(76 days)
The Zerowet Splashield is intended for use as an accessory to an irrigation syringe. It is intended to be attached to the end of said syringe during wound irrigation, in place of the commonly used needle, thereby eliminating the use of a needle during this procedure. Additionally, the Zerower Splashield protects the user from contaminated (bloody) fluid splashing back during wound irrigation.
The device of the current submission is an unsterilized styrene bell-shaped unit, with a 19g nozzle integrated in the stem which attaches to the end of a syringe. The intended use is as attached to the end of an irrigation syringe, during wound irrigation, to protect the user from (a) needlesticks (by eliminating the use of a needle), and (b) bloody splash during this procedure.
This submission, K974288, is for a modified version of an existing device, the Zerowet Splashield. The only difference is the sterility level. The original device was gamma-radiation-sterilized, while the new submission is for an unsterilized, clean device. The manufacturer is arguing for substantial equivalence based on the premise that the sterility level does not impact the device's integrity or performance for its intended use.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No substantial difference in integrity or performance between: |
- Radiation sterilized device (predicate)
- Unsterilized device (new submission)
- Unsterilized device, to be user-sterilized via EtO
- Unsterilized device, to be kit-packer-sterilized via EtO or radiation | The applicant asserts that "there is no substantial difference in the integrity or performance of the Zerowet Splashield between the following four formats." |
| No reasonable likelihood that the use of unsterilized components would adversely impact wound healing, wound infection rates, or general patient care. | The applicant asserts this, stating it's "based on requests from a number of end users who are themselves specialists in the field of emergency wound care, who would prefer to use the Zerowet Splashield in an unsterilized format and feel that sterilization of this component for irrigation of a traumatic, contaminated wound is unnecessary." |
| Sterilization by end user or kit assembler using standard EtO or radiation protocols would not adversely affect the integrity or performance of the device. | The applicant asserts this without further supporting data in the provided text. |
Important Note: The provided document is a 510(k) summary, not a full study report. It primarily contains assertions made by the applicant and the FDA's decision based on that information. It does not present detailed study results or data to prove these acceptance criteria were met through a formal study.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe any formal test set or corresponding sample size. The primary argument is based on:
- Requests/Opinions from end-users: "requests from a number of end users who are themselves specialists in the field of emergency wound care"
- Assertion of no "reasonable likelihood" of adverse impact: This is a qualitative argument, not based on a statistically designed test set.
- Assumption of equivalence in integrity/performance: This is also asserted without presenting data from a test set.
Given this, there is no information on data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of experts: The text refers to "a number of end users who are themselves specialists in the field of emergency wound care." A specific number is not provided.
- Qualifications of experts: They are described as "specialists in the field of emergency wound care." Further details like years of experience or specific credentials (e.g., surgeon, emergency physician) are not given.
- Ground truth: Their opinions formed the basis of the applicant's assertion regarding the adequacy of an unsterilized device for traumatic, contaminated wounds. This is a qualitative "ground truth" based on expert opinion, not a quantitative measurement.
4. Adjudication Method for the Test Set
No formal adjudication method is described because no structured test set with adjudicated outcomes is presented. The "ground truth" relies on the collective opinion of unspecified "specialists."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?
No, an MRMC comparative effectiveness study was not done. This device is a physical medical accessory (splash shield), not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done?
No, a standalone algorithm performance study was not done. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth primarily used in this submission is expert opinion/consensus (from "specialists in the field of emergency wound care") and the assertion of common practice/clinical judgment that an unsterilized device is adequate for traumatic, contaminated wounds.
There is no mention of pathology, outcomes data (e.g., wound infection rates from a comparative study), or other empirical data to establish ground truth.
8. The Sample Size for the Training Set
There is no mention of a training set in the context of this device. This submission relies on justifying the equivalence of a modified (unsterilized) version of an existing device based on clinical judgment and the perceived lack of clinical impact.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, this question is not applicable.
§ 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.