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510(k) Data Aggregation
(14 days)
The intended use is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.
Sterling Medivations, Inc.'s ("SMI") Simplicity ™ Soft QD Silver Infusion Set is designed for use by people with diabetes to provide a means to infuse insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.
The device consists of four main parts: (1) an infusion catheter made from 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 threaded reservoir connector.
The Simplicity Soft QD Silver Infusion administration set, is designed for use by people with diabetes to provide a means to infuse insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow and inserted in the subcutaneous tissue of a patient. The Sterling Medivations Simplicity Soft QD Silver 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 reservoir 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 catheter is introduced into the subcutaneous tissue by a removable 27 gauge insertion needle made of AISI 304 stainless steel. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector needle 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 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) summary for the "Simplicity™ Soft QD Silver Infusion Set." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with acceptance criteria and device performance metrics in the way a clinical trial report would.
Therefore, much of the requested information (like specific acceptance criteria based on performance, sample sizes for test sets, expert involvement, MRMC study details, training set information, or ground truth establishment for performance data) is not present in the provided document. The document primarily focuses on demonstrating that the new device meets established regulatory standards and has similar technological features and intended use as the predicate device.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Met by Simplicity™ Soft QD Silver Infusion Set) | Reported Device Performance (as stated in the document) |
|---|---|
| Compliance with CDRH 21 C.F.R. section 880.54400 Intravascular administration set | Implicitly met by design and testing against ISO standards. The text states: "To provide substantial equivalence the Simplicity Soft QD Silver Infusion Set meets the catheter requirements of: CDRH 21 C.F.R. section 880.54400 Intravascular administration set" |
| Compliance with ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements) | Implicitly met by design and testing against ISO standards. The text states it "meets the catheter requirements of" this standard. |
| Compliance with ISO 10555 Sterile, single use intravascular catheters (Part 5: peripheral catheters) | Implicitly met by design and testing against ISO standards. The text states it "meets the catheter requirements of" this standard. |
| Compliance with ISO 9626 Stainless steel needle tubing for the manufacture of medical devices | Implicitly met by design and testing against ISO standards. The text states it "meets the catheter requirements of" this standard. |
| Compliance with ISO 11135: 1994 Medical devices - Validation and routine control of ethylene oxide sterilization | Implicitly met by design and testing against ISO standards. The text lists this as a standard the device "meets." |
| Compliance with ISO 11138-2:1994 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization | Implicitly met by design and testing against ISO standards. The text lists this as a standard the device "meets." |
| Compliance with ISO 11607: 1997 Packaging for terminally sterilized medical devices | Implicitly met by design and testing against ISO standards. The text lists this as a standard the device "meets." |
| Compliance with ISO 8537: 1991 Sterile single use syringes, with or without needle for insulin | Implicitly met by design and testing against ISO standards. The text lists this as a standard the device "meets." |
| Compliance with FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end-product endotoxin test | Implicitly met by following FDA guidelines. The text lists this as a guideline the device "meets." |
| Adherence to Design Control Guidance for Medical Device Manufacturers (FDA 21 CFR 820.30 and ISO 9001 Sub-clause 4.4) | The design process "adhered to" this guidance. |
| Substantial Equivalence to Predicate Device (Sterling Simplicity™ Soft QD Easy Infusion set, K 010788) | "The Simplicity Soft™ QD Silver Infusion Set proposed for commercial distribution is similar in all significant respects to the existing the Simplicity Soft QD Easy Infusion Set, K010788 and it has the same intended use." |
| "The materials and manufacturing processes are substantially equivalent, the labeling is substantially equivalent and it has the same intended use as the Simplicity Soft QD Easy Infusion Set FDA 510(k) K010788." |
2. Sample size used for the test set and the data provenance
- The document does not provide specific sample sizes for performance testing in a clinical or user study context. The "tests" mentioned are compliance with standards and guidelines for manufacturing, sterilization, and catheter properties.
- Data provenance is not specified beyond indicating compliance with international and US standards. There's no mention of country of origin for specific test data, nor is it described as retrospective or prospective clinical data. This is typical for a 510(k) where "substantial equivalence" is demonstrated through adherence to recognized manufacturing and materials standards, rather than new clinical efficacy studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The document focuses on meeting established technical specifications and standards, which are typically defined by expert committees (e.g., ISO, FDA), but not in the context of individual experts establishing a "ground truth" for a specific test set for this device's performance.
4. Adjudication method for the test set
- This information is not provided. As explained above, the "test set" here refers to compliance with standards, not a specific clinical performance study requiring 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
- This question is not applicable to the device described. The "Simplicity™ Soft QD Silver Infusion Set" is an insulin infusion set, a medical device for drug delivery, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. The device is an insulin infusion set, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the established regulatory standards and guidelines (CDRH regulations, ISO standards for catheters, sterilization, packaging, LAL test guidelines, and design control guidance). The device's compliance with these pre-defined metrics serves as the "ground truth" for its safety and effectiveness relative to the predicate.
8. The sample size for the training set
- This information is not provided and is not relevant for this type of device and submission. "Training sets" are typically associated with machine learning or AI algorithm development, which is not applicable here.
9. How the ground truth for the training set was established
- This information is not provided and is not relevant for this type of device and submission.
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