(29 days)
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No
The provided text describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is intended to provide stabilization during the development of a solid spinal fusion, addressing various medical conditions related to spinal deformities, degeneration, and injury. This aligns with the definition of a therapeutic device designed to treat or manage a disease or condition.
No
This device is for spinal fixation and stabilization, which is a therapeutic purpose, not diagnostic. Its indications for use describe conditions requiring stabilization, not identification or diagnosis of conditions.
No
The device description explicitly states that the system consists of physical components such as plates, screws, nuts, spacers, and staples, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for providing stabilization during spinal fusion. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of implants (plates, screws, nuts, etc.) designed to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
Properly used, the LAURAIN DEWALD™ Anterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4) spinal deformation such as kyphosis and lordosis, (5) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability and/or deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic disease, and/or (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.
Product codes
KWP
Device Description
The LAURAIN DEWALD Anterior Fixation System consists of a variety of shapes and sizes of plates, screws, nuts, spacers and staples, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.
The purpose of this submission is to include additional plates, screws and staples to the LAURAIN DEWALD Anterior Fixation System.
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
spinal
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)
Documentation was provided which demonstrated the LAURAIN DEWALD Anterior Fixation System to be substantially equivalent to itself.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
LAURAIN DEWALD Anterior Fixation System 510(k) Summary December 2002
DEC 1 3 2002
I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
II. Proprietary Trade Name: LAURAIN DEWALD Anterior Fixation System
III. Regulation Number: 888.3060 - KWQ
IV. Product Description
The LAURAIN DEWALD Anterior Fixation System consists of a variety of shapes and sizes of plates, screws, nuts, spacers and staples, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.
The purpose of this submission is to include additional plates, screws and staples to the LAURAIN DEWALD Anterior Fixation System.
V. Indications
Properly used, the LAURAIN DEWALD™ Anterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4) spinal deformation such as kyphosis and lordosis, (5) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability and/or deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic disease, and/or (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.
VI. Substantial Equivalence
Documentation was provided which demonstrated the LAURAIN DEWALD Anterior Fixation System to be substantially equivalent to itself.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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DEC 13 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132
Re: K023797
Trade Name: LAURAIN DEWALD Anterior Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWP Dated: November 13, 2002 Received: November 14, 2002
Dear Dr. Treharne:
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 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.
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Page 2 - Richard W. Treharne, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 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, 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmamain.html.
Sincerely yours,
R. Mark A. Millham
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
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510(k) Number (if known): K023797 Device Name; LAURAIN DEWALD Anterior Fixation System Indications for Use:
Properly used, the LAURAIN DEWALD™ Anterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4) spinal deformation such as kyphosis and lordosis, (5) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability and/or deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic disease, and/or (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)
OR
Over-the-counter Use _
for Minh n Milkum
(Division Sign-C Division of Cereval. Elestorative and Neurological ber ices
510(k) Number K033797