(329 days)
Not Found
No
The device description and performance studies focus on the physical properties and fluid barrier capabilities of a boot, with no mention of AI or ML.
No
The device is described as a fluid barrier boot for protection in a hospital environment, and its performance study focuses on viral penetration; there is no indication of it being used for treatment or diagnosis.
No
Explanation: The device, a Fluid Barrier Boot, is described as providing protection from fluids in a hospital environment. There is no mention of it being used to diagnose any medical conditions.
No
The device description clearly states it is manufactured from Poly Vinyl and is a physical boot, 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 provide protection from fluids in a hospital environment. This is a barrier function, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device is a physical boot made of Poly Vinyl. It does not involve any reagents, instruments, or procedures for analyzing biological samples.
- Performance Studies: The performance study focuses on fluid penetration, which is relevant to its barrier function, not diagnostic accuracy.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, treatment, or prevention of disease. The Fluid Barrier Boot does not fit this description.
N/A
Intended Use / Indications for Use
The Fluid Barrier Boot will be used in indications which are the same as that for other shoe covers. Specifically, the Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.
The Fluid Barrier Boot is a disposable product intended for single use only.
Product codes
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Device Description
The Fluid Barrier Boot is manufactured from 6 gauge Poly Vinyl and is available in both knee-high or ankle high boots is small, medium or large sizes. The boots are secured with straps both at the ankle and over the call on the knee-high boot. The ankle-high boot secures only at the ankle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Footwear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The claim of the fluid barner name was substantiated by Instrument Makar's 6 gauge Poly-Vinyl passing the "Viral Ponetration Tost" ASTM Method F1671-95. Thirty-live samples were actor failurs. All samples 32 samples passed showing no SX174 on the assay plates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
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
K95835
Nov 1 9 1896
510(k) Summary of Safety and Effectiveness
| Submitter: | Instrument Makar, Inc.
2950 E. Mount Hope
Okemos, MI 48864 | Date of Summary: | 12/21/95 |
|------------|------------------------------------------------------------------|------------------------------------|----------|
| Phone: | (517) 332-3593 | | |
| Fax: | (517) 332-1870 | | |
| Contact: | Autumn Johnson | | |
| Product: | Classification Name: | Surgical Apparel (21 CFR 878.4040) | |
| | Generic Name: | Shoe Cover | |
| | Trade/Proprietary Name: | Fluid Barrier Knee-High Boots | |
Substantially Equivalent Product:
Depuy .................. Sterile View Knee-High Boots
Description:
The Fluid Barrier Boot is manufactured from 6 gauge Poly Vinyl and is available in both knee-high or ankle high boots is small, medium or large sizes. The boots are secured with straps both at the ankle and over the call on the knee-high boot. The ankle-high boot secures only at the ankle.
Intended Use:
The Fluid Barrier Boot will be used in indications which are the same as that for other shoe covers. Specifically, the Fluid Barrier Boot is intended to be used in the hospital environment to provide protection from all types of fluids in the Operating Room, Central Sterile and in the Emergency Room.
The Fluid Barrier Boot is a disposable product intended for single use only.
Comparison to Substantially Equivalent Product:
The Fluid Barrier Boot has the same intended use as the Sterile View Boot.
1
ு. இத
Summary of Safety and Effectiveness
The Fluid Barrier Boots, developed by Instrument Makar, Inc., are substantially equivalent to the Sterile View Knee-High Boots from Depuy (K914702)
These products compare as shown in the table below.
| | Instrument Makar, Inc. Depuy
Fluid Barrier
Knee-High Boots | Sterile View
Knee-High Boots |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Usc | Protect user from fluids in
hospital environment | Protect user from fluids in
hospital environment |
| Design | Heat Sealed boot provides
protection to just below the knee.
It is secured at both the ankle
and calf by two vinyl straps
manufactured with the same
material. | Boot provides protection to just
below the knee. It is secured at
the ankle by a strap and at the
calf by a stretch release top. |
| Materials | 6 gauge Heat Sealed Poly-Vinyl | Tyvek and Vinyl |
| Physical Safety | Embossed Vinyl to prevent
slippage | Skid-resistance surface on sole
of boot |
| Target Population | Hospital Personnel | Hospital Personnel |
| Biocompatibility | Boot is worn over shoes and
scrubs, therefore, will not be in
contact with user's skin. | Boot is worn over shoes and
scrubs, therefore, will not be in
contact with user's skin. |
| Anatomical Sites | Footwear | Footwear |
| Additional Notes | Sold Non-Sterile | Sold Non-Sterile |
The claim of the fluid barner name was substantiated by Instrument Makar's 6 gauge Poly-Vinyl passing the "Viral Ponetration Tost" ASTM Method F1671-95. Thirty-live samples were actor failurs. All samples 32 samples passed showing no $X174 on the assay plates.