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510(k) Data Aggregation
(94 days)
The Unity Subcutaneous Delivery System for Remodulin® (the Unity System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) injection for use in adults (greater than 22 years of age).
The Unity Subcutaneous Delivery System for Remodulin® (Unity System) is a wearable infusion pump designed to deliver Remodulin® for the treatment of pulmonary arterial hypertension (PAH). It is intended for continuous subcutaneous delivery of FDA-approved Remodulin® (treprostimil) (hereinafter referred to as 'Remodulin (treprostinily), NDA 021272. The Unity System consists of several components: a wearable pump assembly, a remote interface, a filling and priming aid, and accessories (e.g., rechargeable batteries, battery charging cable, power adapter). A commercially available subcutaneous infusion set is connected to the pump assembly via a standard Luer connector for the delivery of Remodulin from the Unity System to the patient.
The pump assembly is composed of a reusable pump and a disposable single-use cassette with a user-filled drug reservoir, which infuses Remodulin subcutaneously into the patient based on an individualized programmed rate. Each disposable cassette may be used for up to 72 hours after attachment to the pump. The Unity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.
The device is prescription use only.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided FDA 510(k) summary for the Unity Subcutaneous Delivery System for Remodulin.
It's important to note that this document is a 510(k) summary, which provides a brief overview of the information submitted to the FDA for a substantial equivalence determination. It does not contain the full details of all studies, such as raw data, complete study protocols, or detailed statistical analyses that would be found in a full study report. Therefore, some information might be less granular than typically expected for a detailed study description.
Acceptance Criteria and Device Performance for Unity Subcutaneous Delivery System for Remodulin
The provided document describes the Unity Subcutaneous Delivery System for Remodulin, an infusion pump. The "acceptance criteria" for a 510(k) device are primarily the demonstration of substantial equivalence to a predicate device. This is achieved by showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness. The performance metrics below are compared to the predicate device and justified against the intended use and Remodulin's specific requirements.
1. Table of Acceptance Criteria and Reported Device Performance
For an infusion pump, key performance characteristics related to safety and effectiveness often revolve around accurate and reliable fluid delivery, safety features (e.g., occlusion detection), and robust design. The document highlights various performance aspects and compares them to the predicate device.
| Characteristic | Predicate Device (CADD-MS 3 Ambulatory Infusion Pump: K051568) | Proposed Device (Unity Subcutaneous Delivery System for Remodulin: K190182) | Acceptance Criteria (Implicit from Substantial Equivalence Justification) | Reported Device Performance/Justification |
|---|---|---|---|---|
| Infusion Accuracy | ±3% (nominal) | ±6% | Meets Remodulin USPI (United States Pharmacopeia) requirements for subcutaneous administration. | "Compliant with Remodulin USPI an infusion accuracy of ±6% satisfies the Remodulin delivery accuracy requirement for administration by subcutaneous injection." Clinical study demonstrated majority of measured data fell within accuracy specification, with brief intervals outside of -6% attributed to measurement uncertainty or air bubbles (within 25%). |
| Maximum Infusion Pressure | 23 psi (159 kPa) | <16.4 psi (<113 kPa) | Acceptable for intended use; verified through performance testing. | "The maximum infusion pressure is less that the predicate; however, the infusion accuracy was verified through performance testing and validated to be appropriate for the intended use." |
| Programmable Flow Rate Ranges | 0.000 mL/hr to 1.000 mL/hr (increments of .002 mL/hr) | 16 µl/hr to 225 µl/hr (increments of 1 µl/hr) | Infusion accuracy maintained within specification across flow rates relevant to Remodulin delivery; appropriate for intended use. | "Infusion accuracy was maintained within specification across flow rates that span the programmable flow rates of the device through bench testing and is appropriate based on the intended use." |
| Time to Occlusion Alarm | Max: 12-15 min at 124 µl/hr; 9.5-19 hr at 2 µl/hr | Max: <12 min at rates ≥ 100 µl/hr; within 8 hr at rates < 100 µl/hr | Similar to predicate; differences evaluated through risk-based approach to be appropriate for intended use. | "Time to occlusion is similar to the predicate. Differences were evaluated through a risk based approach to be appropriate for the intended use." |
| Post-occlusion Bolus | Approx. 40 µl (min rate); Approx. 210 µl (intermediate rate) | <40 µl at all rates | Tailored for Remodulin delivery; differences do not raise different questions of safety and effectiveness. | "The range for the Unity System is tailored for the delivery of Remodulin. These differences do not raise different questions of safety and effectiveness and have been verified through performance testing." |
| Alarms & Alerts | List of 13 alarms | List of 21 alarms | Validated based on intended use and unique technological characteristics. | "Alarms were validated based on the intended use of the device and the unique technological characteristics." (Specific performance limits for each alarm type are not detailed in this summary, but would have been part of the validation.) |
| Device Service Life | Not stated | 3 years | Essential performance maintained throughout service life via testing. | "The device was evaluated through performance testing to meet the essential performance throughout the service life." (Specific tests and their pass/fail criteria for this are not detailed, but standard for medical devices). |
| Biocompatibility | Cartridge: Polypropylene (other materials unknown) | Cassette fluid path: Polycarbonate, Bromobutyl, SEBS, polyurethane; Pump: ABS, Polycarbonate, Aluminum; Cartridge: Polycarbonate, Acrylic, polyurethane | Materials comply with ISO 10993-1 and FDA guidance; considered biocompatible. | "The materials used for the Unity System comply with biocompatibility requirements outlined in ISO 10993-1:2009 and the Guidance for Industry and Food and Drug Administration Staff... Testing was conducted for cytotoxicity, sensitization, irritation, pyrogenicity, and hemolysis. The acute systemic toxicity, subchronic systemic toxicity, and genotoxicity endpoints were addressed through the extractables/leachables study with a toxicological risk assessment." |
