(82 days)
Not Found
No
The summary describes a mechanical spinal implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, which are therapeutic actions to address various medical conditions like degenerative disc disease, spondylolisthesis, and trauma.
No
The device is described as an implant system (pedicle screw and rod) intended for the immobilization and stabilization of spinal segments as an adjunct to fusion, which falls under therapeutic/surgical devices, not diagnostic devices.
No
The device description explicitly states that the SteriSpine™PS system includes Pedicle Screw and Rod components made of Titanium, which are hardware. The performance studies also focus on mechanical testing of these physical components.
Based on the provided information, the SteriSpine™ PS system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details components made of titanium and supplied sterile for surgical use. This aligns with a surgical implant, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SteriSpine™ PS system is a therapeutic device used in surgery.
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 (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 system 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments, 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)
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. 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.
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
| Safe Orthopaedics | ||
|---|---|---|
| Submitter | Parc des Bellevues | |
| Allée R. Luxembourg - Le Californie | ||
| Contacts | Isabelle Drubaix | |
| idee-consulting@nordnet.fr | ||
| +33 (0) 3 21 05 64 23 | ||
| Trade Name | SteriSpine™PS | |
| Common Name | SteriSpine™PS | |
| Classification Name | Pedicle screw spinal system | |
| Product code | MNI, MNH, KWP, NKB | |
| CFR section | 888.3070 | |
| Legally marketed | ||
| predicate device | Synergy VLS (K011437) manufactured by Interpore Cross | |
| International | ||
| SteriSpine™PS system includes Pedicle Screw and Rod. | ||
| Description | Components of SteriSpine™PS system 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. | ||
| 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. | ||
| 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 | ||
| Performance data | 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. | ||
| 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. | ||
| Different features: Sterispine™ PS consists of a limited range | ||
| of products as compared with predicate. Because of the | ||
| absence of connector, nuts, hooks, Sterispine™ PS is not | ||
| indicated for the treatment of deformities. This different | ||
| Date | feature does not safety or effectiveness concern. |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the staff and a snake winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 1 5 2011
Safe Orthopaedics % Ms. Isabelle Drubaix Parc des Bellevues Allée R. Luxembourg - Le Californie 95610 Eragny sur Oise - France
Re: K112453
Trade/Device Name: SteriSpine™ PS Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB. MNI, MNH Dated: October 24, 2011 Received: November 01, 2011
Dear Ms. Drubaix:
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. Ilisting 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
2
Page 2 – Ms. Isabelle Drubaix
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); 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/ycm115809.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/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 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 vours.
Erin O'Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): K112453
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 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.
Prescription Use Over-The-Counter Use _ イ AND/OR (Part 21 CFR 801 Subpart D) (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 Gil) vision of Surgical. Orthopedic, Jand Restorative Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________