(86 days)
For the mixing, and one-to-one (1:1) delivery, of fibrin sealant for medical applications. It can also be attached to standard hospital wall suction for removal of debris, excess tissue or foreign particles in the wound.
The Sealouette™ Fibrin Sealant Applicator is intended for the mixing and delivery of fibrin sealant for medical applications. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound.
The Sealouette™ Fibrin Sealant Applicator consists of the main housing, which holds the dual chamber syringe barrel and a common plunger that provides for the delivery and mixture of equal volumes of the two-part fibrin sealant through a mixing chamber and application lumen.
The provided document describes the Sealouette™ Fibrin Sealant Applicator, which is intended for the mixing and delivery of fibrin sealant and can also be used for suction. The acceptance criteria and the study performed are focused on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance thresholds.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative acceptance criteria with numerical targets. Instead, the "acceptance criteria" are implied by the need to demonstrate substantial equivalence to predicate devices in various functional and performance aspects. The reported device performance is described qualitatively as meeting these equivalency standards.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance |
|---|---|
| Accuracy and Volume of Fibrin Sealant Delivered: Ability to accurately and reproducibly deliver each component at a fixed, predetermined ratio. | "A battery of non-clinical tests have been performed which demonstrate the functions of the device, and establish equivalence to the predicates in terms of: accuracy and volume of fibrin sealant delivered: the ability of the device to accurately and reproducibly deliver each component of the fibrin sealant at a fixed, predetermined ratio." |
| Homogeneous Mixing: Ability of the device to homogeneously mix the components of the fibrin sealant. | "and the ability of the device to homogeneously mix the components of the fibrin sealant." |
| Clotting Time and Stable Physical Properties: Substantial equivalence of the fibrin sealant delivered by the device to that delivered by the predicate in terms of the time needed for the fibrin sealant to clot and achieve stable physical properties. | "In addition, tests have been performed to demonstrate the substantial equivalence of the fibrin sealant delivered by the device to that delivered by the predicate in terms of: the time needed for the fibrin sealant to clot and achieve stable physical properties;" |
| Physical Characteristics and Geometry of the Clot: Substantial equivalence regarding the physical characteristics and geometry of the clot produced, ensuring they are not adversely affected by the delivery device or mode. | "the physical characteristics and geometry of the clot produced. Testing has demonstrated that the characteristics of the clot are not adversely affected by the delivery device itself or mode of delivery." |
| Suction System Performance: Equivalence to the predicate BioSurgical Multi Chamber Suction Syringe. | "The Sealouette™ suction system design is precisely the same as that of the predicate device, BioSurgical's Multi Chamber Suction Syringe cleared under #K964597." (Implies equivalent performance for fluid and debris removal.) |
| Physical Components, Technological Characteristics, and Fibrin Sealant Delivery: Overall equivalence to predicate devices (Duploject® and Multi Chamber Suction Syringe) in these aspects. | "Conclusions Drawn from Non-Clinical Tests: Islous Drawn is on Non - Smilly equivalent to the Duploject® and the Multi Chamber Suction syringe in terms physical components, technological characteristics, performance, fibrin sealant delivery, and characteristics of the fibrin sealant after delivery." (Though misspelled "Islous Drawn is on Non - Smily", the intent is clear: "Conclusions Drawn from Non-Clinical Tests: Is [the device] substantially equivalent to the Duploject® and the Multi Chamber Suction syringe...") |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "a battery of non-clinical tests" but does not specify numerical sample sizes for these tests.
The tests are "non-clinical," implying they were conducted in a laboratory or engineering setting, rather than with human subjects or patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective clinical data is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The study described is a non-clinical, performance-based study focused on engineering characteristics of the device (delivery accuracy, mixing, clot formation). There is no mention of experts being used to establish a "ground truth" in the sense of medical diagnosis or interpretation for a test set. The "ground truth" for these engineering tests would typically be established by established measurement standards, reference materials, or predicate device performance.
4. Adjudication Method for the Test Set
Given that this is a non-clinical mechanical/performance study, no adjudication method (like 2+1, 3+1) involving human expert opinions for a diagnostic test set is mentioned or applicable. Results would be based on direct measurements and comparisons to predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted or mentioned. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and AI assistance is being evaluated. The Sealouette™ is a delivery and suction device, not a diagnostic one.
6. Standalone Performance Study
The non-clinical tests described are essentially a standalone performance evaluation of the device's engineering characteristics (delivery, mixing, clot formation) and its suction capability, relative to predicate devices. The study aimed to demonstrate the device's inherent functionality without human intervention beyond operating the device. The "algorithm only" concept does not apply here as it's a mechanical device.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests would have been established through:
- Measurement standards and engineering specifications: For accuracy, volume, and mixing.
- Physical and chemical analysis: For characteristics of the fibrin sealant clot (clotting time, physical properties, geometry).
- Predicate device performance: The performance of the Immuno-U.S. Duploject® and BioSurgical Corporation Multi Chamber Suction Syringe served as the benchmark for demonstrating substantial equivalence.
8. Sample Size for the Training Set
The document describes non-clinical performance testing and substantial equivalence demonstration, not a machine learning model. Therefore, there is no training set in the context of AI/ML.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model, this question is not applicable.
§ 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).