(101 days)
Four inch Petri-Dish, Clear Needle Counters, Face Guards
Not Found
No
The device description and intended use clearly describe a physical barrier device with no mention of software, algorithms, or data processing capabilities.
No.
The device functions to protect surgical staff from splashing blood during surgery, not to treat a medical condition or ailment in a patient.
No
Explanation: The device description states its function is to provide protection to surgical staff by preventing blood splashing, not to diagnose any condition or disease.
No
The device description clearly states it is a physical object made of plastic with a handle, designed to be held over a surgical site. This is a hardware device, not software.
Based on the provided information, the Magni-Guard is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens obtained from the human body. The Magni-Guard's intended use is to provide physical protection to surgical staff during procedures by preventing blood splashing. It does not interact with or analyze any biological specimens.
- The device description focuses on physical properties and function. It describes a clear plastic guard with raised walls and a handle, designed to physically block splashing. This is a mechanical function, not a diagnostic one.
- The predicate devices listed are not IVDs. Petri dishes, needle counters, and face guards are all physical barriers or containers used in medical settings, not diagnostic tools.
Therefore, the Magni-Guard is a medical device, but it falls under a different classification than an IVD.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
The basic scientific concept that forms 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 surgical site as required intermittently during the surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical staff / surgical suite
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Various Companies; Four inch Petri-Dish, Various Companies: Clear Needle Counters, Various Companies; Face Guards
Reference Device(s)
Not Found
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.
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ATTACHMENT 4
Image /page/0/Picture/2 description: The image shows the text "LL 25 mg" in a bold, sans-serif font. The letters "LL" are slightly smaller than the numbers "25", and the unit "mg" is also in a smaller font size. The text appears to be part of a label or packaging, possibly indicating the dosage of a medication or supplement. The black text stands out against what is presumed to be a lighter background.
510(K)
Summary
K961454
AMMI AGNI-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: (818) 701-7171 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 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 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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K961454
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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 |