(185 days)
No
The device description and performance studies focus on the mechanical properties and intended use of a spinal implant system, with no mention of AI or ML.
Yes
The device is an implant system designed to facilitate spinal fusion and provide stabilization for various spinal conditions, which are therapeutic interventions.
No
The provided text describes an implant system (AIS® S4 Cervical Occipital Plate Spinal System) used for spinal fusion, which is a treatment rather than a diagnostic process. It consists of physical components like plates, screws, rods, and hooks.
No
The device description explicitly states that the system consists of physical components such as plates, bone screws, rods, hooks, and connectors, which are made from Titanium Alloy. This indicates it is a hardware-based implant system, 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 describes a surgical implant system designed to promote spinal fusion and provide stabilization in the cervical and thoracic spine. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device description details components like plates, bone screws, rods, hooks, and connectors, all of which are physical implants used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is an implant used in vivo for structural support and fusion.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3) and are intended for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies
- Spondylolisthesis .
- Spinal Stenosis
- Fracture/dislocation
- Failed previous fusion
- Atlanto/axial fracture with instability .
- Occipitocervical dislocation
- Revision of previous cervical spine surgery .
- Tumors
The occipital bone screws are limited to occipital fixation only. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The use of the polvaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be place in the cervical spine.
Product codes
KWP, MNI, NKB
Device Description
The AIS® S4 Cervical Occipital Plate Spinal System is an implant system used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occiptio-cervico-thoracic junction (occiput-T3). The AIS® S4 Cervical Occipital Plate Spinal System consists of plates, bone screws, rods, hooks, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The AIS® S4 Cervical Occipital Plate Spinal System is manufactured from Titanium Alloy and will be provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3)
Indicated Patient Age Range
Not Found
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
Testing of the AIS® S4 Cervical Occipital Plating System was performed in accordance with ASTM F1717/F2067/F543 (static compression, static torsion, compression bending, torsion fatigue, and screw pull-out). Testing results demonstrate the Aescular Implant Systems SIBD Spinal System is safe and effective.
Key Metrics
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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JUL 2 8 2010
Page 1 of 1
510(k) SUMMARY (as required by 21 CFR 807.92) B.
S4 Cervical Occipital Plate Spinal System January 18, 2010
| COMPANY: | Aesculap® Implant Systems, LLC.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 3005673311 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle
800-258-1946 (phone)
610-791-6882 (fax) |
| TRADE NAME: | S4 |
| COMMON NAME: | S4 Cervical Occipital Plate Spinal System |
| CLASSIFICATION NAME: | Appliance, Fixation Spinal Interlaminal
Orthosis, Spinal Pedicle Fixation |
| REGULATION NUMBER: | 888.3050/888.3070 |
| PRODUCT CODE: | KWP/MNI/NKB |
SUBSTANTIAL EQUIVALENCE
Aesculap® Implant System (AIS), LLC. believes that the modifications made to the S4 Cervical Occipital Plating Spinal System is substantially equivalent to our predicate system (K062012).
DEVICE DESCRIPTION
The AIS® S4 Cervical Occipital Plate Spinal System is an implant system used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occiptio-cervico-thoracic junction (occiput-T3). The AIS® S4 Cervical Occipital Plate Spinal System consists of plates, bone screws, rods, hooks, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The AIS® S4 Cervical Occipital Plate Spinal System is manufactured from Titanium Alloy and will be provided non-sterile.
INDICATIONS FOR USE
When intended to promote fusion of the cervical spine and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3) and are intended for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by p patient history and radiographic studies
1
- Spondylolisthesis
- Spinal Stenosis ●
- Fracture/dislocation .
- Failed previous fusion .
- Atlanto/axial fracture with instability .
- Occipitocervical dislocation .
- Revision of previous cervical spine surgery .
- . Tumors
The occipital bone screws are limited to occipital fixation only. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The use of the polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be place in the cervical spine.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The AIS® S4 Cervical Occipital Plate Spinal System is considered substantially equivalent to other legally marketed predicate systems. The components of the system are offered in the same range of shapes and sizes as the existing Aesculap predicate device (K062012). Furthermore, the material used for the subject device is the same as that used to manufacture the predicate system.
PERFORMANCE DATA
Testing of the AIS® S4 Cervical Occipital Plating System was performed in accordance with ASTM F1717/F2067/F543 (static compression, static torsion, compression bending, torsion fatigue, and screw pull-out). Testing results demonstrate the Aescular Implant Systems SIBD Spinal System is safe and effective.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap® Implant Systems, LLC % Ms. Lisa M. Boyle 3773 Corporate Parkway Center Valley, Pennsylvania 18034
JUL 2,8 2010
Re: K100147
Trade/Device Name: Aesculap S4 Cervical Occipital Plate System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, KWP Dated: July 01, 2010 Received: July 01, 2010
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
3
Page 2 - Ms. Lisa M. Boyle
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/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 yours,
Mark A. Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
510(k) Number: K100|47
Device Name: Aesculap S4 Cervical Occipital Plate System
Indications for Use:
When intended to promote fusion of the cervical spine and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3) and are intended for the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by � patient history and radiographic studies
- Spondylolisthesis .
- Spinal Stenosis �
- . Fracture/dislocation
- Failed previous fusion t
- Atlanto/axial fracture with instability .
- Occipitocervical dislocation �
- Revision of previous cervical spine surgery .
- . Tumors
The occipital bone screws are limited to occipital fixation only. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The use of the polvaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be place in the cervical spine.
| Prescription Use | X |
|---|---|
| (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
$\overline{\text{(Division Sign-Off)}}$
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100147
002