DEPUY DISPOSABLE FILTER/HOOD

K961791 · Depuy, Inc. · LYU · Aug 9, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961791
• Device Name: DEPUY DISPOSABLE FILTER/HOOD
• Applicant: Depuy, Inc.
• Product Code: LYU · General, Plastic Surgery
• Decision Date: Aug 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 1

Intended Use

The DePuy Disposable Filter/Hood is intended to be used with the Stryker Steri-Shield System as disposable surgical apparel 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.

Device Story

Single-use disposable hood with faceshield; worn over Stryker Steri-Shield helmet; constructed of Dexter paper with spun polypropylene filter media at top and back. Intake/exhaust air passes through filter media. Used in operating room by surgical personnel. Protects patient and personnel from cross-contamination of microorganisms, body fluids, and particulates.

Clinical Evidence

Bench testing only. Comparative filtering efficiency testing performed against Stryker filter material across various particle sizes and flow rates.

Technological Characteristics

Materials: Dexter paper, spun polypropylene filter media. Form factor: Disposable hood with faceshield. Design: Fits over Stryker Steri-Shield helmet. Principle: Mechanical filtration of intake/exhaust air.

Indications for Use

Indicated for operating room personnel during surgical procedures to provide barrier protection against microorganisms, body fluids, and particulate material.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Stryker Steri-Shield Personal Protection System
• DePuy Sterile View Disposable Hood/Gown

Submission Summary (Full Text)

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x961791

# SUMMARY OF SAFETY AND EFFECTIVENESS

**NAME OF FIRM:** DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
AUG - 9 1996

**510(k) CONTACT:** Cheryl Hastings
Manager, Pre-clinical Device Evaluation

**TRADE NAME:** DePuy Disposable Filter/Hood

**COMMON NAME:** Sterile surgical hood

**CLASSIFICATION:** 878.4040 Surgical apparel

**DEVICE PRODUCT CODE:** 79 FYA

**SUBSTANTIALLY EQUIVALENT DEVICES:**
- ☑ Stryker Steri-Shield Personal Protection System
- ☑ DePuy Sterile View Disposable Hood/Gown

## DEVICE DESCRIPTION AND INTENDED USE:

The DePuy Disposable Filter/Hood is a single use, disposable hood with faceshield. The hood is constructed of Dexter paper with spun polypropylene filter media located at the top and back of the hood. The DePuy hood is designed to fit over the Stryker Steri-Shield helmet so that all intake and exhaust air passes through the filter material.

The DePuy Disposable Filter/Hood is intended to be used with the Stryker Steri-Shield System as disposable surgical apparel 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.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Disposable Filter/Hood is designed to be identical to the Stryker Steri-Shield Hood. The DePuy Filter/Hood and the Stryker Hood have the same hood and faceshield design, the same filter location and the same intended use. The only difference between the two hoods are the materials from which they are constructed. The material of the DePuy Filter/Hood (Dexter paper) is the same as the material used for the DePuy Sterile View Disposable Hood/Gown. Comparative testing shows that the filtering efficiency of the DePuy filter material is as good as or better than the Stryker filter material for all particle sizes and flow rates tested.