(41 days)
Not Found
No
The device description and intended use clearly describe a simple physical barrier made of plastic, with no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
The device is described as an "infection control barrier" intended to "reduce gross contamination and provide equipment surface protection." It does not directly treat or diagnose any medical condition.
No
The device is an infection control barrier, which is a physical cover for equipment to reduce contamination, not a tool to diagnose diseases or conditions.
No
The device is described as a physical, disposable plastic barrier, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "single use, transparent plastic, disposable, nonsterile barrier that will help reduce gross contamination and provide equipment surface protection for devices used within the dental/ clinical treatment setting." This describes a physical barrier for equipment, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces this by calling it a "single use, disposable, transparent, polyethylene plastic equipment cover."
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
- Using reagents or assays
The Brixton Infection Control Barrier is a medical device, specifically a barrier device intended to prevent contamination of equipment surfaces. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Brixton Infection Control Barrier is intended as a single use, transparent plastic, disposable, nonsterile barrier that will help reduce gross contamination and provide equipment surface protection for devices used within the dental/ clinical treatment setting. Brixton Infection Control Barriers are available in an assortment of sizes and shapes, designed to accommodate the following types of equipment:
- Light Handles
- Chairs
- Headrests
- Air and Water Syringe sleeves (ties included)
- Stools
- X-Ray Heads
- Trays
Product codes
Not Found
Device Description
The Brixton Infection Control Barrier manufactured by Filmtech. Inc. is intended as a single use, disposable, transparent, polyethylene plastic equipment cover that will help provide surface protection and reduce cross contamination of equipment used in the dental/ clinical setting. The barriers are available in a variety of sizes and shapes, dispensed in boxes containing 200, 250 or 500 covers,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental/ clinical treatment setting
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
OCT 2 4 1996
VI. 510 K Summary for Brixton Barrier Products
I. Submitted by
Filmtech, Inc. 581 McDonald Ave Brooklyn, N.Y. 11218 (718) 438-8900
Contact Person
Jacob Posner Filmtech, Inc. 581 McDonald Ave Brooklyn, N.Y. 11218 (718) 438-8900
Consultant
Suzanne Parisian, M.D. Medical Device Assistance, Inc. P.O.Box 296 Front Royal, VA 22630 (540) 636-2509
Date Prepared
September 6, 1996
- Device Name: Brixton Infection Control Barrier
Classification Name: Dental Handpiece and Accessory FDA Classification: Class II per 21 CFR 872.4200
-
Predicate Devices: Filmtech. Inc. claims substantial equivalence for their Brixton Infection Control Barrier to K900093 Dentsply International Inc. 's Disposa-Shield Infection Control Barrier and K952234 Cottrell, Ltd.'s Barrier All Film.
-
Intended Use: Brixton Infection Control Barrier is intended as a single use, transparent plastic, disposable, nonsterile barrier that will help reduce gross contamination and provide equipment surface protection for devices used within the dental/ clinical treatment setting. Brixton Infection Control Barriers are available in an assortment of sizes and shapes, designed to accommodate the following types of equipment:
- Light Handles
1
-
- Chairs
-
- Headrests
-
- Air and Water Syringe sleeves (ties included)
-
- Stools
-
- X-Ray Heads
-
- Trays
5. Device Description/ Technological Characteristics
The Brixton Infection Control Barrier manufactured by Filmtech. Inc. is intended as a single use, disposable, transparent, polyethylene plastic equipment cover that will help provide surface protection and reduce cross contamination of equipment used in the dental/ clinical setting. The barriers are available in a variety of sizes and shapes, dispensed in boxes containing 200, 250 or 500 covers,
6. Conclusion
The Brixton Infection Control Barrier has no significant difference that will alter the effect or raise new issues of safety and effectiveness; has substantially equivalent technological and performance characteristics as the predicate devices; and raises no new types of safety or effectiveness questions. All characteristics of the Brixton Control Barriers support the finding of substantial equivalence.