(85 days)
No
The document describes a standard infusion set and makes no mention of AI or ML capabilities.
No.
The device is an infusion set used for administering medicine, not for treating or preventing a disease.
No
Explanation: The device is an infusion set used for administering fluids or solutions, not for diagnosing medical conditions. Its intended use is for delivery, not detection or analysis.
No
The device description clearly states it is an "infusion set" and describes physical components like a Luer connection and materials tested for biocompatibility, indicating it is a 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 administration of fluids or solutions (including medicine) into the body (subcutaneous administration). This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description reinforces its function as an infusion set for delivering substances into the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting markers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
The Polylin with Wings infusion set is intended for use as an influsion administration set for delivery of appropriately labeled fluids or solutions from an external infuston purpo or syringe.
Product codes
Not Found
Device Description
This infusion sol is intended for the subculareous administration of medicine, Including from a portable, external purno to a subsble influsion site. The infusion set is designed to be used in conjunction with a Minitod infusion pump, but may be used in other puntus capable of supporting a Lucr connection to a reservoir, however, care must be exercised by the prescriber and user to ensure delivery accuracy if used with other dovices.
Device materials have been successfully tested for biocompairbility. All components liaving contact with solutions being administered most the ISO 10993 standard for medical devices of this (ype.
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)
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
K 96 4455
JAN 30 1997
Part H. Polyfin® with Wings Infusion Set 510(k) Summary
This summary of 510(k) safety and difectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92:
A Submitter: MiniMed® Inc. 12744 San Fornando Road, Sylmar, California 91342. Contact: Don Sclivey, Rogulatory Affairs (818) 362-5958, Ext. 3011. FAX: (818) 362-6928; (520) 527-0107 (VIF).
B. Name of the device: Polyfin® with Wings infusion set, Models 306, 307, and 333.
C, Predicate device: Polylin infusion sets, Models 106, 107, and 133 (K961474).
D. Description of new device: This infusion sol is intended for the subculareous administration of medicine, Including from a portable, external purno to a subsble influsion site. The infusion set is designed to be used in conjunction with a Minitod infusion pump, but may be used in other puntus capable of supporting a Lucr connection to a reservoir, however, care must be exercised by the prescriber and user to ensure delivery accuracy if used with other dovices.
Device materials have been successfully tested for biocompairbility. All components liaving contact with solutions being administered most the ISO 10993 standard for medical devices of this (ype.
E. Intended use of the new device: The Polylin with Wings infusion set is intended for use as an influsion administration set for delivery of appropriately labeled fluids or solutions from an external infuston purpo or syringe.
F. Comparison of the technological features of the new device and predicate device: The new device introduces no new tochnological features, compared to the predicate device. The only substantial difference in the dovices is the addition of wings to make insertion casies by the user and to add stability to the needle once in place. The needle guard has bocn modified in a non-significations raises no new Issues of safety or effectiveness.
Signed
Cto Shuss
noc H. Greag. President and Chief Operating Officer
20 Jan 97
Date
@MiniMad, Polyfin, and Sof-Set are Registerod Tradomarks of MiniMed Inc.