(90 days)
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Not Found
No
The summary describes a mechanical spinal plating system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are mechanical tests.
Yes
The device is described as a "pedicle screw fixation system" intended for various spinal conditions like degenerative disc disease, trauma, and spinal stenosis, which are therapeutic interventions.
No
The device is a pedicle screw fixation system used for treatment, not diagnosis. Its purpose is to fixate the spine for various conditions, not to identify or analyze medical conditions.
No
The device description explicitly lists physical components made of titanium alloy, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Selective-Axis Posterior Noncervical Plating System is a surgical implant used for spinal fixation. It is physically implanted into the patient's body to stabilize the spine.
- Lack of Mention of Biological Samples: There is no mention of the device interacting with or analyzing biological samples.
- Focus on Mechanical Properties: The performance studies mentioned are mechanical tests, which are relevant for surgical implants, not IVDs.
Therefore, the Selective-Axis Posterior Noncervical Plating System is a medical device, specifically a surgical implant, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral), pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (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, tumor, pseudoarthrosis, and failed fusion.
Product codes (comma separated list FDA assigned to the subject device)
MNI, MNH
Device Description
The Selective-Axis Posterior Noncervical Plating System ("Selective-Axis Plating System") is comprised of the following components: Selective-Axis anchor screw assemblies, connecting beam assemblies, and jam nuts. All of the components of the Selective-Axis Plating System are manufactured from Ti6Al4V-ELI titanium alloy per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, noncervical (thoracic, lumbar and sacral)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of the Selective-Axis Plating System was performed in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s, dated May 3, 2004.
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
SEP 2 1 2005
451697
510(k) SUMMARY
Medical Device Advisory Development Group's Selective-Axis Posterior Noncervical Plating System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Medical Device Advisory Development Group 560 Old Ranch Road Seal Beach, CA 90740
Phone: 562-598-1753 Facsimile: 562-594-6583
Contact Person: Robert S. Howland
Date Prepared: June 22, 2005
Name of Device and Name/Address of Sponsor
Selective-Axis Posterior Noncervical Plating System
Medical Device Advisory Development Group 560 Old Ranch Road Seal Beach, CA 90740
Common or Usual Name
Posterior Pedicle Screw System
Classification Name
Orthosis, Spinal Pedicle Fixation; Orthosis, Spondylolisthesis Spinal Fixation (21 C.F.R. § 888.3070); Product Code: MNI, MNH
Predicate Devices
EBI's SpineLink-II Spinal Fixation System Scient'x Aladyn Rigid Spine Plate
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\\PH - 22194/0001 - 19157 v1
1
Image /page/1/Picture/0 description: The image contains a handwritten string of characters. The string appears to be 'K051697'. The characters are written in a cursive style, with some connections between the letters and numbers.
Intended Use / Indications for Use
The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral), pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (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, tumor, pseudoarthrosis, and failed fusion.
Technological Characteristics and Substantial Equivalence
The Selective-Axis Posterior Noncervical Plating System ("Selective-Axis Plating System") is comprised of the following components: Selective-Axis anchor screw assemblies, connecting beam assemblies, and jam nuts. All of the components of the Selective-Axis Plating System are manufactured from Ti6Al4V-ELI titanium alloy per ASTM F136.
The Selective-Axis Plating System is substantially equivalent* to the other currently marketed spinal systems which are referenced above. The Selective-Axis Plating System and its predicate devices all employ multiangular pedicle screws, longitudinal plates or bars that connect the pedicle screws, cross-linking connectors that connect the longitudinal plates or bars, and locking nuts with similar technological features to stabilize the spine as
7 f 3
- Any statement made in conjunction with this submission regarding an FDA determination of substantial equivalence to any other product is intended only to relate to whether the product can be marketed lawfully under FDA's section 510(k) premarket notification process. The term "substantial equivalence" as used herein is not related to "substantial equivalence" as the term is used in the patent context. [See Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.)]
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Image /page/2/Picture/0 description: The image shows the handwritten text "KOS1697" in black ink on a white background. The text is slightly slanted upwards from left to right. The letters and numbers are clearly written, although the overall appearance is somewhat casual due to the handwriting style.
an adjunct to fusion. Thus, the Selective-Axis Plating System raises no new issues of safety or effectiveness.
Performance Data
Mechanical testing of the Selective-Axis Plating System was performed in accordance with FDA's Guidance for Industry and FDA Staff - Spinal System 510(k)s, dated May 3, 2004.
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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The seal is black and white.
SEP 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Device Advisory Development Group C/o C. Stephen Lawrence Hogan & Hartson L.L.P. Century Centre 2603 Main Street. Suite 1170 Irvine, CA 92614
Re: K051697
Trade/Device Name: Selective-Axis Posterior Noncervical Plating System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: June 22, 2005 Received: June 23, 2005
Dear Mr. Lawrence:
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 – Mr. C. Stephen Lawrence
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
M. J. Molloy
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Selective-Axis Posterior Noncervical Plating System
Indications for Use:
The Selective-Axis Posterior Noncervical Plating System is intended for use as a posterior, noncervical (thoracic, lumbar and sacral) pedicle screw fixation system for the following indications: degenerative disc disease ("DDD") (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, tumor, pseudoarthrosis, and failed fusion.
Prescription Use V (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Z
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number COS1697
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