Search Results

The Stryker Steri-Shield Flyte Hybrid Togas are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material. The togas are sterile and single use only.

The Steri-Shield Flyte Hybrid Togas are single use, sterile, disposable devices that comprise part of the Steri-Shield Flyte Hybrid Personal Protection System. They are intended to be worn by healthcare personnel to protect the patient and healthcare personnel against contamination, exposure of infectious bodily fluids and the transfer of microorganisms and particulate material. The devices are prescription use.

The provided FDA 510(k) summary for the Stryker Steri-Shield Flyte Hybrid Togas describes performance testing to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria per se. The context is a "Special 510(k): Device Modifications with no change to fundamental scientific technology or intended use."

The document focuses on comparing the modified device (Stryker Steri-Shield Flyte Hybrid Togas) to its predicate device (Stryker Steri-Shield Flyte Togas, K073017) across various specifications and explicitly states that the "Results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the Steri-Shield Flyte Hybrid Togas are sufficient for their intended use and support a determination of substantial equivalence."

Key points from the provided text:

1. Acceptance Criteria and Reported Device Performance:

   The document doesn't explicitly list "acceptance criteria" but rather presents a comparison table where the subject device's performance is listed against the predicate device's performance, often with "Compliant - Pass" as the reported result for both. The "Explanation of Difference" column clarifies if the subject device meets the same specifications, even if materials or test standards changed.

   Acceptance Criteria (Implied / Specification Met)	Reported Device Performance (Stryker Steri-Shield Flyte Hybrid Togas)
   Biocompatibility: Non-cytotoxic	Non-cytotoxic
   Biocompatibility: Non-sensitizing	Non-sensitizing
   Biocompatibility: Negligible irritant	Not an irritant
   Sterility Assurance Level (SAL)	10⁻⁶
   Lint Level (ISO 9073 part 10)	Compliant - Pass
   Tensile Strength (BS EN 29073-3)	Compliant - Pass
   Tear Resistance (ASTM D 5587-08)	Compliant - Pass
   Evaporative Resistance (ASTM F 1868)	Compliant - Pass
   Bacterial Filtration Efficiency (ASTM F2101-07)	Compliant - Pass
   Particulate Filtration Efficiency (ASTM F2299-03)	Compliant - Pass
   Viral Penetration (ASTM F1671) Level 4 (Critical Zone)	Front/Sleeve material: Pass requirements for Level 4 Protection. Sleeve Seam: Pass requirements for Level 4 Protection. (Note: Hood region material not designed to meet Level 4)
   Water Resistance: Impact Penetration (AATCC 42) Level 1 (Critical Zone)	Hood region material: Pass requirements for Level 1 Protection. Back material: Pass requirements for Level 1 Protection. All other protective seams: Pass requirements for Level 1 Protection.
   Flammability (16 CFR Part 1610)	No Flame Spread
   Shelf Life (initial submission)	1 year (with intent to extend upon further studies)

2. Sample Size Used for the Test Set and Data Provenance:
   The document does not specify exact sample sizes for each performance test. It only states "Results of performance testing demonstrate..." without numerical data on the number of units tested.
   The data provenance is not explicitly stated beyond being "performance testing" conducted by Stryker Instruments. It is prospective testing performed to support the 510(k) submission for the modified device. There is no mention of country of origin for the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
   This information is not applicable to this type of device and study. The testing described is primarily physical, mechanical, and biological performance testing against recognized standards (e.g., ISO, ASTM, AAMI, AATCC, CFR). There is no "ground truth" established by human experts in the context of diagnostic accuracy, for example. The "truth" is whether the material or assembled device meets the specified performance metrics in the standards.

4. Adjudication Method for the Test Set:
   Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that rely on human interpretation of outputs (e.g., imaging devices with radiologists). The Stryker Steri-Shield Flyte Hybrid Togas are surgical apparel, and their effectiveness is evaluated through physical and biological barrier properties, not diagnostic accuracy or human interpretation.

6. Standalone Performance:
   Yes, a standalone performance assessment was done. The performance testing (biocompatibility, sterility, lint level, tensile strength, tear resistance, evaporative resistance, bacterial filtration, particulate filtration, viral penetration, water resistance, flammability, shelf life) evaluates the intrinsic properties and performance of the device itself, separate from human interaction or interpretation beyond fitting and use.

7. Type of Ground Truth Used:
   The "ground truth" used is defined by established international and national standards for medical devices and textiles, such as:

   • ANSI/AAMI/ISO 10993-1:2009 (Biological Evaluation of Medical Devices)
   • ANSI/AAMI/ISO 11135-1:2007 (Sterilization)
   • ISO 9073 part 10 (Lint Level)
   • BS EN 29073-3 (Tensile Strength)
   • ASTM D 5587-08 (Tear Resistance)
   • ASTM F 1868 (Evaporative Resistance)
   • ASTM F2101-07 (Bacterial Filtration Efficiency)
   • ASTM F2299-03 (Particulate Filtration Efficiency)
   • ASTM F1671 (Viral Penetration)
   • AATCC 42 (Water Resistance: Impact Penetration)
   • 16 CFR Part 1610 (Flammability)

   The device performance is compared against the requirements specified in these standards.

8. Sample Size for the Training Set:
   This information is not applicable. This device is not an AI/ML algorithm that requires a training set for model development. The modifications are material changes and dimensional adjustments for physical apparel.

9. How the Ground Truth for the Training Set Was Established:
   Not applicable, as there is no training set for this type of device.

Ask a specific question about this device