(21 days)
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Not Found
No
The device description and performance studies focus on the physical properties and barrier performance of shoe covers, with no mention of AI or ML.
No.
The device's intended use is to protect individuals and prevent the transfer of microorganisms, not to treat or diagnose a disease or condition.
No
Explanation: The device is described as shoe covers intended to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Its function is protective, not diagnostic.
No
The device description clearly states it is composed of physical materials (nonwoven fabric, synthetic polymer film, polypropylene, polyethylene) and the performance studies involve physical qualification tests, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use 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 protection function, not a diagnostic function performed on in vitro samples.
- Device Description: The device is a physical barrier (shoe covers) made of fabric and film. It does not involve any reagents, assays, or analysis of biological samples.
- Performance Studies: The performance studies focus on physical properties like flammability, penetration resistance, tear strength, etc., which are relevant to barrier protection, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The Convertors® Impervious Shoe Covers are devices intended 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
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Device Description
These shoe covers will be composed of a nonwoven fabric hot melt adhesively laminated to a synthetic polymer film. The nonwoven is a 1.5 osy blue spunbonded polypropylene. The film is a 1.25 mil embossed, polyethylene.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel
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
All materials used in the fabrication of this Convertors® shoe cover materials were evaluated through physical qualification tests. The tests performed on the Shoe Covers were Flammability, Hydrostatic head, Synthetic Blood Penetration, Ph X174 Penetration, Alcohol Repellency, Trapezoic Tear, Grab Tensile, Mullen Burst, Elmendorf Tear, Basis Weight, Thickness, Coefficienct of Friction, Electrostatic Decay and Abrasion. These shoe covers have met the requirements of the applicable standards and were found to be acceptable for the intended use.
Key Metrics
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Predicate Device(s)
Kimberly-Clark X-Tra Traction Impervious Boot
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.
0
K970815:
p1/2
:
MAR 2 7 1997
Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word is a symbol that resembles a plus sign made up of many small dots. The word "Allegiance" is slightly slanted to the right, giving it a dynamic appearance.
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
XII. SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Impervious Shoe Covers
| Manufacturer: | Allegiance Healthcare Corporation
Convertors® Operations
One Butterfield Trail
El Paso, Texas 79906 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Sharon Robbins
Allegiance Healthcare Corporation
1500 Waukegan Road MPK
McGaw Park, IL 60085 |
| Telephone: | (847) 785-3311 |
| Date Summary Prepared: | March, 1997 |
| Common Name: | Convertors® Impervious Shoe Covers |
| Classification: | Class I per 21CFR § 878.4040 |
| Predicate Device: | Kimberly-Clark X-Tra Traction Impervious Boot |
| Description: | These shoe covers will be composed of a
nonwoven fabric hot melt adhesively laminated to a
synthetic polymer film. The nonwoven is a 1.5 osy
blue spunbonded polypropylene. The film is a
1.25 mil embossed, polyethylene. |
1
Image /page/1/Picture/8 description: The image shows the word "Allegiance" in a stylized, bold, black font. To the left of the word is a graphic that resembles a plus sign made up of small dots. The word "Allegiance" is written in a slightly italicized font, giving it a dynamic and forward-leaning appearance.
:
K970815
p 2/2
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2460
SMDA REQUIREMENTS (continued) XII.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Convertors® Impervious Shoe Covers
| Intended Use: | The Convertors® Impervious Shoe Covers are
devices intended 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 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Convertors® Shoe cover material is
substantially equivalent to the Kimberly- Clark
X-Tra Traction Impervious Boots in that: |
| | - the intended use is the same |
| | - the performance attributes are similar |
| Summary of testing: | All materials used in the fabrication of this
Convertors® shoe cover materials were evaluated
through physical qualification tests. The tests
performed on the Shoe Covers were Flammability,
Hydrostatic head, Synthetic Blood Penetration, Ph
X174 Penetration, Alcohol Repellency, Trapezoic
Tear, Grab Tensile, Mullen Burst, Elmendorf Tear,
Basis Weight, Thickness, Coefficienct of Friction,
Electrostatic Decay and Abrasion. These shoe
covers have met the requirements of the applicable
standards and were found to be acceptable for the
intended use. |