AMMI MAGNI-GUARD

K961454 · American Medical Mfg., Inc. · LYU · Jul 25, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K961454
• Device Name: AMMI MAGNI-GUARD
• Applicant: American Medical Mfg., Inc.
• Product Code: LYU · General, Plastic Surgery
• Decision Date: Jul 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 1

Indications for Use

Magni-Guard functions in the same manner as predicate devices in that it provides protection to the surgical staff during surgical procedures. The concept of use is to hold it with one hand over a surgical site before releasing clamps from blood vessel grafts or during heavy irrigation to prevent blood splashing.

Device Story

Magni-Guard is a handheld splash prevention device used by surgical staff in the operating room. It consists of a clear, rigid, circular plastic guard (styrene or PETG) with raised side walls and an extended handle. The nurse holds the device over the surgical site during procedures involving potential blood splashing, such as clamp release from blood vessel grafts or heavy irrigation. The device acts as a physical barrier to protect staff from fluid exposure. It is disposable and sterile.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Styrene and PETG. Design: Circular guard with .325" side walls and extended handle. Dimensions: 4" diameter. Properties: Puncture resistant, impact penetration resistant. Sterilization: Sterile. Disposable.

Indications for Use

Indicated for use by surgical staff to prevent blood splashing during surgical procedures, specifically during clamp release from blood vessel grafts or heavy irrigation.

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

• Four inch Petri-Dish
• Clear Needle Counters
• Face Guards

Submission Summary (Full Text)

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K961454
570(k) Summary
K961454
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JUL 25 1996

ATTACHMENT 4

AMMI
MAGNI-GUARD - Splash Prevention Device
510(k) Summary

SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION UPON WHICH AN EQUIVALENCE DETERMINATION COULD BE BASED

SUBMITTER INFORMATION
NAME: American Medical Manufacturing, Inc. (AMMI) TELEPHONE: [phone]
ADDRESS: 9410 DeSoto St. Unit J CONTACT: Mike Hoftman
Chatsworth, CA 91311 DATE OF PREPARATION: April 11, 1996

DEVICE NAMES
NAME: AMMI MAGNI-GUARD™
COMMON/USUAL NAME: SPLASH PREVENTION DEVICE
CLASSIFICATION NAME (if known): Not Known

PREDICATE OR LEGALLY MARKETED DEVICES
Various Companies; Four inch Petri-Dish
Various Companies; Clear Needle Counters
Various Companies; Face Guards

DEVICE DESCRIPTION AND INTENDED USE

Magni-Guard functions in the same manner as predicate devices in that it provides protection to the surgical staff during surgical procedures. The basic scientific concept that forms the basis for the Magni-Guard is that it consists of a clear, rigid, see through plastic. The Guard is made from styrene or PETG. The clear guard has raised side walls throughout its circumference (identical to a Petri-Dish) to prevent the splashing of blood across the surgical suite. It further has an extended handle attached to the circular guard for the nurse to hold over the surgical site as required intermittently during the surgical procedure. The significant physical and performance characteristics of the devices are noted below.

Device/Design/Materials Used/Physical Properties: Magni-Guard includes the same components as other marketed predicate devices. The concept of use is to hold it with one hand over a surgical site before releasing clamps from blood vessel grafts or during heavy irrigation to prevent blood splashing.

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# TECHNOLOGICAL COMPARISON WITH PREDICATE OR LEGALLY MARKETED DEVICE(S)

| Characteristics | Petri-Dish | 1/2 Needle Counter Box | Face Shield | AMMI |
| --- | --- | --- | --- | --- |
| Guard | Clear | Clear | Clear | Clear |
| Side Walls | Yes | Yes | n/a | Yes |
| Size | 4" Diameter | 3"x"4 Rectangular | 3"x6" Rectangular | 4" Diameter |
| Holding | 1 or 2 Hands | 1 or 2 Hands | N/A - On Face | 1 Hand |
| Disposable | Yes | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes | Yes |
| Design | Round Guard with Side Walls | Rectangular with Side Walls | Rectangular without side Walls | Round with Side Walls and Handle |
| Mat'l Wall Thickness | .030" | .055" | .005" | .030" |
| Materials | Styrene | Styrene | PETG | Styrene and PETG |
| Puncture Resistance | Yes | Yes | Yes | Yes |
| Resistant to Impact Penetration | Yes | Yes | Yes | Yes |
| Side Wall Height | .340 | .305 | No Side Walls | .325 |