(203 days)
Surgical apparel are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The standard, fabric- and poly-reinforced gowns are comprised of a single layer of SMS Polyolefin fabric. The fabric-reinforced gowns have an additional layer of SMS Polyolefin fabric in the sleeve and body areas; the poly-reinforced gowns have an additional layer of polyolefin film in the sleeve and body areas.
I am sorry, but I cannot provide an answer based on the provided text. The document describes a 510(k) summary for surgical gowns, outlining their intended use, materials, and substantial equivalence to existing devices. However, it does not contain any information about acceptance criteria, device performance, a study proving device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
The document explicitly states: "Summary of testing:" at the end of the second page, but no testing details or results follow in the provided excerpts.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.
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OCT 28 1996
Surgical Group
Baxter Healthcare Corn 1.500 Waukegan Road McGave Park, Illinois 60085 USA 847.473.1500 FAX: 847.785.2460
Baxter
1
SMDA REQUIREMENTS XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® SMS Polyolefin Gowns
| Manufacturer: | Baxter Healthcare CorporationSurgical GroupConvertors® OperationsOne Butterfield TrailEl Paso, Texas 79906 |
|---|---|
| Regulatory Affairs Contact: | Sharon RichterSurgical Group1500 Waukegan Road MPKMcGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | March, 1996 |
| Common Name: | Convertors® SMS Polyolefin Gowns |
| Classification: | Class II per 21CFR § 878.4040 |
| Predicate Device: | Convertors® SMS Polyolefin StandardGown and the Kimberly-Clark Standard, Fabricand Poly-reinforced Gowns |
| Description: | The standard, fabric- and poly-reinforcedgowns are comprised of a single layer of SMSPolyolefin fabric. The fabric-reinforcedgowns have an additional layer of SMSPolyolefin fabric in the sleeve and bodyareas; the poly-reinforced gowns have anadditional layer of polyolefin film in thesleeve and body areas. |
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XII. SMDA REQUIREMENTS (continued)
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® SMS Polyolefin Gowns
Intended Use:
Substantial Equivalence:
Surgical apparel are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The Convertors® SMS Polyolefin gown is substantially equivalent to the Convertors® SMS Polyethylene standard gown and Kimberly-Clark standard, fabric- and polyreinforced gowns in that:
- the intended use is the same
- the performance attributes are the same
All materials used in the fabrication of this Convertors® SMS Polyolefin gown were evaluated through biological qualification safety tests as outlined in in ISO 10993 Part-1 "Biological Evaluation of of Medical Devices". The biocompatibility tests were cytotoxicity, sensitization, and irritation/ intracutaneous reactivity. These materials have met the requirements of the guidance and were found to be acceptable for the intended use.
Summary of testing:
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XIII. SAMPLE
A prototype of a standard SMS gown has been provided (enclosed) to visually assist with the review. (See Appendlx D).
XIV. KIT INFORMATION
Each gown is packaged with a towel. The towel is the same towel that is currently placed in our gown packs. This towel has been used safely and effectively for many years as a component of the gown pack. This premarket notification (510(k)) is to introduce standard, fabric and poly-reinforced gowns constructed of SMS fabric. There is no change to the towel contained within this pack.
XV. 21 CFR 807.95 -CONFIDENTIALITY
The Surgical Group of Baxter Healthcare Corporation regards its intent to market the Convertors® SMS Polyolefin gown as confidential commercial information. Baxter has not divulged this intent to market information to anyone other than Baxter employees and even then on a need-to-know basis. Therefore, we request that FDA treat this information in a confidential manner.
§ 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.