(38 days)
The intended use of the Simplicity Easy Access 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 Easy Access Infusion Set is designed for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe. The device consists of four main parts: (1) infusion catheters made from AISI 304 stainless steel, (2) an infusion hub that provides the patient the capability of disconnecting the connecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded reservoir connector. The Simplicity Easy Access Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Access Infusion Set may be used with any infusion device that delivers continuous or intermittent flow. The administration set attaches to the reservoir/syringe by means of a threaded luer connector, and under the surface of the skin in the patient through an indwelling needles formed from AISI 304 stainless steel. The connecting tubing is made from a polyethylene tube. The indwelling needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The connector needle is attached to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The with and me work is made from AISI 304 stainless steel and it is connecting tubing. The connecting tubing. The connector tubing proximal end is attached to a threaded luer connector for attachment to the medicine reservoir.
This document describes the 510(k) submission for the Simplicity™ Easy Access Infusion Set, which is a medical device for infusion and/or injection of fluids below the skin. The submission focuses on demonstrating substantial equivalence to a predicate device, the Maersk Medical Pureline™ Comfort™ Infusion Set (K972135).
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and the Reported Device Performance
The submission does not provide specific, quantifiable acceptance criteria or reported device performance in the format of a table with numerical values (e.g., minimum tensile strength of X, actual measured tensile strength of Y). Instead, it states that the device "meets the catheter requirements of" a list of ISO standards and FDA regulations, implying that compliance with these standards serves as the acceptance criteria.
The "reported device performance" is essentially that the device complies with these standards, asserting substantial equivalence. There are no performance metrics provided for specific functionalities like flow rate, leakage, or durability.
| Acceptance Criteria (Reference Standard/Regulation) | Reported Device Performance |
|---|---|
| CDRH 21 C.F.R. Section 880.5440 (Intravascular administration set) | Meets requirements |
| ISO 10555 (Sterile, single use intravascular catheters - Part 1: General Requirements) | Meets requirements |
| ISO 10555 (Sterile, single use intravascular catheters - Part 5: Peripheral Catheters) | Meets requirements |
| 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 |
| 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 |
| ISO 9626: 1991 (Stainless Steel needle tubing for the manufacture of medical devices) | Meets requirements |
| ISO 11607: 1997 (Packaging for terminally sterilized medical devices) | Meets requirements |
| ISO 8535: 1991 (Sterile single use syringes, with or without needle, for insulin) | Meets requirements |
| 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 | Meets requirements |
| ODE Blue Book Memorandum #K90-1 | Meets requirements |
| ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and testing) | Meets requirements |
| Design process adhered to Center for Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS (FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001) | Substantially equivalent to predicate device |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a sample size for any test set (e.g., number of infusion sets tested). The provenance of the data is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The "Performance Data Supporting Substantial Equivalence" section refers to adherence to standards, which implies in-house testing or testing by accredited labs, but no details on the specific data generated are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is compliance with established engineering and biological standards for medical devices, not a clinical determination requiring expert consensus on a diagnostic outcome. The document relies on adherence to published standards rather than expert evaluation of a test set.
4. Adjudication Method for the Test Set
As there's no "test set" in the sense of a set of cases requiring adjudication (e.g., images for diagnostic AI), an adjudication method is not applicable and not mentioned.
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 document describes an infusion set, which is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Similar to point 5, this device is a physical infusion set, not an algorithm or AI system. Standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" in this context is the compliance with established international and FDA standards for medical device manufacturing, materials, sterilization, and performance characteristics (e.g., Luer taper, biocompatibility, packaging integrity). It is an engineering and regulatory "ground truth" rather than a clinical or diagnostic one.
8. The Sample Size for the Training Set
This document describes a physical medical device, not a machine learning model. Therefore, the concept of a "training set" and its sample size is not applicable and not mentioned.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for a machine learning model, this question is not applicable. The "ground truth" for the device's development (its design specifications and performance benchmarks) would be rooted in the referenced ISO and FDA standards and guidance documents.
§ 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.