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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).

Device Description

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.

AI/ML Overview

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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K Number

K240256

Device Name

Remunity System

Manufacturer

Deka Research and Development

Date Cleared

2024-06-12

(133 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K202690

Predicate For

N/A

Intended Use

Device Description

The device is prescription use only.

The modified device utilizes a touchscreen remote controller.

AI/ML Overview

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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K Number

K202690

Device Name

Remunity Pump for Remodulin (treprostinil) Injection

Manufacturer

DEKA Research and Development

Date Cleared

2020-12-30

(106 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K191313

Predicate For

K240256

Intended Use

The Remunity Subcutaneous Infusion System (the Remunity System) is intended for continuous subcutaneous delivery of Remodulin® (treprostinil) Injection for use in adults (greater than 22 years of age).

Device Description

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 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 pharmacy-filled cassette is intended to be stored (inclusive of shipping time) up to 14-days and is intended to be in use for up to 72-hours. The cassettes are identical to those cleared under K191313, with the exception that the luer lock cap material was changed from Polycarbonate to ABS. The device is prescription use only.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Remunity Subcutaneous Delivery System for Remodulin, based on the provided document:

This document is a 510(k) Premarket Notification, which is generally used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials for a novel device. The primary change in this submission is a material change to a luer lock cap. Therefore, the "study" described is focused on validating this specific change against established standards and functions.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are largely derived from the predicate device (Unity Subcutaneous Delivery System for Remodulin K191313) and are confirmed to be the same for the subject device (Remunity Subcutaneous Delivery System for Remodulin). The primary focus of the reported performance is to confirm that the change in a material does not compromise these established criteria.

Acceptance Criterion	Reported Device Performance (Remunity System)
Mechanism of action	Same (Microprocessor controlled Micro- dosing pump mechanism supplemented with acoustic volume sensor (AVS) feedback for monitoring delivery accuracy)
Infusion Accuracy	Same (± 6%)
Maximum Infusion pressure	Same (<16.4 psi (<113 kPa))
Programmable Flow rate ranges	Same (16 µl/hr to 225 µl/hr with increments of 1 μl/hr)
Time to occlusion alarm	Same (Maximum time to occlusion alarm: <12 min. at rates ≥ 100 µl/hr; within 8 hr, at rates < 100 µl/hr)
Post-occlusion bolus	Same (<40 µl at all rates)
Alarms & Alerts	Same (Numerous, including Battery depleted, Low, Cassette problems, Occlusion, Error, Communication, etc.)
Device Service Life	Same (3 years)
Dimensions & Weight	Same (6 cm x 6 cm x 2 cm, 50 g)
Materials (Cassette fluid path)	Same (Polycarbonate, Bromobutyl, SEBS, polyurethane)
Materials (Pump)	Same (ABS, Polycarbonate, Aluminum)
Materials (Cartridge)	Same (Polycarbonate, Acrylic, polyurethane)
Materials (Filling Aid)	Same (PC-ABS)
Materials (Luer Lock Cap)	Changed from Polycarbonate to ABS
Environment of Use	Same (In professional healthcare facility and home healthcare environments)
Ingress protection	Same (IP58 when connected to the reservoir)
Power source	Same (Rechargeable Lithium-Ion Battery)
Storage Conditions	Same (Temperature: -13°F to 158°F; Non-condensing humidity: up to 90%; Pressure: 500 hPa to 1060 hPa)
Operating Conditions	Same (Temperature: 41°F to 104°F; Non-condensing humidity: up to 90%; Pressure: 700 hPa to 1060 hPa)
Remote user feedback	Same (Audible, vibratory)
Administration Set	Same (Medtronic Quick-set, Medtronic Silhouette, Smiths Medical Cleo 90)
Cassette	Same (Remodulin Unity cassettes, 3 ml, Specialty Pharmacy filled)
Expiration - Cassette	Same (Pharmacy-Fill, 14 Days (consistent with USP 797))
End User Packaging - Cassette	Same (Aseptically filled cassette with female luer lock fluid path closure, placed in plastic clamshell tray and sealed in foil pouch)
Biocompatibility	Complies with ISO 10993-1 and FDA guidance
Luer Lock Cap packaging	Same (Tyvek/LDPE pouch)
Luer Lock Cap sterility assurance level	Same (SAL 10-6)

Study Proving Device Meets Acceptance Criteria

The study described is non-clinical performance testing focused on the specific change introduced: the material of the Luer Lock Cap.

Sample size used for the test set and the data provenance:
- The document does not specify numerical sample sizes for the non-clinical tests (e.g., how many luer lock caps were tested for container closure or biocompatibility).
- The data provenance is internal to DEKA Research & Development ("DEKA's design control process"). No specific country of origin for test data is mentioned, but DEKA is a U.S.-based company. The retrospective/prospective nature of the tests is not explicitly stated. These are typically controlled laboratory tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the non-clinical testing described. The "ground truth" for non-clinical performance evaluation comes from established engineering standards, regulatory guidance (like ISO 10993-1 and FDA Infusion Pumps guidance), and predefined specifications, rather than expert consensus on individual cases.
Adjudication method for the test set:
- Not applicable in the human-reader sense. The "adjudication" is against established engineering and regulatory standards for biocompatibility and container closure performance.
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 or human reader study was done, as this device is an infusion pump, not an imaging or diagnostic AI-driven device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not directly applicable in the terms of typical AI/software performance. However, standalone non-clinical testing of the device components (specifically the luer lock cap material change) was performed to ensure it met functional and safety standards without human interaction during the test itself. This included:
  - Container Closure performance testing: This evaluated the device's ability to maintain protection against microbial ingress.
  - Biocompatibility testing: This confirmed that the new material complies with ISO 10993-1 and relevant FDA guidance.
  - Functional (container closure) testing: This was performed to demonstrate equivalence to the predicate device.
The type of ground truth used:
- Regulatory Standards: ISO 10993-1:2009 for biocompatibility and FDA's "Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process."
- Engineering Specifications: Performance metrics listed in the table (e.g., infusion accuracy, maximum infusion pressure, alarm parameters) are based on established design specifications and validated against the predicate device's performance.
- Functional Equivalence: The primary ground truth for this 510(k) submission is demonstrating equivalence in safety and effectiveness to the predicate device (Unity Subcutaneous Delivery System for Remodulin K191313), despite the material change.
The sample size for the training set:
- No "training set" in the machine learning sense is relevant here, as this is a hardware medical device with a minor material change, not an AI/ML algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.

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K Number

K191313

Device Name

Unity Subcutaneous Infusion System for Remodulin

Manufacturer

DEKA Research & Development

Date Cleared

2020-02-21

(282 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K190182

Predicate For

K202690,K243354

Intended Use

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).

Device Description

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.

AI/ML Overview

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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