(226 days)
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No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various acute and chronic instabilities or deformities, which are therapeutic actions.
No
The device is a pedicle screw system used for immobilization and stabilization of spinal segments, acting as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a spinal fixation system consisting of physical components like pedicle screws, hooks, and rods, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The provided text clearly describes the Micomed Posterior Doublerod System as a surgical implant used to provide immobilization and stabilization of spinal segments. It is a physical device implanted into the body to treat structural issues in the spine.
- Lack of Specimen Examination: There is no mention of this device being used to examine any biological specimens (blood, tissue, etc.) outside of the body. Its function is entirely within the body.
Therefore, based on the provided information, the Micomed Posterior Doublerod System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Micomed Posterior Doublerod System is a pedicle screw system indicated for treatment of severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Micomed Posterior Doublerod System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
When used as a non-pedicle screw fixation system, the Micomed Posterior Doublerod System is also intended for scoliotic, lordotic, or kyphotic deformities such as scollosis, Scheuermann's disease); degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, and fractures of the posterior thoracolumbar spine from levels T4 to S1.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH, KWP
Device Description
The Micomed Posterior Doublerod System is a low profile, top-loading spinal fixation system available in titanium. The system consists of pedicle screws of varying lengths and diameters, open and closed hooks, and fluted and threaded rods. A set of instruments is available for use with the Micomed Posterior Doublerod 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
L5-S1 vertebra, lumbar and sacral spine (L3 to sacrum), thoracic, lumbar, and sacral spine, posterior thoracolumbar spine from levels T4 to S1.
Indicated Patient Age Range
Skeletally mature patients
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)
The Micomed Posterior Doublerod System has been shown to have acceptable biomechanical behavior when compared to TSRH (Sofamor Danek), VSP (AcroMed), ISOLA (AcroMed), AcroMed Pedicle Screw (AcroMed) Dyna-Lok (Danek) and Miami Moss (DePuy Motech).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
K99/862
JAN 1 3 2000
510(k) Summary
| Company:
Tradename:
Classification: | Schafer Micomed GmbH
Sparweiser Weg 4
73035 Goppingen, Germany
Phone: +49 71 61 94 96 43 Fax: +49 71 61 94 96 46
Micomed Posterior Doublerod System
Class II |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description: | The Micomed Posterior Doublerod System is a low profile, top-loading
spinal fixation system available in titanium. The system consists of
pedicle screws of varying lengths and diameters, open and closed hooks,
and fluted and threaded rods. A set of instruments is available for use
with the Micomed Posterior Doublerod System. |
| Material: | The components of the Micomed Posterior Doublerod System are
manufactured from titanium in conformance with ASTM F136. |
| Indications: | The Micomed Posterior Doublerod System is a pedicle screw
system indicated for treatment of severe spondylolisthesis (Grades 3 and
4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by
autogenous bone graft having implants attached to the lumbar and sacral
spine (L3 to sacrum) with removal of the implants after the attainment of a
solid fusion. |
| | The Micomed Posterior Doublerod System is a pedicle screw system
intended to provide immobilization and stabilization of spinal segments in
skeletally mature patients as an adjunct to fusion in the treatment of the
following acute and chronic instabilities or deformities of the thoracic,
lumbar, and sacral spine: degenerative spondylolisthesis with objective
evidence of neurological impairment, fracture, dislocation, scoliosis,
kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis). |
| | When used as a non-pedicle screw fixation system, the Micomed
Posterior Doublerod System is also intended for scoliotic, lordotic, or
kyphotic deformities such as scoliosis, Scheuermann's disease);
degenerative disk disease defined as back pain of discogenic origin with
degeneration of the disc confirmed by patient history and radiographic
studies, and fractures of the posterior thoracolumbar spine from levels T4
to S1. |
| Performance
Data: | The Micomed Posterior Doublerod System has been shown to
have acceptable biomechanical behavior when compared to
TSRH (Sofamor Danek), VSP (AcroMed), ISOLA (AcroMed), AcroMed
Pedicle Screw (AcroMed) Dyna-Lok (Danek) and Miami Moss (DePuy
Motech). |
- The Micomed Posterior Doublerod System is substantially Substantial Equivalence: equivalent to TSRH (Sofamor Danek), VSP (AcroMed), ISOLA (AcroMed), AcroMed Pedicle Screw (AcroMed) Dyna-Lok (Danek) and Miami Moss (DePuy Motoch).
P . 03
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, composed of three curved lines that suggest a profile. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2000
Ms. Charmaine Henderson Consultant to Shafer Micomed, GmbH 511 Catalina Road Fullerton, California 92835
Re: K991862
Trade Name: Micomed Posterior Doublerod System (MPDS) Regulatory Class: II Product Code: MNI, MNH and KWP Dated: December 2, 1999 Received: December 6, 1999
Dear Ms. Henderson:
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.
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.
2
Page 2 - Ms. Charmaine Henderson
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,
.
Hina W. Sayer
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
22000
K991862
P.06
INDICATIONS FOR USE ENCLOSURE
K991862 210k:
Micomed Posterior Doublerod System Device:
Indications for Use:
The Micomed Posterior Doublerod System is a pedicle screw system indicated for treatment of severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Micomed Posterior Doublerod System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
When used as a non-pedicle screw fixation system, the Micomed Posterior Doublerod System is also intended for scoliotic, lordotic, or kyphotic deformities such as scollosis, Scheuermann's disease); degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies, and fractures of the posterior thoracolumbar spine from levels T4 to S1.
Aunell Ison
(Division Sign-Off)
Division of General Restorative Devices 510(k) Number .
Prescription use
Over the Counter Use