(69 days)
Not Found
No
The description focuses on the mechanical components and intended use of a spinal fixation system, with no mention of AI or ML capabilities.
Yes
The device is a spinal fixation system intended to treat various spinal conditions, including degenerative disc disease, deformities, tumors, and fractures, which directly address health problems in patients.
No
Explanation: The device description clearly states it is an anterior spinal system with plates, screws, and rods, intended for fixation. There is no mention of it being used to diagnose conditions or process diagnostic information.
No
The device description clearly outlines physical components such as spinal plates, screws, rod couplers, and rods, which are hardware.
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 for spinal fixation. It is used in vivo (within the body) to stabilize the spine.
- Device Description: The device components are physical implants (plates, screws, rods) designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a therapeutic device used to treat a physical condition through surgical intervention.
N/A
Intended Use / Indications for Use
The Kaneda SR Anterior Spinal System is intended for anterolateral screw fixation to the T10-L3 levels of the spine, with all metal at least 1 cm. from a major vessel. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, kyphosis, lordosis), tumor, fracture and revision of previous surgery. The Kaneda system is used in conjunction with the Isola Spine System. Specifically, the 1) Isola ¼" Rods 2) Isola Open Caps and 3) the Isola Set Screws are interchangeable parts.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The components of the Kaneda SR Anterior Spinal System consist of spinal plates, anterior vertebral body screws, transverse rod couplers and rods. This system can also be used in conjunction with some components of the Isola Spine System. Specifically, 1) the Isola ¼" rods 2) the Isola Open Caps and 3) the Isola Set Screws. The contoured spiked plates are designed to help the construct anchors resist axial forces and serve as a guide for placement of the screws. The plates are available in three sizes (small, medium and large) and are designed as pairs with specific caudal and rostral components. The screws serve to anchor the vertebral bodies to the longitudinal rods. The screws are available in open and closed formats designed to fit the 1/4" rod in cancellous lengths of 35 mm to 60 mm. The Kaneda Anterior Spinal System utilizes the 1/4" diameter rod, available in 18" lengths or in precut lengths from 45 mm to 150 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T10-L3 levels of the spine
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)
Static and fatigue testing show the Kaneda SR Anterior Spinal System to perform consistently with previously cleared components.
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
§ 888.3060 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
June 11, 1997 AcroMed Kaneda Anterior Spinal System 510(k) SUMMARY
.
| COMPANY: | AcroMed Corporation
3303 Carnegie Avenue
Cleveland, OH 44115 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| TRADENAME: | Kaneda SR Anterior Spinal System |
| CLASSIFICATION: | Spinal Intervertebral Body Fixation Orthosis
Class II |
| DESCRIPTION: | The components of the Kaneda SR Anterior Spinal System consist
of spinal plates, anterior vertebral body screws, transverse rod
couplers and rods. This system can also be used in conjunction with
some components of the Isola Spine System. Specifically, 1) the
Isola ¼" rods 2) the Isola Open Caps and 3) the Isola Set Screws.
The contoured spiked plates are designed to help the construct
anchors resist axial forces and serve as a guide for placement of the
screws. The plates are available in three sizes (small, medium and
large) and are designed as pairs with specific caudal and rostral
components. The screws serve to anchor the vertebral bodies to the
longitudinal rods. The screws are available in open and closed
formats designed to fit the 1/4" rod in cancellous lengths of 35 mm
to 60 mm. The Kaneda Anterior Spinal System utilizes the 1/4"
diameter rod, available in 18" lengths or in precut lengths from 45
mm to 150 mm. |
| MATERIAL: | The components of the Kaneda SR Anterior Spine System are
manufactured from titanium alloy conforming to ASTM F 136
specifications. |
1
The Kaneda SR Anterior Spinal System is intended for anterolateral INDICATIONS: screw fixation to the T10-L3 levels of the spine, with all metal at least 1 cm. from a major vessel. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, kyphosis), tumor, fracture and revision of previous surgery.
PERFORMANCE DATA:
Static and fatigue testing show the Kaneda SR Anterior Spinal System to perform consistently with previously cleared components.
SUBSTANTIAL EQUIVALENCE:
The Kaneda SR Anterior Spinal System is substantially equivalent to the Kaneda Anterior Spinal Instrumentation as cleared under K873826, the Kaneda Anterior Spinal Multisegmental Fixation Device as cleared under K923703 and the ISOLA Anterior Spinal System as cleared under K943819.
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 an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN || 1997
Mr. William Christianson "Vice President, Requlatory Affairs and Quality Assurance AcroMed® 3303 Carnegie Avenue Cleveland, Ohio 44115
Re : K971248 Kaneda SR Anterior Spinal System Requlatory Class: II Product Code: KWQ Dated: April 2, 1997 Received: April 3, 1997
Dear Mr. Christianson:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act You may, therefore, market your device system subject (Act). to the general controls provisions of the Act and the limitations identified below.
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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f)(1) of the Act.
FDA identifies that any device system, it intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
-
- You may not label or in any way promote this device system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the
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Page 2 - Mr. William Christianson
package insert must include the following statement, "WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";
All labeling for this device system, including the 2. package label, must state that there are labeling limitations. The package insert must prominently state that the device system is intended for the specific use(s) described in the enclosure only; and
- 本
- Pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a siqnificant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510 (k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required.
4
Page 3 - Mr. William Christianson
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.
-Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K971248 510(k) Number (if known):
Kaneda SR Anterior Spinal System Device Name:
Indications for Use:
系
The Kaneda SR Anterior Spinal System is intended for anterolateral screw fixation to the T10-L3 levels of the spine, with all metal at least 1 cm. from a major vessel. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, kyphosis, lordosis), tumor, fracture and revision of previous surgery. The Kaneda system is used in conjunction with the Isola Spine System. Specifically, the 1) Isola ¼" Rods 2) Isola Open Caps and 3) the Isola Set Screws are interchangeable parts.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| (Division Sign-Off) |
| Division of General Restorative Devices |
| Prescription Use (per 21 CRF 801.109) | X | OR | Over-The Counter Use |
|---|---|---|---|
| --------------------------------------- | --- | ---- | ---------------------- |
| 510(k) Number | K971248 |
|---|---|
| --------------- | --------- |