(25 days)
No
The document describes a mechanical implant system (plates and screws) and manual surgical instruments. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended for "anterior cervical intervertebral body fixation" to provide "stability" after fusion, implying it is used to treat a medical condition.
No
The device is described as a surgical implant (plates and screws) for stabilizing the cervical spine following fusion, and not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of plates, screws, manual surgical instruments, and cases, which are all hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior cervical intervertebral body fixation" and is used "following anterior cervical fusion." This describes a surgical implant used within the body to provide structural support.
- Device Description: The device consists of "plates and screws" and "manual surgical instruments and cases." These are all components of a surgical system, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific markers, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for structural support after a procedure.
N/A
Intended Use / Indications for Use
The SWIFT™ Plus Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as pain with degeneration of the disc discogenic confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
Product codes
Not Found
Device Description
The SWIFT Plus Anterior Cervical Plate System consists of an assortment of plates and screws. The SWIFT Plus Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, levels C2 to T1
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data were submitted to characterize the SWIFT Plus Anterior Cervical Plate System.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
IX. 510(k) Summary
| SUBMITTER: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Frank S. Jurczak |
| DATE PREPARED: | September 5, 2007 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis |
| PROPRIETARY NAME: | SWIFT™ Plus Anterior Cervical Plate System |
| PREDICATE DEVICES: | SWIFT™ Anterior Cervical Plate System
(K040655) |
| | EAGLE™ Plus Anterior Cervical Plate System
(K070994) |
| DEVICE DESCRIPTION: | The SWIFT Plus Anterior Cervical Plate System
consists of an assortment of plates and screws. |
| | The SWIFT Plus Anterior Cervical Plate System also
contains Class 1 manual surgical instruments and
cases that are considered exempt from premarket
notification. |
| INTENDED USE: | The indications for use for the modified devices
described in this submission are the same as those
for the previously cleared SWIFT Anterior Cervical
Plate System. The indications are as follows: |
| | The SWIFT™ Plus Anterior Cervical Plate System is
intended for anterior cervical intervertebral body
fixation. This system is indicated for patients in which
stability is desired following anterior cervical fusion for
the indications listed below. The intended levels for
treatment range from C2 to T1. |
| | Indications include symptomatic cervical spondylosis,
trauma, fracture, post-traumatic kyphosis or lordosis,
tumor, degenerative disc disease (defined as |
1
pain with degeneration of the disc discogenic confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
- MATERIALS: Manufactured from ASTM F-136 implant grade titanium alloy.
| PERFORMANCE |
|---|
| DATA: |
Performance data were submitted to characterize the SWIFT Plus Anterior Cervical Plate System.