(11 days)
MiniMed Paradigm Silhouette Infusion Set, Maersk Medical Comfort Infusion Set, Disetronic Tender Infusion Set
Not Found
No
The device description focuses solely on the mechanical components and function of an infusion set, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is intended to provide continuous infusion of medicine, including insulin, into the body, which is a therapeutic purpose.
No
The device description indicates that the Animas EZ Set Infusion Set is used for the "infusion of medicine" and acts as a conduit for delivering substances to the body, not to assess or diagnose a medical condition.
No
The device description clearly details physical components such as tubing, needles, cannulas, and connectors, indicating it is a hardware device for delivering medication.
Based on the provided information, the Animas EZ Set Infusion Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "provide infusion of medicine, including insulin, from an external infusion pump." This describes a device used to deliver substances into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a system for subcutaneous delivery of medication, involving a cannula inserted into the tissue and tubing connected to a pump. This is consistent with a drug delivery device, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Animas EZ Set Infusion Set's function is to administer medication, which falls under the category of a drug delivery device.
N/A
Intended Use / Indications for Use
The Animas EZ Set Infusion Set is intended for infusion of medicine, including insulin, from an external infusion pump. This device is intended for home use and is a prescription device.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Animas EZ Set Infusion Set is an infusion administration set with the proximal end connecting to a medicine reservoir syringe within an infusion pump and the distal end inserted in the subcutaneous tissue of a user.
The device consists of two components, an infusion site assembly and a tubing connector assembly. The infusion site assembly consists of a cannula housing with a disposable insertion hub assembly. The main body of the cannula housing has a thin self-adhesive pad for attachment to the skin. A soft flexible 22 gauge cannula extends below the flat bottom of the housing to penetrate the skin at a slight angle. A detachable insertion needle assembly is initially connected to the cannula housing assembly to insert the soft flexible cannula subcutaneously. It is then removed and replaced by the needle hub assembly to deliver medication. An elastomeric septum seals the entrance to the cannula when the needle hub assembly is removed.
The tubing connector assembly consists of a length of flexible plastic tubing made from polyvinyl chloride with a co-extruded polyethylene liner. The tubing is attached to a female Luer Lock connector at one end and a short needle mounted in the main body of the needle hub at the opposite end. The main body provides a means to align and attach the needle hub to the cannula housing assembly by means of a quick release connector. When the cannula housing and the needle hub are connected, the needle penetrates the septum allowing medication to flow from the pump through the flexible tubing, the needle, and the cannula into the patient's body. The needle hub assembly may be easily released from the cannula housing by squeezing the resilient side members deflecting the retaining band above a bump on the cannula housing. This allows the needle housing to slide freely off the cannula housing. The quick release connector allows the user to temporarily disconnect the tubing at the insertion site for activities such as dressing or bathing.
In addition to complete administration sets, infusion site sets without the tubing and quick release connector will also be available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MiniMed Paradigm Silhouette Infusion Set, Maersk Medical Comfort Infusion Set, Disetronic Tender Infusion Set
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 2 7 2001
Section 1 – Information Required by the Safe Medical Devices Act of 1990
1.1 510(k) Summary
Submitter: Animas Corporation, 590 E. Lancaster Avenue, Frazer, PA 19355
Michael J. Andrews, Ph.D., Director, Regulatory Affairs, Contact: Telephone: (610)-6448990, ext 166, Fax: (610)-644-8717, Email: michaela@animascorp.com
Name of Device: Animas EZ Set Infusion Set
- Predicate Device: MiniMed Paradigm Silhouette Infusion Set, Maersk Medical Comfort Infusion Set, Disetronic Tender Infusion Set
Description of the New Device: The Animas EZ Set Infusion Set is an infusion adminstration set with the proximal end connecting to a medicine reservoir syringe within an infusion pump and the distal end inserted in the subcutaneous itssue of a user.
The device consists of two components, an infusion site assembly and a tubing connector assembly. The infusion site assembly consists of a cannula housing with a disposable insertion hub assembly. The main body of the cannula housing has a thin self-adhesive pad for attachment to the skin. A soft flexible 22 gauge cannula extends below the flat bottom of the housing to penetrate the skin at a slight angle. A detachable insertion needle assembly is intitially connected to the cannula housing assembly to insert the soft flexible cannula subcutaneously. It is then removed and replaced by the needle hub assembly to deliver medication. An elastomeric septum seals the entrance to the cannula when the needle hub assembly is removed.
The tubing connector assembly consists of a length of flexible plastic tubing made from polyvinyl chloride with a co-extruded polyethylene liner. The tubing is attached to a female Luer Lock connector at one end and a short needle mounted in the main body of the needle hub at the opposite end. The main body provides a means to align and attach the needle hub to the cannula housing assembly by means of a quick release connector. When the cannula housing and the needle hub are connected, the needle penetrates the septum allowing medication to flow from the pump through the flexible tubing, the needle, and the cannula into the patient's body. The needle hub assembly may be easily released from the cannula housing by squeezing the resilient side members deflecting the retaining band above a bump on the cannula housing. This allows the needle housing to slide freely off the cannula housing. The quick release
1
connector allows the user to temporarily disconnect the tubing at the insertion site for activities such as dressing or bathing.
In addition to complete administration sets, infusion site sets without the tubing i and quick release connector will also be available.
Intended Use of the New Device: The Animas EZ Set Infusion Set is intended intended ose of the Now Dones infusion of medicine, including insulin, from an external infusion pump.
This device is intended for home use and is a prescription device.
Comparision of the Technological Features of the New Device and the Companision of the Toolinerogical