(179 days)
No
The document describes a mechanical spinal stabilization system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "Anterior Spinal Stabilization System" and "is intended to provide stabilization during the development of a solid spinal fusion" for various spinal conditions, which indicates a therapeutic purpose.
No
The device description clearly states "The MACS 1 HMA Anterior Spinal Stabilization System includes implantable metallic plates, rods, clamps, locking nuts and screws. The components are used in various combinations to form a construct for use during anterior spinal fusion surgery." This device is intended for surgical stabilization, not for diagnosing conditions.
No
The device description explicitly states that the system includes "implantable metallic plates, rods, clamps, locking nuts and screws," which are hardware components.
Based on the provided information, 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this system consists of implantable metallic components (screws, plates, rods, etc.) used for stabilization during spinal fusion surgery. This is a surgical implant, not a device that analyzes biological samples.
- Lack of IVD-related terms: There is no mention of analyzing samples, performing tests, or providing diagnostic information based on biological markers.
Therefore, this device falls under the category of a surgical implant or spinal fixation system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This anterolateral/anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T3-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral/anterior spine plate and rod system, the macs " HMA Anterior Spinal Stabilization System is indicated for patients with:
- . Degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis ●
- Spondylolysis
- . Fracture
- . Spinal stenosis
- Deformities (i.e., scoliosis, kyphosis, lordosis, whether . neuromuscular or related to deficient posterior elements)
- . Tumors (neoplastic disease)
- Pseudarthrosis
- Failed previous fusion surgery ●
Product codes
KWQ
Device Description
The MACS 1 HMA Anterior Spinal Stabilization System includes implantable metallic plates, rods, clamps, locking nuts and screws. The components are used in various combinations to form a construct for use during anterior spinal fusion surgery. The MACS" modular anterior construct system (K002824), which was cleared on May 8, 2001, consists of the twin screws, where as the MAC™ HMA Anterior Spinal Stabilization System consists of the HMA Polyaxial and Monoaxial Screws. Both of these systems are considered a part of each other. The stabilization plates, connection rods, fixation nut, locking screw, bone graft clamp and screw have been cleared under the MACS" modular anterior construct system (K002824).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and thoracic spine (T3-L5)
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
Fatigue testing of a "worst case" system configuration was conducted on samples of constructs made of titanium. A summary of this testing can be found in Section IV and the final reports are provided in Appendix I.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In Accordance with SMDA of 1990
NOV 1 6 2001
MACS™ HMA Anterior Spinal Stabilization System
May 16, 2001
| COMPANY: | Aesculap ®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Millington, Regulatory Associate
800-258-1946 (phone)
610-231-3713 (fax)
lisa.millington@aesculap.com (email) |
| TRADE NAME: | MACSTL HMA Anterior Spinal Stabilization System |
| COMMON NAME: | Anterior-Lateral Spinal Stabilization System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | KWQ |
| CLASSIFICATION: | 888.3060 – Spinal intervertebral body fixation orthosis |
| REVIEW PANEL: | Orthopedic and Rehabilitation Devices Panel |
INTENDED USE
This anterolateral/anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T3-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral/anterior spine plate and rod system, the macs " HMA Anterior Spinal Stabilization System is indicated for patients with:
- . Degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis ●
- Spondylolysis
- . Fracture
- . Spinal stenosis
- Deformities (i.e., scoliosis, kyphosis, lordosis, whether . neuromuscular or related to deficient posterior elements)
- . Tumors (neoplastic disease)
- Pseudarthrosis
- Failed previous fusion surgery ●
1
DEVICE DESCRIPTION
The MACS 1 HMA Anterior Spinal Stabilization System includes implantable metallic plates, rods, clamps, locking nuts and screws. The components are used in various combinations to form a construct for use during anterior spinal fusion surgery. The MACS" modular anterior construct system (K002824), which was cleared on May 8, 2001, consists of the twin screws, where as the MAC™ HMA Anterior Spinal Stabilization System consists of the HMA Polyaxial and Monoaxial Screws. Both of these systems are considered a part of each other. The stabilization plates, connection rods, fixation nut, locking screw, bone graft clamp and screw have been cleared under the MACS" modular anterior construct system (K002824).
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new MACST System conforms to applicable ASTM and ISO standards.
Fatigue testing of a "worst case" system configuration was conducted on samples of constructs made of titanium. A summary of this testing can be found in Section IV and the final reports are provided in Appendix I.
SUBSTANTIAL EQUIVALENCE
MACS" HMA Anterior Spinal Stabilization System is substantially equivalent in their intended use, design, and basic operating principles to the following predicate devices:
K-Centrum Anterior Spinal Fixation System .
By The Spineology Group (#K990959 & K002371) The K-Centrum® - Anterior Spinal Fixation System is cleared for marketing. K-Centrum® is an anterior spinal construct made up of one rod connected to two cage-like vertebral body screws. This system was tested using ASTM F-1717-96 recommendations. Properties of stiffness. strength and fatique life were determined. The K-Centrum® is intended to be used for the surgical treatment of vertebral body fractures and tumors. Equivalence can be seen in the design, material composition, surgical technique, testing methodologies and intended use.
2
Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized eagle with three curved lines representing its wings. The eagle is facing to the right. The eagle is surrounded by text that is arranged in a circular pattern. The text is difficult to read due to the image quality.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Ms. Lisa M. Millington Regulatory Associate Aesculap®. Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: KOI 1556 Trade/Device Name: MACST HMA Anterior Spinal Stabilization System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 24, 2001 Received: August 29, 2001
Dear Ms. Millington:
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 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.
3
Page 2 - Ms. Lisa M. Millington
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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colie M. Witter, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NOV 1 6 2001
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Kollste
Device Name: MACS™ HMA Anterior Spinal Stabilization System
Indication for Use:
This anterolateral / anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T3-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral / anterior spine plate and rod system, the macs " HMA Anterior Spinal Stabilization System is indicated for patients with:
- Degenerative disk disease defined as back pain of discogenic origin with ● degeneration of the disc confirmed by history and radiographic studies
- . Spondvlolisthesis
- . Spondvlolysis
- Fracture ●
- Spinal stenosis .
- Deformities (i.e., scoliosis, kyphosis, lordosis, whether neuromuscular or . related to deficient posterior elements)
- Tumors (neoplastic disease) ●
- Pseudarthrosis ●
- Failed previous fusion surgery .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (6
for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K011556
Prescription Use X or Over-the-Counter Use
(per 21 CFR 801.109) (Optional Format 3-10-98)