(28 days)
When used as a pedicle screw fixation system in skeletally mature patients, the NGarde System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment and kyphosis.
In addition, when used as a pedicle screw fixation system, the NGarde System is indicated in patients:
Who are receiving fusions with autogenous graft only; Who are having the device fixed or attached to the lumbar or sacral spine; Who are having the device removed after the development of a solid fusion mass.
The NGarde System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polyaxial top-loading design, are composed of titanium 6Al-4V alloy or titanium 6A1-7Nb, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium 6A104V alloy and synthetic polycarbonate urethane (PCU) polymer, are 6.0mm in diameter, and are also available in a range of lengths, from 40mm to 200mm.
The modification which is the subject of this Special 510(k) consists of the addition to the NGarde System of two alternate pedicle screws, offered in commercial distribution, which may be used at the physician's discretion as an alternative to the NGarde Systems screws. These alternative pedicle screws are similar and comparable to the NGarde screws and are available in a range of diameters and lengths.
The provided document describes the NGarde System, a pedicle screw system, and its 510(k) summary for a modification. The document explicitly states that no clinical testing was conducted to support this submission. Therefore, it does not contain the detailed information requested regarding device performance, sample sizes, expert involvement, or comparative effectiveness studies.
However, it does provide some information about non-clinical performance and a general statement about acceptance criteria.
Here's the breakdown of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly detailed | "met all acceptance criteria." (for verification and validation tests identified through risk analysis for the modification) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "verification and validation tests."
- Data Provenance: Not specified, as no clinical testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as no clinical testing was performed, and thus no "ground truth" was established in a clinical context for a test set. The validation was based on non-clinical performance data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical testing was performed.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. The device is a physical pedicle screw system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical ground truth. For the non-clinical verification and validation, the "ground truth" would be defined by engineering specifications, material properties, and biomechanical standards against which the device performance was measured.
8. The sample size for the training set
- Not applicable as this is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study:
The study referenced for the NGarde System's modification (a Special 510(k)) was primarily a non-clinical performance evaluation. The document states:
- "Non-Clinical Performance and Conclusions: Such verification and validation tests were identified as appropriate to address the results of a risk analysis for the subject Modification were completed, and met all acceptance criteria."
- "Clinical Performance: No clinical testing was conducted to support this submission."
Therefore, the "study" demonstrating that the device meets acceptance criteria was a series of non-clinical verification and validation tests. These tests were designed to address potential risks associated with the modification (addition of two alternate pedicle screws) and ensure that the modified system performed comparably to its predicate devices in terms of mechanical and material properties, as defined by "rigorous design control and risk analysis procedures." The specific acceptance criteria and detailed test results are not provided in this summary but were presumably part of the comprehensive submission to the FDA.
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510(k) Summary 2
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
|---|---|
| 510(k) Contact: | Susan LewandowskiManager, Spine Regulatory AffairsTelephone: 610-719-5712Facsimile: 610-719-5102Email: lewandowski.susan@synthes.com |
| Date Prepared: | September 15, 2008 |
| Trade Name: | NGarde System |
| Common Name: | Pedicle Screw System |
| Classification: | 21 CFR 888.3070 - Posterior metal/polymer spinal systemClass IIOrthopaedic and Rehabilitation Devices PanelProduct Code NQP |
| Predicate Device: | NFix II Pedicle Screw System (N Spine, Inc. K061774)Pangea Pedicle Screw System (Synthes, Inc. K052123)Click'X Pedicle Screw System (Synthes, Inc. K992739) |
| Device Description: | The NGarde System is a posterior, non-cervical instrumentationsystem consisting of both pedicle screws and connecting rods.Screws are of polyaxial top-loading design, are composed oftitanium 6Al-4V alloy or titanium 6A1-7Nb, and are available in arange of diameters and lengths to accommodate physiologicalrequirements. The rods are composed of titanium 6A104V alloyand synthetic polycarbonate urethane (PCU) polymer, are 6.0mmin diameter, and are also available in a range of lengths, from40mm to 200mm.The modification which is the subject of this Special 510(k)consists of the addition to the NGarde System of two alternatepedicle screws, offered in commercial distribution, which may beused at the physician's discretion as an alternative to the NGardeSystems screws. These alternative pedicle screws are similar andcomparable to the NGarde screws and are available in a range ofdiameters and lengths. |
| Image: Synthes LogoSpine | |
| Intended Use /Indications for Use: | The subject device is indicated for use as follows:When used as a pedicle screw fixation system in skeletally maturepatients, the NGarde System is intended to provideimmobilization and stabilization of spinal segments as an adjunctto fusion in the treatment of the following acute and chronicinstabilities or deformities of the lumbar and sacral spine:degenerative spondylolisthesis with objective evidence ofneurological impairment and kyphosis.In addition, when used as a pedicle screw fixation system, theNGarde System is indicated in patients:Who are receiving fusions with autogenous graft only; Who are having the device fixed or attached to the lumbaror sacral spine; Who are having the device removed after the developmentof a solid fusion mass. |
| Comparison of thetechnologicalcharacteristics of thedevice to thepredicate device: | In accordance with the agency guideline entitled The New 510(k)Paradigm - Alternate Approaches to Demonstrating SubstantialEquivalence in Premarket Notifications, issued March 1998, it hasbeen established, through rigorous design control and riskanalysis procedures, that the subject Modification of the NGardeSystem is substantially equivalent to the predicate systems. |
| Performance Data(Nonclinical and/orClinical) | Non-Clinical Performance and Conclusions:Such verification and validation tests were identified asappropriate to address the results of a risk analysis for the subjectModification were completed, and met all acceptance criteria.Clinical Performance:No clinical testing was conducted to support this submission.Conclusions:The results of all design, risk analysis, and verification andvalidation activities supported the substantial equivalence of theModified System to the predicate systems. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes Spine Company, LP % Ms. Susan Lewandowski Manager, Spine Regulatory Affairs 1302 Wrights Lane East West Chester, Pennsylvania 19380
DEC 12 2008
K072685 Re: Trade/Device Name: NGarde System Regulation Number: 21 CFR 888.3070 Regulation Name: Posterior Metal/Polymer Spinal System Regulatory Class: Class II Product Code: NQP Dated: September 19, 2007 Received: September 21, 2007
Dear Ms. Lewandowski:
This letter corrects our substantially equivalent letter of October 19, 2007.
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warning section of the device's labeling:
"The safety and effectiveness of this device for use in the treatment of spinal stabilization for non-fusion have not been established."
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
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Page 2 - Ms. Susan Lewandowski
The FDA finding of substantial equivalence of your device to a legally marked predicate The FDA finding of substantial cquirated or your device and permits your device to proceed to the device results in a classification for your device as described in your Section market. "This letter will anow you to ovegni marroung your write in the move is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified too about of . 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.
If you desire specific information about the application of other labeling requirements to your device (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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Wayne Ray Tillman, Ph.D., M.B.A.
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 1
Indications for Use Statement
K072685 510(k) Number:
Device Name: NGarde System
Indications: When used as a pedicle screw fixation system in skeletally mature patients, the NGarde System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, and kyphosis.
In addition, when used as a pedicle screw fixation system, the NGarde System is indicated in patients:
- Who are receiving fusions with autogenous graft only; ●
- Who are having the device fixed or attached to the lumbar or sacral . spine;
- Who are having the device removed after the development of a . solid fusion mass.
X Prescription Use (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)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072688
Add to Fiie - K072685 NGarde System
Page 1 of 3
§ 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.