(83 days)
No
The description focuses on mechanical components and surgical instruments for spinal fixation, with no mention of AI or ML capabilities.
Yes
The device is described as "intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft" and is used to treat various medical conditions such as "degenerative disc disease", "spondylolisthesis", "trauma", "spinal stenosis", "curvatures", and "tumor". These descriptions clearly indicate its therapeutic purpose.
No
The device is described as a "Posterior Fixation System" intended for "spinal fixation" and "stabilization," indicating it is a therapeutic device for internal fixation rather than a diagnostic one. Its purpose is to provide stabilization during fusion, not to diagnose a condition.
No
The device description explicitly lists hardware components such as screws, rods, and instrumentation, indicating it is a physical medical device, not software-only.
Based on the provided information, the Illico MIS Posterior Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Illico MIS Posterior Fixation System Function: The description clearly states that this system is a surgical implant used for posterior, non-cervical, spinal fixation. It provides temporary internal fixation and stabilization during bone graft healing and fusion.
- No Specimen Analysis: The device description and intended use do not involve the analysis of any biological specimens from the patient. It is a physical device implanted within the body.
Therefore, the Illico MIS Posterior Fixation System falls under the category of a surgical implant/device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Illico MIS Posterior Fixation System is intended for posterior, non-cervical, spinal fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft. It is intended that this device, in any system configuration, be removed after development of solid fusion mass.
Product codes
NKB, MNI, MNH
Device Description
The Illico MIS Posterior Fixation System is a Noncervical Pedicle Screw and Rod System intended to facilitate the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Illico MIS Posterior Fixation System provides implants and instruments for percutaneous and "mini-open" access and includes:
- Non-cannulated titanium polyaxial pedicle screws assemblies .
- Cannulated titanium polyaxial pedicle screws assemblies .
- Titanium set screws .
- Titanium and Cobalt Chrome rods .
- Instrumentation unique to the Illico MIS Systems .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical, spinal
Indicated Patient Age Range
skeletally mature patients
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)
Construct testing was conducted in accordance with ASTM F-1717 including dynamic compression, static compression and static torsion. All testing met the acceptance criteria and the results were comparable to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K033090, K042673, K071890, K091189
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
510(k) Summary
FEB 1 4 2013
Submission Date:
Submitter Information:
December 5, 2012
Alphatec Spine 5818 El Camino Real Carlsbad, CA 92008
Ph# (760) 431-9286 Fax# (760) 431-0289
Nadine Smith Senior Regulatory Affairs Specialist Ph# (760) 494-6717
Illico MIS Posterior Fixation System
Pedicle Screw System
Trade/Model Name:
Common Name:
Contact:
Classification Regulation:
21 CFR 888.3070 Class III
Product Code(s):
NKB, MNI, MNH
Device Description:
The Illico MIS Posterior Fixation System is a Noncervical Pedicle Screw and Rod System intended to facilitate the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Illico MIS Posterior Fixation System provides implants and instruments for percutaneous and "mini-open" access and includes:
- Non-cannulated titanium polyaxial pedicle screws assemblies .
- Cannulated titanium polyaxial pedicle screws assemblies .
- Titanium set screws .
- Titanium and Cobalt Chrome rods ●
- Instrumentation unique to the Illico MIS Systems .
Indications for Use:
The Illico MIS Posterior Fixation System is intended for posterior, non-cervical, spinal fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft. It is intended that this device, in any system configuration, be removed after development of solid fusion mass.
1
Substantial Equivalence Claimed:
The Illico MIS Posterior Fixation System is substantially equivalent to Alphatec Spine's previously cleared Icon/Zodiac Polyaxial Pedicle Screw System (K033090) and Zodiac Cannulated Polyaxial Spinal Fixation System (K042673, K071890, and K091189). The Illico MIS Posterior Fixation System instruments are substantially equivalent to instrumentation in Medtronic's CD Horizon System (K091442).
Technical Characteristics
The intended use and technological features of the Illico MIS Posterior Fixation System Implants do not substantially differ from the legally marketed predicate devices except that the predicate device is available with hooks and crossbars where the Illico MIS System does not. The Illico MIS Posterior Fixation System also includes instruments for minimally invasive access and implantation.
Non-Clinical Performance Testing
Construct testing was conducted in accordance with ASTM F-1717 including dynamic compression, static compression and static torsion. All testing met the acceptance criteria and the results were comparable to the predicate device.
Conclusion
The Illico MIS Posterior Fixation System was demonstrated to be substantial equivalent to the Illico MIS Implants is based on design, materials, intended use, and performance to the predicate systems identified.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with three bars on its wing, symbolizing service, science, and security. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2013
Alphatec Spine, Incorporated % Ms. Nadine Smith Senior Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K123623
Trade/Device Name: Illico MIS Posterior Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI Dated: November 21, 2012 Received: November 23, 2012
Dear Ms. Smith:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Nadine Smith
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Image /page/3/Picture/6 description: The image shows the name "Erin Skeith" in a stylized font. The first name, "Erin," is written in a bold, sans-serif font. The "S" in "Skeith" is designed with a maze-like pattern, while the rest of the letters are in a similar bold font as "Erin" but with decorative lines.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123623
Device Name: Illico MIS Posterior Fixation System
Indications For Use:
The Illico MIS Posterior Fixation System is intended for posterior, non-cervical, spinal fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion. It is intended to provide stabilization during the development of fusion utilizing autograft or allograft bone graft. It is intended that this device, in any system configuration, be removed after development of solid fusion mass.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P!Nean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123623
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