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510(k) Data Aggregation
(66 days)
CD HORIZON**®** Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
IPC® System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC® POWEREASE® System is indicated for drilling, tapping and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASET™ System.
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The subject devices in this submission include:
Additions to the existing CD HORIZON® SOLERA® Ø5.5/6.0 Spinal System
● Ø5.5/6.0 Awl Tap Screws (ATS)
● Ø5.5 Capped Rods
● Ø5.5 Percutaneous Rods
Additions to the existing CD HORIZON® SOLERA® VOYAGER™ Ø4.75 Spinal System
. Ø4.75 Awl Tap Screws (ATS)
Creating the new CD HORIZON® SOLERA® VOYAGER™ Ø5.5/6.0 Spinal System
● Cannulated Multi-Axial Screws (MAS)
● Awl Tap Screws (ATS)
● Capped Rods
Percutaneous Rods
● ● Tab Extenders
Extender Cap
● . Taps and Driver compatible with IPC® POWEREASE® System
. Navigated Driver compatible with STEALTHSTATION® and IPC® POWEREASE® Systems
. System specific cases and trays
Medtronic Reusable Instruments Only Compatible with the IPC® POWEREASE® System
The subject Medtronic Reusable taps and driver are spine preparation instruments made of high grade stainless steel. The subject taps and driver are compatible with Medtronic's IPC® POWEREASE® System and may be connected to the IPC® POWEREASE® handpiece. The subject taps and driver can be used manually using existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece.
Medtronic Reusable Instruments Compatible with the STEALTHSTATION® System and IPC® POWEREASE® Systems
The subject Medtronic Navigated Reusable driver is a spine preparation instrument made of high grade stainless steel. This instrument was specifically designed for use in procedures where the use of stereotactic surgery may be appropriate. The subject driver is also compatible with Medtronic's IPC® POWEREASE™ System when connected to the POWEREASE™ handpiece or may be used manually with existing Medtronic Class I Exempt quick connect handles in place of the IPC® POWEREASE® handpiece or the NavLock™ tracker.
The provided text is a 510(k) summary for a medical device (CD HORIZON® Spinal System and associated instruments). It describes the device, its indications for use, comparison to predicate devices, and performance data. However, it does not contain any information about an AI/ML-based medical device, its acceptance criteria, or a study proving its performance.
The document primarily focuses on the substantial equivalence of the subject devices (spinal system implants and instruments) to established predicate devices through mechanical testing and validation activities in cadaver models. It explicitly states:
- "Medtronic believes that testing is not warranted for the subject implants, subject instruments compatible with IPC® POWEREASE® System and subject Tab Extenders and Extender Cap as they do not present a new worst case when compared to the predicate devices."
- "For the subject instruments compatible with STEALTHSTATION® System and IPC® POWEREASE™ Systems, software verification testing and activities were performed that demonstrated that the subject instruments performed as intended."
This indicates that the "software verification testing" mentioned is likely for deterministic software functionality related to navigation and system compatibility, not for an AI/ML algorithm that would require the detailed breakdown of acceptance criteria and study methodology requested in the prompt (e.g., sample size, expert ground truth, MRMC study, etc.).
Therefore, I cannot fulfill the request as the necessary information for an AI/ML device is not present in the provided text.
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(28 days)
CD HORIZON**®** Spinal System
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailor-made for the individual case.
A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this submission is to modify Medtronic's CD HORIZON® Spinal System to add additional components to the system, specifically non-sterile 30° and 45° Transverse Hooks.
The provided document is a 510(k) premarket notification for the Medtronic CD HORIZON® Spinal System, specifically for the addition of new 30° and 45° Transverse Hooks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than rigorously proving the device meets acceptance criteria through extensive clinical studies as one might find for novel device approvals.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader multi-case studies is largely not applicable nor present in this document, as the submission method (510(k)) and the nature of the device (an modification to an existing spinal system component) do not typically require such detailed clinical performance data.
However, I can extract the information that is present concerning the demonstration of substantial equivalence which serves the purpose of regulatory acceptance for this type of device.
