(833 days)
The Tissomat® and Spray Set are intended for use in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces. The Spray Set is or ure the Duploject® two-syringe holder and is equipped with a Spray Head and a connection tube which connects the Spray Head to the Tissomat® device, a propellant gas control device.
The Spray Set is a sterile, pyrogen-free, single-use device indicated for use in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces. It consists of a Spray Head and connection tube with sterile filter. The Spray Set is attached to the Duploiect® two-syringe holder, a device that has already been cleared by the FDA through Premarket Notification [510(k)]. The connection tube connects the Spray Head to the Tissomat® device, a propellant gas control device.
The Tissomat® device controls and releases propellant gas provided by a propellant gas source (compressed air or nitrogen). The Tissomat® device is indicated for use only with the Spray Set in the simultaneous application (by spraying) of the two components of Tisseel® Fibrin Sealant onto wound surfaces.
The Tissomat® and Spray Set are used for the spraying of wound surfaces, when uniform coverage is essential.
This document describes the Tissomat® and Spray Set, a device intended for the simultaneous application of Tisseel® Fibrin Sealant onto wound surfaces. The information provided focuses on the safety and effectiveness testing conducted to support its 510(k) clearance.
Here's an analysis of the provided text in the requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Degree of Mixing of Fibrin Sealant (compared to application needle) | At least an equal degree of mixing was reached. |
| Hemostatic Efficacy (in rabbit liver abrasion model, compared to application needle) | Efficacy is equivalent. |
| Maximum Gas Pressure at Wound Surface | Recommended maximum pressure of 2 bars (28.5 psi). |
| Minimum Spraying Distance | Recommended minimum spraying distance of 10 cm. |
| Adverse Events in Clinical Use (pediatric burn victim) | No adverse events associated with use. |
| Efficacy in Clinical Use (pediatric burn victim - surgeon's report) | Efficacious method of providing optimal coverage. |
| Overall Safety and Efficacy | Safe and efficacious, performs according to required specifications. |
| Product Specifications (adequate mixing, appropriate pressure regulation) | Performs according to required specifications. |
2. Sample Size Used for the Test Set and Data Provenance
- Degree of Mixing Study: No specific sample size is mentioned.
- Hemostatic Efficacy Study: No specific sample size is mentioned, but it was conducted in a "rabbit liver abrasion model." This indicates an animal study.
- Gas Pressure Measurement Study: No specific sample size is mentioned, but it involved measuring pressure at a "simulated wound surface."
- Clinical Use (Case Study): One "pediatric burn victim" was treated.
- Wider Clinical Experience: "Many years of clinical experience" from Europe, Canada, and other countries, with "more than 250,000 applications." This is retrospective data from outside the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For the three in vitro or animal studies (mixing, hemostasis, pressure), no information is provided on expert involvement for ground truth establishment. These likely relied on measurable outcomes.
- For the single clinical case study, the "surgeon reported this device to be an efficacious method." This implies one expert (the surgeon) provided subjective feedback on efficacy. No specific qualifications (e.g., years of experience) are provided for this surgeon.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication methods (like 2+1 or 3+1 consensus) for establishing ground truth in any of the studies. The nature of the studies (measurable lab outcomes, animal model, single case report) does not typically require multi-reader adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or described. The studies were focused on the device's technical performance and equivalence to an application needle, not on human reader performance with or without AI assistance. This device is not an AI-based diagnostic tool.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable as the Tissomat® and Spray Set is a medical device for application, not an algorithm or AI system. Its performance is inherent in its mechanical operation and delivery of the sealant, not in computational output requiring human interpretation. The described studies evaluate the device's functional performance.
7. Type of Ground Truth Used
- Degree of Mixing Study: Objective measurement of mixing.
- Hemostatic Efficacy Study: Clinical outcomes in an animal model (rabbit liver abrasion).
- Gas Pressure Measurement Study: Objective measurement of pressure.
- Clinical Case Study: Subjective expert opinion (surgeon's report) on efficacy, and absence of observed adverse events.
- General conclusion of safety and efficacy: Based on nonclinical testing and retrospective clinical experience.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or AI system. The device's design and engineering would be based on general principles and prior knowledge, but there is no explicit mention of data used for "training" in the machine learning sense. The extensive "many years of clinical experience" from other countries with "more than 250,000 applications" could be considered analogous to a large dataset informing the device's real-world performance and safety profile, but it does not represent a structured "training set" for an AI model.
9. How the Ground Truth for the Training Set Was Established
As there is no concept of a "training set" for an AI algorithm in this submission, this question is not applicable. The device's design and validation rely on engineering principles, functional testing, and clinical observations from its use.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).