(157 days)
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No
The device description and performance studies focus on the physical properties of the fabric and its similarity to a predicate device, with no mention of AI or ML.
No
Explanation: The device is a surgeon's vest for protection during surgery, not for treating or diagnosing a medical condition. Its description focuses on protective features (fluid resistance, flame resistance) and disposal, not therapeutic action. The performance studies also focus on biocompatibility and similarity to a predicate protective device.
No
Explanation: The device is described as a "surgeon's vest" used for "additional protection for surgeons during a surgical procedure." Its properties relate to material characteristics (flame resistant, fluid resistant, low lint, strong, tear resistant, dissolvable) for protective purposes, not for diagnosing medical conditions.
No
The device description clearly describes a physical garment (a surgeon's vest) made of fabric, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a "surgeon's vest" for "additional protection for surgeons during a surgical procedure." This is a protective garment used on a person during a medical procedure, not a device used to examine specimens in vitro (outside of the body) to diagnose or monitor a condition.
- Device Description: The description focuses on the physical properties of the vest and its material (flame resistant, fluid resistant, low lint, strength, tear resistant, dissolvable). These are characteristics of a protective barrier, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for protection during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A surgeon's vest contructed of OREX nonwoven fabric for use as additional protection for surgeons during a surgical procedure.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
A surgeon's vest contructed of OREX nonwoven fabric for use as additional protection for surgeons during a surgical procedure. The material is flame resistant, and is resistant to fluid penetration. The material also has low lint characteristics, meets suitable strength requirements for its intended use, and is resistant to tearing. The material is dissolvable after use in an OREX processor or may be disposed of using the hospital or healthcare facilities standard disposal method.
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
surgeons during a surgical procedure. The material is dissolvable after use in an OREX processor or may be disposed of using the hospital or healthcare facilities standard disposal method.
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
All testing conducted on the fabric used in this product was tested according to guidance documents published for biocompatibility.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results from these tests were found to be acceptable when compared to that of the predicate device. In some instances test results were found to exceed those of the predicate device. Through these test results determination has been established that this device and the predicate device are similar in use and functionality.
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
Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "K961083". The characters are written in a bold, sans-serif font and are black against a white background.
P.2/2
AUG 23 1996
510 (k) Summary
The Isolyser Company, Inc. 4320 International Boulevard Norcross, Georgia 30093 770-381-7566
Contact Person: Thomas Bonner - V.P. Regulatory Affairs
Date summary prepared: May 31, 1996
OREX Surgeon's Vest
Legally marketed equivelent device: Surgeon's Vest Isolyser/White Knight
Material: OREX nonwoven fabric
Description of Device: A surgeon's vest contructed of OREX nonwoven fabric for use as additional protection for surgeons during a surgical procedure. The material is flame resistant, and is resistant to fluid penetration. The material also has low lint characteristics, meets suitable strength requirements for its intended use, and is resistant to tearing. The material is dissolvable after use in an OREX processor or may be disposed of using the hospital or healthcare facilities standard disposal method.
All testing conducted on the fabric used in this product was tested according to guidance documents published for biocompatibility. The results from these tests were found to be acceptable when compared to that of the predicate device. In some instances test results were found to exceed those of the predicate device. Through these test results determination has been established that this device and the predicate device are similar in use and functionality.