(449 days)
Not Found
No
The description focuses on the physical mechanism of air filtration and flow, with no mention of AI/ML for control, analysis, or any other function. The performance studies describe clinical trials measuring the effectiveness of the physical barrier.
No.
The device produces a non-turbulent flow of HEPA-filtered air to reduce particulate matter and microorganisms at the surgical site, but it does not directly treat a medical condition or ailment. It is a system for controlling contaminants in the surgical environment, not a therapeutic intervention for the patient.
No
The device is a portable system that generates a directed flow of HEPA-filtered air to a surgical site to reduce particulate matter and microorganisms during surgery. It is designed to act as a barrier and is not described as diagnosing any condition.
No
The device description clearly outlines two hardware components: a Filter/Blower and an Air Delivery System (consisting of an Air Supply Hose and Nozzle). This indicates it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Air Barrier System (ABS) is a physical device that creates a sterile air environment over a surgical site. It filters ambient air and directs it to reduce airborne contaminants.
- Intended Use: The intended use is to reduce particulate matter and microorganisms at the surgical site during surgery, not to analyze biological specimens from the patient.
- Device Description: The description focuses on the mechanical components (filter, blower, hose, nozzle) and their function in creating an air barrier.
- Performance Studies: The performance studies measure the reduction of airborne particles and microorganisms in the surgical environment, not the analysis of patient samples.
The ABS is a device used in vivo (on or within the living body, in this case, the surgical environment around the body) to maintain a sterile field, not to perform diagnostic tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Air Barrier System is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty and posterior vertebral fusion and laminoplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on an anatomical surface with no gap between the bottom of the nozzle and the surface, (2) the incision plane is parallel with the direction of air flow, and (3) the incision dimensions are within: 6" (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable at a distance of 20 inches from the Nozzle, and effectiveness depreciates beyond this specified area.
Product codes
ORC
Device Description
The ABS device controls the airborne surgical environment at a specific and limited location adjacent to and over surgical incisions by emitting a non-turbulent flow of HEPA filtered air that displaces the presence of airborne colony-forming units and particulate matter within surgical site dimensions of 6" (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable outside of these dimensions and effectiveness depreciates beyond this specified area.
The Air Barrier System (ABS) has two components: a Filter/Blower and an Air Delivery System.
The ABS Filter/Blower filters ambient air found in a typical surgical operating room through a High Efficiency Particle Arresting (HEPA) filter. The HEPA filtered air exits the Filter/Blower from an exit port on the top of the unit. The Filter/Blower is nonsterile and reusable.
The Air Delivery System, consisting of an Air Supply Hose and Nozzle, is sterile, single-use. The Nozzle portion is applied to the surgery site, on top of the incision drape and adjacent to a surgical incision. The end of the Air Supply Hose is plugged into the Filter/Blower's air exit port. HEPA filtered air then flows through the Air Supply Hose through the Nozzle and directly to the incision site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site, hip, posterior vertebral, incision site
Indicated Patient Age Range
Patient age restrictions: none.
Intended User / Care Setting
surgical operating room, clinical settings
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
Clinical studies were conducted at two sites by different investigators.
First study: Twenty-nine (29) patients were randomized into one of three groups: with the ABS active (experiment), with the ABS present but not active (sham), and with no ABS device present (control). Airborne particulate and microorganism samples were collected simultaneously at a discrete single location at the surgical incision within the ABS area of effect and from a discrete single location within the sterile field, but not within the ABS area of effect.
Second study: Thirty-eight (38) patients undergoing instrumented posterior vertebral fusion or laminoplasty were randomized into one of two groups: with the ABS device (experiment) and with no ABS device (control). Airborne particulate and microorganism samples were collected simultaneously at a discrete single location at the surgical incision in both groups at ten-minute intervals for the first 100 minutes of the procedures.
Additional clinical data was provided in this submission demonstrating clinical performance of the ABS during posterior cervical and lumbar fusion procedures at the Michael E. DeBakey VA Medical Center (MEDVAMC). This was a prospective randomized trial with one control group and one experiment group with an enrollment of up to 40 patients (41 patients actually enrolled). Statistically valid conclusions were able to be made regarding the ABS intended use after analyzing 38 surgery cases.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical studies at two sites by different investigators have been conducted to demonstrate the performance characteristics of the Air Barrier System (ABS) during surgical procedures:
In the first study, twenty-nine (29) patients were randomized into one of three groups: with the ABS active (experiment), with the ABS present but not active (sham), and with no ABS device present (control). The airborne particulate and microorganism counts observed in the experiment group were significantly lower (P
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
510(k) Summary
Date Prepared: December 9, 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Air Barrier System (ABS).
1. Company making the submission:
| Owner/Submitter: | Nimbic Systems, Inc.
4910 Wright Road, Suite 170
Stafford, Texas 77477 |
|------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Sean Self
President
281-565-5715
281-565-5712 fax
self@nimbicsystems.com |
2. Device Name and Classification:
| Common/Usual Name | : | Air-handing apparatus for a surgical
operation room |
|-------------------|---|--------------------------------------------------------|
| Proprietary Name | : | Air Barrier System (ABS) |
| Device Class | : | Class II |
| Regulation Number | : | 21 CFR 878.5070 |
| Product Code | : | ORC |
| 510(k) Number | : | K123006 |
3. Predicate Device
This submission for the Air Barrier System (ABS) Model 5001 is for new claims only. The Air Barrier System (ABS) Model 5001 specifications are the same as the model 1001 released to market [K092801]. The Air Barrier System (ABS) Model 1001 is the primarily predicate device.
4. Intended Use Statement
The Air Barrier System is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty and posterior vertebral fusion and laminoplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on an anatomical surface with no gap between the bottom of the
1
nozzle and the surface. (2) the incision plane is parallel with the direction of air flow, and (3) the incision dimensions are within: 6" (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable at a distance of 20 inches from the Nozzle, and effectiveness depreciates beyond this specified area.
5. Description of Device
The ABS device controls the airborne surgical environment at a specific and limited location adjacent to and over surgical incisions by emitting a non-turbulent flow of HEPA filtered air that displaces the presence of airborne colony-forming units and particulate matter within surgical site dimensions of 6" (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable outside of these dimensions and effectiveness depreciates beyond this specified area.
Clinical studies at two sites by different investigators have been conducted to demonstrate the performance characteristics of the Air Barrier System (ABS) during surgical procedures:
In the first study, twenty-nine (29) patients were randomized into one of three groups: with the ABS active (experiment), with the ABS present but not active (sham), and with no ABS device present (control). Airborne particulate and microorganism samples were collected simultaneously at a discrete single location at the surgical incision within the ABS area of effect and from a discrete single location within the sterile field, but not within the ABS area of effect. The airborne particulate and microorganism counts observed in the experiment group were significantly lower (P