(87 days)
Not Found
No
The summary describes a mechanical spinal fixation system and its components, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various medical conditions, which aligns with the definition of a therapeutic device.
No
The device is described as an implantable system (pedicle screws and rods) used for spinal fusion and immobilization, which is a therapeutic intervention, not a diagnostic one. Its intended use is to provide support as an adjunct to fusion for listed conditions, not to identify or diagnose them.
No
The device description explicitly states that the SteriSpine™PS system includes physical components such as pedicle screws and rods made of Titanium. It also mentions a sterile single-use set of surgical instruments. This indicates it is a hardware-based medical device, not software-only.
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 of spinal segments in skeletally mature patients as an adjunct to fusion." This describes a surgical implant used directly on the patient's body for structural support and stabilization.
- Device Description: The device is described as including "pedicle screws and rods," which are physical implants.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs are used to diagnose diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
The SteriSpine™PS system is a surgical implant, not a 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 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, MNH, MNI, KWP
Device Description
SteriSpine™PS system includes pedicle screws (multiaxial and cannulated) and rods (straight and prebent). Implantable components of SteriSpine™PS system are made of Titanium Ti-6Al-4V ELI according to ASTM F136. The SteriSpine™PS 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
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 according to ASTM F1717 and ASTM F1798 Standard. Performed mechanical testing includes the following: Static Compression, static torsion, dynamic torsion, static slipping, static bending and static rotation. The following non-clinical tests were conducted: Packaging validation according to ISO 11607-1 and 11607-2 and sterilization revalidation according to ISO 11137-1, 11137-2 and 11137-3. Mechanical testing demonstrates comparable mechanical properties to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human profiles. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 8, 2015
Safe Orthopaedics % Mr. Pierre Dumouchel Industrialization Director / QARA Director Parc des Bellevues, Allée R. Luxembourg - Le Californie 95610 Eragny sur Oise FRANCE
Re: K151921 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 23, 2015 Received: July 27, 2015
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
1
Page 2 - Mr. Pierre Dumouchel
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 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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151921
Device Name SteriSpineTMPS
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) |
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Traditional 510k
SteriSpine ™ PS
510(k) SUMMARY
| 510k | Traditional |
|---|---|
| Submitted by | Safe Orthopaedics |
| Parc des Bellevues | |
| Allée R. Luxembourg - Le Californie | |
| 95610 Eragny sur Oise - FRANCE | |
| Contacts | Pierre DUMOUCHEL Industrialization Director / QARA Director |
| p.dumouchel@safeorthopaedics.com | |
| +33 (0) 1 34 21 50 00 | |
| Isabelle DRUBAIX Regulatory contact | |
| idee-consulting@nordnet.fr | |
| +33 (0)3 21 05 64 23 | |
| Date Prepared | October 6th 2015 |
| Common Name | Pedicle screw spinal system |
| Trade Name | SteriSpine™PS |
| 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 | Primary predicate device: Synergy VLS (K011437) manufactured by |
| Interpore Cross International. | |
| Other predicate device: STERISPINE™ PS manufactured by SAFE | |
| ORTHOPAEDICS (K112453) | |
| 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 | SteriSpine™PS system includes pedicle screws (multiaxial and |
| cannulated) and rods (straight and prebent). Implantable | |
| components of SteriSpine™PS system are made of Titanium Ti-6Al- | |
| 4V ELI according to ASTM F136. The SteriSpine™PS range of | |
| products is supplied sterile with a sterile single-use set of surgical | |
| instruments. | |
| Technological | |
| Characteristics | The purpose of this 510(k) submission is to obtain clearance for a |
| new extended head max cannulated screw and the associated | |
| extended head screwdriver as well as the addition of a «window» to | |
| the external packaging of SteriSpine ™ PS devices supplied sterile. | |
| Performance data | SteriSpine™ PS conforms to special control established for Pedicle |
| Screw spinal system. Mechanical testing was conducted according | |
| to ASTM F1717 and ASTM F1798 Standard. Performed mechanical | |
| testing includes the following: Static Compression, static torsion, | |
| dynamic torsion, static slipping, static bending and static rotation. | |
| The following non-clinical tests were conducted: Packaging | |
| validation according to ISO 11607-1 and 11607-2 and sterilization | |
| revalidation according to ISO 11137-1, 11137-2 and 11137-3. | |
| No clinical data has been presented. | |
| Discussion of | |
| Testing | Mechanical testing demonstrates comparable mechanical properties |
| to the predicate devices. | |
| Conclusion | Non clinical performance testing demonstrates that the added |
| devices are substantially equivalent to predicate devices in terms of | |
| intended use, materials, design and function. |
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