Here's the closest interpretation of your requests based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" primarily refers to demonstrating equivalent technological characteristics and performance compared to existing predicate devices, rather than predefined clinical performance metrics. The "reported device performance" is framed in terms of this equivalence.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (vs. Predicate) |
|---|---|
| Intended Use | The subject hooks (30° and 45° Transverse Hooks) have the same intended use as the predicate devices. (Page 5, Section V; Page 7, Section VI) |
| Indications for Use | The subject hooks have the same indications for use as the predicate devices: posterior, non-cervical fixation as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudarthrosis, and/or failed previous fusion. (Page 5, Section V; Page 7, Section VI) |
| Material | The subject transverse hooks are manufactured from the same material (titanium alloy - Ti-6Al-4V ELI) as the predicates. This material has a long history of safe and effective use. (Page 7, Section VII) |
| Fundamental Scientific Technology | The subject and predicate hooks are based on the same fundamental scientific technology of providing posterior, non-cervical fixation, connecting to 5.5mm/6.0mm rods in the T1-S1 region, and being secured with set screws. The only difference is a transition offset that "does not raise any issues of safety and effectiveness." (Page 7, Section VI) |
| Sterilization Method | The subject hooks use the same sterilization method as the predicate devices. (Page 5, Section V; Page 7, Section VI) |
| Mechanical Performance (Safety/Effectiveness) | Medtronic evaluated the subject transverse hooks through an engineering rationale and a risk analysis. Both evaluations demonstrated that the subject hooks do not introduce a new worst case to the CD HORIZON® Spinal System. Therefore, no new mechanical testing was required because existing tests on the predicate devices are considered sufficient to demonstrate equivalence for the modified components. (Page 7, Section VII) (No specific performance values are given, only a qualitative assessment of non-inferiority/equivalence through engineering rationale.) |
| Biocompatibility | Due to the use of the same implant material (Ti-6Al-4V ELI) that has a long history of safe and effective use in similar spinal implants, no additional biocompatibility testing was required. (Page 7, Section VII) |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not applicable/Not provided in the context of this 510(k) submission. No clinical "test set" in the traditional sense was used. The evaluation was primarily based on engineering rationale, risk analysis, and comparison to existing mechanical testing data from predicate devices.
- Data provenance: Not applicable/Not provided. The data is internal engineering and risk analysis documentation from Medtronic Sofamor Danek USA, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" was established by experts in the context of clinical data for this type of submission. The safety and effectiveness are established through demonstrating substantial equivalence to predicate devices, supported by internal engineering/risk assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical "test set" requiring adjudication.
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
Not applicable. This device is a mechanical spinal implant component, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a mechanical spinal implant component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" equivalent in a 510(k) for a device component like this is the established safety and effectiveness of the predicate devices and the physical/mechanical properties of the materials and design, confirmed through engineering rationale and risk analysis. The regulatory acceptance depends on demonstrating that the new components are equally safe and effective as the predicates.
8. The sample size for the training set
Not applicable/Not provided. There was no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. There was no "training set" or "ground truth" in this context.
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(84 days)
CD HORIZON**®** Spinal System
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis) or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation' attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The subject CD HORIZON® Solera™ Spinal System offers dual rod multi-axial screws (DRMAS) that have an opened head. The subject screws offer the ability to place two rods in parallel. The subject DRMAS are provided sterile.
The provided text is a 510(k) summary for the Medtronic CD HORIZON® Spinal System. It describes the device's indications for use, comparison to predicate devices, and performance data from mechanical testing and biocompatibility assessments.
However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device.
The document describes a spinal implant system, not a software or AI/ML device. The "performance data" section refers to mechanical testing (Static Compression, Static Torsion, Compression Fatigue, Axial Grip, Axial Torsional Grip, Flexion Extension Fatigue) and biocompatibility of the physical implant components, not performance metrics like sensitivity, specificity, or accuracy that would be relevant for an AI/ML device.
Therefore, the requested information specifically related to acceptance criteria and studies proving an AI/ML device meets them, along with details about sample sizes, data provenance, ground truth establishment, expert qualifications, and MRMC studies, cannot be extracted from this document.
The document primarily focuses on demonstrating substantial equivalence of a physical medical device (spinal system) to predicate devices through material properties and mechanical performance.
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(27 days)
CD HORIZON**®** Spinal System
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fosion 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of degenerative disc disease, the CD HORIZON® LEGACY™ 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: degenerative disc disease (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK® Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailor-made for the individual case.
