(82 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and components of a spinal fixation system, with no mention of AI or ML technologies.
Yes
The device is intended for the treatment of various medical conditions such as degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, and failed previous fusion, making it a therapeutic device.
No
The S4 Spinal System is described as an implantable device used for non-cervical pedicle and non-pedicle fixation, intended as an adjunct to fusion. Its purpose is to treat instabilities or deformities, not to diagnose them. The text discusses its components, materials, and mechanical testing, which are characteristic of a treatment device, not a diagnostic one.
No
The device description explicitly lists physical components made of Titanium and Titanium alloy, such as screws, staples, hooks, rods, and connectors. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the S4 Spinal System is not an IVD (In Vitro Diagnostic) device.
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.
- S4 Spinal System Function: The S4 Spinal System is a collection of implants (screws, rods, hooks, etc.) designed for surgical fixation of the spine. It is a physical device implanted into the body to provide structural support and stability.
- Intended Use: The intended use clearly describes the device as being used for "anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation" as an "adjunct to fusion." This is a surgical intervention, not a diagnostic test performed on a specimen.
The description focuses on the physical components, materials, and mechanical testing of the implants, which are characteristic of surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:
1 ) degenerative disc disease (defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic studies)
- 2) spondylolisthesis,
-
- trauma (i.e., fracture or dislocation),
-
- spinal stenosis,
-
- deformities or 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)
NKB, MNI, MNH, KWP
Device Description
The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, staples, various hook styles, rods of varying lengths, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical (spinal)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the S4 Staples are substantially equivalent to other predicate devices. The following testing was performed:
- Static Axial Compression per ASTM 1717-12 .
- Dynamic Axial Compression per ASTM F1717-12 .
- Static Torsion per ASTM 1717-12 .
The results of these studies showed that the subject S4 Staples meet or exceed the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
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
MAR 1 2 2013
Special 510(k) Premarket Notification
S4 Spinal System Modification Dual Rod Extension
510(k) SUMMARY (as required by 21 CFR 807.92) B.
S4 Spinal System March 11, 2013
COMPANY:
Aesculap®Implant Systems (AIS), LLC. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311
Lisa M. Boyle CONTACT: 610-984-9274 (phone) 610-791-6882 (fax)
S4 Spinal System TRADE NAME Pedicle Screw System COMMON NAME:
888.3070 - Orthosis, Spinal Pedicle Fixation For Degenerative REGULATION NUMBER: Disc Disease 888.3070 - Orthosis, Spinal Pedicle Fixation 888.3070 - Orthosis, Spondyloisthesis Spinal Fixation 888.3050 - Appliance, Fixation, Spinal Fixation
NKB, MNI, MNH, and KWP PRODUCT CODE: Orthopedics REVIEW PANEL:
SUBSTANTIAL EQUIVALENCE
Aesculap® Implant Systems (AIS), LLC., believes that the new components of the S4 Spinal System are substantially equivalent in design to the components that are previously cleared in the MACS TL System (K002824) and the S4 Spinal Systems (K032219/K 100623).
DEVICE DESCRIPTION
The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, staples, various hook styles, rods of varying lengths, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.
INDICATIONS FOR USE
The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:
1 ) degenerative disc disease (defined as discogenic back pain with
1
S4 Spinal System Modification Dual Rod Extension
Page 2 of 2
degeneration of the disc confirmed by history and radiographic studies)
-
- spondylolisthesis,
-
- trauma (i.e., fracture or dislocation),
-
- spinal stenosis,
-
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
- tumor.
-
- pseudoarthrosis, and
- failed previous fusion.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}
The new components of the Aesculap® Implant Systems (AIS) S4 Spinal System are offered in similar shapes and sizes as the predicate devices. All the components are manufactured from Titanium and Titanium Alloy, which is the same material as the predicate devices.
PERFORMANCE DATA
As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the S4 Staples are substantially equivalent to other predicate devices. The following testing was performed:
- Static Axial Compression per ASTM 1717-12 .
- Dynamic Axial Compression per ASTM F1717-12 .
- Static Torsion per ASTM 1717-12 .
The results of these studies showed that the subject S4 Staples meet or exceed the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is horizontally oriented and appears to be a title or heading. The words are all capitalized and evenly spaced.
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract design that resembles an eagle or other bird-like figure.
Public Health Service
Letter dated: March 12, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Aesculap® Implant Systems, LLC % Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K123939
Trade/Device Name: S4 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP Dated: December 19, 2012 Received: December 20, 2012
Dear Ms. Boyle:
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
3
Page 2 - Ms. Lisa M. Boyle
forth in the quality systems (OS) 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/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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
K123939 510(k) Number:
Device Name: S4 Spinal System
Indications for Use:
The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:
1 ) 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),
-
spinal stenosis,
-
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
-
tumor.
-
pseudoarthrosis, and
-
failed previous fusion.
X ============================================================================================================================================================================ Prescription Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123939