(82 days)
Not Found
No
The 510(k) summary describes a mechanical implant (plate and screws) and manual surgical instruments. There is no mention of AI, ML, image processing, or any software component that would suggest the use of these technologies.
Yes
The device is described as an anterior cervical plate system intended for intervertebral body fixation following anterior cervical fusion, with indications including various spinal conditions like spondylosis, trauma, and degenerative disc disease. This directly addresses medical conditions.
No
The device description clearly states it is a plate system used for fixation and fusion, indicating it is a therapeutic or reconstructive device, not a diagnostic one.
No
The device description explicitly states that the system consists of "an assortment of plates and screws" and "Class 1 manual surgical instruments and cases," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "anterior cervical intervertebral body fixation." This describes a surgical implant used to stabilize the spine.
- Device Description: The device consists of "plates and screws" and "manual surgical instruments." These are physical devices used in surgery.
- 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 description of the Swift Anterior Cervical Plate System does not involve any such testing or analysis of biological samples.
Therefore, the Swift Anterior Cervical Plate System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Swift Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are 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, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
Product codes
KWQ
Device Description
The Swift Anterior Cervical Plate System consists of an assortment of plates and screws.
The Swift 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
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 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 | JUN - 2 2004 K040655
Page 1 of 2 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02780 |
| CONTACT PERSON: | Lisa A. Gilman |
| DATE PREPARED: | March 5, 2004 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis |
| PROPRIETARY NAME: | Swift Anterior Cervical Plate System |
| PREDICATE DEVICES: | Peak Polyaxial Anterior Cervical Plate System
(K971730)
Codman SLIM-LOC Anterior Plating System
(K013877) |
| DEVICE DESCRIPTION: | The Swift Anterior Cervical Plate System consists of
an assortment of plates and screws.
The Swift 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 Peak Polyaxial Anterior Cervical Plate System
(K971730). The indications are as follows:
The Swift Anterior Cervical Plate System is intended
for anterior cervical intervertebral body fixation.
These systems are 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
discogenic pain with degeneration of the disc 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 Anterior Cervical Plate System. |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a bird-like figure, which is the department's symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UN - 2 2004
Ms. Sharon Starowicz Director, Regulatory Affairs DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Re: K040655
Trade/Device Name: Swift Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 8, 2004 Received: March 12, 2004
Dear Ms. Starowicz:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 – Ms. Sharon Starowicz
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
111. Indications for Use
Page 1 of 1
510(k) Number (if known): __ Koyo G55
Swift Anterior Cervical Plate System Device Name:
Indications For Use:
The Swift Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are 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, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: (Per 21 CFR 801.109) | X |
|---|---|
| OR Over-The-Counter Use: | ____________________ |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices