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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.

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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).

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)

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The MiniMed Quick-serter is indicated to use as an aid for inserting compatible devices. It is for use by a single patient. It is not for use by multiple patients.

The modified MiniMed Quick-serter (MMT-305) is a non-sterile, single patient, multi-use, hand held accessory product designed to be used as an insertion aid for compatible devices, including specific infusion sets. It is used to insert the introducer needle and cannula through the skin and into the subcutaneous tissue. The MiniMed Quick-serter is intended to be used by a patient or clinician as a means to insert an infusion set with minimum discomfort and technique dependency.

The MiniMed Quick-serter consists of a plastic barrel containing a stainless steel spring and a handle. The device user places and securely seats the infusion set into the MiniMed Quick-serter is loaded and locked by pulling the handle (compressing the spring) until it clicks/locks into place. The serter is placed in contact with the insertion site and fired to release the infusion set. This is done by depressing the green side buttons to release the spring, which drives the infusion set forward and the insertion needle and cannula are inserted into the user's subcutaneous tissue. The release button on the top of the device is then pressed to ease the release of the infusion set from the serter.

The provided text describes a 510(k) submission for the "MiniMed Quick-serter" (MMT-305) and compares it to a predicate device (MMT-395). This device is a syringe needle introducer, and the submission is focused on demonstrating substantial equivalence, not necessarily on detailing a study proving the device meets acceptance criteria in the way one would for a novel AI/software medical device.

Therefore, the information I can extract will be specific to the type of device and submission, which involves engineering and biocompatibility testing rather than clinical study protocols for diagnostic accuracy or comparative effectiveness with human readers.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document lists performance testing that was conducted to verify the device's mechanical properties and functions. The "acceptance criteria" are implied by the statement "Results from performance testing indicate that the product meets the established performance requirements." Specific numerical acceptance criteria are not explicitly detailed for each test in this summary, but the reported device performance for some characteristics is given in the comparison table.

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The neria™ soft 90 infusion set is Indicated for subcutaneous infusion of medication administered by an external pump.

The neria™ soft 90 subcutaneous infusion set is a new product designed by Unomedical based on the Unomedical Inset™ Subcutaneous Infusion Set and Unomedical Quick-Set® Subcutaneous Infusion Set.

The neria™ soft 90 is a 90 degree soft cannula infusion set with a standard luer-lock connection. The neria™ soft 90 subcutaneous infusion set consists of an introducer needle/insertion handle that inserts the soft cannula into the skin and is removed immediately after insertion, a cannula housing that rests upon the skin with adhesive tape, securing the soft cannula in place under the skin, tubing with disconnect option and a reservoir connector (standard luer lock) and disconnect cover for the tubing and cannula housing.

The proposed configurations are:

• includes tubing and cannula . Infusion Set
• Tubing Only ●
• . Cannula only

Acceptance Criteria and Device Performance for neria™ soft 90 Infusion Set

This document details the acceptance criteria and study information for the neria™ soft 90 Infusion Set, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the device as being substantially equivalent to its predicate devices based on non-clinical performance data. Therefore, the "acceptance criteria" are implied by the successful execution of these tests and compliance with relevant standards. The "reported device performance" is that the device passed all tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each of the non-clinical tests. It only indicates that "a number of tests" were completed. Given that this is a 510(k) submission for substantial equivalence based on non-clinical data, it is highly likely that standard testing protocols and sample sizes specified by relevant national and international standards (e.g., ISO, ASTM) were followed.

The data provenance is from Unomedical A/S (the manufacturer) and is retrospective in the sense that these tests were performed on the device prototypes and finalized designs prior to submission. The country of origin of the data is Denmark (where Unomedical A/S is located), as well as any external testing facilities used for specific tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the evaluation relies on non-clinical performance data (functional, mechanical, material, and sterilization tests) rather than human interpretation of medical images or clinical outcomes requiring clinical ground truth establishment. These tests are assessed against predefined specifications and industry standards by qualified laboratory personnel and engineers.

