(116 days)
K # 926158
None
No
The device description and performance studies focus on the physical properties and function of a plastic cover, with no mention of AI or ML technologies.
No
The device is described as a plastic cover for a laryngoscope blade aiming to reduce cleaning time, not to treat or diagnose a medical condition.
No
The device is a plastic cover for a laryngoscope blade, designed to reduce cleaning time. It does not perform any medical diagnosis.
No
The device description clearly states it is a molded plastic cover, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover a laryngoscope blade and handle during endotracheal intubation to potentially reduce cleaning time. This is a physical barrier device used during a medical procedure.
- Device Description: The description details a molded plastic cover for a laryngoscope blade and handle. It functions as a physical cover.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological specimens.
The device is a medical device, but its function is mechanical and procedural, not diagnostic based on in vitro analysis of biological samples.
N/A
Intended Use / Indications for 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.
Product codes
73CCW
Device Description
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
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
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
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) |
Key Metrics
Not Found
Predicate Device(s)
K # 926158
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
0
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.
1
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) |