(99 days)
No
The device description and performance studies focus on the mechanical properties and components of a spinal implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is an implant system intended to provide immobilization and facilitate fusion of spinal segments for various acute and chronic instabilities, which are therapeutic functions.
No
This device is an implant system (spinal fusion system) intended to provide immobilization and restore the integrity of the spinal column as an adjunct to fusion for various spinal conditions, not to diagnose them.
No
The device description explicitly states that the system consists of physical components such as plates, bone screws, rods, hooks, and connectors, and is manufactured from Titanium alloy. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing immobilization of spinal segments as an adjunct to fusion for various spinal instabilities and conditions. This is a surgical implant used directly on the patient's body.
- Device Description: The device description details the components of an implant system (plates, screws, rods, hooks, connectors) made from Titanium alloy, intended to facilitate spinal fusion. This is a physical device implanted in the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided text does not mention any testing of samples or analysis of biological materials.
Therefore, the Aesculap S4 Cervical Spinal and Occiput Systems are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aesculap S4 Cervical Spinal and Occiput Systems are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (T-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap S4 Cervical Spinal and Occiput Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.
Product codes
NKG, KWP
Device Description
The Aesculap S4 Cervical Spinal and Occiput Systems are implant systems 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 occipito-cervico-thoracic junction (occiput-T3). The Aesculap S4 Cervical Spinal and Occiput Systems consist of plates, bone screws, rods, hooks, and connectors. This consists of 3.5mm rod, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and cross connectors. The occipital plate is fixed to the occiput with bone screws and the transition by a locking mechanism. The end of the construct is stabilized with polyaxial screws to the upper thoracic spine, as required. The components are available in a variety of lengths in order to accommodate patient anatomy. The Aesculap S4 Cervical Spinal and Occiput Systems are 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
craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3)
Indicated Patient Age Range
Not Found
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)
Published literature and Non-clinical testing demonstrate that the Aesculap S4 Cervical Spinal and Occiput Systems are substantially equivalent to other predicate devices. The following testing was performed:
- Static Torsion Bending per ASTM F1717-04 and ASTM Work Item 455-● Z9592Z (Test No. V684-A)
- Dynamic Torsion Testing per ASTM F1717-04 and ASTM Work Item 455-Z9592Z (Test No. V809)
- Dynamic Compression Testing per ASTM F1717-04 and ASTM Work Item. 455-Z9592Z (Test No. V697)
- Static Compression Bending per ASTM F1717-04 and ASTM Work Item 455-Z9592Z (Test No. V683-A)
The results showed that the subject Aesculap S4 Cervical Spinal and Occiput Systems 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)
Reference Device(s)
K050979, K060152, K062012, K062327, K100147
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3075 Posterior cervical screw system.
(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.
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Image /page/0/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 image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2015
Aesculap Implant Systems, LLC Ms. Lisa M. Boyle Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K151938
Trade/Device Name: S4 Cervical Spinal and Occiput Systems Regulatory Class: Unclassified Product Code: NKG, KWP Dated: September 21, 2015 Received: September 22, 2015
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 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.
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Page 2 - Ms. Lisa M. Boyle
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) K151938
Device Name S4 Cervical Spinal and Occiput Systems
Indications for Use (Describe)
The Aesculap S4 Cervical Spinal and Occiput Systems are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (T-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap S4 Cervical Spinal and Occiput Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.
| 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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510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap® Implant Svstems (AIS), LLC. S4 Cervical Spinal and Occiput Systems
September 21, 2015
| COMPANY: | Aesculap®Implant Systems (AIS), 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 Cervical Spinal and Occiput Systems |
| COMMON NAME: | Posterior, Cervical Pedicle Screw Spine Fixation, Spinal |
| Interlaminal Fixation Orthosis, Posterior Cervical System | |
| CLASSIFICATION NAME: | Posterior, Cervical Pedicle Screw Spine Fixation |
| Orthopaedic and Rehabilitation Devices Panel | |
| Unclassified; Pre-Amendment Device | |
| Product Code: NKG | |
| Appliance, Fixation, Spinal Interlaminal | |
| Orthopaedic and Rehabilitation Devices Panel | |
| Class 2 per 21 CFR 888.3050 | |
| Product Code: KWP |
PURPOSE FOR PREMARKET NOTIFICATION
The Aesculap S4 Cervical Spinal and Occiput Systems described in this submission represent an expanded indication for the entire S4 Cervical System, including the Aesculap S4C Spinal System cleared under K050979, the Aesculap S4C Spinal System (Additional lengths polyaxial screws) cleared under K060152, the Aesculap S4C Spinal System: Occiput Plate cleared under K062012, the Aesculap S4C Spinal System (Modification to Cross Connector & Add. Smooth Shank Screws) cleared under K062327, and the Aesculap S4C Mini-Occiput Spinal System cleared under K100147.
DEVICE DESCRIPTION
The Aesculap S4 Cervical Spinal and Occiput Systems are implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote
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fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap S4 Cervical Spinal and Occiput Systems consist of plates, bone screws, rods, hooks, and connectors. This consists of 3.5mm rod, thin and thick lamina hooks, 3.5 and 4.0mm polyaxial screws of various lengths and cross connectors. The occipital plate is fixed to the occiput with bone screws and the transition by a locking mechanism. The end of the construct is stabilized with polyaxial screws to the upper thoracic spine, as required. The components are available in a variety of lengths in order to accommodate patient anatomy. The Aesculap S4 Cervical Spinal and Occiput Systems are manufactured from Titanium alloy and will be provided non-sterile.
INDICATIONS FOR USE
The Aesculap S4 Cervical Spinal and Occiput Systems are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap S4 Cervical Spinal and Occiput Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the Aesculap S4 Lumbar System may be connected to the Aesculap S4 Cervical Spinal and Occiput Systems using connectors and rods.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicates)
As is established in this submission, the Aesculap S4 Cervical Spinal and Occiput Systems are substantially equivalent to other predicate devices cleared by FDA. The subject device is shown to be substantially equivalent and has the same technological characteristics to its predicate devices through comparison in design, intended use, material composition, function and range of sizes.
PERFORMANCE DATA
Published literature and Non-clinical testing demonstrate that the Aesculap S4 Cervical Spinal and Occiput Systems are substantially equivalent to other predicate devices. The following testing was performed:
- Static Torsion Bending per ASTM F1717-04 and ASTM Work Item 455-● Z9592Z (Test No. V684-A)
5
- . Dynamic Torsion Testing per ASTM F1717-04 and ASTM Work Item 455-Z9592Z (Test No. V809)
- Dynamic Compression Testing per ASTM F1717-04 and ASTM Work Item . 455-Z9592Z (Test No. V697)
- Static Compression Bending per ASTM F1717-04 and ASTM Work Item 455-Z9592Z (Test No. V683-A)
The results showed that the subject Aesculap S4 Cervical Spinal and Occiput Systems meet or exceed the performance of the predicate devices, and the device is therefore found to be substantially equivalent.
PREDICATE DEVICE
- Synapse Occipital-Cervical-Thoracic (OCT) System (K142838) ●
REFERENCE DEVICES
- Aesculap S4C Spinal System (K050979) ●
- Aesculap S4C Spinal System (Additional lengths polyaxial screws) (K060152) .
- . Aesculap S4C Spinal System: Occiput Plate (K062012)
- . Aesculap S4C Spinal System (Modification to Cross Connector & Add. Smooth Shank Screws) (K062327)
- . Aesculap S4C Mini-Occiput Spinal System (K100147)