(21 days)
The intended use of the Simplicity Easy Soft Infusion Set is to provide a means to 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 Soft Infusion designed for infusion and/or injection of fluids into the body below the surface of the skin when attached to a external pump or syringe. The device consists of four main parts: (1) infusion catheters are made from Polytetrafluoroethylene (PTFE), (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and threaded reservoir connector and (4) an insertion needle ring. The Simplicity Easy Soft 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 Soft Infusion Set may be used with any infusion device that delivers continuous or intermittent flow. The administration set attaches to the reservoir/svringe by means of a threaded luer connector, and under the surface of the skin in the patient through an indwelling cannula formed from PTFE. The connecting tubing is made from a polyethylene tube. The PTFE indwelling cannula are insertion needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The insertion needle is removed and the connector needle is attached to the hub fixed 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 connector needle is made from AISI 304 stainless steel and it is connecting tubing. The connector tubing proximal end is attached to a threaded luer connector for attachment to the medicine reservoir.
The provided document is a 510(k) summary for the Symplicity™ Easy Soft Infusion Set. It details the device's technical specifications, intended use, and comparison to a predicate device to establish substantial equivalence. However, this document does not contain a study that proves the device meets specific acceptance criteria in the format requested.
Instead, it lists the acceptance criteria as compliance with various FDA regulations and international standards for medical devices, particularly those related to intravascular administration sets, sterilization, and material safety. The document states that the device "meets the catheter requirements of" numerous standards and regulations, implying that performance data was collected to demonstrate this compliance. However, it does not provide the specific results of those tests or detailed performance metrics.
Therefore, many of the requested fields cannot be filled directly from the provided text. I will fill in what information is available and note where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (from document) | Directly Reported Device Performance (from document) |
|---|---|---|
| Intravascular Administration Set Requirements | CDRH 21 C.F.R. Section 880.5440 Intravascular administration set. | Implicitly met. The document states: "To prove substantial equivalence the Simplicity Easy Soft Infusion Set meets the catheter requirements of: - CDRH 21 C.F.R. Section 880.5440 Intravascular administration set." No specific performance data (e.g., flow rates, pressure limits) are provided. |
| Sterile, Single-Use Intravascular Catheters | ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements) | Implicitly met. The document states the device "meets the catheter requirements of" this standard. No specific performance data are provided. |
| ISO 10555 Sterile, single use intravascular catheters (Part 5: Peripheral Catheters) | Implicitly met. The document states the device "meets the catheter requirements of" this standard. No specific performance data are provided. | |
| Sterilization | ISO 11135:1994 Medical devices -- Validation and routine control of ethylene oxide sterilization | Implicitly met. The document states the device "meets the catheter requirements of" this standard. No specific performance data are provided. |
| ISO 11138-2:1994 Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization. | Implicitly met. The document states the device "meets the catheter requirements of" this standard. No specific performance data are provided. | |
| Luer Fittings | ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements | Implicitly met. The document states the device "meets the catheter requirements of" this standard. No specific performance data are provided. |
| ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings | Implicitly met. The document states the device "meets the catheter requirements of" this standard. No specific performance data are provided. | |
| Material Specifications | ISO 9626: 1991 Stainless Steel needle tubing for the manufacture of medical devices. | Implicitly met. The document states the device "meets the catheter requirements of" this standard. The description mentions "insertion needles formed from AISI 304 stainless steel," which aligns with this standard but isn't direct performance data. |
| Packaging | ISO 11607: 1997 Packaging for terminally sterilized medical devices. | Implicitly met. The document states the device "meets the catheter requirements of" this standard. No specific performance data are provided. |
| Insulin Syringes (Contextual) | ISO 8535: 1991 Sterile single use syringes, with or without needle, for insulin. | Implicitly met. While the device is an infusion set, not a syringe, it's listed as a criterion the device "meets." No specific performance data are provided. |
| Endotoxin Testing | 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. | Implicitly met. The document states the device "meets the catheter requirements of" these guidelines. No specific performance data (e.g., endotoxin levels) are provided. |
| Design Process | ODE Blue Book Memorandum #K90-1. | Implicitly met. The document states the design process adhered to this memorandum. No specific data are provided. |
| 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). | Implicitly met. The document states the design process adhered to this guidance. No specific data are provided. | |
| Biocompatibility | ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing. | Implicitly met. The document states the device "meets the catheter requirements of" this standard. No specific data (e.g., cytotoxicity, sensitization results) are provided. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to meeting standards but does not detail the specific test methodologies, sample sizes, or provenance of the data collected to demonstrate compliance with these standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable / not provided. The document describes a medical device seeking substantial equivalence based on meeting engineering and safety standards, not a diagnostic algorithm requiring ground truth established by medical experts. The compliance with standards would typically be assessed by engineers, quality control personnel, and regulatory bodies, not by medical experts establishing ground truth in a clinical context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable / not provided. Adjudication methods are typically relevant for clinical studies or studies evaluating diagnostic performance where subjective interpretation is involved. This document refers to compliance with objective performance and safety standards, where adjudication in this sense is not typically used.
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 / not provided. The device is an infusion set, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable / not provided. The device is an infusion set, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable / not provided. For this type of medical device (an infusion set), "ground truth" refers to meeting established engineering, safety, and performance specifications as defined by the listed ISO standards and FDA regulations. There isn't an equivalent of clinical "ground truth" derived from expert consensus, pathology, or outcomes data in the context of proving the basic functional and safety compliance of such a device for regulatory submission.
8. The sample size for the training set
This information is not applicable / not provided. The device is a physical medical device, not a machine learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable / not provided. As explained in point 8, there is no "training set" for this physical medical device.
§ 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.