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510(k) Data Aggregation
(32 days)
The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (the RemunityPRO System) is intended for continuous subcutaneous delivery of Remodulin (treprostinil) Injection for use in patients, ages 17 and older.
The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is a wearable infusion pump designed to deliver Remodulin® (treprostinil) subcutaneously for the treatment of pulmonary arterial hypertension (PAH). Remodulin® was FDA-approved under NDA 021272. The system consists of several components: a wearable pump assembly, a remote interface, 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 system to the patient. The RemunityPRO™ Pump for Remodulin® (treprostinil) Injection is prescription use only. The pump assembly is composed of a durable pump and a disposable, single-use cassette with a userfilled drug reservoir. The pump 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 subject system utilizes a micro-dosing pump mechanism supplemented with acoustic volume sensor feedback to ensure delivery accuracy. The subject device has updated branding and also modifies the predicate device to be used with an additional infusion set.
The provided text describes a 510(k) summary for the RemunityPRO™ Pump for Remodulin® (treprostinil) Injection. This is a submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to establish acceptance criteria for an entirely new device or an AI algorithm. Therefore, many of the requested categories related to medical AI studies (like expert involvement, MRMC studies, or training sets) are not applicable.
The core of this submission is to show that the minor changes to an existing device (the RemunityPRO™ Pump compared to the Remunity® 2.0 Pump) do not raise new questions of safety or effectiveness. The primary change highlighted is the addition of compatibility with an additional infusion set.
Here's an attempt to fill in the requested information based on the provided text, noting where information is not applicable to this type of regulatory submission:
Acceptance Criteria and Device Performance
The provided document details a comparison between the subject device (RemunityPRO™ Pump) and its predicate (Remunity® 2.0 Pump). The "acceptance criteria" can be inferred from the performance characteristics of the predicate device, which the subject device is shown to match or be equivalent to.
| Acceptance Criteria (Based on Predicate Performance) | Reported Device Performance (Subject Device) |
|---|---|
| Device Classification: Class II Infusion Pump, 21 CFR 880.5725, Product Code: FRN | No change (Equivalent) |
| Indications for Use: Continuous subcutaneous delivery of Remodulin (treprostinil) Injection for patients, ages 17 and older. | No change (Equivalent) |
| Prescription Use or OTC: Prescription | No change (Equivalent) |
| Intended Patient Population: Age 17 years and older | No change (Equivalent) |
| Patient Environment: On-body wearable ambulatory pump | No change (Equivalent) |
| Delivery Method: Microprocessor controlled micro-dosing pump mechanism supplemented with acoustic volume sensor (AVS) feedback for monitoring delivery accuracy | No change (Equivalent) |
| Delivery type: Subcutaneous infusion | No change (Equivalent) |
| Dimensions: 6 cm x 6 cm x 2 cm (2.4 in x 2.4 in x 0.4 in) | No change (Equivalent) |
| Weight: 50 g (1.76 oz.) | No change (Equivalent) |
| Basal Delivery Rate Range: 8 µL/hr – 225 µL/hr, with increments of 1 µL/hr | No change (Equivalent) |
| Basal Accuracy: ±6% | ±6% (No change/Equivalent) |
| Bolus Volume after Occlusion Release: < 8 µL at all rates | < 8 µL at all rates (No change/Equivalent) |
| Time to Occlusion Alarm: Maximum time to occlusion alarm: • ≥ 100 µL/hr: 12 minutes • < 100 µL/hr: 8 hours | Maximum time to occlusion alarm: • ≥ 100 µL/hr: 12 minutes • < 100 µL/hr: 8 hours (No change/Equivalent) |
| Material Biocompatibility: Fluid contacting: Polycarbonate (PC), COP, Bromobutyl, SEBS, Polyurethane. Patient contacting: PC, Acrylic, Polyurethane, ABS, Aluminum. | No change (Equivalent) |
| Cassette Shelf Life: 2 years | 2 years (No change/Equivalent) |
| Service Life: 3 years | 3 years (No change/Equivalent) |
| Applicable Safety Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24, ISO 11137-1, ISO 10993-1, ISO 14971, IEC 60601-4-2, ANSI C63.27, AIM 7351731 | No change (Equivalent) |
| Power Source: Rechargeable Lithium Ion Battery | No change (Equivalent) |
| Pump Storage Conditions: Temperature: -25 °C to 70 °C (-13 °F to 158 °F), Non-condensing humidity: up to 90%, Pressure: 50 kPa to 106 kPa | No change (Equivalent) |
| Operating Conditions: Temperature: 5 °C to 40 °C (41 °F to 104 °F), Non-condensing humidity: up to 90%, Pressure: 70 kPa to 106 kPa | No change (Equivalent) |
| Remote Interface System User Feedback: Touchscreen Device, Visual, audible, vibratory | No change (Equivalent) |
| Battery Operating Time: 72 hours | 72 hours (No change/Equivalent) |
| Infusion Set Compatibility: Medtronic Quick-set, Medtronic Silhouette, Smiths Medical Cleo 90 Infusion Sets | Equivalent - The subject device adds compatibility with the Neria Guard Infusion Set. Performance testing with Neria Guard demonstrated equivalent performance to the predicate device with established methods and acceptance criteria. |
| Cassette: Unity 2.0 Cassettes, 3 mL, user-filled | No change (Equivalent) |
| Priming Method: Primed by Pump after Cassette attachment to the Pump | No change (Equivalent) |
Study Details
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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):
- The document states: "Bench performance testing was conducted in order to qualify the additional infusion set for use with the subject device, and to establish substantial equivalence to the predicate device in terms of safety and effectiveness."
- Specific sample sizes for these bench tests are not provided in the summary.
- Data provenance is not specified, but it would typically be internal laboratory testing by DEKA Research & Development Corp.
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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. This is a bench performance study for a physical medical device (infusion pump), not a study involving interpretation of medical data by experts to establish ground truth for an AI algorithm. The performance metrics are objective and measurable (e.g., flow rate accuracy, occlusion alarm time).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is a bench performance study of a physical device, there is no "adjudication" in the sense of resolving discrepancies between human readers or AI outputs. The tests involve direct measurement against established physical standards.
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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:
- No. This is not an AI-assisted diagnostic or interpretative device; it's an infusion pump. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. While the pump contains a microprocessor and control algorithms, the "standalone" context typically refers to the performance of an AI algorithm in isolation for diagnostic tasks. This device is a complete system with mechanical, electronic, and software components, and its performance is evaluated as a whole in bench testing.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this type of device performance would be established physical and electrical measurement standards, regulatory standards (e.g., IEC 60601-2-24 for infusion pumps), and the known performance characteristics of the predicate device. These are objective engineering and regulatory requirements, not medical "ground truth" derived from patient data or expert consensus.
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The sample size for the training set:
- Not Applicable. This device, while containing software, is not an AI/ML-driven device that undergoes a "training" phase in the context of machine learning. Its operation is based on programmed control logic and physical components.
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How the ground truth for the training set was established:
- Not Applicable. As there is no AI/ML training set, this question is not relevant.
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(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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