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510(k) Data Aggregation
(133 days)
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otothinolaryngology; Craniofacial; Dental; and Endoscopic applications.
The specific applications include Craniotomy, Laminotomy, Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, splitting, fragmenting, extracting, removing, drilling, and reaming. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, smoothing or shaping of metal, and removing/rounding sharp edges.
The Stryker Elite and HD Attachments are used within a system consisting of a variety of devices, including a console, powered motors, and cutting accessories. The attachments connect to the motors and the cutting accessories to complete the system for physician use. The Stryker Elite and HD Attachments are offered for prescription use only. The Elite and HD Attachments are intended to serve as interfaces between powered motors and cutting accessories for the purposes of:
- Cutting bone, bone cement, and teeth;
- Placing or cutting screws, metal, wires, pins, and other fixation devices; and
- Providing a location for the user to hold and grip the device system. ●
The Elite and HD Attachments are provided in straight and angled configurations. The subject Elite Attachments are offered in the following lengths: 7cm, 12cm, 17cm, and 20cm. The Stryker HD Attachments are offered in the following lengths: 9cm and 14cm. The Elite and HD Attachments are powered by, and compatible with, the Stryker electric and pneumatic motors. The attachments are also used with the cutting accessories (burs). All the attachments demonstrate a rotary mode of action by transmitting torque.
The Elite and HD Attachments are made of stainless steel (SST). The attachments display a color band on the outer surface. The color bands serve to enhance the distinction of attachment and cutting accessory compatibility.
The purpose of this submission is to gain clearance for colorant band modification for the Subject Device Attachments color band that exceeds the threshold as per FDA Guidance, "Deciding When to Submit a 510(k) for a Change to an Existing Device".
The provided text is a 510(k) summary for the Stryker Elite and Heavy Duty (HD) Attachments, focusing on a colorant band modification. This document does not contain the detailed acceptance criteria or the study results for the original device's performance, but rather for the modification.
Therefore, I cannot populate all sections of your request comprehensively. However, I can provide information based on what is available regarding the modification to the device.
Here's a breakdown of the available information and what is missing:
Description of Acceptance Criteria and Study for Colorant Band Modification
The submission concerns a modification to the colorant band on the Stryker Elite and Heavy Duty (HD) Attachments. The primary purpose of this 510(k) is to gain clearance for this specific modification which "exceeds the threshold as per FDA Guidance, 'Deciding When to Submit a 510(k) for a Change to an Existing Device'". The underlying assumption is that the original device, without this specific color band modification, has already met its acceptance criteria through prior submissions (e.g., K143320).
The study performed here specifically addresses the safety and effectiveness of the new colorant band material and colorant.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Color Band Modification) | Reported Device Performance (as stated in document) |
|---|---|
| Safety: No new questions of safety raised | "No new questions of safety and effectiveness were raised." |
| Effectiveness: No new questions of effectiveness raised | "No new questions of safety and effectiveness were raised." |
| Performance Bench Testing: Met all pre-defined acceptance criteria | "The Subject Device met all pre-defined acceptance criteria." |
| Biocompatibility: Followed ISO 10993-1:2018 and FDA Guidance for limited exposure ( |
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(155 days)
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otothinolaryngology; Craniofacial and Maxillofacial; Dental; and Endoscopic applications.
The specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine. Expanded Endonasal (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, splitting, fragmenting, extracting, removing, drilling, and reaming.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, smoothing or shaping of metal, and removing/rounding sharp edges.
The Stryker® Elite and HD Attachments are used within a system consisting of a variety of devices, including a console, powered motors, and cutting accessories. The attachments connect to the motors and the cutting accessories to complete the system for physician use. The Stryker® Elite and HD Attachments are offered for prescription use only. The Elite and HD Attachments are intended to serve as interfaces between powered motors and cutting accessories for the purposes of:
- Cutting bone, bone cement, and teeth; ●
- Placing or cutting screws, metal, wires, pins, and other fixation devices; and ●
- Providing a location for the user to hold and grip the device system. ●
The Elite and HD Attachments are provided in straight and angled configurations. The subject Elite Attachments are offered in the following lengths: 7cm, 12cm, 14cm, 17cm, and 20cm. The Stryker® HD Attachments are offered in the following lengths: 9cm and 14cm.
