FLUID BARRIER BOOT KNEE & ANKLE-HIGH

K955835 · Instrument Makar, Inc. · FXP · Nov 19, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K955835
• Device Name: FLUID BARRIER BOOT KNEE & ANKLE-HIGH
• Applicant: Instrument Makar, Inc.
• Product Code: FXP · General, Plastic Surgery
• Decision Date: Nov 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 1

Intended Use

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.

Device Story

Fluid Barrier Knee-High Boots; disposable shoe covers; manufactured from 6 gauge Poly Vinyl; heat-sealed construction; secured via ankle and calf straps; worn over shoes/scrubs in hospital settings (OR, Central Sterile, ER); protects personnel from fluid exposure; embossed surface prevents slippage; non-sterile.

Clinical Evidence

Bench testing only. ASTM Method F1671-95 (Viral Penetration Test) performed on 32 samples of 6 gauge Poly-Vinyl material. Zero failures reported; no φX174 detected on assay plates.

Technological Characteristics

Material: 6 gauge Poly Vinyl; heat-sealed construction; embossed surface for slip resistance; secured with vinyl straps at ankle and calf; disposable; non-sterile.

Indications for Use

Indicated for hospital personnel requiring fluid protection in operating rooms, central sterile, and emergency rooms. Not for direct skin contact; worn over shoes and scrubs.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sterile View Knee-High Boots (K914702)

Submission Summary (Full Text)

{0}

Nov 14, 1996 05:46PM FROM instrument Yakar Inc
2.02
K955835
NOV 19 1996

# 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: [phone]

Fax: [phone]

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 calf 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}

Nov 14, 1996 05:46PM FROM instrument takar Inc
P.03
K955835

# 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.

| Intended Use | 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 barrier name was substantiated by Instrument Makar's 6 gauge Poly-Vinyl passing the "Viral Penetration Test" ASTM Method F1671-95. Thirty-two samples were tested. There were zero failures. All samples 32 samples passed showing no φX174 on the assay plates.

TOTAL P.03