(34 days)
No
The description focuses on the mechanical design and materials of a needlefree connector, with no mention of AI or ML.
No
This device is a needleless injection port intended for connecting to Luer Lock connectors, facilitating access to a patient's intravenous line without directly delivering or administering a therapeutic substance. Its purpose is primarily for connection and access, not for treating a condition or disease itself.
No
Explanation: The device is described as a needleless injection port intended for attaching to a Luer Lock connector and maintaining line patency. Its function is to facilitate fluid delivery or access, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description clearly indicates it is a physical, one-piece Luer interfacing injection port made of materials, not software.
Based on the provided information, the Douglas Medical Products Maxcess Needlefree Connector is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "needleless injection port" for accessing a Luer Lock connector. This describes a device used for administering or withdrawing fluids from a patient's vascular system, which is a clinical procedure performed in vivo (within the living body).
- Device Description: The description focuses on its physical characteristics, materials, and packaging, all related to its function as a medical device for patient access.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed for testing biological samples to provide diagnostic information. This device's function is related to patient access and fluid management, not diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and can be swabbed and then accessed multiple times within the limits of CDC guidelines and or institutional guidelines. The closure system has been found to maintain line patency throughout the labeled duration of use.
Product codes
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Device Description
The Douglas Medical Products Maxcess Needlefree Connector is a one piece design, Luer interfacing injection port. It is sterile, non-pyrogenic and packaged in a tyvek\polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use. The indicated use of the Maxcess Needlefree Connector is the same or the equivalent of the predicate device named in this submission. The named predicate device in this submission is the Clavem Connector currently marketed by ICU Medical, Inc. under 510(k) #K915571. The Douglas Medical Products Maxcess Needlefree Connector is sterilized per AAMI guidelines to a 10 -6 sterility assurance level. Each production lot is LAL tested per USP guidelines.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the logo for Douglas Medical Products. The logo consists of a geometric shape on the left, followed by the word "Douglas" in a large, stylized font. Below "Douglas" is the text "A SoloPak Company", and to the right of "Douglas" is the text "Medical Products" in a smaller font.
MAR 2 1 1996
January 26, 1996
To Whom it may concern:
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act and CFR 807.92:
Trade Name - Maxcess Needlefree Connector Common Name - Needleless Injection Port or Needlefree Injection Site Classification Name - Intravascular Administration Set
The Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and can be swabbed and then accessed multiple times within the limits of CDC guidelines and or institutional guidelines. The closure system has been found to maintain line patency throughout the labeled duration of use.
The Douglas Medical Products Maxcess Needlefree Connector is a one piece design, Luer interfacing injection port. It is sterile, non-pyrogenic and packaged in a tyvek\polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use. The indicated use of the Maxcess Needlefree Connector is the same or the equivalent of the predicate device named in this submission. The named predicate device in this submission is the Clavem Connector currently marketed by ICU Medical, Inc. under 510(k) #K915571. The Douglas Medical Products Maxcess Needlefree Connector is sterilized per AAMI guidelines to a 10 -6 sterility assurance level. Each production lot is LAL tested per USP guidelines.
Based on the fact that the Douglas Medical Products Maxcess Connector utilizes similar and equivalent designs, and materials, as currently legally marketed products, it is safe and effective when used as intended.
Sincerely,
Ron Hamilton
Ron Haselhorst Director of RAIQA Douglas Medical Products