(169 days)
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No
The device description and performance studies focus on the material properties and barrier performance of a surgical gown, with no mention of AI or ML technology.
No
The device is described as disposable surgical apparel intended to protect both the surgical patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material; it does not treat or cure any medical condition.
No
The device is described as disposable surgical apparel intended to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. It is a barrier, not a tool for diagnosis.
No
The device description clearly outlines physical components like Dexter paper, Sontara polyester fabric, Hytrel polymeric coating, and a polycarbonate face shield, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device's Intended Use: The intended use of the Barrier Hood/Gown with Hytrel is to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic test performed on a sample.
- Device Description: The description details the materials and construction of a surgical gown and hood, emphasizing its protective qualities and resistance to fluids and pathogens. It does not describe any components or functions related to analyzing biological samples.
The device is clearly a piece of personal protective equipment (PPE) intended for use in a surgical setting, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Sterile View Barrier Hood/Gown with Hytrel is intended 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 Barrier Hood/Gown with Hytrel is a sterile surgical gown, manufactured from Dexter paper and Sontara polyester fabric with a Hytrel polymeric coating. The Dexter paper is used for the hood and gown back. The Sontara/Hytrel material is used on the gown front and sleeves. A molded, polycarbonate face shield is sealed to the hood material. The Sontara/Hytrel material is fluid resistant but vapor transmissive. The gown therefore protects the wearer from fluid borne pathogens, while maintaining "breathability". The Barrier Hood/Gown with Hytrel is available in three sizes: size 1, size 2 and size 2 long. Testing has shown that the Sontara/Hytrel material of the Barrier Hood/Gown with Hytrel passes ASTM standard tests ES-21 for resistance to synthetic blood and ES-22 for resistance to penetration by blood borne pathogens using viral penetration as a test system.
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)
Testing has shown that the Sontara/Hytrel material of the Barrier Hood/Gown with Hytrel passes ASTM standard tests ES-21 for resistance to synthetic blood and ES-22 for resistance to penetration by blood borne pathogens using viral penetration as a test system.
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 EFFECTIVENESS
| 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 Sterile View® Barrier Hood/Gown with
Hytrel® |
| CLASSIFICATION: | 878.4040 Surgical apparel |
| DEVICE PRODUCT CODE: | 79 FYA |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | • DePuy Sterile View Barrier Hood/Gown UV |
| | • Stackhouse Freedom Mark III Surgical Helmet
System |
| | • Baxter Converters Breathable Gown |
INTENDED USE AND DEVICE DESCRIPTION:
The Sterile View Barrier Hood/Gown with Hytrel is intended 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.
The Barrier Hood/Gown with Hytrel is a sterile surgical gown, manufactured from Dexter paper and Sontara polyester fabric with a Hytrel polymeric coating. The Dexter paper is used for the hood and gown back. The Sontara/Hytrel material is used on the gown front and sleeves. A molded, polycarbonate face shield is sealed to the hood material. The Sontara/Hytrel material is fluid resistant but vapor transmissive. The gown therefore protects the wearer from fluid borne pathogens, while maintaining "breathability". The Barrier Hood/Gown with Hytrel is available in three sizes: size 1, size 2 and size 2 long. Testing has shown that the Sontara/Hytrel material of the Barrier Hood/Gown with Hytrel passes ASTM standard tests ES-21 for resistance to synthetic blood and ES-22 for resistance to penetration by blood borne pathogens using viral penetration as a test system.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Sterile View Barrier Hood/Gown with Hytrel is identical in design and intended use to the DePuy Sterile View Barrier Hood UV. The only difference between these two products is that the material of the hood/gown has been changed from a polyester/wood pulp blend with a polyethylene coating to paper and polyester with a Hytrel polyester polyether coating. The primary advantage of the Hytrel coated material is that it is more breathable (and therefore more comfortable) than the previous material, but is still an effective barrier against fluids and microorganisms.
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The Sterile View Barrier Hood/Gown with Hytrel is also similar in design and intended use to the Stackhouse Freedom III Toga Gown and the Baxter Converters Breathable Gown.
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