(16 days)
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No
The description focuses on the mechanical design and materials of a cervical spine plate and screws, with no mention of AI or ML capabilities.
Yes
The device is intended to provide stabilization and aid in the development of spinal fusion, as well as restore disc height for various conditions, indicating a therapeutic purpose.
No
This device is a cervical plate system intended for stabilization and fusion of the cervical spine, not for diagnosing medical conditions.
No
The device description clearly states it is a physical plate system made of titanium alloy, intended for surgical implantation in the cervical spine. It is a hardware device, not software.
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 designed to stabilize the cervical spine and aid in spinal fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical plate and screws made of titanium alloy, intended for surgical implantation. This is consistent with a medical device used in surgery, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Osteonics® ACCP System does not fit this description.
N/A
Intended Use / Indications for Use
The Osteonics® ACCP System components are intended to provide stabilization at single or multiple levels of the cervical spine, thus aiding in the development of a solid spinal fusion. Additionally, the Osteonics® ACCP System may be used to aid in the restoration of disc height in the presence of a tumor, vertebral trauma, or degenerative disease, pseudarthrosis, or previously failed fusions.
The indications for the use of the Osteonics® ACCP System are as follows:
- degenerative disc disease (neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
- decompression of the spinal cord following total or partial cervical vertebrectomy.
- trauma (fractures)
- tumors
- pseudarthrosis
- failed previous fusions.
Product codes
KWQ
Device Description
The Osteonics® ACCP System is an anterior cervical single or multi-level plate that incorporates either a monoblock or modular design, which is measured from end to end. Modular end plate sections are secured to each other using locking screws, and are provided preassembled. The Osteonics® ACCP is placed longitudinally on the long axis of the cervical spine and is affixed by unicortical bone screws. All Osteonics® ACCP System components are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
The subject Osteonics® ACCP System Line Extension components are substantially equivalent to the anterior cervical plates in the Osteonics® ACCP System.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) PREMARKE T NOTIFICAT SUMMARY OF SAFETY AND EFFECTIVENESS OSTEONICS® ACCP SYSTEM - LINE EXTENSION
| Submission Information | |
|---|---|
| Name and Address of the Sponsor | |
| of the 510(k) Submission: | Howmedica Osteonics Corp. |
| 59 Route 17 | |
| Allendale, NJ 07401-1677 | |
| 201-825-4900 | |
| Contact Person: | Kate Sutton |
| Regulatory Affairs Consultant | |
| Date Summary Prepared: | July 12, 1999 |
| Device Identification | |
| Proprietary Name: | Osteonics® Anterior Cervical Compression |
| Plating System - Line Extension | |
| Common Name: | Anterior Cervical Compression Plate |
| Classification Name and Reference: | Spinal Invertebral Body Fixation |
| 21 CFR §888.3060 |
Predicate Device Identification
The subject Osteonics® ACCP System Line Extension components are substantially equivalent to the anterior cervical plates in the Osteonics® ACCP System.
Device Description
The Osteonics® ACCP System is an anterior cervical single or multi-level plate that incorporates either a monoblock or modular design, which is measured from end to end. Modular end plate sections are secured to each other using locking screws, and are provided preassembled. The Osteonics® ACCP is placed longitudinally on the long axis of the cervical spine and is affixed by unicortical bone screws. All Osteonics® ACCP System components are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy.
Intended Use
The Osteonics® ACCP System components are intended to provide stabilization at single or multiple levels of the cervical spine, thus aiding in the development of a solid spinal fusion.
1
Additionally, the Osteonics® ACCP System may be used to aid in the restoration of disc height in the presence of a tumor, vertebral trauma, or degenerative disease, pseudarthrosis, or previously failed fusions.
Statement of Technological Comparison
The subject Osteonics® ACCP System Line Extension components are substantially equivalent in design and intended use to the monoblock cervical plates in the predicate Osteonics® ACCP System. The subject and predicate anterior cervical plates are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Ms. Kate Sutton Regulatory Affairs Consultant Howmedica Osteonics Corporation 59 Route 17 Allendale. New Jersey 07401-1677
Re: K992344 Trade Name: Osteonics® ACCP System Regulatory Class: II Product Code: KWQ Dated: July 12, 1999 Received: July 14, 1999
Dear Ms. Sutton:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) 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.
This letter will allow you to begin marketing your device as described in your 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.
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Page 2 – Ms. Kate Sutton
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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
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510(k) Number (if known): K___________________________________________________________________________________________________________________________________________________
Device Name: Osteonics® ACCP System - Line Extension
Indications For Use:
. 13:40
The indications for the use of the Osteonics® ACCP System are as follows:
- degenerative disc disease (neck pain of discogenic origin with degeneration of the disc confirmed . by patient history and radiographic studies).
- decompression of the spinal cord following total or partial cervical vertebrectomy .
- . trauma (fractures)
- . tumors
- pseudarthrosis .
- failed previous fusions .
(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 | |
| 510(k) Number | K992344 |
| Prescription Use | |
| (Per 21 CFR 801.109) | OR |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |