(199 days)
The Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is indicated to improve direct visualization of larynx and assist in both non-complicated and difficult intubation of unpredictable airway condition.
GSV200.DBL is designed to assist in tracheal intubation procedure by direct visualization of laryngeal anatomy in closed position and use movable blade with camera as accessory from different angle in open position. The physical shape of GSV200.DBL is a modification of traditional Macintosh blade similar to Propper flip tip laryngoscope with added movable blade with camera as accessory to provide visualization to insert endotracheal tube.
Girgis Scope Video DBL is designed to use two power sources, one in the stationary handle for fiber optic illumination of the airway and the second in the DVR monitor to illuminate the Larynx for the video camera. Battery chargers, cables to computer and cable to connect to TV screen are accessories included in the kit. The GSV200.DBL is provided non-sterile and is reusable and can be disassembled to provide cleaning and disinfection.
The provided document is a 510(k) summary for the Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL). It outlines the device's characteristics and compares it to a predicate device, concluding that it is substantially equivalent. However, it explicitly states, "No clinical studies were conducted." Therefore, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria with a specified performance, sample sizes, ground truth establishment, or expert evaluations.
The document primarily focuses on non-clinical performance data, which consists of adherence to various electrical safety and biocompatibility standards, and a simulated use/usability study.
Here's a breakdown of the available information and a direct statement about what is not present:
1. Table of acceptance criteria and reported device performance:
The document does not provide a table of acceptance criteria with corresponding device performance metrics from a clinical study. The conclusion section mentions that "the usability study demonstrated ease-of-use of the system," but no specific performance metrics or acceptance criteria for this usability are detailed.
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable, as no clinical efficacy study was performed. For the "Simulated Use/Usability study," the sample size is not specified, only the roles of the participants: Anesthesiologists, Emergency Room Physicians, and Emergency Medical Service (EMS).
- Data provenance: Not applicable for a clinical study. For the usability study, it's a simulated use, likely conducted in a controlled environment, not a retrospective or prospective study from a specific country.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable, as no clinical efficacy study was performed requiring ground truth established by experts.
4. Adjudication method for the test set:
Not applicable, as no clinical efficacy study was performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size:
No MRMC comparative effectiveness study was done.
6. If a standalone performance study was done:
No standalone (algorithm only without human-in-the-loop performance) study was done, as this refers to a medical device, not an AI algorithm.
7. The type of ground truth used:
Not applicable, as no clinical efficacy study was performed.
8. The sample size for the training set:
Not applicable, as no AI algorithm was developed or trained.
9. How the ground truth for the training set was established:
Not applicable, as no AI algorithm was developed or trained.
Summary of Non-Clinical Performance Data (as mentioned in the document):
The device's performance is demonstrated through adherence to various industry and safety standards, rather than clinical efficacy studies. These include:
- Electrical Safety Standards: IEC 60335-1, IEC 60335-2-29, IEC 60950-1, IEC 60601-1, IEC 60601-1-2.
- Biocompatibility Standards: USP 24, NF 19 Biological Test for Plastics (Class VI 70 degrees C), ISO 10933-5 (in vitro Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization - Kligman Maximization Test and Intracutaneous Injection Test), ISO 10993-11 (Systemic Toxicity), ASTM F 756-08 (Hemolytic Properties), ASTN F 619-03 (Extraction of Medical Plastics).
- Sterilization Standard: AAMI/ANSI ST79 (Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities).
- Software Validation: "Software Validation per Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Usability Study: "A Simulated Use/Usability study was conducted using Anesthesiologists, Emergency Room Physicians, and Emergency Medical Service (EMS)." The conclusion states this study "demonstrated ease-of-use of the system," but no specific performance metrics or acceptance criteria for usability are provided in the document.
The core argument for substantial equivalence relies on the device's design and indications for use being "identical" or "similar" to the predicate device (Propper Flip-Tip™ Laryngoscope, K915804), coupled with adherence to the aforementioned non-clinical standards and the usability study.
§ 868.5540 Rigid laryngoscope.
(a)
Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.(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