(65 days)
No
The 510(k) summary describes a mechanical spinal implant system and its components, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is described as providing immobilization and stabilization of spinal segments as an "adjunct to fusion" for various medical conditions like degenerative disc disease, spondylolisthesis, and trauma, clearly indicating its therapeutic purpose in treating and alleviating these conditions.
No
This device is an implantable system (pedicle screws and rods) intended for immobilization and stabilization of spinal segments as an adjunct to fusion. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly states it includes physical components such as Pedicle Screws, Rods, and surgical instruments made of Titanium. It also details mechanical testing of these physical components.
Based on the provided information, 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 and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion." This describes a surgical implant used to support the spine, not a test performed on biological samples to diagnose a condition.
- Device Description: The device is described as including "Pedicle Screws and Rods" made of Titanium. These are physical implants, not reagents, instruments, or software used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections. The SteriSpine™PS system is a surgical implant used to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
The SteriSpine™PS system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to 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.
Product codes
NKB, MNI, MNH, KWP
Device Description
SteriSpineTMPS system includes Pedicle Screws and Rods. Components of SteriSpineTMPS system are made of Titanium Ta6V Eli grade conforming to ASTM F136. Components added within this submission include multi-axial extended head screws and multi axial extended head cannulated screws Ø 5.5, 6.5 and 7.5 (length from 25 to 60 mm), additional lengths for straight and prebent rods ø5.5mm, additional surgical instruments (screw head breakage tip, set screw holder and racking compression pliers, Ratchet module). The SteriSpineTMPS range of products is supplied sterile with a sterile single-use set of surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical pedicle, spinal segments
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)
Mechanical testing was conducted per ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model and ASTM F1798 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. Testing according to ASTM F1717 includes Static Compression, Static Torsion and Dynamic Compression. Testing according to ASTM F1798 includes Static slipping, Static bending and Static rotation. Results demonstrate comparable mechanical properties to the predicate device. Cadaver testing performed to validate the instrumentation have been presented. No additional testing has been performed for the added components. Clinical data from a review of the literature has been presented in the class III summary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sterispine™ PS Pedicle Screw K112453, K121299 and K130632
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.
0
510(k) SUMMARY
.
JUN 0 4 2014
:
:
| 510k | SPECIAL |
|---|---|
| Submitted by | Safe Orthopaedics |
| Parc des Bellevues | |
| Allée R. Luxembourg - Le Californie | |
| 95610 Eragny sur Oise - FRANCE | |
| Phone: +33 (0) 1 34 21 50 00 | |
| Contacts | Pierre DUMOUCHEL – Quality affairs & Regulatory affairs Director |
| p.dumouchel@safeorthopaedics.com | |
| Regulatory contact : Isabelle DRUBAIX (Idée Consulting) | |
| idee-consulting@nordnet.fr | |
| Date Prepared | April 30th 2014 |
| Common Name | Pedicle screw spinal system |
| Trade Name | SteriSpine™PS Pedicle Screw |
| Classification Name | Pedicle screw spinal system |
| Class | III |
| Product Code | NKB, MNI, MNH, KWP |
| CFR section | 888.3070 |
| Device panel | Orthopedic |
| Legally marketed | |
| predicate devices | Sterispine™ PS Pedicle Screw K112453, K121299 and K130632 |
| manufactured by SAFE ORTHOPAEDICS | |
| Indications for use | The SteriSpine™PS system is intended to provide immobilization and |
| stabilization of spinal segments in skeletally mature patients as an | |
| adjunct to 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 & | |
| Technological | |
| Characteristics | SteriSpineTMPS system includes Pedicle Screws and Rods. Components |
| of SteriSpineTMPS system are made of Titanium Ta6V Eli grade | |
| conforming to ASTM F136. Components added within this submission | |
| include multi-axial extended head screws and multi axial extended head | |
| cannulated screws Ø 5.5, 6.5 and 7.5 (length from 25 to 60 mm), | |
| additional lengths for straight and prebent rods ø5.5mm, additional | |
| surgical instruments (screw head breakage tip, set screw holder and | |
| racking compression pliers, Ratchet module). | |
| The SteriSpineTMPS range of products is supplied sterile with a sterile | |
| single-use set of surgical instruments. | |
| Discussion of Testing | SteriSpineTMPS conforms to special control established for Pedicle |
| screw spinal system and to « Spinal System 510(k)s - Guidance for | |
| Industry and FDA Staff Document » issued on: May 3, 2004. | |
| Mechanical testing was conducted per ASTM F1717 Standard Test | |
| Methods for Spinal Implant Constructs in a Vertebrectomy Model and | |
| ASTM F1798 Standard Guide for Evaluating the Static and Fatigue | |
| Properties of Interconnection Mechanisms and Subassemblies Used in | |
| Spinal Arthrodesis Implants. Testing according to ASTM F1717 includes | |
| Static Compression, Static Torsion and Dynamic Compression. Testing | |
| according to ASTM F1798 includes Static slipping, Static bending and | |
| Static rotation. Results demonstrate comparable mechanical properties | |
| to the predicate device. Cadaver testing performed to validate the | |
| instrumentation have been presented. | |
| No additional testing has been performed for the added components. | |
| Clinical data from a review of the literature has been presented in the | |
| class III summary. | |
| Conclusion | The extended range of SteriSpineTMPS system is substantially equivalent |
| to its predicate devices SteriSpineTMPS system (K112453, K121299 and | |
| K130632) in terms of intended use, material, design, mechanical | |
| properties and function. | |
| Verification Activity and Validation Activity demonstrate that | |
| components added to SteriSpineTMPS system are substantially | |
| equivalent to predicates. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2014
Safe Orthopaedics Mr. Pierre Dumouchel Quality Affairs & Regulatory Affairs Director Parc des Bellevues - Allée R. Luxembourg - Bat. Californie 95610 Eragny sur Oise - FRANCE
Re: K140802
Trade/Device Name: SteriSpine™ PS Pedicle Screw Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB. MNI, MNH, KWP Dated: May 6. 2014 Received: May 9. 2014
Dear Mr. 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. 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 device-related 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.
3
Page 2 - Mr. Pierre Dumouchel
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140802
Device Name SteriSpine™ PS Pedicle Screw
Indications for Use (Describe)
The SteriSpine™ PS system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY ·
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Zane W. Wyatt Division of Orthopedic Devices
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