(94 days)
No
The description focuses on the physical components and intended use of a conventional oral airway, with no mention of AI or ML.
No
The device is an oropharyngeal airway used to maintain a patent airway and facilitate fiberoptic intubation, which are supportive functions for medical procedures rather than directly treating a disease or condition.
No
Explanation: The device is described as an oropharyngeal airway used to maintain a patent airway and facilitate fiberoptic tracheal intubation. Its function is to provide an airway, not to diagnose a condition.
No
The device description clearly states it is a physical device made of PVC and polyurethane, designed for oral insertion. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is an "oropharyngeal airway" used to "maintain a patent airway through the mouth to the pharynx and allow fiberoptic tracheal intubation." This is a mechanical device used to facilitate breathing and a medical procedure (intubation).
- No Sample Analysis: There is no mention of the device being used to analyze any biological samples. Its function is purely physical.
Therefore, based on the provided information, the Rusch Optosafe is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Rusch Optosafe, sterile, for oral insertion to provide an airway though the patient's mouth and allow fiberoptic tracheal intubation is substantially equivlent in design, use and materials to the Williams Airway Intubator K830767 currently being marketed and sold in inter-state commerce.
The device is designed as a single use, sterile, oropharyngeal airway to maintain a patent airway through the mouth to the pharynx and allow fiberoptic tracheal intubation. It will be available in a variety of sizes from 5 to 17 mm inside diameters.
Product codes
Not Found
Device Description
The device consists of a clear, implant tested, PVC tube formed into the conventional hooked shape of an oral airway. The tube is bonded with a polyurethane adhesive to a clear implant tested PVC bite block and flange molding. The flange is printed with the manufacturer's name, date code and size (nominal inner diameter of tube).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth to the pharynx
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
§ 868.5110 Oropharyngeal airway.
(a)
Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
0
Image /page/0/Picture/0 description: The image shows the logo for RUSCH International Group Regulatory Affairs, a subsidiary of Teleflex Incorporated (USA). The word "RUSCH" is in large, bold, black letters. Below that, in smaller letters, is "INTERNATIONAL Group Regulatory Affairs A Subsidiary of Teleflex Incorporated (USA)".
Tall Pines Park Jaffrey, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
To: Whom it mav concern
Substantial Equivalence 510(k) Summary
Reference: Rusch Optosafe
The Rusch Optosafe, sterile, for oral insertion to provide an airway though the patient's mouth and allow fiberoptic tracheal intubation is substantially equivlent in design, use and materials to the Williams Airway Intubator K830767 currently being marketed and sold in inter-state commerce.
The device consists of a clear, implant tested, PVC tube formed into the conventional hooked shape of an oral airway. The tube is bonded with a polyurethane adhesive to a clear implant tested PVC bite block and flange molding. The flange is printed with the manufacturer's name, date code and size (nominal inner diameter of tube).
The device is designed as a single use, sterile, oropharyngeal airway to maintain a patent airway through the mouth to the pharynx and allow fiberoptic tracheal intubation. It will be available in a variety of sizes from 5 to 17 mm inside diameters.
Based upon the equivalence in materials, design and intended use between this tube and others presently being marketed and sold, no difference in safety and effectiveness is forecasted.
signed
Authorized, Regulatory Affairs Department 11 January 1996