(129 days)
No
The 510(k) summary describes a mechanical implant (cervical plating system) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the treatment of cervical spine instability resulting from various medical conditions, indicating a therapeutic purpose.
No
The device is an implantable medical device (cervical plating system) used for spinal stabilization, not for diagnosing conditions.
No
The device description clearly states it is a cervical extension plate, which is a physical implant used in spinal surgery. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the ABC Cervical Plating System is a physical implant used for stabilizing the cervical spine during surgery. It is a mechanical device used to treat structural instability.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples or provide diagnostic information. Its function is purely therapeutic and structural.
Therefore, the ABC Cervical Plating System falls under the category of a surgical implant or spinal fixation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), posttraumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
ABC extension plates MUST only be used with existing ABC plates and screws. They are NOT to be used with another manufacturers system.
Product codes
KWQ
Device Description
The ABC Cervical Extension Plate is used to extend the existing anterior The ADO OUrloar Like was cleared through the Anterior Cervical Spine Plates Stablication plate (K974706) and Anterior Cervical Screw Spinal Fixation System (K000486).
The ABC E-Plates are exclusively used to extend an existing anterior stabilization plate on the cervical spine, which has been carried out using the ABC system. The E-Plate allows a mono-segmental or bi-segmental extension at the cranial or caudal end of the existing ABC plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-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)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic AOther those and the Guidance for Spinal System 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974706, K000486, K992344, K993181
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
MAY 1 4 2004
K040017
Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990
ABC Caudal and Cranial Extension Plate
December 30, 2003
| COMPANY: | Aesculap®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Joni Swoveland, Regulatory Affairs Assistant
800-258-1946 (phone)
610-791-6882 (fax)
joni.swoveland@aesculap.com (e-mail) |
| TRADE NAME: | ABC Caudal and Cranial Extension Plate |
| COMMON NAME: | Anterior Cervical Spinal Stabilization System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | KWQ |
| CLASSIFICATION: | 888.3060 - Appliance, Fixation, Spinal Intervertebral Body |
| REVIEW PANEL: | Orthopedic |
The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain inistablily rounting from degs confirmed by history and radiographic studies), with degoneration or or ures), post-traumatic kyphosis or lordosis, tumors, and retrauma (inoluling fractare); fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
This device is not approved for screw attachment to the WARNING: posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
ABC extension plates MUST only be used with existing ABC plates and screws. They are NOT to be used with another manufacturers system.
DEVICE DESCRIPTION
The ABC Cervical Extension Plate is used to extend the existing anterior The ADO OUrloar Like was cleared through the Anterior Cervical Spine Plates Stablication plate (K974706) and Anterior Cervical Screw Spinal Fixation System (K000486).
The ABC E-Plates are exclusively used to extend an existing anterior stabilization plate on the cervical spine, which has been carried out using the ABC system. The E-Plate allows a mono-segmental or bi-segmental extension at the cranial or caudal end of the existing ABC plate.
1
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the No performance Standards nave boon promaignes. The new ABC System conforms Food, Drug and Cosmetic Aother those and the Guidance for Spinal System 510(k).
SUBSTANTIAL EQUIVALENCE
Aesculap believes that the ABC Extension is substantially equivalent to our Aesculap believes that the ABO Plates and Screws (K974706) and Anterior existing Antenor Oervical Opine Plater and Cordinal Collection predicate devices:
Osteonics Anterior Cervical Compression Plating System, Line Extension -Howmedica Osteonics Corp. (K992344). Howmediou Sotoonics Series (compression Plating System, Cortical Screws –
Howmedica Osteonics Corp. (K993181).
2
Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center consists of three stylized lines that resemble a person with outstretched arms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2004
Ms. Joni L. Swoveland Regulatory Affairs Assistant Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034
Re: K040017
Trade/Device Name: ABC Caudal and Cranial Extension Plate (e-Plate) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 5, 2004 Received: January 12, 2004
Dear Ms. Swoveland:
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
3
Page 2 -- Ms. Joni Swoveland
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. production of the month of begin marketing your device as described in your Section 510(k) I mis lotter will and hy a very of substantial equivalence of your device to a legally premated 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 If you doon 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,
Cly Witte
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
Page 1 of 1
INDICATIONS FOR USE STATEMENT
K040017 510(k) Number (if known):
Device Name:
Indication for Use:
The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), posttraumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
This device is not approved for screw attachment to the posterior WARNING: elements (pedicles) of the cervical, thoracic, or lumbar spine.
ABC extension plates MUST only be used with existing ABC plates and screws. They are NOT to be used with another manufacturers system.
| Prescription Use | X |
|---|---|
| (per 21 CFR 801.109) | |
| or Over-the-Counter Use | |
| (Optional Format 3-10-98) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
- Restorative, Division of Gene and Neurological Devices
510(k) Number
k04 0017