(91 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical instrumentation, with no mention of AI or ML.
No.
The device is described as an implantable system (pedicle screw and rod system) for immobilization and stabilization of spinal segments, which falls under the category of a surgical implant rather than a therapeutic device that administers treatment or therapy.
No
Explanation: The SteriSpine PS system is an orthopedic implant system (pedicle screws and rods) used for spinal stabilization and fusion. Its function is mechanical support, not the diagnosis of medical conditions.
No
The device description explicitly lists hardware components (Pedicle Screw, Rod, surgical instruments) made of Titanium. The performance studies also focus on mechanical testing of these physical components.
Based on the provided information, 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 and Intended Use: The SteriSpine™ PS system is a surgical implant (pedicle screws and rods) intended for the immobilization and stabilization of spinal segments in patients. It is used in vivo (within the body) during surgery.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory procedures, or diagnostic information derived from such analysis.
Therefore, the SteriSpine™ PS system falls under the category of a surgical implant or device used directly on the patient's body, not an in vitro diagnostic.
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 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 (comma separated list FDA assigned to the subject device)
MNI, MNH, KWP, NKB
Device Description
SteriSpine™PS system includes Pedicle Screw and Rod. Components of SteriSpine™PS systems are made of Titanium Ta6V Eli grade conforming to ASTM F136.
SteriSpine™PS components are supplied sterile with a single-use set of surgical instruments. The components added within this submission include:
- New references of Pedicle screws, .
- New references of Straight Rods,
- New references of Rods, compatible with a new Rod holder
- 3 Instruments :
- o Open Screw Extender PSANC024,
- Open Set Screw Guide PSANC022, o
- o Rod Holder PSANC025.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments, posterior, non cervical pedicle
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
STERISPINE PS PEDICLE SCREW K112453
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 30 2012
| Safe Orthopaedics | |
|---|---|
| Submitter | Parc des Bellevues |
| Allée R. Luxembourg - Le Californie | |
| 95610 Eragny sur Oise - France | |
| Contacts | Pierre DUMOUCHEL p.dumouchel@safeorthopaedics.com |
| +33 (0) 1 34 21 50 00 | |
| Regulatory contact : | |
| Isabelle Drubaix idee-consulting@nordnet.fr | |
| +33 (0) 3 21 05 64 23 | |
| Trade Name | SteriSpine™PS |
| Common Name | Pedicle screw spinal system |
| Classification Name | |
| Product code | MNI. MNH. KWP. NKB |
| CFR section | 888.3070 |
| Legally marketed predicate | |
| device | STERISPINE PS PEDICLE SCREW K112453 Manufactured by SAFE |
| ORTHOPAEDICS | |
| SPECIAL 510k | Modification to STERISPINE PS PEDICLE SCREW (Extension of |
| range of products) |
Description:
SteriSpine™PS system includes Pedicle Screw and Rod. Components of SteriSpine™PS systems are made of Titanium Ta6V Eli grade conforming to ASTM F136.
SteriSpine™PS components are supplied sterile with a single-use set of surgical instruments. The components added within this submission include:
- New references of Pedicle screws, .
- New references of Straight Rods,
- New references of Rods, compatible with a new Rod holder
- 3 Instruments :
- o Open Screw Extender PSANC024,
- Open Set Screw Guide PSANC022, o
- o Rod Holder PSANC025.
Indications for use:
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.
Performance data:
SteriSpine™PS 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
1
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.
Substantial equivalence:
SteriSpine™PS system is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function.
Non clinical performance testing according to special control demonstrate that SteriSpine™PS is as safe, as effective, and performs as safely and effectively as its predicate devices.
- April 27th
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
JUL 30 2012
Safe Orthopaedics % Mr. Pierre Dumouchel Parc des Bellevues Allee R.Luxembourg- Le Californie 95610 Eragny sur Oise - France
Re: K121299
Trade/Device Name: SteriSpine™ PS Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP Dated: July 03, 2012 Received: July 03, 2012
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.
3
Page 2 - Mr. Pierre Dumouchel
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K12 | 299
Device Name: SteriSpine™PS
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.
Prescription Use >| (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________