(18 days)
K838445A, K861436
Not Found
No
The summary describes a standard infusion set, a passive device for delivering medication. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is used for subcutaneous infusion of medicine, including insulin, which is a therapeutic intervention.
No
Explanation: The device is an infusion set intended for the administration of medicine, not for diagnostic purposes. Its function is to deliver medication from an external pump to a subcutaneous site.
No
The device description explicitly 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 information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "subcutaneous infusion of medicine, including insulin, from an external pump, for up to 48 hours." This describes a device used for delivering substances into the body, not for examining specimens from the body to provide diagnostic information.
- Device Description: The description focuses on the administration of medicine from a pump to a subcutaneous site. It mentions biocompatibility and connection types, all related to the physical delivery of a substance.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the delivery of medication.
N/A
Intended Use / Indications for Use
The intended use of the new device is subcutaneous infusion of medicine, including insulin, from an external pump, for up to 48 hours.
Product codes
Not Found
Device Description
This infusion set is intended for the administration of medicine, including insulin, from a portable, external pump to a subcutaneous infusion site, for up to 48 hours. The infusion set is designed to be used in conjunction with a MiniMed infusion pump, but may be used in other pumps capable of supporting a Luer connection to a reservoir; however, care must be exercised by the prescriber and user to ensure delivery accuracy if used with other devices.
Device materials have been successfully tested for biocompatibility. All components having contact with solutions being administered meet the ISO 10993 standard for medical devices of this type.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous infusion site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescriber and user
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)
K838445A, K861436
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
- 6 1996
Part H. Polyfin® Infusion Set 510(k) Summary
This summary of 510(k) safety 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, Regulatory Affairs and Clinical Research (818) 362-5958, Ext. 3011. FAX: (818) 362-6928; (520) 527-0107 (V/F).
B. Name of the device: Polyfin® infusion set, Models MMT-107, and MMT-107, and MMT-133.
C. Predicate device: Pacesetter infusion set, model 124 and 142 (K838445A); Sof-set® Infusion Set, Models MMT-111 and MMT-112 (K861436).
D. Description of new device: This infusion set is intended for the administration of medicine, including insulin, from a portable, external pump to a subcutaneous infusion site, for up to 48 hours. The infusion set is designed to be used in conjunction with a MiniMed infusion pump, but may be used in other pumps capable of supporting a Luer connection to a reservoir; however, care must be exercised by the prescriber and user to ensure delivery accuracy if used with other devices.
Device materials have been successfully tested for biocompatibility. All components having contact with solutions being administered meet the ISO 10993 standard for medical devices of this type.
E. Intended use of the new device: The intended use of the new device is subcutaneous infusion of medicine, including insulin, from an external pump, for up to 48 hours.
F. Comparison of the technological features of the new device and predicate device: This device was initially introduced by Pacesetter as a subcutaneous infusion set, models 124 and 142. Several individually non-significant modifications have been made to this device since its initial introduction to the marketplace.
Signed,
Signed,
Date
Terrance H. Gregg, Executive Vice President Operations