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510(k) Data Aggregation
(282 days)
The Unity Subcutaneous Infusion System (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® (treprostinil) (hereinafter referred to as 'Remodulin' or 'Remodulin (treprostinil)'). 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 subcutaneous 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 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.
Cassettes are identical to those cleared under K190182, with the specialty pharmacy will take the cassettes out of their sterile packaging, cap the cassette and aseptically fill the cassette reservoir through the cassette filling septum following USP 797 Compounding Sterile Preparations. The specialty pharmacy will then package these filled cassettes and ship to the intended end user under controlled conditions outlined in the labeling. The pharmacy-filled cassette is intended to be stored (inclusive of shipping item) up to 14-days and is intended to be in use for up to 72-hours.
The device is prescription use only.
Here's a summary of the acceptance criteria and the study information based on the provided text, formatted to address your specific questions.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a previously cleared device (predicate device K190182). Therefore, much of the performance evaluation for this submission (K191313) builds upon the predicate device's data and specifically addresses changes related to the pre-filled cassettes. A full, comprehensive study proving all acceptance criteria might have been conducted for the original K190182 clearance.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the "Same" performance characteristics compared to the predicate device, which would have had its own established performance targets. The "Discussion of Differences" column indicates how the current submission evaluated the impact of the specific changes.
| Acceptance Criteria (Implied from Predicate/Evaluated) | Reported Device Performance (K191313) |
|---|---|
| Mechanism of Action | Microprocessor controlled, micro-dosing pump mechanism supplemented with acoustic volume sensor (AVS) feedback for monitoring delivery accuracy. (Same as predicate) |
| Infusion Accuracy | ±6% (Same as predicate) |
| Maximum Infusion Pressure | <16.4 psi (<113 kPa) (Same as predicate) |
| Programmable Flow Rate Ranges | 16 µl/hr to 225 µl/hr with increments of 1 µl/hr (Same as predicate) |
| Time to Occlusion Alarm | Maximum time to occlusion alarm: <12 min. at rates ≥ 100 µl/hr; within 8 hr, at rates < 100 µl/hr (Same as predicate) |
| Post-Occlusion Bolus | <40 µl at all rates. (Same as predicate) |
| Alarms & Alerts | Identical list of alarms and alerts as the predicate device. (Same as predicate) |
| Device Service Life | 3 years (Same as predicate) |
| Dimensions & Weight | 6 cm x 6 cm x 2 cm; 50 g (1.76 oz) (Same as predicate) |
| Materials | Additional materials for the cap (Polycarbonate). Evaluated and deemed to not introduce new biocompatibility issues. |
| Environment of Use | In professional healthcare facility and home healthcare environments. (Same as predicate) |
| Ingress Protection | IP58 when connected to the reservoir. (Same as predicate) |
| Power Source | Rechargeable Lithium-Ion Battery. (Same as predicate) |
| Storage Conditions | Temperature: -13°F to 158°F (-25°C to 70°C); Non-condensing humidity: up to 90%; Pressure: 500 hPa to 1060 hPa. (Same as predicate) |
| Operating Conditions | Temperature: 41°F to 104°F (5°C to 40°C); Non-condensing humidity: up to 90%; Pressure: 700 hPa to 1060 hPa. (Same as predicate) |
| Remote User Feedback | Audible, vibratory. (Same as predicate) |
| Administration Set Compatibility | Medtronic Quick-set Infusion Set, Medtronic Silhouette and Infusion Set, Smiths Medical Cleo 90 Infusion Set. (Same as predicate; verification confirmed compatibility) |
| Cassette Type | Remodulin Unity cassettes, 3 ml, Specialty Pharmacy filled. (Difference from predicate, which was user-filled) |
| Expiration – Cassette (Filled) | Pharmacy-Fill, 14 Days. (Difference from predicate, which was 6 months from manufacture for user-filled) |
| End User Packaging | Aseptically filled cassette with female luer lock fluid path closure, placed in plastic clamshell tray and sealed in foil pouch. (Difference from predicate, which was unfilled, terminally sterilized) |
| Drug Stability (with new cassette) | Maintained adequate assurance of drug stability for 14 days + 72 hours in-use. (Evaluated through drug stability studies) |
| Microbial Ingress Protection (with new cassette) | Maintained adequate assurance of protection from microbial ingress. (Evaluated through container closure integrity and antimicrobial effectiveness testing) |
| Biocompatibility (new materials) | Materials for new components comply with ISO 10993-1:2009 and FDA guidance. |
| Sterility/Packaging Integrity | Packaging for terminally sterilized medical devices (ISO 11607-1:2006 + A1:2014); Validation per FDA Guidance for Reprocessing Medical Devices in Health Care Settings. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state specific sample sizes for each test in the "Non-Clinical/ Performance Testing" section. It broadly mentions "drug stability studies," "container closure integrity and antimicrobial effectiveness testing," and "verification of the pump essential performance."
- Sample Size: Not explicitly quantified in this summary.
- Data Provenance: The studies were conducted by the device manufacturer (DEKA Research & Development) as part of their regulatory submission to the FDA. The location/country of data origin is not specified, but it's internal testing for a U.S. market submission. The studies detailed were conducted to support the changes in the device and are considered prospective in relation to this specific 510(k) submission (K191313).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The studies listed are performance, engineering, and laboratory-based tests (e.g., infusion accuracy, material testing, stability) rather than clinical studies requiring expert ground truth for a test set in the same way a diagnostic AI might.
4. Adjudication Method for the Test Set
This information is not applicable to the type of non-clinical, performance-based testing described. Adjudication methods are typically used in clinical trials or studies where expert review is needed to resolve discrepancies in diagnoses or assessments.
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
- No, an MRMC comparative effectiveness study was not done.
- The device is an infusion pump, not a diagnostic AI system intended to assist human readers. Therefore, this type of study is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical infusion pump with integrated software, not a standalone AI algorithm. It operates to deliver medication based on programmed rates. The "essential performance requirements of the device were verified through performance testing" which can be considered its standalone performance.
7. The Type of Ground Truth Used
The ground truth for the performance testing is based on:
- Engineering Specifications/Standards: (e.g., ±6% infusion accuracy, acceptable occlusion alarm times, material biocompatibility standards like ISO 10993-1).
- Regulatory Guidance: (e.g., FDA guidance for Infusion Pumps Total Product Life Cycle, FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices", FDA Guidance for "Reprocessing Medical Devices").
- Established Test Methods: (e.g., drug stability studies, container closure integrity, antimicrobial effectiveness testing as per pharmaceutical and medical device standards).
8. The Sample Size for the Training Set
This information is not applicable. This document describes an infusion pump (a hardware device with software), not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "safety assurance case" and performance testing are based on engineering principles and regulatory compliance rather than machine learning models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for an AI algorithm described for this device.
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