| Ingress Protection | IPX8 (pump's labels and outer shell intact) | IP58 (when connected to reservoir) | Provides protection against particle ingress and moisture, appropriate for intended use. | "The Unity System provides protection against particle ingress in addition to moisture protection. This is appropriate based on the intended use of the device." |
| Electrical Safety | N/A (implied by predicate) | AAMI/ANSI ES 60601-1; IEC 60601-1-2 | Compliance with relevant standards. | Successful testing per AAMI/ANSI ES 60601-1:2005/(R)2012 and IEC 60601-1-2:2014. |
| Wireless Coexistence & RF Testing | N/A (implied by predicate) | FDA Guidance Document "Radio Frequency Wireless Technology in Medical Devices"; ANSI C63.27-2017 | Compliance with relevant standards and guidance. | Successful testing per FDA Guidance and ANSI C63.27-2017. |
| Human Factors | N/A (implied by predicate) | FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices | Validation of device per intended use with intended user population/environment/scenarios. | "Human factors studies... were conducted with the intended user population, use environment and use scenarios to simulate clinical conditions. Results... demonstrate validation of the device per the intended use." |
| Reprocessing, Cleaning, Sterility | N/A (implied by predicate) | ISO 11137-1; ISO 11607-1; FDA Guidance for Reprocessing Medical Devices | Validation of cleaning/disinfection instructions and terminal sterilization. | "Validation per the FDA Guidance... confirmed cleaning and disinfection instruction provided in instructions for use." and compliance with ISO 11137-1 and ISO 11607-1. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study): "All participants were healthy subjects between 18 and 55 years of age, inclusive, at the time of informed consent." The exact sample size (N) is not explicitly stated in this summary for the clinical test set. It's common in 510(k) summaries for the detailed sample size to be omitted, but it would be present in the full study report.
- Data Provenance: The document does not specify the country of origin. It indicates it was a "Performance Assessment of The Unity Infusion System with 0.9% Sodium Chloride Injection in Healthy Volunteers study." It was a prospective study, as it involved healthy volunteers being infused and monitored.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For this device (an infusion pump), the "ground truth" for the clinical study was the actual volumetric flow rate of the saline infusion compared to the programmed flow rate. This "ground truth" is established by the calibrated measurement equipment used in the study, not by human experts adjudicating images or diagnoses.
- Therefore, the concept of "experts establishing ground truth" as it applies to medical imaging AI (e.g., radiologists) is not applicable here. The accuracy of the device's delivery is measured physically.
4. Adjudication Method for the Test Set
- Since the ground truth for infusion accuracy is based on objective, physical measurement of fluid delivery, adjudication methods (like 2+1, 3+1, etc.) are not applicable in the same way they would be for subjective clinical assessments or image interpretations in AI studies. The performance is assessed against instrumental measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. MRMC studies are typically used to evaluate the diagnostic performance of a medical imaging AI system, often comparing AI-assisted vs. unassisted human reader performance on a set of medical images.
- This device is an infusion pump, and its primary function is accurate drug delivery, not diagnostic imaging. The clinical study focused on the physical performance of the pump (infusion accuracy, reliability, safety) in humans.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in essence, standalone performance was a primary focus. The non-clinical/performance testing sections describe extensive bench testing and engineering verification of the device's core functions (infusion accuracy, alarm reliability, electrical safety, biocompatibility, etc.).
- "Device performance: The essential performance requirements of the device were verified through performance testing in accordance with the intended use of the device..."
- The clinical study then confirms key aspects of this performance in vivo (in healthy volunteers) and validates the Acoustic Volume Sensor (AVS) design. While used by humans, the AVS measurement process itself is an "algorithm only" aspect of the device's function being validated. The clinical study's objective was to assess the pump's performance, not a human-AI interaction.
7. The Type of Ground Truth Used
- For the non-clinical (bench) testing: The ground truth was established by calibrated metrology/testing equipment for parameters like infusion accuracy, pressure, flow rates, and alarm thresholds.
- For the clinical study: The ground truth for infusion accuracy was the measured volumetric flow rate of 0.9% sodium chloride, presumably obtained using highly accurate and calibrated measuring equipment. Safety ground truth was based on reported adverse events (AEs), serious adverse events (SAEs), and unanticipated adverse device effects (UADEs), which are outcome data.
8. The Sample Size for the Training Set
- This device is an electromechanical infusion pump with a microprocessor and software. It's not a machine learning/AI model in the typical sense that requires a "training set" of data for learning patterns.
- Therefore, the concept of a "training set" as it applies to deep learning or AI models is not applicable to this device. Its software and control algorithms are developed and verified through engineering principles and software validation (e.g., IEC 62304), not data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
- As explained in #8, there is no "training set" in the context of machine learning for this device. The "ground truth" for verifying its software and algorithms comes from engineering specifications, recognized standards (e.g., IEC 62304 for software), and internal quality assurance processes during development. These specifications define the desired behavior and performance, and the software is tested against them.
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