(13 days)
The i-port Advance™ injection port is indicated for patients who administer, or to whom is administered, multiple daily subcutaneous injections of physician prescribed medications, including insulin. The device may remain in place for up to 72 hours to accommodate multiple drug injections without the discomfort of additional needle sticks. The i-port Advance™ may be used on a wide range of patients, including adults and children. Model numbers for the device include 020110, 020210, 020102 and 020202.
The i-port Advance™ injection port was designed and developed through a technological collaboration between Unomedical A/S and Patton Medical Devices and modifies the Patton Medical Device i-port@ injection port (K052389) to include the automated insertion component ("Inserter") of the Unomedical Inset™ Infusion Sct (K032854).
The Injection Port component is a prescription only, sterile, single use, non-pyrogenic, external, disposable injection port with an indwelling catheter through which physician-prescribed medications can be injected subcutaneously from a standard syringe and needle, pen or alternative manual injection device. The indwelling catheter is installed using the integrated Inserter, a manually-operated springloaded catheter insertion tool that introduces the indwelling catheter into the subcutaneous tissue by automatically inserting the prefixed introducer needle to a predetermined depth below the skin surface.
Once applied, the insertion needle is removed, and only the soft cannula remains under the skin, acting as a gateway to the subcutaneous tissue. The user injects medicines directly through the resealable septum at the top of the device. The needle of the syringe or insulin pen remains above the surface of the skin, while the medication is delivered through the soft cannula and into the subcutaneous tissue. The device, which may be worn for up to 72 hours and receive up to 75 injections, is designed to reduce the hardships of multiple daily subcutaneous injections.
The Unomedical A/S i-port Advance™ injection port is indicated for patients requiring multiple daily subcutaneous injections of physician-prescribed medications, including insulin. The device can remain in place for up to 72 hours, accommodating multiple injections without additional needle sticks. This device is suitable for both adults and children.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria with specific numerical thresholds for each test, but rather confirms that the device "meets all applicable design and performance requirements." The performance tests conducted are standard for this type of medical device and are designed to ensure safety and effectiveness.
| Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Flow Testing (before & after maximum punctures) | Confirmed to meet internal Unomedical protocols. (Ensures proper medication delivery) |
| Leak Testing (before & after maximum punctures) | Confirmed to meet internal Unomedical protocols. (Ensures no leakage of medication or bodily fluids) |
| Catheter Tension Testing (per ISO 10555) | Confirmed to meet standard requirements. (Evaluates the catheter's ability to withstand tensile forces) |
| Introducer Needle Pull Testing (per ISO 10555 & ISO 11070) | Confirmed to meet standard requirements. (Assesses the securement and removal forces of the introducer needle) |
| Adhesive Weld Strength Test (internal protocol) | Confirmed to meet internal Unomedical protocols. (Ensures the integrity of adhesive bonds) |
| Injection Port Disconnection Strength Testing (internal protocol) | Confirmed to meet internal Unomedical protocols. (Ensures the injection port remains securely connected) |
| Spring Loading Force Testing (internal protocol) | Confirmed to meet internal Unomedical protocols. (Ensures the automated inserter functions correctly) |
| Insertion Depth Testing (internal protocol) | Confirmed to meet internal Unomedical protocols. (Verifies consistent and appropriate insertion depth of the cannula) |
| Biocompatibility (AAMI/ANSI/ISO 10993-1:2009) | Materials are biocompatible and safe; drug/patient contact materials are the same as cleared predicate devices. (Ensures materials do not cause adverse biological reactions) |
| Sterilization (AAMI/ANSI/ISO 11135-1:2007) | Sterilized with Ethylene Oxide (EtO) to a Sterility Assurance Level (SAL) of 10⁻⁶; EtO residuals comply with AAMI/ANSI/ISO 10993-7:2008. (Ensures product sterility and safety from residual chemicals) |
| Pyrogenicity (LAL Testing) | Fluid path confirmed to be Pyrogen-free. (Ensures absence of fever-inducing substances) |
| Packaging Integrity | Tested to applicable standards to ensure integrity and durability. (Ensures product remains sterile and intact until use) |
| Risk Management (ISO 14971:2007) | Risk Management Plan established; risks identified, evaluated, and mitigated using FMECA and FTA. Overall risks determined to be within "As Low as Reasonably Practicable" (ALARP) and "Broadly Acceptable" regions. (Ensures potential risks are identified, assessed, and controlled) |
2. Sample Size for the Test Set and Data Provenance
The document provided does not specify the sample sizes used for each performance test. The data provenance is "internal Unomedical protocols" and adherence to international standards (ISO, AAMI/ANSI). It is implied these are prospective tests conducted during the device development and validation phases, likely conducted in various Unomedical facilities. The country of origin of the data is implied to be relevant to Unomedical A/S (Denmark) and potentially Patton Medical Devices (USA), given the collaboration.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not indicate the use of experts to establish ground truth for a test set. The studies conducted are performance and safety tests against engineering specifications and international standards, rather than clinical studies requiring expert interpretation of results (e.g., image analysis by radiologists). The "ground truth" for these engineering tests is derived directly from the test methodologies and metrics defined by the standards and internal protocols.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as the tests are for device performance against predefined specifications, not for interpretation by multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. This device is a physical medical device (an injection port), not an AI algorithm or diagnostic tool. Therefore, a study comparing human readers with and without AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone algorithm study was done or mentioned. As stated, this is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for the performance tests conducted (Flow, Leak, Tension, Pull, Weld Strength, Disconnection Strength, Spring Loading Force, Insertion Depth, Biocompatibility, Sterility, Pyrogenicity, Packaging Integrity) is based on engineering specifications, international consensus standards (e.g., ISO, AAMI/ANSI), and internal Unomedical protocols. This means the device's performance was measured against established benchmarks for safety and functionality. For instance:
- Biocompatibility: Conformance to AAMI/ANSI/ISO 10993-1:2009.
- Sterility: Conformance to AAMI/ANSI/ISO 11135-1:2007 to a SAL of 10⁻⁶.
- Ethylene Oxide Residuals: Compliance with AAMI/ANSI/ISO 10993-7:2008.
8. Sample Size for the Training Set
No training set is mentioned or applicable as this is a physical medical device, not an AI/machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this type of device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).