(11 days)
The intended use of the Simplicity Easy P 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 a MiniMed Paradigm pump or syringe.
Sterling Medivations Inc.'s ("SMI") Simplicity Easy P Soft designed for use by people with diabetes for the infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe. It is inserted into the tissue of a patient and the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Soft Infusion Set, K020912 and Soft YP Infusion Set, FDA 510 (k) K011187.
The Simplicity Easy P Soft Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Soft Infusion Set, FDA 510 (k) K020912 and it has the same intended use.
The device consists of four main parts: (1) infusion catheters 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 (4) a threaded YP connector.
The Simplicity Easy P 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 Paradigm infusion device that delivers continuous or intermittent flow.
The administration set attaches to the reservoir/syringe by means of a threaded YP connector, and under the surface of the skin in the patient through an indwelling cannulas formed from PTFE. The connecting tubing is made from a polyethylene tube.
The indwelling cannulas formed from PTFE are introduced below the skin using and insertion ring with AISI 304 stainless steel 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 comected to the connecting tubing. The connector tubing proximal end is attached to a threaded YP connector for attachment to the Paradigm medicine reservoir.
The provided document is a 510(k) Summary for a medical device (Simplicity Easy P Soft Infusion Set) seeking substantial equivalence to a predicate device. It primarily discusses the device's features, intended use, and a list of standards and regulations it complies with to demonstrate performance and safety.
However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in detailed performance studies. This is a common characteristic of 510(k) summaries, which focus on demonstrating equivalence to existing legally marketed devices rather than presenting novel performance studies against predefined acceptance criteria for a new clinical claim.
Therefore, many of the requested details cannot be extracted directly from this document.
Here's what can be addressed based on the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Cannot be provided directly. The document lists compliance with various standards (e.g., ISO, CDRH regulations) for catheters, sterilization, packaging, and biological evaluation. These standards inherently contain performance requirements and acceptance criteria for specific aspects (like sterility, material compatibility, strength), but the document does not explicitly state these criteria or report specific device performance values against them. It simply states that the device "meets the catheter requirements of" and "adhered to" these standards.
2. Sample size used for the test set and the data provenance:
- Cannot be provided directly. The document does not describe specific testing sample sizes for any performance evaluation, nor does it mention data provenance (country of origin, retrospective/prospective). The studies implied are likely bench testing or compliance evaluations against engineering standards, not clinical trials with "test sets" in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This question pertains to studies involving expert review for establishing ground truth, typically in image analysis or diagnostic performance studies. The provided document is for an infusion set and does not describe such a study.
4. Adjudication method for the test set:
- Not applicable. Same reasoning as point 3.
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 medical device for fluid infusion, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.
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:
- Cannot be directly answered in the context of typical "ground truth" for diagnostic studies. For a device like an infusion set, "ground truth" would relate to its physical and biological properties. The "performance data supporting substantial equivalence" refers to compliance with established technical standards (e.g., ISO for sterility, material properties, packaging integrity, biocompatibility), rather than a "ground truth" established by an expert panel or pathology for a diagnostic claim.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. Same reasoning as point 8.
Summary of available information from the document:
The document focuses on demonstrating substantial equivalence to existing predicate devices (Simplicity Easy Soft Infusion Set, K020912, and Soft YP Infusion Set, K011187) by stating that:
- The new device is similar in all significant respects, has the same intended use, and similar materials and manufacturing processes as the predicate device.
- The primary difference is the indwelling catheter connector, designed for use with the MiniMed Paradigm pump, which is equivalent to the YP connector on an existing Sterling Medivations infusion set (K011187).
- Performance Data Supporting Substantial Equivalence: The device "meets the catheter requirements of" a list of national and international standards and regulations. These standards implicitly define acceptance criteria for various performance aspects (e.g., sterility, biocompatibility, material strength, packaging integrity).
List of Standards and Regulations the device reports to meet:
- CDRH 21 C.F.R. Section 880.5440 Intravascular administration set
- ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements)
- ISO 10555 Sterile, single use intravascular catheters (Part 5: Peripheral Catheters)
- ISO 11135:1994 Medical devices -- Validation and routine control of ethylene oxide sterilization
- ISO 11138-2:1994 Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators for ethylene oxide sterilization
- ISO 9626: 1991 Stainless Steel needle tubing for the manufacture of medical devices
- ISO 11607: 1997 Packaging for terminally sterilized medical devices
- ISO 8535: 1991 Sterile single use syringes, with or without needle, for insulin
- FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end product endotoxin test
- ODE Blue Book Memorandum #K90-1
- ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing
- The design process adhered to 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).
In essence, the "study" proving the device meets implied acceptance criteria is the demonstration of compliance with these listed standards and regulations, which are recognized for ensuring safety and performance of such medical devices. The document does not provide a separate, detailed "performance study report" with specific data points or statistical analyses.
§ 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.