(18 days)
The intended use of the Simplicity Euro QD Infusion Set is to infuse or inject insulin subcutaneously when the device is attached to a pump or syringe.
The intended use of the Simplicity Euro QD Infusion Set is to provide a means to infuse insulin subcutaneously from a pump or syringe.
Sterling Medivations, Inc.'s ("SMI") Simplicity ™ Euro QD 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 AISI 304 stainless steel, (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 pump connector.
The Simplicity Euro QD 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 Euro QD 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 AISI 304 stainless steel. The connecting tubing is made from a polyethylene tube.
The 27 gauge-indwelling catheter is introduced into the subcutaneous tissue. A connector needle is attached to the hub fixed to the indwelling catheter. This connector needle pierces a septum forming a seal that permits the infusion of medication without leakage. The connected to the 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 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) submission for the "Simplicity™ Euro QD Infusion Set" and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria and device performance in the manner of an AI/algorithm-based device.
Therefore, many of the requested categories (like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Training set sample size," and "How the ground truth for the training set was established") are not applicable to this type of medical device submission.
However, I can extract information related to the performance data supporting substantial equivalence, which serves a similar function to acceptance criteria in this context.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
For non-AI devices like infusion sets, "acceptance criteria" are typically defined by compliance with established national and international standards and regulations. The "reported device performance" is the claim of meeting these standards.
| Acceptance Criteria (Standards and Regulations) | Reported Device Performance (Claim of Compliance) |
|---|---|
| CDRH 21 C.F.R. section 880.5440 (Intravascular administration set) | Device meets these requirements |
| ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements) | Device meets these requirements |
| ISO 10555 Sterile, single use intravascular catheters (Part 5: peripheral catheters) | Device meets these requirements |
| ISO 9626 Stainless steel needle tubing for the manufacture of medical devices | Device meets these requirements |
| ISO 11135: 1994 Medical devices - Validation and routine control of ethylene oxide sterilization | Adhered to for sterilization |
| ISO 11138-2: 1994 Sterilization of health care products - Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization | Adhered to for sterilization |
| 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 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 requirements |
| ISO 11607: 1997 Packaging for terminally sterilized medical devices | Device meets these requirements |
| ISO 8537: 1991 Sterile single use syringes, with or without needle for insulin | Device meets these requirements |
| FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test | Adhered to for endotoxin testing |
| FDA 21 CGR 820.30 and Sub-clause 4.4 of ISO 9001 (Design Control Guidelines) | Design process adhered to these guidelines |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. Performance data implies various types of testing, but specific sample sizes for each test are not provided.
- Data Provenance: The data is based on compliance with manufacturing and performance standards for medical devices, rather than clinical efficacy data from patient populations. It would be considered internal testing and validation data to demonstrate adherence to specified standards. Its origin is the manufacturing and design process of Sterling Medivations, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical medical device, not an AI or diagnostic algorithm that requires expert-established ground truth for performance evaluation in the context of a clinical study. Performance is assessed against engineering standards and material specifications.
4. Adjudication method for the test set:
- Not Applicable. See point 3. Testing involves compliance with physical and sterile standards, not judgmental adjudication.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is defined by established engineering standards, material specifications, sterility requirements, and regulatory guidelines (e.g., ISO standards, FDA regulations for Luer fittings, catheter materials, sterilization, and packaging). The device is shown to be substantially equivalent by demonstrating compliance with these pre-defined benchmarks.
8. The sample size for the training set:
- Not Applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. See 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.