(92 days)
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No
The device description and performance studies focus on the physical filtering capabilities of a disposable hood, with no mention of AI or ML technologies.
No
This device is described as disposable surgical apparel designed to protect personnel and patients from microorganisms, body fluids, and particulate material, not to treat a disease or condition.
No
Explanation: The device is described as disposable surgical apparel intended to protect against the transfer of microorganisms, body fluids, and particulate material during surgical procedures, not to diagnose a condition.
No
The device description clearly indicates it is a physical, disposable hood with a faceshield made of paper and polypropylene filter media. It is a piece of surgical apparel, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "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." This describes a barrier device used for personal protection and infection control during a procedure.
- Device Description: The description details a disposable hood with a faceshield and filter material, designed to be worn over a helmet. This aligns with personal protective equipment (PPE) used in a surgical setting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a physical barrier and filter used during a surgical procedure.
N/A
Intended Use / Indications for 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.
Product codes
79 FYA
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel / operating room
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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SUMMARY OF SAFETY AND EFFECTIVENE
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|------------------------------------------------------------------------------------------------|
| 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 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 DePuv 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.