(233 days)
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Not Found
No
The 510(k) summary describes surgical apparel and its material properties, with no mention of AI or ML technology.
No
The device is described as "Surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel," which indicates it is a protective barrier, not a device intended to treat or cure a disease or condition.
No.
The device is described as "Surgical apparel" intended to protect personnel and patients during surgical procedures, not to diagnose medical conditions.
No
The device is described as "Surgical apparel" and its performance studies focus on material properties like colorfastness, cytotoxicity, and flammability, indicating it is a physical product, 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 the device is "Surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel." This describes a physical barrier and protective garment, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: While "Not Found" is listed, the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information related to biological samples, analysis, or diagnostic purposes in the other sections (image processing, AI/ML, input imaging modality, anatomical site, patient age range, training/test sets, performance studies metrics) further supports that this is not an IVD.
IVDs are devices like blood glucose meters, pregnancy tests, or laboratory analyzers that are used to test samples from the body to get information about a person's health. Surgical apparel does not fit this description.
N/A
Intended Use / Indications for Use
Disposable / Single Use Only Surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel.
Product codes
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Device Description
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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
Safety and effectiveness evaluation of the fabric combinations have been performed by the material manufactures and Bemiss Jason. These evaluations have shown the materials to be colorfast and non cytotoxic. Preliminary ETO residual testing has shown to be well below the 1978 FDA proposed ETO residual quidelines. Some manufactures have shown their materials to be free of skin irritation and sensitization. Flammability classification has been determined as Class I.
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
FEB 2 7 1997
SMDA-1990 510(k) Summary -- K962666
In response to the requirements addressed by the SMDA of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is Substantial equivalence for the Bemiss Jason Surgical Gowns (reinforced and nonbased. reinforced) is claimed due to material similarities, intended uses and safety/effectiveness.
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Submitted by: A.
Bemiss Jason / Triad Medical Division 405 Walnut Street PO Box 1436 Waynesville, NC 28786 704-452-1919 Phone: Fax: 704-452-3702 -
B. Contact: Sandra L. McGee Quality Assurance/Compliance Officer
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். Submission Date: July 03, 1996
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D. Common or Usual Names: Sterile Surgical gown Non - Sterile Surgical gown
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ய் Trade or Proprietary Names:
Bemiss Jason Sterile Surgical Gown - Sontara Bemiss Jason Sterile Surgical Gown - Dexter® Bemiss Jason Sterile Surgical Gown - Securon®
Bemiss Jason Non-Sterile Surgical Gown - Sontara® Bemiss Jason Non-Sterile Surgical Gown - Dexter® Bemiss Jason Non-Sterile Surgical Gown - Securon®
Bemiss Jason Reinforced Sterile Surgical Gown - Sontara® Bemiss Jason Reinforced Sterile Surgical Gown - Dexter® Bemiss Jason Reinforced Sterile Surgical Gown - Securon®
Bemiss Jason Reinforced Non-Sterile Surgical Gown - Sontara® Bemiss Jason Reinforced Non-Sterile Surgical Gown - Dexter® Bemiss Jason Reinforced Non-Sterile Surgical Gown - Securon®
1
SMDA-1990 -- 510(k) Summary (Continued) K962666 Page 2
ட் Intended Use
Disposable / Single Use Only Surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and operating room personnel.
ું. Summary
The substantial equivalence (SE) is primarily based upon surgical gowns presently manufactured by Isolyser (Mars White Knight) composed of an SIM/S trilaminate polypropylene spunbond outers / meltblown (polypropylene) inner layer. This fabric has shown fluid and alcohol repellency. Other referenced materials have also been shown to be fluid and alcohol repellent. Physical properties comparisons have shown that not only is one of the materials identical, the other materials have similar properties. All fabrics identified have previously been on the market.
Intended uses for these materials by Bemiss Jason is consistent with current (existing) usage for surgical gowns.
Safety and effectiveness evaluation of the fabric combinations have been performed by the material manufactures and Bemiss Jason. These evaluations have shown the materials to be colorfast and non cytotoxic. Preliminary ETO residual testing has shown to be well below the 1978 FDA proposed ETO residual quidelines. Some manufactures have shown their materials to be free of skin irritation and sensitization. Flammability classification has been determined as Class I.
In summary, the materials referenced in this SE submission for 510(k) is not new, nor is it for a new intended use. The materials have been widely available and used as surgical gowns. Manufacturers are currently shaping this material into gowns in both reinforced and non-reinforced styles. Physical, aesthetic, tactile and functional qualities of the material selected for the Bemiss Jason Surgical Gowns have been analyzed and evaluated. The materials are safe for both providers and patients and effective in function when used with standard normal intended use.