A subset of CD HORIZON® Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK® Plates and connecting components. Similarly to the CD HORIZON® implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this Special 510(k) is to obtain clearance for the minor print changes to the dimensioning scheme for Percutaneous Rod Inserter, which was originally cleared in CD HORIZON® Spinal System K132639 (S.E. 11/25/2013). The minor print changes include modifications to hard dimensions/tolerances and Geometric Dimensioning and Tolerances (GD&T) for ease of manufacturing, as well as the addition of a laser mark for visual purposes to the end user.
This document is a 510(k) premarket notification for a modification to an existing medical device, the CD HORIZON® Spinal System, specifically for a Percutaneous Rod Inserter. It's a submission to the FDA, arguing for substantial equivalence to a previously cleared device. Therefore, it does not contain the kind of detailed acceptance criteria and study data typically found in an original device approval or a clinical trial report for AI/software devices.
Here's an analysis based on the provided text, highlighting why most of your requested information is not present:
Key Takeaway: This submission is for minor print changes to an existing Percutaneous Rod Inserter (a physical surgical tool), not for an AI/software device or a new medical device requiring extensive performance studies. The "performance data" section focuses on demonstrating that these minor changes do not negatively impact the device's safety or effectiveness compared to the predicate, rather than establishing new performance metrics.
1. A table of acceptance criteria and the reported device performance:
- Not Applicable in the traditional sense for this document. This document is for a mechanical device modification, not a software or AI device with performance metrics like sensitivity, specificity, accuracy, etc.
- The "acceptance criteria" here implicitly revolve around ensuring the modified design of the Percutaneous Rod Inserter (minor print changes, hard dimensions/tolerances, GD&T, laser mark) does not compromise the device's safety and effectiveness compared to the predicate device.
- Reported device performance: The document states that a "risk analysis," "print review," "mechanical strength rationale," and "tolerance stack analysis" were completed. These analyses "demonstrated that the minor print changes... do not introduce new issues of safety or effectiveness." This is the reported performance in the context of this submission – that the changes are benign.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. This is a design/engineering assessment of manufacturing changes, not a clinical study on a test set of data. There isn't a "test set" in the sense of patient data or clinical images. The "sample" implicitly refers to the device design itself and its components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. There is no "ground truth" establishment in this document as it's not a diagnostic or AI device being evaluated against a clinical gold standard. The "experts" would likely be Medtronic's internal engineers and quality assurance personnel conducting the risk analysis and design reviews, but their number and specific qualifications are not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or clinical judgment/adjudication involved in this type of submission.
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:
- Not Applicable. This is explicitly not an AI device. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. Not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No clinical ground truth is established or used for this submission. The "ground truth" for the assessment is the predicate device's established safety and effectiveness, and the current submission aims to show the modified device is equally safe and effective through engineering analysis.
8. The sample size for the training set:
- Not Applicable. No training set, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or ground truth in this context.
Summary of Relevant Information from the Document:
- Device: CD HORIZON® Spinal System (specifically, modifications to a Percutaneous Rod Inserter component).
- Purpose of Submission: Obtain clearance for minor print changes a mechanical component (Percutaneous Rod Inserter), including modifications to hard dimensions/tolerances, Geometric Dimensioning and Tolerances (GD&T) for ease of manufacturing, and the addition of a laser mark for visual purposes.
- Predicate Device: CD HORIZON® Spinal System (K132639, S.E. 11/25/2013).
- Basis for Substantial Equivalence:
- Technological Characteristics: The modified Percutaneous Rod Inserter has the "same fundamental scientific technology and material" as the predicate. It retains the same locking mechanism, arc orientation, rod orientation, and clamping mechanism.
- Materials: Manufactured from the same Medical Grade Stainless Steel (MGSS) and silicone as the predicate device, which have "a long history of safe and effective use; therefore, biocompatibility testing is not required."
- Performance Data (for the modification): A "risk analysis of the print changes was completed in accordance with Medtronic design control procedures." This included a "print review, mechanical strength rationale, and tolerance stack analysis." These analyses "demonstrated that the minor print changes... do not introduce new issues of safety or effectiveness; therefore, no additional testing is required."
- Conclusion: The subject Percutaneous Rod Inserter is considered "as safe and effective as the following predicate" based on the risk analysis and supporting documentation.
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