(74 days)
The MiniMed™ Mio™ Advance infusion set is indicated for subcutaneous infusion of medication administered by an external pump.
The MiniMed™ Mio™ Advance infusion set manufactured by Unomedical is a sterile, non-pyrogenic, single use subcutaneous infusion set which includes a 90-degree soft cannula. It is delivered ready to use in a pre-loaded insertion device with automatic needle retraction. The product is indicated for subcutaneous infusion of medication.
The insertion needle and soft cannula of the MiniMed™ Mio™ Advance infusion set are hidden from the user before, during and after insertion of the soft cannula. This feature helps prevents needle stick injuries as the device does not require loading with the needle by the user, the needle is then automatically retracted after use.
The MiniMed™ Mio™ Advance infusion set will include a 27-gauge introducer needle, and will be available in two different soft cannula lengths of 6 and 9mm and three different tubing lengths of 46, 60 and 110cm. The tube set is available in P-Cap assembly or luer lock.
The MiniMed™ Mio™ Advance infusion set has been updated from the predicate K032854 Unomedical Inset ''M Subcutaneous Infusion Set by the same manufacturer. The only modifications were made to the inserter component and include a single molded component rather than two pieces, and the addition of a needle safety shield. The connector and tubing of the tubing set remains unchanged.
The provided text describes a 510(k) premarket notification for the MiniMed™ Mio™ Advance infusion set. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or provided in this document as it pertains to a clinical trial.
Instead, the document details non-clinical performance data and a comparison to a predicate device to establish substantial equivalence.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of acceptance criteria for a clinical study. Instead, it refers to a set of non-clinical performance tests and adherence to various national and international standards. The "Performance" in this context refers to meeting these engineering and safety standards, rather than clinical efficacy metrics.
| Test Category | Standards / Requirements Met |
|---|---|
| Functional Tests | - Tensile tests of introducer needle from needle hub, soft cannula from Fluid Part assembly, Fluid Part assembly from base assembly, connector needle from cannula housing. |
- Serter functionality tests. |
| Packaging Tests | - Dynamic and Visual Peel Test. - Print on Packaging and labelling. |
| Transportation Tests | - In accordance with ASTM D4169-16. |
| Dimensional Tests | - Distance soft cannula to set. - Distance of introducer needle bevel to soft cannula.
- Length of tubes. |
| Biocompatibility Tests | - Cytotoxicity Testing in accordance with ISO 10993-5. - Sensitization Testing in accordance with ISO 10993-10.
- Irritation Sensitivity Testing in accordance with ISO 10993-10.
- Acute Systemic Toxicity testing in accordance with ISO 10993-11.
- Pyrogen/Endotoxin Testing in accordance with ISO 11737-1.
- Biocompatibility testing for the insertion device. (The infusion set which remains on the patient is the same as the predicate device, thus existing biocompatibility data is relied upon). |
| Sterilization & Shelf Life | - Shelf life Testing in accordance with ISO 11607. - Sterilization Testing in accordance with ISO 11135:2014.
- ISO 10993-7:2008 (Ethylene Oxide Sterilization Residual).
- ISO 11607-1:2009 (Packaging for terminally sterilized medical devices).
- ISO 11607-2:2006 (Validation requirements for forming, sealing and assembly processes).
- ISO 11737-1:2006 (Determination of a population of microorganisms on products).
- ISO 11737-2:2009 (Tests of sterility performed in the definition, validation and maintenance of a sterilization process).
- EN 556-1:2001 & EN556-1/AC:2006 (Requirements for medical devices to be designated "sterile").
- EN ISO 11138-1: 2006 (Biological indicators - General requirements).
- EN ISO 11138-2: 2006 (Biological indicators for ethylene oxide sterilization processes). |
| Usability Testing | - In accordance with IEC 62366-1:2015. |
| Other Standards | - ASTM F1980:2011 (Accelerated Aging of Sterile Barrier Systems). - ISO 10993-1:2009 (Biological evaluation of medical devices -- Part 1).
- ISO 10993-18:2009 (Chemical characterization of materials).
- ISO 14971:2012 (Application of risk management to medical devices).
- ISO 15223-1:2016 (Symbols for medical device labels). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The submission relies on non-clinical performance data and comparison to a predicate device, not a human clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. There was no clinical ground truth established for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set was used 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:
Not applicable. The device is an infusion set, not an AI-powered diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the clinical sense. The "ground truth" for this submission is established through adherence to recognized national and international engineering and safety standards, and documented performance in non-clinical laboratory tests.
8. The sample size for the training set:
Not applicable. There is no AI component or training set described.
9. How the ground truth for the training set was established:
Not applicable. There is no AI component or training set described.
§ 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.