(226 days)
The Medtronic AVE Solstice™ Solstice Balloon Temporary Occlusion System is intended to be used for temporary vascular occlusion in selectively stopping or controlling blood flow in the peripheral, cerebral, and visceral vasculature.
The Solstice is a single lumen balloon catheter that uses the QS 10 guidewire to occlude the central lumen and allow inflation of the balloon. This is accomplished by advancing any part of the QS 10 through the catheter. The single lumen then becomes occluded allowing fluid to fill the balloon.
The Medtronic AVE Solstice™ Temporary Occlusion Balloon System (K994141) is a medical device designed for temporary vascular occlusion. This document summarizes the acceptance criteria and the study used to establish its substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
The provided text, a Summary of Safety and Effectiveness for a 510(k) submission, describes the general approach to demonstrating safety and effectiveness rather than a specific table of acceptance criteria with numerical performance targets. The overall acceptance criteria are implied to be achieving equivalence in intended use, design, and physical characteristics to the predicate device, the MTI Equinox™ Occlusion Balloon System (K990487).
The reported device performance is stated broadly: "Based on in-vitro and in vivo testing results, Medtronic AVE believes the Solstice and QS 10 are safe and effective for their intended use."
To provide a structured table, we can infer the categories of acceptance criteria based on the testing performed.
| Acceptance Criteria Category | Reported Device Performance (Implied) |
|---|---|
| Biocompatibility | Device demonstrates acceptable biocompatibility, indicating it is safe for contact with biological systems and does not elicit adverse reactions. |
| Reliability | Device exhibits satisfactory reliability, suggesting consistent performance over its expected lifespan and under various conditions. |
| Mechanical Properties | Solstice Catheter and QS 10 Guidewire meet specified mechanical performance requirements (e.g., strength, flexibility, inflation/deflation). |
| In-vitro Performance | Laboratory testing confirms the device functions as intended for temporary occlusion in simulated environments. |
| In-vivo Performance | Animal studies confirm the device's ability to safely and effectively achieve temporary vascular occlusion within a living system. |
2. Sample Size and Data Provenance
The provided text does not specify the exact sample sizes used for the "physical bench testing," "biocompatibility," and "animal studies." It states that "Testing was conducted on final, testing, mounted catheters and QS 10 Guidewires."
The data provenance is not explicitly stated in terms of country of origin. The studies are described as "animal studies" and "in-vitro testing," suggesting laboratory and preclinical environments. The nature of the submission (510(k)) implies the data is retrospective, as it was gathered prior to the submission for regulatory clearance.
3. Number of Experts and Qualifications for Ground Truth
The provided text does not mention the use of experts to establish a "ground truth" in the context of human-readable data (e.g., image interpretation). The evaluation focuses on the physical and biological performance of the device through bench and animal testing. Therefore, this section is not applicable in the context of the provided information. If this were a clinical study with human outcomes data requiring expert interpretation, then such information would be relevant.
4. Adjudication Method
Since the assessment is based on physical bench testing, biocompatibility, and animal studies, and not on human-interpreted data, an "adjudication method" as typically understood in clinical trials (e.g., 2+1 reading) is not applicable. The assessment would have been based on pre-defined test protocols and measurable outcomes from the various tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study is not applicable to this device. This type of study is typically used for diagnostic or screening devices where human readers interpret images or other data, and the focus is on how an AI system might improve human performance. The Medtronic AVE Solstice™ is an interventional device, and its evaluation is based on its physical properties and in-vivo performance, not human interpretive accuracy.
6. Standalone (Algorithm Only) Performance
A standalone performance evaluation (algorithm only, without human-in-the-loop) is not applicable for this device. The device itself is a physical medical instrument, not an AI algorithm. Its performance is inherent to its design and manufacturing, evaluated through physical, chemical, and biological testing, not through algorithmic output.
7. Type of Ground Truth Used
For the safety and effectiveness studies, the "ground truth" was established through:
- Bench Test Results: Measurable physical and mechanical properties of the device (e.g., balloon inflation/deflation times, material strength, integrity under stress).
- Biocompatibility Standards: Compliance with established biological safety standards for medical devices (e.g., lack of cytotoxicity, sensitization, irritation).
- Physiological Outcomes in Animal Models: Direct observable and measurable effects in living animal models (e.g., successful vascular occlusion, no adverse tissue reactions, patency after occlusion removal).
These are objective, direct measurements and observations, not expert consensus on an interpretation of data.
8. Sample Size for the Training Set
The concept of a "training set" is primarily relevant for AI/ML algorithms. Since this is a physical medical device and not an AI solution, there is no training set in the traditional sense. The manufacturing process and quality control would involve statistical sampling during production and validation, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for an AI algorithm, this question is not applicable. The "ground truth" for the device's performance was established through rigorous physical, chemical, and biological testing according to established medical device standards and protocols, as outlined in earlier sections.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).