DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS
Device Facts
| Record ID | K964114 |
|---|---|
| Device Name | DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS |
| Applicant | Depuy, Inc. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | May 6, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
Intended Use
The DePuy Opti-Con and E-Z Shield Systems are intended as face shields to be worn by operating room personnel during surgical procedures to provide splash protection to protect the operating room personnel from the transfer of microorganisms, body fluids and particulate material. The Opti-Con Shields, E-Z Shield and Opti-Con goggles are intended to be disposable. The Opti-Con head gear is intended to be re-usable.
Device Story
System provides splash protection for OR personnel eyes, nose, mouth, ears. Components: Opti-Con (disposable polycarbonate faceshields, reusable headgear); E-Z Shield (one-piece disposable PETG faceshield/headband); Opti-Con goggles (disposable polycarbonate). Used in surgical settings to prevent transfer of microorganisms, body fluids, and particulates. Protects wearer via physical barrier. No electronic or algorithmic components.
Clinical Evidence
Bench testing only; impact resistance testing performed.
Technological Characteristics
Materials: Polycarbonate (Opti-Con shields/goggles), PETG (E-Z Shield). Form factor: Faceshields (standard/long), goggles, headgear. Energy source: None. Connectivity: None. Sterilization: Sterile or non-sterile options.
Indications for Use
Indicated for operating room personnel during surgical procedures to provide splash 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
- Splash Shield Splash Shields
- DePuy Disposable Filter/Hood
- DePuy Shades™ Protective Glasses
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