(73 days)
The ACCU-CHEK® Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.
The ACCU-CHEK Ultraflex is an ethylene oxide sterilized, single-use, disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The infusion set includes a stainless steel introducer needle to facilitate insertion of the soft cannula into the dermis. The unit is designed to interface with commercially available insulin infusion pumps with suitable luer connections. The insulin infusion pump systems are designed to control the delivery of U100 insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.
The provided text describes the ACCU-CHEK® Ultraflex Infusion Set and its substantial equivalence to a predicate device. However, it does not contain information on acceptance criteria for device performance or the details of a study proving the device meets specific performance criteria.
The document states that "Non-clinical testing of the modified ACCU-CHEK Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use" and "Non-clinical testing included: soft cannula length confirmation, introducer needle length confirmation, insertion force, and system functional verification testing."
It also explicitly states: "Clinical testing was not required to validate the device modification or support substantial equivalence."
Therefore, I cannot populate the table or answer most of your detailed questions because the information is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device through material and design similarities and non-clinical testing, rather than a clinical performance study with detailed acceptance criteria and expert-adjudicated ground truth.
Here's what I can extract based on the provided text, along with what is explicitly missing:
Acceptance Criteria and Device Performance
| Criteria | Acceptance Criteria (Required Performance) | Reported Device Performance | Study Proving Compliance |
|---|---|---|---|
| Soft Cannula Length | (Not specified in document) | Confirmed (implicitly meets design specifications) | Non-clinical testing |
| Introducer Needle Length | (Not specified in document) | Confirmed (implicitly meets design specifications) | Non-clinical testing |
| Insertion Force | (Not specified in document) | Meets requirements (implicitly within acceptable range) | Non-clinical testing |
| System Functional Verification | (Not specified in document) | Meets requirements (implicitly functions as intended) | Non-clinical testing |
| Substantial Equivalence (Overall) | Device is as safe and effective as the predicate device (K101196 ACCU-CHEK Ultraflex Infusion Set) | Demonstrated through similar materials, design, indications for use, intended use, sterilization, packaging, and non-clinical testing. | Non-clinical testing and comparison to predicate. |
Detailed Study Information (Based on what is NOT in the document)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document refers to "non-clinical testing" without detailing sample sizes for specific tests. No clinical test set.
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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. No clinical test set with expert-established ground truth was reported.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set with expert adjudication was reported.
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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 or imaging device that would involve human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an infusion set; it does not involve algorithms or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical ground truth was established as clinical testing was not required. Non-clinical testing would rely on engineering specifications and measurement standards.
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The sample size for the training set
- Not applicable. No "training set" in the context of machine learning or AI is relevant here. If referring to design verification or validation, it's not specified.
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How the ground truth for the training set was established
- Not applicable.
In summary, the provided K122686 510(k) summary focuses on demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical engineering tests (soft cannula length confirmation, introducer needle length confirmation, insertion force, and system functional verification). It explicitly states that clinical testing was not required for this submission.
§ 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.