(116 days)
The intended use of this device is to cover the laryngoscope blade and the top of the handle during endotracheal intubation to possibly reduce the cleaning time of the laryngoscope blade.
This device is a molded plastic cover for a larvngoscope blade. It is made in two models, for either the Miller #2 or the MacIntosh #3 laryngoscope blade. Also, a portion of the device covers the upper portion of the laryngoscope handle. The device functions to cover the laryngoscope blade prior to use in the mouth. The device is made of a linear low density polycthylene copolymer, approved by the FDA, 21 CFR 177,1520, and is 1 mm thick. The master file number is #11624. It is made to conform to the laryngoscope blade. The cover adheres to the laryngoscope blade by a plastic clip that is formed from the plastic matcrial that encircles the top of the laryngoscope handle. It is a single use device
The provided 510(k) summary for the K961832 Blue Ridge Products Laryngoscope Blade Cover describes a device intended to cover a laryngoscope blade. However, the document does NOT contain information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as requested in the instructions.
The summary focuses on comparing the Blue Ridge device to a predicate device (Slater Sleeve) based on technological characteristics and some non-clinical physical properties (Tensile Strength, Light Absorption, Ultimate Elongation). The "reported device performance" in the context of the provided text only refers to these physical properties, not clinical performance or diagnostic accuracy.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to a diagnostic or clinical outcome, nor can I provide information on study design aspects like sample size, ground truth, expert involvement, or comparative effectiveness studies.
The provided text does not contain the necessary information to answer the majority of the questions posed.
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SEP - 6 1995
510(K) SUMMARY
l) Submitter:
Blue Ridge Products, LP Box 8664 Gray, TN 37615 (423) 477-3318 fax (423) 477-3640 Contact Person: Mark J. Ricc General Manager Date of Summary Preparation: August 12, 1996
- Name of the Device:
Blue Ridge Products Laryngoscope Blade Cover Common Name: Blue Ridge Products Laryngoscope Blade Cover Classification Name: The product is an accessory to the Laryngoscope, Rigid. 73CCW
- Legally Marketed Equivalent Device (Predicate Device):
The predicate device is the Slater Sleeve, which is a substantially equivalent device with a cleared 510(k) (K # 926158). It is currently marketed by Tadco. Inc.
- A Description of the Device:
This device is a molded plastic cover for a larvngoscope blade. It is made in two models, for either the Miller #2 or the MacIntosh #3 laryngoscope blade. Also, a portion of the device covers the upper portion of the laryngoscope handle. The device functions to cover the laryngoscope blade prior to use in the mouth. The device is made of a linear low density polycthylene copolymer, approved by the FDA, 21 CFR 177,1520, and is 1 mm thick. The master file number is #11624. It is made to conform to the laryngoscope blade. The cover adheres to the laryngoscope blade by a plastic clip that is formed from the plastic matcrial that encircles the top of the laryngoscope handle. It is a single use device
5) Statement of Intended Use:
The intended use of this device is to cover the laryngoscope blade and the top of the handle during endotracheal intubation to possibly reduce the cleaning time of the laryngoscope blade.
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This is the same intended use as the device identified as the predicate device above. The manufacturer's guidelines for cleaning the laryngoscope blade need to be followed.
- A Summary of the Technological Characteristics of the Device Compared to the Predicate Device:
The function of the Blue Ridge device compared to the predicate device is the same, namely, they both cover the laryngoscope blade and the top portion of the handle. The predicate device is a loose fitting, flexible plastic, whereas the Blue Ridge device is molded to the shape of the laryngoscope blade. The predicate device is held in place by a rubber band around the end of the handle, whereas the Blue Ridge device is attached to the laryngoscope blade by a plastic clip around the top of the laryngoscope handle.
The non-clinical testing data comparing the Blue Ridge device and the Slater Sleeve are as follows:
| The Blue Ridge Device | The Slate Sleeve Device | |
|---|---|---|
| Tensile Strength | l 900 psi | 1500-3500 psi (direction dependent) |
| Light Absorption | 12 + 2% | 8 + 2% |
| Ultimate Elongation | 560% | 2000-4000% (direction dependent) |
§ 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