Search Results
Found 1 results
510(k) Data Aggregation
(29 days)
The intended use of the Simplicity Infusion reservoir is to infuse medicine, including insulin, from an external infusion pump. The reservoir is not intended for use with blood or blood products.
The intended use of the Simplicity Infusion reservoir is to provide a means to infuse medicine, including insulin, from an external infusion pump. The reservoir is not intended for use with blood or blood products.
for the Simplicity™ Infusion reservoir for use with MiniMed pumps. The Simplicity Infusion reservoir is a single use 3.0 ml piston syringe consisting of a hollow barrel, movable plunger with O-rings for sealing, and a male Luer lock fitting at the distal end of the barrel. The device is used in conjunction with an external infusion pump and infusion set to deliver medication subcutaneous. The male luer fitting of the reservoir is connected to the female Luer fitting of an infusion set, and the reservoir is placed in an external infusion pump. The Simplicity infusion reservoir is designed for use with the MiniMed infusion pumps. It is first filled from a standard medication vial by attaching the accompanying disposable luer lock needle inserted into the septum of the vial. The reservoir is filled similarly to filling an insulin syringe. Once filled and inspected for entrapped air the reservoir is inserted into the MiniMed pump per the pump manufactures instructions and the attaches an infusion set to the reservoir using a standard luer connector to attached it to the infusion set.
This 510(k) summary describes a medical device, the Simplicity™ Infusion reservoir, but it does not contain information about acceptance criteria for device performance or a study proving it meets such criteria in the way you've outlined for AI/diagnostic devices.
Here's why and what information is available based on the request:
This submission is for a physical medical device (an infusion reservoir) and seeks to establish substantial equivalence to a predicate device (MiniMed 3.0 ml reservoir K991936). For such devices, the "performance data" typically refers to adherence to recognized industry standards, material properties, and manufacturing processes, rather than a diagnostic performance study with sensitivity, specificity, or reader improvement metrics.
Therefore, many of the requested fields are not applicable to this type of 510(k) submission.
Applicable Information from the Provided Text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance (Claimed Conformance) |
|---|---|
| CDRH 21 C.F.R. section 801.403 INSULIN SYRINGES. | Meets catheter requirements of this regulation. |
| ISO 9626 Stainless steel needle tubing for the manufacture of medical devices. | Adheres to this standard. |
| ISO 11135: 1994 Medical devices -- Validation and routine control of ethylene oxide sterilization. | Adheres to this standard. |
| ISO 11138-2:1994 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization. | Adheres to this standard. |
| ISO 594-1: 1986 Conical fittings with a 6% )Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements. | Adheres to this standard. |
| ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings. | Adheres to this standard. |
| ISO 11607: 1997 Packaging for terminally sterilized medical devices. | Adheres to this standard. |
| ISO 8537: 1991 Sterile single use syringes, with or without needle for insulin. | Adheres to this standard. |
| FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. ODE Blue Book Memorandum #K90-1. | Adheres to these guidelines. |
| Center of Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS. (FDA 21 CGR 820.30 and Sub-clause 4.4 of ISO 9001). | Design process adhered to this guidance, claiming substantial equivalence to predicate. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not a diagnostic device with "test sets" in the typical sense. Performance is demonstrated through adherence to standards and material properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical medical device like this is typically established by engineering specifications, material testing, and compliance with regulatory standards, not expert consensus on diagnostic cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" relates to compliance with established engineering and manufacturing standards, material specifications, and regulatory requirements (e.g., sterility, Luer taper dimensions, syringe integrity, endotoxin levels).
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
Page 1 of 1