(616 days)
Not Found
No
The device description and performance studies focus on the physical mechanism of air filtration and flow, with no mention of AI or ML components.
No.
The device is intended to reduce the presence of particulate matter and microorganisms at the surgical site, not to treat a specific medical condition or disease. It provides an environmental control rather than a direct therapeutic intervention on the patient.
No
The device is described as an "Air Barrier System" that produces a directed flow of HEPA-filtered air to a surgical site to reduce particulate matter and microorganisms, preventing infection during hip arthroplasty. Its purpose is to perform a therapeutic or preventative function by maintaining sterility, not to diagnose a condition or disease.
No
The device description clearly outlines physical hardware components: a Filter/Blower and an Air Delivery System (including a Hose and Nozzle). This is not a software-only device.
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 taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Air Barrier System (ABS) is a physical device that creates a barrier of filtered air at a surgical site. It does not analyze any biological specimens from the patient.
- Intended Use: The intended use is to reduce airborne particulate matter and microorganisms at the surgical site during hip arthroplasty, which is a physical intervention, not a diagnostic process.
- Performance Studies: The performance studies measure the reduction of airborne particles and microorganisms in the environment around the surgical site, not the analysis of patient samples.
Therefore, the Air Barrier System falls under the category of a surgical device or an environmental control device used in a surgical setting, not an In Vitro Diagnostic device.
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-fittered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on anatomical surface with no gap between the bottom of the nozzle and the surface, (2) the incision plane is parallel to the direction of airflow, 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 (comma separated list FDA assigned to the subject device)
ORC
Device Description
The Air Barrier System (ABS) is used in the surgical operating room. The Air Barrier System (ABS) has two components: a Filter/Blower and an Air Delivery System. The Filter/Blower is nonsterile and reusable. The Air Delivery System is sterile, single-use. The ABS Filter/Blower captures and filters ambient air found in a typical surgical operating room through a High Efficiency Particle Arresting (HEPA) filter. The HEPA filtered air leaves the Filter/Blower via the exit port where it is connected to the Hose portion of the sterile, single-use Air Delivery System. The Hose ends in the Nozzle portion of the Air Delivery System; the Nozzle is gently applied to the incision drape adjacent to a surgical incision. The Nozzle delivers HEPA filtered air directly to the surgical site area to reduce the presence of airborne particulate and microorganisms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site during hip arthroplasty
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical operating room
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Data: Bench testing included: medical electrical safety, electromagnetic compatibility, sterilization, biocompatibility, microbial precipitation testing, simulated use performance testing, simulated worst-case use performance testing, cadaver surgical procedure testing, maximum air velocity testing in simulated and actual OR settings, turbulence testing at distances from simulated incision sites, and turbulence testing in clinical environment. Results of all bench and cadaver testing demonstrate the safety and effectiveness of the Air Barrier System and its substantial equivalence to the predicate device.
Clinical Performance Data: A clinical study at a single investigator was conducted to demonstrate the performance characteristics of the Air Barrier System (ABS) during total hip arthroplasty surgery. 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 samples were the nt ten-minute increments throughout the duration of the surgical procedures. The airborne particulate and microorganism counts observed in the experiment group (with the ABS device active) 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
APPENDIX B
510(k) SUMMARY - K092801
The 510(k) Summary is submitted per 21 CFR Section 807.92(c)
Submitter's Name: Nimbic Systems, Inc.
Submitter's Address: 4910 Wright Road, Suite 170, Stafford, Texas 77477
125 Telephone: 281-565-5715
Fax: 281-565-5712
Contact Person: Sean D. Self
Date Prepared: 1 April 2011
Device Trade Name: Air Barrier System
130 Device Common Name: Air Barrier System or ABS
Device Classification Name: Air Handling Apparatus for Surgical Operating Room
Device Classification: Class II
Summary of Substantial Equivalence: The design, materials, mode of operation and intended use features and performance of the ABS System is substantially equivalent with regard to features and performance of the predicate device, SIBS (K831531).
Device Description: The Air Barrier System (ABS) is used in the surgical operating room. The Air Barrier System (ABS) has two components: a Filter/Blower and an Air Delivery System. The Filter/Blower is nonsterile and reusable. The Air Delivery System is sterile, single-use. The ABS Filter/Blower captures and filters ambient air found in a typical surgical operating room through a High Efficiency Particle Arresting (HEPA)
- The HEPA filtered air leaves the Filter/Blower via the exit port where it is connected to the Hose 140 filter. portion of the sterile, single-use Air Delivery System. The Hose ends in the Nozzle portion of the Air Delivery System; the Nozzle is gently applied to the incision drape adjacent to a surgical incision. The Nozzle delivers HEPA filtered air directly to the surgical site area to reduce the presence of airborne warticulate and microorganisms.
145 Indications for Use:
150
135
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-fittered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on anatomical surface with no gap between the bottom of the nozzle and the surface, (2) the incision plane is parallel to the direction of airflow, 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.
1
Image /page/1/Picture/0 description: The image shows a handwritten string of characters. The string starts with the letter 'K', followed by the numbers '092801'. The characters are written in a cursive style, with the numbers being slightly slanted. The image has a white background.
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Technological Characteristics: Comparisons of the ABS System and predicate device show that technological 155 characteristics such as materials, biocompatibility, mode of operation, performance properties, sterilization and packaging are substantially equivalent to the predicate device.
Non-clinical Performance Data: Bench testing included: medical electrical safety, electromagnetic compatibility, sterilization, biocompatibility, microbial precipitation testing, simulated use performance 160 testing, simulated worst-case use performance testing, cadaver surgical procedure testing, maximum air velocity testing in simulated and actual OR settings, turbulence testing at distances from simulated incision sites, and turbulence testing in clinical environment. Results of all bench and cadaver testing demonstrate the safety and effectiveness of the Air Barrier System and its substantial equivalence to the predicate device. -
Clinical Performance Data: A clinical study at a single investigator was conducted to demonstrate the performance characteristics of the Air Barrier System (ABS) during total hip arthroplasty 165 surgery. 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,
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but not within the ABS area of effect. The airborne particulate and microorganism samples were the nt 170 ten-minute increments throughout the duration of the surgical procedures. The airborne particulate and microorganism counts observed in the experiment group (with the ABS device active) were significantly lower (P