(120 days)
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:
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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) -
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. -
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. -
Adjudication Method for the Test Set:
Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication. -
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. -
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. -
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.
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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. -
How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.