(79 days)
The Parcus GFS II and GFS Mini are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus GFS Naked devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The GFS Ultimate devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The GFS BTB devices are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
The Parcus ATLAS is indicated for adjunct fixation of the 1st and 2nd metacarpals in CMC arthroplasty.
The Parcus Actiflip Naked, Actiflip Cinch, and Actiflip Whip are used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications: anterior cruciate ligament, pectoralis repair (minor), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.
The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.
The Parcus Synd-EZ Ti are intended to be used as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. The Parcus Synd-EZ Ti are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of the syndesmosis disruptions) in connection with Weber B and Weber C ankle fractures.
The Parcus GFS II, GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip are a range of devices design for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. Each device is made from a medical grade titanium alloy, Ti-6AI4V ELI, and may also include an UHMWPE polyblend suture component. Each device is provided sterile.
This document is a 510(k) Premarket Notification from Parcus Medical, LLC for several orthopedic fixation devices. It is a submission to the FDA for market clearance, asserting substantial equivalence to previously cleared predicate devices. The primary focus of the performance data in this submission is related to MR Conditional safety, as the devices themselves are largely unchanged from their predicates.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implicit for MR Conditional) | Reported Device Performance |
|---|---|---|
| Magnetically Induced Force | Devices should not pose a significant hazard due to magnetic forces in specified MR environments. | Evaluated; worst-case devices selected for testing; results used to establish MR system conditions for safe use. |
| Magnetically Induced Torque | Devices should not pose a significant hazard due to magnetic torque in specified MR environments. | Evaluated; worst-case devices selected for testing; results used to establish MR system conditions for safe use. |
| Heating by RF Fields | Devices should not heat to an unsafe level in specified MR environments. | Evaluated; worst-case devices selected for testing; results used to establish MR system conditions for safe use. |
| Image Artifact | Devices should produce acceptable levels of image artifact in specified MR environments, allowing for diagnostic interpretation where relevant. | Evaluated; results used to establish MR system conditions for safe use. |
| Biocompatibility | Should be biocompatible as per predicate devices. | Unchanged from predicate devices. |
| Packaging | Should have appropriate packaging as per predicate devices. | Unchanged from predicate devices. |
| Shelf-life | Should have appropriate shelf-life as per predicate devices. | Unchanged from predicate devices. |
| Sterilization Process | Should have an effective sterilization process as per predicate devices. | Unchanged from predicate devices. |
| LAL Testing (Endotoxin) | Endotoxin levels within acceptable limits. | Tested on representative samples; concluded no additional concern. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states that "worst-case devices were selected for testing" for the MR environment evaluation. It does not provide a specific number for the sample size.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. It implies the testing was conducted by or for Parcus Medical, LLC, which is based in Sarasota, Florida, USA. The testing was likely prospective for the specific purpose of this submission (determining MR Conditional status).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is based on objective physical measurements of the devices' interaction with an MR environment and chemical testing (LAL), not on expert subjective interpretation or clinical outcomes. The evaluation against standards like the "FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards" serves as the "ground truth" criteria.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation is based on objective physical and chemical testing against established standards, not on expert consensus or adjudication of subjective data.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI algorithms, not for the safety assessment of orthopedic implants.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This submission is for medical devices (implants), not for an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation in this submission is based on:
- Physical measurements and compliance with established standards: For MR Conditional safety, this refers to measurements of magnetic force, torque, and heating in MR environments, assessed against the "FDA Guidance Document - Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and applicable ASTM standards."
- Chemical testing results: For LAL (Limulus Amebocyte Lysate) testing, the ground truth is the measured endotoxin level against a defined acceptable limit.
- Predicate device characteristics: For biocompatibility, packaging, shelf-life, and sterilization, the "ground truth" is that these aspects remain unchanged and were previously deemed acceptable based on predicate devices.
8. The Sample Size for the Training Set
This is not applicable. This submission is for medical devices (implants) and does not involve an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reason stated above.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.