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510(k) Data Aggregation
(29 days)
The Remunity® Pump for Remodulin® (treprosimil) Injection (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in adults (greater than 22 years old).
The Remunity Subcutaneous Delivery System for Remodulin® (Remunity 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 Remunity System consists of several components: a wearable pump assembly, a remote interface, a filling and priming aid, and accessories (e.g., rechargeable batteries, battery charger, 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 Remunity System to the patient.
The pump assembly is composed of a reusable pump and a disposable single-use cassette with a pharmacy-filled or 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 Remunity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.
The device is prescription use only.
The modified device can be used with an additional infusion set.
The provided text describes a 510(k) premarket notification for a medical device called the "Remunity System," which is an infusion pump. The submission is for a modified version of an already cleared device, and the primary modification discussed is the addition of a compatible infusion set.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner for specific performance characteristics of the new infusion set. Instead, it states that "Performance testing with the Neria Guard demonstrates that subject device performance is equivalent to the predicate device. The methods and acceptance criteria used in this testing are well established in previous clearances."
However, the table comparing the predicate device and the subject device does list several performance characteristics and their values, which implicitly serve as the performance requirements that the modified device must meet to be considered equivalent. Since the subject device is stated to have "No change" in all these characteristics except the infusion set, it implies that the modified device performs identically to the predicate device for these parameters.
Acceptance Criteria (Implicit from Predicate Device Performance)
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Subject Device) |
|---|---|---|
| Basal Delivery Rate Range | 16 µL/hr – 225 µL/hr, increments of 1 µL/hr | No change (implies 16 µL/hr – 225 µL/hr, increments of 1 µL/hr) |
| Basal Accuracy | ±6% | No change (implies ±6%) |
| Bolus Volume after Occlusion Release | < 40 µL at all rates | No change (implies < 40 µL at all rates) |
| Time to Occlusion Alarm (≥ 100 µL/hr) | Maximum 12 minutes | No change (implies Maximum 12 minutes) |
| Time to Occlusion Alarm (< 100 µL/hr) | Maximum 8 hours | No change (implies Maximum 8 hours) |
| Pump Service Life | 3 years | No change (implies 3 years) |
| Ingress Protection | IP58 when connected to the Cassette | No change (implies IP58) |
| Battery Operating Time | 72 hours | No change (implies 72 hours) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses "bench performance testing." It does not specify the sample size for this testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective. Given that it is bench testing, it would inherently be prospective data collected in a laboratory setting.
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)
This information is not provided in the document. The testing described is "bench performance testing" which typically does not involve human experts establishing "ground truth" in the same way clinical or diagnostic studies do. The "ground truth" in this context would be physical measurements of pump performance against engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable for bench performance testing of an infusion pump. Adjudication methods are typically used in clinical studies, especially those involving human interpretation of medical images or outcomes.
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 MRMC study was done. The device in question is an infusion pump, which is a hardware device for delivering medication, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, questions about human readers and AI assistance are not relevant to this device and its clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an infusion pump; therefore, the concept of "standalone algorithm performance" as typically applied to AI/ML devices is not directly applicable. The device's performance, as measured in bench testing, is inherently its "standalone" performance without "human-in-the-loop" assistance in terms of its core function (drug delivery accuracy, occlusion detection, etc.).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench performance testing of the infusion pump, the "ground truth" would be engineering specifications and metrology measurements. This isn't based on expert consensus, pathology, or outcomes data. It's about measuring physical phenomena (e.g., fluid volume delivered, time to alarm) against predefined design requirements.
8. The sample size for the training set
This information is not provided and is not applicable. This device is an infusion pump, which is a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data in the conventional sense. Its function is based on mechanical and electronic engineering principles.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as explained in point 8.
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(133 days)
The Remunity® Pump for Remodulin® (treprosimil) Injection (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in adults (greater than 22 years old).
The Remunity Subcutaneous Delivery System for Remodulin® (Remunity 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 Remunity System consists of several components: a wearable pump assembly, a remote interface, a filling and priming aid, and accessories (e.g., rechargeable batteries, battery charger, 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 Remunity System to the patient.
The pump assembly is composed of a reusable pump and a disposable single-use cassette with a pharmacy-filled or 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 Remunity System utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy.
The device is prescription use only.
The modified device utilizes a touchscreen remote controller.
The provided text describes the Remunity System, an infusion pump. However, the document is a 510(k) summary for a substantial equivalence determination, not a study report proving a device meets specific acceptance criteria.
The 510(k) process primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety or effectiveness. It does not typically involve the presentation of detailed clinical study results or performance data in the format of acceptance criteria and proven performance as might be found in a clinical trial report or a comprehensive validation study.
Specifically, the document states:
- "No animal study or clinical trial data was obtained in support of this premarket submission."
- "Performance testing was conducted in order to verify and validate the subject device remote interface for its intended use, and to establish substantial equivalence to the respective predicate device remote interface in terms of safety and effectiveness." This indicates that performance testing was done, but the details of acceptance criteria and reported numerical performance values are not provided within this summary.
- The only "performance data" mentioned are the types of tests conducted (e.g., Touchscreen Remote Reliability, Functionality, Wireless Communication, Software and Cybersecurity, Human Factors, Electrical Safety, EMC, Alarms), not the quantitative results of those tests.
Therefore, Based solely on the provided FDA 510(k) summary (K240256), I cannot extract the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, as detailed as your prompt requires. The document attests that appropriate testing was performed and that the modified device (with a touchscreen remote controller) is substantially equivalent to its predicate, but it does not present the raw or summarized performance data against explicit acceptance criteria.
The information you are asking for, such as sample size for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details, are typically found in more detailed study reports (e.g., clinical study reports, validation reports) that might be referenced in a 510(k) submission but are not fully elaborated in the summary itself.
In summary, the provided text does not contain the detailed information required to fill out the table and answer the specific questions about acceptance criteria and performance study methods.
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