(182 days)
Target population: Surgeons or other members of the surgical team.
The Gown Back is to be worn over a surgeon's gown during procedures and in situation when the surgeon's back needs to be considered sterile. This accessory device is used to protect both operating room personnel and the surgical patient from the transfer of microorganisms, body fluids, and particulate matter.
The device is a vest, commonly called a Gown Back, with a front snap opening. The Gown Back is fluid repellent; it is Single Use. The primary intended use for the Gown Back is as a sterile vest to be worn over a surgeon's gown during procedures or in situations when the surgeon's back needs to be considered sterile. It provides a supplementary layer of protection for the chest and back in light to moderate fluid situations. The Gown Back is not a primary protective garment. The vest design does not provide complete coverage, and the fabric is fluid repellent, not a fluid barrier.
The provided text describes a medical device called "Gown Back" (a surgeon's vest) and its 510(k) premarket notification. However, it does not contain any information about acceptance criteria or a study proving the device meets them.
The document is a 510(k) summary and the FDA's response letter indicating substantial equivalence to legally marketed predicate devices. This type of submission generally relies on demonstrating that a new device is as safe and effective as a pre-existing legally marketed device, often through comparison of materials, design, and performance data from internal testing or comparison to recognized standards, rather than new clinical trials with acceptance criteria for device performance in human use.
Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the provided text.
Here's what I can extract from the provided text regarding the device and its claimed performance, even without formal "acceptance criteria" being explicitly stated as such:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Claim | Reported Device Performance | Study Proving Acceptance Criteria Met |
|---|---|---|
| Fluid repellent | Is fluid repellent | Not detailed in the provided text. The submission states it's made of the same fabric and treated with the same fluid repellency treatment as the predicate device (Optima® Surgical Gowns). |
| Single Use | Is Single Use | Not applicable (design feature) |
| Sterile vest | Considered a sterile vest | Not detailed in the provided text. Implied by its intended use over a surgeon's gown where the back needs to be considered sterile. |
| Protection for chest and back | Provides a supplementary layer of protection for the chest and back in light to moderate fluid situations. | Not detailed in the provided text. Implied by its design and comparison to predicate devices. |
Missing Information:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not a diagnostic device or a study involving ground truth in the typical clinical sense.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical garment, not a software algorithm.
- Type of ground truth used: Not applicable in the context of this device. The "ground truth" for substantial equivalence would be the performance of the predicate devices.
- Sample size for the training set: Not applicable for a physical garment.
- How the ground truth for the training set was established: Not applicable.
Summary of available information:
- Device: GOWN BACK (Surgeon's Vest) manufactured by Techstyles, Inc.
- Function: A fluid repellent, single-use vest worn over a surgeon's gown to provide a supplementary layer of protection for the chest and back in light to moderate fluid situations. Intended to be worn when the surgeon's back needs to be considered sterile.
- Comparison Basis: Substantial equivalence claimed based on comparison to Optima® Surgical Gowns (same fabric, same fluid repellency treatment), Orex Surgeon's Vest, and White Knight Surgeon's Vest (functionally the same).
- Regulatory Conclusion: FDA found the device substantially equivalent to pre-amendments devices. This means the FDA agreed it is as safe and effective as the predicate devices. This determination is based on the information provided in the 510(k) submission, which typically includes material safety, biocompatibility, performance testing (e.g., fluid repellency tests against standards), and manufacturing controls. The specific details of these underlying tests are not in the provided summary.
§ 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.