(284 days)
The HydroFix Vaso Shield™ is indicated for use as a cover for vessels following anterior vertebral surgery.
The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is a slippery, clear pliable, conformable, nanoporous provided in valled over that minimizes tissue contact between the vessels and the spine. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.
Acceptance Criteria and Study for HydroFix™ Vaso Shield (K101805)
The provided document describes the 510(k) premarket notification for the HydroFix™ Vaso Shield. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a new study with predefined acceptance criteria. Instead, the "acceptance criteria" are implied by the demonstration of comparable performance to existing, legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Characteristics and Functionality comparable to predicate devices. | The device is a flexible sheet of polyvinyl alcohol (PVA). It is described as slippery, clear, pliable, conformable, and nanoporous, designed to minimize tissue contact between vessels and the spine. It has no holes or perforations, no markings, and is provided sterile and hydrated. This aligns with the basic function of a "vessel guard." |
| Similar Indications for Use as predicate devices. | Indicated as a cover for vessels during anterior vertebral surgery. This is directly comparable to the stated intended use of the Paradis Vaso Shield™ (K090022 and K093551) and Gore PRECLUDE® Vessel Guard (K061727). |
| Demonstrated reduction in risk of potential vessel damage in vivo. | A sheep model (animal study) was conducted to demonstrate the reduction in the risk of potential vessel damage during anterior vertebral revision surgery. The implanted devices (HydroFix™ Vaso Shield) allowed a separation of the soft tissue adjacent to the study site from the study site. This provides evidence for the device's protective function. |
| Safety profile comparable to predicate devices. | While not explicitly detailed, the 510(k) process inherently requires a demonstration that the new device does not introduce new or different questions of safety or effectiveness compared to predicate devices. The absence of adverse findings in the animal study and the comparison to established predicate devices serve as the basis for this. |
| Materials comparable to predicate devices or acceptable for medical use. | The device is made of polyvinyl alcohol (PVA). The overall assessment of substantial equivalence suggests this material is acceptable for the intended purpose, aligning with the materials of predicate devices (polypropylene, polyethylene terephthalate, or polytetrafluoroethylene for the general class, though specific predicate materials are not detailed for comparison). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions a "Large Animal Implantation A sheep model (animal study)." It does not specify the exact number of sheep used in the study.
- Data Provenance: The study was an in vivo animal study conducted on sheep. The country of origin for the data is not specified. It is a prospective study as an experiment was conducted to generate the data for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number or qualifications of experts used to establish ground truth for the animal study. Veterinary surgeons or researchers would likely have been involved in the implantation and assessment of the devices in the sheep model.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the animal study data. The results would likely have been analyzed and interpreted by the research team involved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices involving human interpretation of images or other data, which is not applicable to this physical implantable device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is not
applicable. The HydroFix™ Vaso Shield is a physical implantable device, not an algorithm or software. Its performance is assessed through its physical interaction with tissues in vivo.
7. Type of Ground Truth Used
The ground truth for the in vivo testing was established through direct observation and assessment of the implanted devices in the animal model. This would likely involve:
- Direct observation/histology: Assessing the physical separation of soft tissue, the presence or absence of vessel damage, and tissue responses at the implant site.
- Pathology: Likely the most definitive ground truth, involving histological examination of tissues around the implant to confirm device presence, tissue separation, and absence of adverse reactions or damage.
8. Sample Size for the Training Set
No training set is mentioned or applicable. This device's performance was evaluated through an in vivo study, not through a machine learning or algorithm-based approach that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).