(60 days)
The HemaMyst Surgical Applicator System is indicated for the simultaneous application of the two separate components of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to the treatment site.
The HemaMyst Surgical Applicator System is a sterile, single-use device consisting of a Head that attaches by Luer connectors to currently available dual syringe spray noals and is coupled to an air regulator base unit by means of a sterile filtered air applicators, and is obablicator System allows simultaneous delivery, by spraying, of the two components of fibrin sealant to the treatment site.
The provided text describes a 510(k) summary for the HemaMyst Surgical Applicator System. However, it does not contain information about acceptance criteria, device performance, a specific study proving acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily focuses on:
- Device Description: A sterile, single-use device for simultaneous delivery of two components of fibrin sealant.
- Changes from Predicate: The key change is the indication for application of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant.
- Functionality Testing: States that functionality testing shows the device is "function[al] with 3, 50 and 11, 2017 [sic] and and Spray of HEMASEEL APR or Tisseel VH fibrin sealant." This is a very brief and incomplete statement regarding testing and doesn't provide detailed performance metrics or acceptance criteria.
- Intended Use/Indications for Use: Simultaneous application of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to the treatment site.
- Substantial Equivalence: The FDA's letter confirming substantial equivalence to predicate devices (K994023 and K981089).
Therefore, based solely on the provided text, I cannot complete the requested tables and information.
Here's an attempt to fill in what can be inferred or directly stated, and to explicitly highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "Functionality Testing") | Reported Device Performance (From "Functionality Testing") |
|---|---|
| Device functions for spraying fibrin sealant. | "Functionality testing shows that the HemaMyst Surgical Applicator System is Function[al] with 3, 50 and 11, 2017 [sic] and and Spray of HEMASEEL APR or Tisseel VH fibrin sealant." |
| Specific quantitative performance metrics (e.g., spray pattern, flow rate, consistency, delivery accuracy, seal strength) | Not provided in the text. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The phrase "function[al] with 3, 50 and 11, 2017" is unclear. It might refer to three specific tests, or some other parameters, but it's not a clear sample size.
- Data Provenance (country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is mechanical. The concept of "ground truth" and "experts" as in diagnostic AI studies typically doesn't apply to this kind of functionality testing in the same way. The assessment would likely be based on engineering specifications and direct measurement, not expert consensus on an image or medical condition.
- Number of experts: Not applicable/Not specified.
- Qualifications of experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Not applicable/Not specified, as this refers to a diagnostic assessment process. For a mechanical device, performance is typically measured against specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. This is a mechanical device, not a diagnostic algorithm involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, implicitly. The "Functionality testing" refers to the device's performance. Since it's a mechanical applicator for fibrin sealant, its performance would inherently be evaluated in a standalone manner, separate from a human operator's skill, to ensure it delivers the sealant correctly. However, a specific study detailed as "standalone performance" is not described.
7. The type of ground truth used
- The "ground truth" for a mechanical device's functionality would be its adherence to engineering specifications and proper delivery of the fibrin sealant. The text does not detail these specifications or measurement methods.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- 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).