(65 days)
Not Found
Not Found
No
The device description and intended use clearly define a simple, disposable tubing for suction, with no mention of any computational or analytical capabilities that would involve AI/ML.
No.
The device is described as a connecting conduit for general suction procedures, and its sole function is to transfer fluids; it does not provide any therapeutic benefit to the patient.
No
Explanation: The device is described as a connecting conduit for general suction procedures, facilitating the removal of fluids. It does not analyze or interpret physiological data to diagnose a condition.
No
The device description clearly states it is a physical tubing made of PVC plastic, which is a hardware component.
Based on the provided information, the MedCare Suction Connecting Tubing is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general suction procedures as a connecting conduit from a suction device... to a suction collection canister." This describes a physical function in a medical procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the physical construction of tubing and connectors. It doesn't mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
Therefore, the MedCare Suction Connecting Tubing is a medical device used for a procedural function, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source).
Product codes
Not Found
Device Description
The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). The Suction Connecting Tubing is constructed of polyvinyl chloride (PVC) plastic extruded tubing with injection molded tapered connectors solvent bonded to each end. The connectors and made of PVC and have tapered internal diameters with internal ribs
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Suction Connecting Tubing
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
0
K96/880
1 9 1996
(I) 510(k) Summary:
This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992.
- (1) Submitted By:
MedCare Medical Group, Inc. 234 Old Homestead Highway E. Swanzey, NH 03446
Contact Person:
Craig J. Bell Director of Research and Development (603)352-3230
- (2) Name of Device:
Suction Connecting Tubing
Classification Name:
Class II device, reference 21 CFR, Part 880.6740
-
(3) Identification of Predicate Devices:
Suction Connecting Tubing -
(a) Kendall Healthcare Products Company Mansfield, MA 02048
-
(4) Description of Device Subject to Premarket Notification:
The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). The Suction Connecting Tubing is constructed of polyvinyl chloride (PVC) plastic extruded tubing with injection molded tapered connectors solvent bonded to each end. The connectors and made of PVC and have tapered internal diameters with internal ribs
1
(ર) Intended Use of the Device:
The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Y ankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source).
(6) Technological Characteristics
The MedCare Suction Connecting Tubing is made of similar construction and similar design to the predicate device for, as the name suggests, providing a tubing connection from the suction canister to a suction device. The MedCare Suction Connecting Tubing is provided with tapered fittings to allow secure fitment to a variety of suction devices.