(108 days)
Not Found
No
The provided text describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as being "intended for immobilization and stabilization of the spine" and used as an "adjunct to fusion" for various spinal conditions, indicating its direct role in treating and managing a medical condition.
No
The Santis Pedicle System is described as a spinal fixation system, intended for immobilization and stabilization of the spine as an adjunct to fusion. It is a surgical implant designed to treat conditions like degenerative disc disease, spondylolisthesis, and trauma, rather than to diagnose them.
No
The device description explicitly lists hardware components such as rods, screws, and connectors made of titanium or cobalt chrome, which are physical implants.
Based on the provided information, the Santis Pedicle 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 the spine" and is used 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 like rods, screws, and connectors made of titanium or cobalt chrome. These are materials and components typical of surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Santis Pedicle System is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Santis Pedicle System is intended for immobilization and stabilization of the spine. The Santis Pedicle System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, NKB
Device Description
The Santis Pedicle Screws Spinal Fixation is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, compression retaining assemblies, cross connectors and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Santis system can be implanted either by an open procedure or percutaneous MIS approach, or a combination of both during the same procedure.
Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, or cobalt chrome per ASTM F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical 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)
The pre-clinical testing performed includes static and dynamic compression bending, static torsion and static tension bending per ASTM F1717-10, axial grip strength per ASTM F1798-97, and three point bend test per ASTM F543-07.
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.
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K133063 Page 1 of 3
510(k) Summary
JAN 1 3 2014
| Date Prepared: | September 27, 2013 |
|---|---|
| Contact: | Horace Hale |
| Lanterna Medical Technologies | |
| Rorschacherstrasse 294 | |
| St. Gallen, Switzerland, CH-9016 | |
| +41 71 280-0930 | |
| +41 71 288-2226 (Fax) | |
| Regulatory Contact: | Rich Jansen, Pharm. D. |
| Silver Pine Consulting, LLC | |
| richj@s-pineconsulting.com | |
| Trade Names: | Santis Pedicle Screw System |
| Product Class: | Class III |
| Classification: | 21 CFR §888.3070 Pedicle Screw Spinal System |
| Common Name: | Pedicle Screw System |
| Product Codes: | MNI, MNH, NKB |
| Panel Code: | 87 |
Indications for Use:
The Santis Pedicle System is intended for immobilization and stabilization of the spine. The Santis Pedicle System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Device Descriptions:
The Santis Pedicle Screws Spinal Fixation is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, compression retaining assemblies, cross connectors and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Santis system can be implanted either by an open procedure or percutaneous MIS approach, or a combination of both during the same procedure.
Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, or cobalt chrome per ASTM F1537.
1
Predicate Device(s):
The Santis Pedicle Screw is substantially equivalent to the AnyPlus Spinal Fixation System from GS Medical (K091717).
| Feature | Santis Pedicle Screw System | AnyPlus Spinal Fixation System |
|---|---|---|
| Indications for Use | See above | AnyPlus Spinal Fixation System are non- |
| cervical spinal fixation devices intended for | ||
| use as posterior pedicle screw fixation | ||
| systems (T1-S2), a posterior hook fixation | ||
| system (T1-L5), or as a anterolateral fixation | ||
| system (T8-L5). All components in the system | ||
| are limited to skeletally mature patients. | ||
| System components are to be used for | ||
| immobilization and stabilization of the spine | ||
| as an adjunct to fusion. These devices are | ||
| indicated for all of the following regardless of | ||
| the intended use: degenerative disc disease | ||
| (defined as discogenic back pain with | ||
| degeneration of the disc confirmed by history | ||
| and radiographic studies), spondylolisthesis, | ||
| trauma (i.e., fracture or dislocation), | ||
| deformities or curvatures (i.e., scoliosis, | ||
| kyphosis, and/or lordosis, Scheuemann's | ||
| Disease), tumor, stenosis, pseudoarthrosis | ||
| and failed previous fusion. | ||
| Screw types | Cannulated and non- | |
| cannulated screws in both | ||
| regular and reduction | ||
| screws | Cannulated and non-cannulated screws | |
| non-cannulated reduction screws | ||
| Screw sizes | Diameters: 5.5, 6.5 and 7.5mm | |
| Lengths: 30-60mm | Diameters: 5.5, 6.5 and 7.5mm | |
| Lengths: 30-55mm | ||
| Straight Titanium | ||
| rods | Diameter 5.5mm | |
| Lengths 40-500mm | Diameter 5.5mm | |
| Lengths 40-500mm | ||
| Straight CoCr Rods | Diameter 5.5mm | |
| Lengths 250 & 500mm | NA | |
| Pre-curved titanium | ||
| rods | Diameter 5.5mm | |
| Lengths 40-200mm | Diameter 5.5mm | |
| Lengths 40-200mm | ||
| Polyaxial head and | ||
| polyaxial reduction | ||
| head | 5.5, 6.5, 7.5mm | 5.5, 6.5, 7.5mm |
| Swivel cross | ||
| connector | 30, 40 and 50mm | 35. 38, 42, 50mm |
| Straight cross | ||
| connector | 30, 40 and 50mm | NA |
Predicate Comparison:
2
Performance Standards:
The pre-clinical testing performed includes static and dynamic compression bending, static torsion and static tension bending per ASTM F1717-10, axial grip strength per ASTM F1798-97, and three point bend test per ASTM F543-07.
Conclusion:
Lanterna concludes that the Santis Pedicle Screw System is substantially equivalent to the predicate pedicle screw system in regards to indications for use, materials, function, sizes and mechanical test results and raises no new questions of safety or effectiveness.
3
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
January 13, 2014
Lanterna Medical Technologies % Rich Jansen. Pharm.D. Silver Pine Consulting, LLC 13540 Guild Avenue Apple Valley, Minnesota 55124
Re: K133063
Trade/Device Name: Santis Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: October 24, 2013 Received: October 24, 2013
Dear Dr. Jansen:
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
4
Page 2 - Rich Jansen, Pharm.D.
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ronald#Jean -S for
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
The Santis Pedicle System is intended for immobilization and stabilization of the spine. The Santis Pedicle System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft 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 (l.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); 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 Center for Devices and Radiological Health (CDRH)
Zane Wyatt -S
(Division Sign-off) Division of Orthopedic Devices 510(k) Number: K133063