(203 days)
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No
The device description and intended use are solely focused on physical splash protection and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is a face shield intended to protect operating room personnel from splashes and the transfer of microorganisms, rather than to treat or diagnose a disease or condition in a patient.
No
The device is a face shield intended to provide splash protection during surgical procedures, not to diagnose a medical condition.
No
The device description clearly outlines physical components made of polycarbonate and PETG, indicating it is a hardware device (face shields and goggles). There is no mention of software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing splash protection to operating room personnel during surgical procedures. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components of face shields and goggles designed for protection. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a personal protective equipment (PPE) designed for physical protection in a surgical setting.
N/A
Intended Use / Indications for 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 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 reusable.
Product codes
79 FXX
Device Description
The Opti-Con Faceshield System consists of a disposable faceshield which is designed to provide splash protection to the wearer's eves, nose, mouth and ears during surgical procedures and re-usable headgear which fits over the top of the head and holds the faceshield in place. The disposable faceshields are manufactured from polycarbonate and are available in a standard and a long length, either sterile or nonsterile. The Opti-Con Faceshields are substantially equivalent to the Splash Shields in that they have similar designs and the same intended use. Impact testing of both designs demonstrates that the impact resistance of the Opti-Con Shields is greater than that of the Splash Shields.
The E-Z Shield is a one-piece disposable faceshield and headband which is also designed to provide splash protection to the wearer's eyes, nose, mouth and ears during surgical procedures. The E-Z Shield is identical to the Splash Shield Splash Shield but is relabeled by DePuy. The E-Z Shield is manufactured from PETG as is the faceshield of the DePuy Disposable Filter/Hood.
The Opti-Con goggles are disposable goggles designed to protect the eyes during surgical procedures. They are substantially equivalent to the DePuy Shades Protective Glasses in that they have similar designs, the same intended use, and both are manufactured from polycarbonate.
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 / surgical procedures
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)
Impact testing of both designs demonstrates that the impact resistance of the Opti-Con Shields is greater than that of the Splash Shields.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
MAY -6 1997
510(k) SUMMARY (K964114)
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|--------------------------------------|-------------------------------------------------------------------|
| 510(k) CONTACT: | Cheryl Hastings
Manager, Clinical Affairs |
| TRADE NAME: | DePuy Opti-Con and E-Z Shield Systems |
| COMMON NAME: | Surgical faceshields |
| CLASSIFICATION: | 878.4040 Surgical apparel |
| DEVICE PRODUCT CODE: | 79 FXX |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | · Splash Shield Splash Shields
· DePuy Disposable Filter/Hood |
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 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 reusable.
· DePuy Shades™ Protective Glasses
DEVICE DESCRIPTIONS AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The Opti-Con Faceshield System consists of a disposable faceshield which is designed to provide splash protection to the wearer's eves, nose, mouth and ears during surgical procedures and re-usable headgear which fits over the top of the head and holds the faceshield in place. The disposable faceshields are manufactured from polycarbonate and are available in a standard and a long length, either sterile or nonsterile. The Opti-Con Faceshields are substantially equivalent to the Splash Shields in that they have similar designs and the same intended use. Impact testing of both designs demonstrates that the impact resistance of the Opti-Con Shields is greater than that of the Splash Shields.
The E-Z Shield is a one-piece disposable faceshield and headband which is also designed to provide splash protection to the wearer's eyes, nose, mouth and ears during surgical procedures. The E-Z Shield is identical to the Splash Shield Splash Shield but is relabeled by DePuy. The E-Z Shield is manufactured from PETG as is the faceshield of the DePuy Disposable Filter/Hood.
The Opti-Con goggles are disposable goggles designed to protect the eyes during surgical procedures. They are substantially equivalent to the DePuy Shades Protective Glasses in that they have similar designs, the same intended use, and both are manufactured from polycarbonate.