The Elite and HD Attachments are powered by, and compatible with, the Stryker electric and pneumatic motors. The attachments are also used with the cutting accessories (burs). All the attachments demonstrate a rotary mode of action by transmitting torque.
The Elite and HD Attachments are made of stainless steel (SST). The attachments display a color band on the outer surface. The color bands serve to enhance the distinction of attachment and cutting accessory compatibility. The Elite and HD Attachment outer profiles feature a sleeker design. The Elite and HD Attachment outer surface textures include laterally grooved and continuous knurling textures for improved user grip.
The Elite and HD Attachments are reusable, provided non-sterile, and end user sterilized. The attachments may be cleaned by manual or mechanical (automated) cleaning procedures. The attachment end user sterilization method is moist heat (steam) and the sterility assurance level (SAL) is 10-6. The Elite and HD Attachments have an expected life of one (1) year. The attachments are individually packaged in a sealed retention insert. The attachment labels contain a label specified part description, quantity, lot number, and contact information. There are no known contraindications for the Elite and HD Attachments.
The provided text describes the acceptance criteria and study results for the Stryker Elite and Heavy Duty (HD) Attachments. However, it is important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive detailing of a standalone clinical study for device effectiveness in a clinical setting. The tests described are primarily non-clinical performance and safety tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Sensitization | Non-sensitizing | Non-sensitizing | |
| Irritation | Negligible irritant | Negligible irritant | |
| Acute Systemic Toxicity | Non-toxic | Non-toxic | |
| Material Mediated Pyrogenicity | Non-pyrogen | Non-pyrogen | |
| Colorant Leachables | Pass | Pass | |
| Functional Life Verification | Run time for 1 year | Pass | Pass |
| 1 year of Autoclave cycles | Pass | Pass | |
| 1 year of Automatic wash cycles | Pass | Pass | |
| 1 year of Locking mechanism actuations (with drill) | Pass | Pass | |
| 1 year of Locking mechanism actuations (with bur) | Pass | Pass | |
| Maximum surface temperature on attachment during end of life evaluation | ≤ 46°C | Pass | |
| Bur Performance | Mean bur whip | ≤ 0.63mm | Pass |
| Mean bur whip | ≤ 0.30mm (appears to be a separate or more stringent criterion for a specific aspect of bur whip) | Pass | |
| Mean bur deflection | ≤ 1.28mm | Pass | |
| Packaging | Package integrity | Package must maintain the product within its confines. Labels must remain attached and legible. The packaging may exhibit minimal damage. Product aesthetics should not be compromised and the product must be fully functional after this test procedure. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical testing was deemed necessary for this 510(k) premarket notification." Therefore, there is no test set in the sense of patient data. The testing performed was non-clinical (laboratory/bench testing). The provenance of this (non-clinical) data is from Stryker Instruments' testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical testing with a "test set" requiring expert ground truth assessment was conducted. The "ground truth" for the non-clinical tests is established by the specified acceptance criteria for each test (e.g., maximum temperature, whip displacement, material properties).
4. Adjudication Method for the Test Set
Not applicable, as no clinical testing with a "test set" requiring adjudication was conducted.
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 surgical attachment (drill handpiece accessory), not an AI-assisted diagnostic or imaging device used by "human readers." No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a mechanical surgical device, not an algorithm or AI.
7. The Type of Ground Truth Used
For the non-clinical performance and safety tests, the "ground truth" is defined by established engineering and biocompatibility standards and internal specifications set by Stryker. For example, for biocompatibility, the ground truth is "non-cytotoxic," "non-sensitizing," etc., as defined by the referenced ISO standards. For functional tests like temperature, it's a quantitative limit (≤ 46°C).
8. The Sample Size for the Training Set
Not applicable, as there is no "training set" for this type of mechanical device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of mechanical device.
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