(85 days)
Not Found
No
The document describes a standard infusion set and does not mention any AI or ML capabilities.
No
This device is an infusion set used to deliver medicine, not to treat a disease or condition itself.
No
This device is an infusion set used to administer medicine, not to diagnose a condition.
No
The device description clearly states it is an "infusion set" intended for "subcutaneous administration of medicine" and mentions "device materials" and "components having contact with solutions," indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of appropriately labeled fluids or solutions from an external infusion pump or syringe" and "subcutaneous administration of medicine, including insulin". This describes a device used for administering substances into the body, not for testing samples from the body to diagnose or monitor conditions.
- Device Description: The description focuses on the mechanics of delivering medication subcutaneously from a pump.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is for delivering substances to the body.
N/A
Intended Use / Indications for Use
The Polyin OR with Wings infusion set is intended for use an influsion administration set for delivery of appropriately labeled finids or solutions from an external influsion punp or syringe.
Product codes
Not Found
Device Description
This infusion set is intended for the subculancous administration of medicine, including insulin, from a portable external pump to a suitable infusion site. The infusion set is designed to be used in conjunction with a Minited infusion pump, but may be used in other purness capable of supporting a I her connection to a reservoir; however, care must be excreised by the prescriber and user to ensure dolivery accuracy if used with other devices.
Device thaterials luve been successfully tested for biocompatibility. All components luxing contact with solutions being administered meet the ISO 10993 standard for modical devices of this type.
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
JAN 30 1997
Part H. Polyfin QR® with Wings Infusion Set 510(k) Summary
This summary of 510(k) saley and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92:
A. Submitter: MiniMed® Inc. 12744 San Fernando Road, Sylmar, California 91342. Contact: Don Selvey, Rogulatory Affairs (818) 362-5958, Ext. 3011, FAX: (818) 362-6928; (520) 527-0107 (VIF).
B. Name of the device; Polyfin QR® with Wings infusion set, Models 365, 366, and 367.
C. Predicate device: Polyfin QR infusion sets, Models 165, 166, and 167 (K961474).
D. Description of new device: This infusion set is intended for the subculancous administration of medicine, including insulin, from a portable external pump to a suitable infusion site. The infusion set is designed to be used in conjunction with a Minited infusion pump, but may be used in other purness capable of supporting a I her connection to a reservoir; however, care must be excreised by the prescriber and user to ensure dolivery accuracy if used with other devices.
Device thaterials luve been successfully tested for biocompatibility. All components luxing contact with solutions being administered meet the ISO 10993 standard for modical devices of this type.
E. Intended use of the new device: The Polyin OR with Wings infusion set is intended for use an influsion administration set for delivery of appropriately labeled finids or solutions from an external influsion punp or syringe.
F. Comparison of the technological features of the new device and predicate device: The new device introduces no new technological features, compared to the prodicate device. The only substantial difference in the devices is the addition of wings to make insertion easier by the user and to add stability to the needle in place, This modifications raises no now issues of safety or effectiveness.
Signed,
signature
l'errunce H. Gregg, President and Chici Operating Officer MiniMed Inc.
20 Jan 97
Date
ಸ್ಮಿತ
WhiliMed and Polyin are Registered Trademarks of MiniMod Inc. " Polyfin OR in a trademark of MiniMed Inc.