4. Adjudication Method for the Test Set

This information is not applicable for the non-clinical performance data presented. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human readers/interpreters where there is an element of subjective judgment, and discrepancies need to be resolved. The non-clinical tests involve objective measurements and pass/fail criteria based on established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." Therefore, there is no effect size related to human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, there was no standalone algorithm performance study conducted. The neria™ soft 90 Infusion Set is a physical medical device, not an AI/software-as-a-medical-device (SaMD) or an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on pre-established physical, chemical, and biological specifications and standards. For example:

• Engineering specifications: Tensile strength limits, flow rates, dimensional tolerances.
• Material standards: Biocompatibility according to ISO 10993 standards.
• Sterilization standards: Assurance of sterility.
• Packaging standards: Peel strength, integrity.

These standards and specifications serve as the "ground truth" against which the device's performance is measured.

8. The Sample Size for the Training Set

This information is not applicable. The neria™ soft 90 Infusion Set is a physical medical device. It does not employ machine learning or AI algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this device.

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The intended use of the Simplicity Easy Access P Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.

Sterling Medivations Inc.'s ("SMI") Simplicity Easy Access P designed for use by people with diabetes for the infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe. It is inserted into thssue of a patient and the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Access Infusion Set, K014062 and Soft YP Infusion Set, FDA 510 (k) K011187.

The Simplicity Easy Access P Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Access Infusion Set, FDA 510 (k) K014062 and it has the same intended use.

The device consists of four main parts: (1) infusion catheters made from AISI 304 stainless steel, (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded YP connector.

The Simplicity Easy Access P Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Access Infusion Set may be used with any Paradigm infusion device that delivers continuous or intermittent flow.

The administration set attaches to the reservoir/syringe by means of a threaded YP connector, and under the surface of the skin in the patient through an indwelling needles formed from AISI 304 stainless steel. The connecting tubing is made from a polyethylene tube.

The indwelling needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The connector needle is attached to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is connecting tubing. The connector tubing proximal end is attached to a threaded YP connector for attachment to the Paradigm medicine reservoir.

The provided document is a 510(k) premarket notification for a medical device called the "Simplicity™ Easy Access P Infusion Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a formal study with detailed acceptance criteria and performance data as might be found for a new and novel device.

Therefore, much of the requested information (acceptance criteria in terms of performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or not present in this type of regulatory document.

However, based on the information provided, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly presented in the typical format of performance metrics and thresholds. Instead, the "acceptance criteria" are compliance with established medical device standards and the "reported device performance" is the demonstration that the device meets these standards, thus proving substantial equivalence.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document states that the device "meets the catheter requirements of" various ISO standards and FDA guidelines, implying that relevant tests were conducted. However, the specific sample sizes for these tests are not provided in this summary.
• Data Provenance: Not specified, but implied to be from internal testing conducted by Sterling Medivations, Inc. to ensure compliance with the listed standards. This would be prospective testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This type of information is not relevant for a 510(k) submission concerning an infusion set. Ground truth, in the context of diagnostic or AI devices, refers to a definitive correct answer for a medical condition. For an infusion set, compliance is demonstrated through engineering and biocompatibility testing against established standards, not expert clinical assessment of "ground truth."

4. Adjudication method for the test set

• Not applicable/not specified. Adjudication methods are typically employed in clinical trials or studies where there's subjectivity in outcome assessment, often involving multiple expert readers. This is not reported for the testing of an infusion set.

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

• Not applicable. This device is an infusion set, not an AI-powered diagnostic or decision support tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is an infusion set, not an algorithm.

7. The type of ground truth used

• Not applicable in the conventional sense of clinical ground truth (e.g., pathology for a diagnosis). The "ground truth" for this device's performance is adherence to established engineering specifications, material standards (e.g., AISI 304 stainless steel), biocompatibility criteria (ISO 10993-1), sterility standards (ISO 11135), and regulatory requirements. The tests verify that the device physically functions and is manufactured safely according to these pre-defined standards.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not applicable.

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