(15 days)
The intended use of the Simplicity QD Soft Infusion Set is to provide a means for infusion and/or The intended as of the body below the surface of the skin when attached to an external pump or syringe.
Sterling Medivations, Inc.'s ("SMI") Simplicity ™ QD 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 Fluorinated Ethylene Propylene (FEP), (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a female Luer connector. The Simplicity QD Soft Infusion Set is an infusion administration to a pump or syringe and inserted in the subculaneous tissue of a patient. The Sterling Medivations Simplicity QD Soft Infusion Set may 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 Fluorinated Ethylene Propylene (FEP). The connecting tubing is made from a polyethylene tube. The 25 gauge-indwelling FEP 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 connecting tubing and a 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 connect allows the patient to temporally disconnect the pump reservoir from the indwelling catheter to better facilitate bathing and reservoir changes.
The Sterling Medivations Simplicity QD Soft Infusion Set is a medical device for subcutaneous insulin infusion. The provided document is a 510(k) summary demonstrating its substantial equivalence to a predicate device, the Sterling Medivations Simplicity™ Silver Soft Infusion (K010846).
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Simplicity QD Soft Infusion Set are adherence to various ISO standards and FDA guidelines related to intravascular administration sets, sterilization, packaging, and Luer connectors. The document states that the device meets these requirements, implying performance in line with these standards. However, the document does not provide specific quantitative performance data (e.g., tensile strength values, leakage rates, or sterility assurance levels) or a direct comparison table. Instead, it offers a list of the standards the device is stated to comply with.
| Acceptance Criteria (Standard / Guideline) | Reported Device Performance |
|---|---|
| CDRH 21 C.F.R. section 880.54400 Intravascular administration set | Device meets these catheter requirements. |
| ISO 10555 Sterile, single-use intravascular catheters (Part 1: General Requirements) | Device meets these catheter requirements. |
| ISO 10555 Sterile, single-use intravascular catheters (Part 5: Peripheral catheters) | Device meets these catheter requirements. |
| ISO 9626 Stainless steel needle tubing for the manufacture of medical devices | Device meets these catheter requirements. |
| ISO 11135: 1994 Medical devices - Validation and routine control of ethylene oxide sterilization (and repeated entry) | Device meets these catheter requirements. |
| ISO 11138-2:1994 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization (and repeated entry) | Device meets these catheter requirements. |
| ISO 594-1: 1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements | Device meets these catheter requirements. |
| ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings | Device meets these catheter requirements. |
| ISO 11607: 1997 Packaging for terminally sterilized medical devices | Device meets these catheter requirements. |
| ISO 8537: 1991 Sterile single-use syringes, with or without needle for insulin | Device meets these catheter requirements. |
| FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end-product endotoxin test (ODE Blue Book Memorandum #K90-1) | Device meets these catheter requirements. |
| Center of Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS (related to FDA 21 CGR 820.30 and Sub-clause 4.4 of ISO 9001) | The design process adhered to this guidance and is substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set. It states that performance data supports substantial equivalence by meeting listed catheter requirements and ISO standards, but it doesn't describe specific tests, the number of devices tested, or the provenance of any data (e.g., country of origin, retrospective/prospective). This is typical for a 510(k) submission where equivalence is often demonstrated by adherence to recognized standards rather than new clinical trials or large-scale performance testing results detailed in the summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The study presented is a technical assessment of compliance with standards, not a study involving expert review for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in the context of expert review.
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
Not applicable. This is a 510(k) for a physical medical device (an infusion set), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. As noted above, this is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established requirements and specifications within the referenced ISO standards and FDA regulations. The device's performance is compared against these predetermined technical and safety benchmarks, rather than against clinical outcomes, pathology, or expert consensus on clinical cases.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. This term is relevant for machine learning or AI models, which are not involved here.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set mentioned or implied.
§ 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.