(29 days)
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No
The device description and intended use focus on a physical implant (anterior cervical plate) and its mechanical properties, with no mention of software, algorithms, or data processing that would typically involve AI/ML.
Yes
The device is listed for use in treating various conditions such as degenerative disc disease, trauma (fractures), and tumors, which are therapeutic applications.
No
The device is a system of plates and screws used to provide stability to the cervical spine, indicated for conditions like degenerative disc disease, trauma, and tumors. Its purpose is treatment, not diagnosis. While its use is for conditions confirmed by "radiographic studies," the device itself does not perform those studies or interpret their results.
No
The device description explicitly states it is a physical plate system made of titanium alloy, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Howmedica Osteonics® ACCP System is a surgical implant (an anterior cervical plate) used to stabilize the cervical spine. It is physically placed within the body.
- Intended Use: The intended uses listed are all related to surgical procedures and the treatment of structural issues in the cervical spine (degenerative disc disease, trauma, tumors, etc.).
Therefore, based on the provided information, the Howmedica Osteonics® ACCP System is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The indications for the use of the Howmedica 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 vertebrectorny .
- trauma (fractures) ●
- . tumors
- pscudarthrosis
- failed previous fusions ●
Product codes
KWQ
Device Description
The Howmedica 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 Howmedica Osteonics® ACCP is placed longitudinally on the long axis of the cervical spine and is affixed by cortical bone screws. All Howmedica 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
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Intended User / Care Setting
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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)
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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
0CT 22 1999
SPECIAL 510(k) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS HOWMEDICA OSTEONICS® ACCP SYSTEM - CORTICAL SCREWS
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: | Mary-Catherine Dillon
Regulatory Affairs Team Member |
| Date Summary Prepared: | September 22, 1999 |
Device Identification
| Proprietary Name: | Howmedica Osteonics® Anterior Cervical Compression Plating System - Cortical Screws |
|---|---|
| Common Name: | Anterior Cervical Compression Plate |
| Classification Name and Reference: | Spinal Invertebral Body Fixation |
| 21 CFR §888.3060 |
Predicate Device Identification
The Howmedica Osteonics® ACCP System Cortical Screws are substantially equivalent to the cortical bone screws in the Howmedica Osteonics® ACCP System.
Device Description
The Howmedica 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 Howmedica Osteonics® ACCP is placed longitudinally on the long axis of the cervical spine and is affixed by cortical bone screws. All Howmedica Osteonics® ACCP System components are manufactured from ASTM F-136-98 (ISO 5832/3) titanium alloy.
1
Intended Use
The indications for the use of the Howmedica 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 vertebrectorny .
- trauma (fractures) ●
- . tumors
- pscudarthrosis
- failed previous fusions ●
Statement of Technological Comparison
The subject Howmedica Osteonics® ACCP System Cortical Screw components are substantially equivalent in design and intended use to the cortical bone screws in the predicate Osteonics® ACCP System. The subject and predicate bone screws 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 U.S. Department of Health & Human Services. The logo consists of a circle with the text "HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 22 1999
Ms. Elizabeth A. Staub Vice President - Quality Assurance, Regulatory Affairs, Clinical Reasearch Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677
K993181 Re: Howmedica Osteonics® ACCP Trade Name: System Cortical Screws Requlatory Class: II Product Code: KWQ September 20, 1999 Dated: Received: September 23, 1999
Dear Ms. Staub:
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. 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 requlations.
3
Page 2 - Ms. Elizabeth A. Staub
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.
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.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten Ph.D. M.D.
Ph.D., M.D. Celia M. Witten, 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): K99318/
Device Name: Howmedica Osteonics® ACCP System Cortical Screws
Indications For Use:
The indications for the use of the Howmedica 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 | K993181 |
| Prescription Use | X |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |