(24 days)
The Stryker T4 Hytrel Toga is a component of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
The Stryker T4 Hytrel Toga is a single use sterile product that covers the user to minimize potentially hazardous contact between the user and patient.
This document is a 510(k) summary for the Stryker T4 Hytrel Toga, a surgical gown. The FDA's letter of substantial equivalence confirms its marketing authorization.
Based on the provided text, a detailed description of acceptance criteria and a study proving the device meets that criteria cannot be fully generated. This document primarily focuses on establishing substantial equivalence to previously marketed devices rather than presenting specific performance study results against defined acceptance criteria.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "The Stryker T4 Hytrel Toga is substantially equivalent to (SE) devices in commercial distribution. The Stryker T4 Hytrel Togas have the same intended use, similar patient contact materials, same operating principles and physical specifications as compared to predicate devices. There are no new safety or efficacy concerns."
This indicates that the "acceptance criteria" appear to be based on equivalence to predicate devices, rather than specific numerical performance metrics for the new device itself. The document does not provide quantitative acceptance criteria or reported device performance data in a table format.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Same intended use as predicate devices | Meets intended use (as deemed substantially equivalent) |
| Similar patient contact materials as predicate devices | Has similar materials (as deemed substantially equivalent) |
| Same operating principles as predicate devices | Has same operating principles (as deemed substantially equivalent) |
| Similar physical specifications as predicate devices | Has similar physical specifications (as deemed substantially equivalent) |
| No new safety concerns compared to predicate devices | No new safety concerns (as deemed substantially equivalent) |
| No new efficacy concerns compared to predicate devices | No new efficacy concerns (as deemed substantially equivalent) |
| Provides a barrier against contamination/exposure to infectious body fluids and harmful microorganisms (Intended Use) | (Implicitly meets this through substantial equivalence) |
Missing Information: Specific quantifiable performance metrics (e.g., barrier effectiveness ratings, material strength, fluid repellency, etc.) that would typically be associated with acceptance criteria for a surgical gown are not provided.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned. It's likely that any testing, if conducted beyond comparing specifications to predicate devices, would have been done by or for Stryker Instruments. The document does not specify if data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable or not mentioned. This type of submission relies on comparing specifications and intended use to predicate devices, not on expert consensus for "ground truth" in clinical scenarios.
- Qualifications of Experts: Not applicable or not mentioned.
4. Adjudication Method:
- Adjudication Method: Not applicable or not mentioned for a study of the new device's performance. The "adjudication" in this context is the FDA's review and determination of substantial equivalence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No. An MRMC study is not relevant for a surgical gown, which is a physical barrier product, not an imaging or diagnostic device requiring human reader interpretation.
- Effect Size of Human Readers with/without AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study:
- Was it done?: No. This device is not an algorithm or AI-driven system.
7. Type of Ground Truth Used:
- The "ground truth" for this submission is the established performance, safety, and specifications of the predicate devices (K040764, K011755, K944393). The new device is deemed substantially equivalent based on its comparison to these existing devices. There isn't a "ground truth" derived from patient outcomes or pathology for this type of device submission as described.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- How Established: Not applicable. This is not an AI/ML device.
In summary, this 510(k) submission for the Stryker T4 Hytrel Toga focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than providing detailed performance study results of the new device against specific, quantifiable acceptance criteria. The FDA's acceptance is based on this finding of substantial equivalence, meaning the new device is considered as safe and effective as the predicates without requiring new clinical trials or extensive performance studies with specific acceptance metrics.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.