(38 days)
The intended use of the Simplicity StarPlus Soft Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.
Sterling Medivations, Inc.'s ("SMI") Simplicity ™ StarPlus Soft Infusion Set is designed for use by people with diabetes to infuse insulin subcutaneously from a pump or syringe. The device consists of four main parts: (1) an infusion catheter made from polytetrafluorthylene (PTFE), (2) an infission hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a comecting tube and (4) a female Luer connector. The Simplicity StarPlus Soft Infusion Set is an infusion administration set, connecting to a pump or syringe and inserted in the subcutaneous tissue of a patient. The Sterling Medivations Simplicity StarPlus Soft Infusion Set may be used with any infusion device that delivers continuous or intermittent flow. The administration set attaches to the pump or syringe by means of a female Luer connector, and subcutaneously in the patient through an indwelling catheter made of polytetrafluorthylene (PTFE). The connecting tubing is made from a polyethylene tube. The 25 gauge-indwelling PTFE catheter is introduced into the subcutaneous tissue using an insertion needle. The insertion needle is removed and a connector housing is attached to the indwelling catheter. This connector needle part of the connector hub pierces a septum formits the infusion of medication without leakage. The connector needle is connected to the connector housing. The connector housing. The connector tubing proximal end is attached to a female Luer connector for attachment to the medicine reservoir. The connecting tube is solvent bonded to the connector housing and to the Luer connector. The quick disconnect allows the patient to temporally disconnect the pump reservoir from the indwelling catheter to better facilitate bathing and reservoir changes.
The provided text describes a 510(k) premarket notification for a medical device called the "Simplicity StarPlus Soft Infusion Set." This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the context of diagnostic accuracy or clinical effectiveness. Therefore, many of the requested categories for a diagnostic device study are not applicable or cannot be extracted from this documentation.
Here's a breakdown of the available information based on your request, with an emphasis on what can and cannot be provided from this particular document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not detail specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be typical for a diagnostic device. Instead, the "acceptance criteria" are compliance with various standards for medical device manufacturing, materials, and sterilization, and the "reported device performance" is the statement that the device meets these standards, thus supporting substantial equivalence.
| Acceptance Criteria Category | Specific Standard/Requirement Met | Reported Device Performance |
|---|---|---|
| Intravascular Administration Set Requirements | CDRH 21 C.F.R. section 880.54400 Intravascular administration set | Meets requirements |
| Sterile, Single-Use Intravascular Catheters | ISO 10555 (Part 1: General Requirements) | Meets requirements |
| ISO 10555 (Part 5: Peripheral catheters) | Meets requirements | |
| Stainless Steel Needle Tubing | ISO 9626 Stainless steel needle tubing for the manufacture of medical devices | Meets requirements |
| Ethylene Oxide Sterilization | ISO 11135: 1994 Medical devices -- Validation and routine control of ethylene oxide sterilization | Meets requirements |
| ISO 11138-2: 1994 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization | Meets requirements | |
| Conical Fittings (Luer Taper) | ISO 594-1: 1986 Conical fittings with a 6%) (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements | Meets requirements |
| ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings | Meets requirements | |
| Packaging for Sterilized Medical Devices | ISO 11607: 1997 Packaging for terminally sterilized medical devices | Meets requirements |
| Sterile Single Use Syringes for Insulin | ISO 8537: 1991 Sterile single use syringes, with or without needle for insulin | Meets requirements |
| Endotoxin Test | FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. ODE Blue Book Memorandum #K90-1. | Meets requirements |
| Design Control | Center of Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS (FDA 21 CGR 820.30 and Sub-clause 4.4 of ISO 9001) | Adhered to |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" in the context of clinical or performance data involving patient samples. The "performance data" refers to the device meeting the specified engineering, material, and sterilization standards. Therefore, information on sample size and data provenance for a "test set" is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. No ground truth establishment by experts for a clinical "test set" is described.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable. No adjudication method for a clinical "test set" is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. The device is an infusion set, not a diagnostic AI tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical infusion set, not an algorithm, so standalone algorithm performance is irrelevant.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. For this type of submission, "ground truth" relates to the device specifications and documented compliance with recognized standards, not clinical outcomes or diagnostic accuracy.
8. The Sample Size for the Training Set
This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms, which this device is not.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.