(60 days)
Not Found
No
The summary describes a mechanical implant system and surgical instruments, with no mention of software, algorithms, or AI/ML terms.
No.
The device is a Cervical Plating System intended for stabilization and fixation of the cervical spine, not for therapeutic purposes like diagnosis or treatment through active intervention.
No
The device, the ABC Cervical Plating System, is an implant used for the treatment of cervical spine instability, such as fractures and degenerative disc disease, and is designed for surgical fixation rather than diagnosing medical conditions.
No
The device description explicitly states that the system consists of physical components: bone plates, bone screws, and surgical instruments, all made of metal alloys. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The ABC Cervical Plating System is described as a system of spinal implants (bone plates and screws) and surgical instruments. These are physical devices intended to be surgically implanted or used during surgery.
- Intended Use: The intended use is for the treatment of cervical spine instability through surgical fixation. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The description clearly indicates a surgical device used for treatment within the body, not a test performed on a sample outside the body.
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), post-traumatic 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.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes
KWQ
Device Description
The ABC Cervical Plating System consists of two spinal implant components: bone plates and self-locking bone screws. The implants are manufactured from titanium alloy, Ti6Al4V (according to ISO 5832/3) and are provided non-sterile. The specialized ABC instruments are made primarily of surgical grade stainless steel (according to ISO 7153/1) and are hand-held, re-usable devices.
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 applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system.
The ABC implants subject to this 510(k) submission, however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy. The results indicate that the modified and new implants are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974706, K990005, K993855, K974885, K982798, K992344
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.
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Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
ABC CERVICAL PLATING SYSTEM
February 11, 2000
- Aesculap®, Inc. COMPANY: 1000 Gateway Blvd. So. San Francisco, CA 94080
- CONTACT: Lia S. Jones, Regulatory Associate 650-624-5073 (phone) 650-589-3007 (fax) lia.iones@aesculap.com (email)
- TRADE NAME: ABC Cervical Plating System
- COMMON NAME: Anterior Cervical Screw Spinal Fixation System
- DEVICE CLASS: Class II
PRODUCT CODE: 87 KWQ
CLASSIFICATION: 888.3060 - Spinal Intervertebral Body Fixation Orthosis
REVIEW PANEL: Orthopedic Devices Branch Division of General and Restorative Devices
DEVICE DESCRIPTION
The ABC Cervical Plating System consists of two spinal implant components: bone plates and self-locking bone screws. The implants are manufactured from titanium alloy, Ti6Al4V (according to ISO 5832/3) and are provided non-sterile. The specialized ABC instruments are made primarily of surgical grade stainless steel (according to ISO 7153/1) and are hand-held, re-usable devices.
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), post-traumatic 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.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
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Page 2 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
in Accordance with SMDA of 1990
ABC CERVICAL PLATING SYSTEM
February 11, 2000
PERFORMANCE DATA
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system.
The ABC implants subject to this 510(k) submission, however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy. The results indicate that the modified and new implants are substantially equivalent to the predicate devices.
SUBSTANTIAL EQUIVALENCE
The new and modified components described in this premarket notification are substantially equivalent to those in Aesculap's current ABC Cervical Plating System (K974706) with regard to intended use, fundamental scientific technology, design, and material.
In addition, the following predicate anterior cervical plating systems recently received FDA clearance for similar device modifications and system expansions:
- AcuFix™ Anterior Cervical Plate System (K990005) .
- ATLANTIS™ Anterior Cervical Plate System (K993855) .
- Blackstone™ Anterior Cervical Plate System (K974885) .
- Osteonics ACCP System (K982798, K992344) .
These competitor systems are substantially equivalent to the modified ABC Cervical Plating System with regard to intended use, material composition, labeling, implant size and design.
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 stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2000
Ms. Lia S. Jones Regulatory Associate Aesculap, Inc. 1000 Gateway Boulevard South San Francisco 94080-7028
Re: K000486 Trade Name: ABC Cervical Plating System Regulatory Class: II Product Code: KWQ Dated: February 11, 2000 Received: February 14, 2000
Dear Ms. Jones:
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.
3
Page 2 - Ms. Lia S. Jones
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,
Donna R lochner
1/2Celia 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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Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
ABC Cervical Plating System
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), post-traumatic kyphosis or lordosis, tumors, and re-operation (including fractores), posions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Dana R. Lochner.
(Division Sign-Off) Division of General Restorative Devices 510(k) Number_K 000 48 6
Prescription Use
(per 21 CFR 801.109)
or Over-the-Counter Use
(Optional Format 3-10-98)