(16 days)
The intended use of the Simplicity Simplex P Infusion Set is to provide a means for infusion and/or injection of fluids into the body the surface of the skin when attached to a MiniMed Paradigm pump or syringe.
Sterling Medivations Inc.'s ("SMI") Simplicity™ Simplex P Infusion Set is designed to provide a nicans to infuse or inject medication subcutaneously when attached to the MiniMed Paradigni infusion pump or syringe.
The Simplicity Simplex P Infusion Set is designed for use by people with diabetes to provide a means to infuse or inject medication subcutaneously when attached to the MiniMcd Paradigm influsion purpor syringe. It is inserted into the subcutaneous tissue of a patient and the Simplicity YP concector is stached to the medication reservoir. This is substantially equivalent to the predicate device and it has the same intendcd use.
The device cousists of four main parts: (1) an infusion catheter made from PTFE, (2) an infusion lub that provides the patient the capability of disconnecting the comnecting tube from the infusion catheren (3) a connecting tube and (4) a Simplicity YP connector consisting of a needle hub and reused causes. (1) a and reservoir connector.
The Simplicity Simplex P Infusion Set is an infusion administration set, connecting to the Paradig m reservoir by means of a Simplicity YP connector consisting of a needle but and reuseble purpose and rescrvoir connector and subcutancously in the patient through an indwelling catheter made of Polytetrafluorthylene (PTFE). The Stcrling Medivations Simplicity Simplex P Infusion Set may je used with any paradigm infusion device that delivers continuous or internattent flow. The connecting tubing is made from a polyethylene tube.
The 25 gauge-indwelling catheter is introduced into the subcutancous tissue by a removable 27-gauge insertion necdle formed from a lumen made of AISI 304 stainless stecl. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector ne-dle mates with the indwelling catheter forming a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless stcel and it is connected to the connecting tubing with a connector housing. The connector tubing proximal end is attached to a Simplicity YP connector consisting of a needle bub and reusable pump adapter and reservoir connection to a MiniMed Paradign pump and reservoir. The connecting tube is solvent bonded to the connector housing and to the aecdle hub
The provided text describes a 510(k) submission for the "Simplicity™ Simplex P Infusion Set." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a specific study with acceptance criteria and results in the way typically seen for novel or high-risk devices.
Therefore, many of the requested categories like sample size, ground truth, expert qualifications, and MRMC studies are not applicable to the information contained in this 510(k) summary. The "acceptance criteria" here refer to conformity with established standards for similar devices.
Here's an attempt to structure the available information according to your request, with significant portions marked as "Not Applicable" or "Not Specified" due to the nature of the document:
Acceptance Criteria and Study to Prove Device Meets Criteria
The Simplicity™ Simplex P Infusion Set achieved substantial equivalence to predicate devices by demonstrating conformity to various international and national standards governing intravascular administration sets, sterilization, materials, and packaging. The "acceptance criteria" are therefore defined by successful adherence to these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Governing Standard) | Reported Device Performance |
|---|---|
| CDRH 21 C.F.R. Section 880.5440 Intravascular administration set | Device meets the catheter requirements of this regulation. |
| ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements) | Device meets the catheter requirements of this standard. |
| ISO 10555 Sterile, single use intravascular catheters (Part 5: Peripheral Catheters) | Device meets the catheter requirements of this standard. |
| ISO 11135:1994 Medical devices -- Validation and routine control of ethylene oxide sterilization | Device manufacturing and sterilization processes adhere to this standard. |
| ISO 11138:1994 Sterilization of health care products -- Biological indicators -- Part 2: Ethylene oxide | Biological indicators for sterilization conform to this standard. |
| ISO 9626: 1991 Stainless Steel needle tubing for the manufacture of medical devices | Materials used for needle tubing conform to this standard. |
| ISO 11607: 1997 Packaging for terminally sterilized medical devices | Packaging for the device conforms to this standard. |
| ISO 8535: 1991 Sterile single use syringes, with or without needle, for insulin | Not explicitly stated how this applies to the infusion set, but listed. |
| ISO 10993: 1991 Bearing of the Limulus Amebocyte Lysate (LAL) Test as an end product | LAL test for endotoxin validation conforms for product release. |
| ODE Blue Book Memorandum #K90-1 | Design process adheres to this guidance. |
| ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing | Biological evaluation of materials and device conforms to this standard. |
| Manufacturer's Quality System Requirements (e.g., QSR, ISO 9001) | Design process adheres to and comes under MANUFACTURERS. (Reference to QC guidance and ISO 9001) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document indicates adherence to standards, which implies testing was conducted, but the specific number of units tested is not detailed in this summary.
- Data Provenance: Not specified, but generally refers to internal company testing and validation processes in adherence to the listed standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this type of submission is conformity to established engineering and medical device standards. There is no mention of external experts or clinical judgement for performance evaluation in this summary.
4. Adjudication method for the test set
Not applicable. This is not a clinical study requiring adjudication of expert opinions.
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 device is an infusion set, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an infusion set, not an algorithm.
7. The type of ground truth used
The "ground truth" implicitly used is conformity to established engineering and biocompatibility standards (e.g., ISO for sterility, materials, and intravascular catheters; CDRH regulations). This is demonstrated through various tests and validations that verify the device's physical, chemical, and biological properties meet the requirements of these standards.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not a machine learning model.
§ 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.