(189 days)
The Single Cannula Extended Applicator is intended for medical purposes to irrigate or instill fluids to a wound or body cavity.
The Single Cannula Extended Applicator has two components: an applicator instrument and a replaceable spray tip. The spray tip is assembled to the instrument by the user. The assembled applicator product is installed on a standard medical syringe, and allows fluids to be applied from the syringe to a treatment site that is otherwise difficult to access. The entire device is packaged sterile and labeled for single-use. The applicator instrument contains a stainless steel hypodermic tube with a molded polymer luer lock connector on the input (proximal) end. It is enclosed in a stainless steel sheath that provides rigidity and allows the device to effectively seal off in a 5mm endoscopic cannula. A replaceable molded polymer spray tip is attached to the output (distal) end of the sleeve by the user. A replacement tip is included in the package.
The provided document describes a 510(k) submission for a medical device called the "Single Cannula Extended Applicator." This device is intended for medical purposes to irrigate or instill fluid to a wound or body cavity. The submission aims to demonstrate substantial equivalence to a predicate device, the "Biomaterial Spray Syringe" (K982372).
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission details nonclinical tests performed to demonstrate the device's design suitability for its intended use. The document states, "All test results meet the acceptance criteria and demonstrate that the device is appropriately designed for the intended use." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the types of tests performed.
| Test Type | Acceptance Criteria (Not Explicitly Stated Quantitatively) | Reported Device Performance |
|---|---|---|
| Leak test | (Implied: No leaks to be observed) | Met acceptance criteria |
| Flow test | (Implied: Adequate fluid flow) | Met acceptance criteria |
| Pull test | (Implied: Sufficient strength/retention) | Met acceptance criteria |
| Fit and sealing in 5mm endoscopic cannula | (Implied: Proper fit and seal) | Met acceptance criteria |
| ISO-594-1 Conical fittings with 6% (Luer) taper | (Implied: Conformance to ISO standard) | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for the nonclinical tests (Leak test, Flow test, Pull test, Fit and sealing, ISO-594-1). It only states that "Micromedics, Inc. conducts risk analysis and design verification tests are based on the result of these analyses."
Regarding data provenance, all listed tests are nonclinical, performed by the manufacturer, Micromedics, Inc. Therefore, the data provenance is internal to the manufacturer, within the United States (where Micromedics, Inc. is located). The testing is prospective for the current device and retrospective in terms of experience with the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes nonclinical tests, not a study involving expert-established ground truth for medical imaging or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The submission explicitly states: "No clinical tests have been performed on the Single Cannula Extended Applicator or the predicate."
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not conducted. This device is a manual, mechanical applicator, not an algorithm or software. The "performance" is demonstrated through nonclinical engineering tests.
7. Type of Ground Truth Used
The "ground truth" for the nonclinical tests was established by engineering specifications, recognized standards (like ISO-594-1), and design requirements derived from risk analysis. It does not involve expert consensus, pathology, or outcomes data in the medical diagnostic sense.
8. Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm or a system that requires a "training set" for its development. Its performance is based on its mechanical design and materials.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 880.6960 Irrigating syringe.
(a)
Identification. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.