruments
Overall functional testing demonstrates that the new added surgical instruments can be assembled with each component of the Sterispine PS instrument/implant kit. No deterioration or blocking were observed during the functional testing. Additional mechanical and / or functional testings conducted on Jamshidi, threaded rod introducer, spatula, screw extender arm, fenestrated screwdriver, persuader and handle show that surgical instruments are suitable and fulfill requirements for single-use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K170528, K170347, K011437, K151921, K151747, K150092, K140802, K130632, K121299, K112453
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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Safe Orthopaedics Pierre Dumouchel CEO Parc des Bellevues, Le Californie - Allee Rosa Luxemburg Eragny Sur Oise, 95610 France
Re: K201648
Trade/Device Name: Sterispine™ PS Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWQ Dated: June 16, 2020 Received: June 18, 2020
Dear Pierre Dumouchel:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
July 30, 2020
1
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 (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. Acting 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) K201648
Device Name Sterispine™ PS
Indications for Use (Describe)
The Sterispine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct of fusion. Sterispine™ PS system is intended for posterior non-cervical, pedicle and nonpedicle fixation for the following indications: 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 ; tumor ; pseudoarthrosis and failed previous fusion.
| 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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Traditional 510k STERISPINE™ PS
Image /page/3/Picture/2 description: The image shows the logo for Safe Orthopaedics. The logo features a stylized letter "S" in a light green color, with a small dot to the right of the "S". Below the "S", the words "Safe Orthopaedics" are written, with "Safe" in green and "Orthopaedics" in gray.
510(k) SUMMARY
| 510k | Traditional |
|---|---|
| Basis for submission | Extension of the product line |
| Submitted by | Safe Orthopaedics |
| Parc des Bellevues | |
| Le Californie - Allée Rosa Luxemburg | |
| 95610 Eragny-sur-Oise, France | |
| Contacts | Pierre DUMOUCHEL (CEO) |
| Phone number 33 (0) 1 84 28 01 79 | |
| e-mail p.dumouchel@safeorthopaedics.com | |
| Regulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr | |
| Date Prepared | July 23, 2020 |
| Common Name | Pedicle screw spinal system |
| Trade Name | Sterispine™ PS |
| Classification Name | Thoracolumbosacral pedicle screw system |
| Class | II |
| Product Code | NKB, KWQ |
| CFR section | 888.3070 |
| Device panel | ORTHOPEDIC |
| Legally marketed | |
| predicate devices | Primary predicate: Sterispine™ PS manufactured by SAFE ORTHOPAEDICS (K170528) |
| Additional predicates: CD HORIZON™ Fenestrated Screw Set manufactured by | |
| Medtronic Sofamor Danek (K170347), Synergy 4.0 mm, 4.5 mm VLS screws | |
| manufactured by Interpore Cross Intl (K011437), Sterispine™ Ps manufactured by | |
| SAFE ORTHOPAEDICS (K151921, K151747, K150092, K140802, K130632, K121299, | |
| K112453) |
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| Indications for use | The Sterispine™ PS system is intended to provide immobilization and stabilization
of spinal segments in skeletally mature patients as an adjunct of fusion.
Sterispine™ PS system is intended for posterior non-cervical, pedicle and non-
pedicle fixation for the following indications: 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 ; tumor ; pseudoarthrosis and failed previous fusion. |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of the
device | The cleared range of Sterispine™ PS system includes multiaxial screws and
cannulated multiaxial screws with or without extended head (Ø5.5, 6.5 and
7.5mm, lengths from 25 to 85mm) and straight and prebent rods (Ø5.5, 6.5 and
7.5mm, lengths from 30 to 380mm). Sterispine™ PS implants are supplied sterile
with a sterile single-use set of surgical instruments supplied in kits. Bacterial
endotoxin testing as specified in USP standard is used for pyrogenicity testing to
achieve the Endotoxin limit of 20 EU / device. |
| Technological
characteristics
compared to the
predicate devices | The present submission is an extension of the product line that includes
- Modified and new sterile single-use surgical instruments
- Add of a cross-connector kit
- Add of multi-axial fenestrated screws (with and without extended head)
- Add of Ø4.5 mm for all STERISPINE™ PS screws
As established in this submission, the modified or added components are
substantially equivalent to predicate devices in areas including indications for use,
function materials in contact with patients and technological and mechanical
characteristics.
The safety and effectiveness of Sterispine™ PS fenestrated screws have not been
established when used in conjunction with bone cement or for use in patients with
poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to
be used with saline or radiopaque dye. |
| Discussion of Testing | The following non-clinical tests were conducted on the STERISPINE™ PS system
Mechanical testing of fenestrated screw φ4.5 mm / with cross -connector where
applicable): - Axial Grip, Flexural Grip, Torsional Grip and Dynamic Flexion per ASTM F1798
- Static Compression Bending, Static Tension Bending, Static Torsion and
Dynamic compression per ASTM F1717.
Results demonstrate that the Sterispine™ PS system meets or exceeds functional
requirements and suitability for use. Additionally, the Sterispine™ PS system
performs equivalent or better than predicates systems. - Functional evaluation of the cross-connector and associated surgical
instrumentation
All tests met the acceptance criteria - Functional testing of the single-use surgical instruments |
5
| Overall functional testing demonstrates that the new added surgical instruments can be assembled with each component of the Sterispine PS instrument/implant kit. No deterioration or blocking were observed during the functional testing. Additional mechanical and / or functional testings conducted on Jamshidi, threaded rod introducer, spatula, screw extender arm, fenestrated screwdriver, persuader and handle show that surgical instruments are suitable and fulfill requirements for single-use. | |
|---|---|
| Conclusion | Based on the design features, technological characteristics, feature comparisons, indications for use, and non-clinical performance testing, the added surgical implants and the added or modified sterile single-use surgical instruments have demonstrated substantial equivalence to the identified predicate devices. |