(169 days)
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are focused on mechanical testing.
Yes
The device is a spinal fixation system intended to treat various spinal conditions like fractures, deformities, and spondylolisthesis, which aims to improve the patient's health and function.
No
The device is a spinal fixation system, intended for surgical implantation to treat various spinal conditions like fractures, deformities, and spondylolisthesis. It is a treatment device, not for diagnosis.
No
The device description explicitly states it is a "spinal fixation system comprised of various types and sizes of components that are implanted via a posterior surgical approach and assembled to create a spinal construct," including "bone screws and hooks," "longitudinal rods," and "transverse connecting elements." This indicates a physical, implantable medical device, not a software-only device.
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: The Alpha Mirage® Top Tightening Spinal System is described as a spinal fixation system comprised of components (bone screws, hooks, rods, connectors) that are implanted via a posterior surgical approach.
- Intended Use: The intended uses all relate to providing structural support and fixation to the spine for various conditions like fractures, deformities, and spondylolisthesis. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is clearly an implantable surgical device used to treat spinal conditions, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
The Alpha Mirage® Top Tightening Spinal System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Alpha Mirage® Top Tightening Spinal System are dependent in part on the configuration of the assembled device and method of attachment to the spine.
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.
-
- The Alpha Mirage® Top Tightening Spinal System, when used as a hook and sacral screw fixation system (non-pedicle screw) is intended for:
- a. Patients having fractures of the thoracic and lumbar spine.
- b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
- c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, deqenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
-
- The Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumore and failed previous fusion (pseudoarthrosis).
-
- In addition, the Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw fixation system is intended for:
- a. Patients receiving only autogenous bone graft.
- b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
-
- The Alpha Mirage® Top Tightening Spinal System, when used as a laminar hook and bone screw system is intended for:
- a. Patients having fractures of thoracic and lumbar spine.
- b. Patients having thoracolumbar deformity (i.e., idioscoliosis, · neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
- c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
Product codes
MNH, MNI, KWP, KWQ
Device Description
The Alpha Mirage® Top Tightening Spinal System is a spinal fixation system comprised of various types and sizes of components that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems, the Alpha Mirage® Top Tightening Spinal System is comprised of 1) bone screws and hooks for attachment to the spine, 2) longitudinal rods that are attached to the bone screws and hooks directly/indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoraco-lumbo-sacral portion of the spine, thoracic and lumbar spine, sacrum, T7-L5, L5-S1 vertebral joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Mechanical and dynamic testing of the Alpha Mirage® Top Tightening Spinal System constructs was performed as described in 510(k) applications K951846 and K930515. The test results demonstrated that the mechanical performance and biocompatibility characteristics are at least comparable to, if not better than, those of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
KClO3rle p½
Alpha Mirage® Top Tightening Spinal System 510(k) SUMMARY February 2002
- Alphatec Manufacturing, Inc. l. Company: 6110 Corte Del Cedro Carlsbad. CA 92009 USA (760) 431-9286
- Ellen Hicks, Director of Regulatory Affairs II. Contact Person:
- Alpha Mirage® Top Tightening Spinal System III. Trade/Proprietary Name:
IV. Product Description:
The purpose of this 510(k) is to expand the indications for use and to add components to the system.
The Alpha Mirage® Top Tightening Spinal System is a spinal fixation system comprised of various types and sizes of components that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems, the Alpha Mirage® Top Tightening Spinal System is comprised of 1) bone screws and hooks for attachment to the spine, 2) longitudinal rods that are attached to the bone screws and hooks directly/indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.
V. Intended Use:
The Alpha Mirage® Top Tightening Spinal System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Alpha Mirage® Top Tightening Spinal System are dependent in part on the configuration of the assembled device and method of attachment to the spine.
VI. Substantial Equivalence:
The expanded indications for the Alpha Mirage® Top Tightening Spinal System are substantially equivalent to the following predicate device:
1
020376p²/h
Alpha Mirage® Top Tightening Spinal System 510(k) SUMMARY February 2002
Trade/Proprietary Name TSRH
Manufacturer Sofamor-Danek
Clearance K982990
The new pedicle screw classification indications described in the classification Final Rule, July 17, 1998 were referenced. Applicable specifications, testing and validation was included in other 510(k) applications or are included in this application.
VI. Performance Data:
Mechanical and dynamic testing of the Alpha Mirage® Top Tightening Spinal System constructs was performed as described in 510(k) applications K951846 and K930515. The test results demonstrated that the mechanical performance and biocompatibility characteristics are at least comparable to, if not better than, those of the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2002
Ms. Ellen Hicks Director of Regulatory Affairs Alphatec Manufacturing; Inc. · 6110 Corte Del Cedro Carlsbad. California 92009
g, Inc.
Re: K020356
Trade/Device Name: Alpha Mirage® Top Tightening Spinal System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050, 21CFR 888.3060 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: MNH, MNI, KWP, KWQ Dated: June 10, 2002 Received: June 11, 2002
Dear Ms. Hicks:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Ellen Hicks
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 and additionally 21 CFR Part 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" (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/dsma/dsmamain.html
Sincerely yours,
Mark A Milken
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): KO20 3TY
Device Name: Alpha Mirage® Top Tightening Spinal System
Indications for Use:
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.
-
- The Alpha Mirage® Top Tightening Spinal System, when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
- a. Patients having fractures of the thoracic and lumbar spine.
- b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
- c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, deqenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
-
- The Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumore and failed previous fusion (pseudoarthrosis).
-
- In addition, the Alpha Mirage® Top Tightening Spinal System, when used as a pedicle screw fixation system is intended for:
- a. Patients receiving only autogenous bone graft.
- b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
-
- The Alpha Mirage® Top Tightening Spinal System, when used as a laminar hook and bone screw system is intended for:
- a. Patients having fractures of thoracic and lumbar spine.
21
for Mark N. Milburn
(Division Sign-Off)
Divir General, Restorative
and cal Devices
000013
5
- b. Patients having thoracolumbar deformity (i.e., idioscoliosis, · neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
- c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The Counter Use
(Per 21 CFR 801.109)
Mark N. Millikan
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020356
KU20356
piz