(208 days)
The Invia Ease Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and by removing exudates and infectious material. When used on closed surgical incisions, the Invia Ease NPWT System is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy (NPWT).
The Invia Ease NPWT system is intended for use in acute, extended and home care settings.
The Invia Ease NPWT system is appropriate for the following indications:
- Acute or subacute wounds
- Chronic wounds
- Dehisced wounds
- Pressure ulcers
- Diabetic/Neuropathic ulcers
- Venous insufficiency ulcers
- Traumatic wounds
- Partial thickness burns
- Flaps and grafts
- Closed surgical incisions
The Invia Ease Negative Pressure Wound Therapy (NPWT) System is a suction pump designed to help promote wound healing through Negative Pressure Wound Therapy (NPWT). The Invia Ease pump is reusable and portable pump intended to be used in acute, extended and home care settings.
The Invia Ease pump provides adjustable negative pressure with constant and intermittent therapy modes. Invia Ease NPWT System comprises the Invia Ease pump and the following accessories: Invia Ease canisters with integrated tubing, Invia Ease carrying case, Invia Ease handle, Invia Ease IV pole/ bed holder, and Invia Ease charger US.
The Invia Ease user interface includes two tactile buttons: an on/off button on the side of the pump and a mute button on the top of the pump. The pump is also equipped with a large touchscreen display on top of the pump, a status indicator bar on the front-side of the pump, which wraps around the side of the pump, as well as a charging port below the on/off button. Optical status of the pump is provided on the touchscreen and acoustic notifications are also used.
The pump is used with 300 ml, 500 ml and 1000 ml canisters that include a release button and canister tubing with Quick-Connector. The pump is compatible with Invia dressings (NPWT dressings from Medela AG) that interface via the Quick-Connector.
Invia Ease NPWT system is intended to be used in conjunction with the Invia dressings only.
The provided document is a 510(k) Premarket Notification from the U.S. FDA for the Medela AG Invia Ease Negative Pressure Wound Therapy (NPWT) System. It details the device, its intended use, comparison to a predicate device, and summaries of non-clinical tests.
However, this document does not contain information about the acceptance criteria or a study proving the device meets clinical acceptance criteria. The document explicitly states under "Summary of Clinical Tests" that "Clinical testing was not needed to support substantial equivalence."
Instead, the document focuses on non-clinical tests to demonstrate substantial equivalence to a predicate device. For devices like NPWT systems, "performance" is often assessed through engineering and bench testing rather than clinical trials for 510(k) clearance, unless there are significant technological differences or new indications for use that warrant clinical data.
Therefore, I can provide the following based on the document's content, focusing on non-clinical performance and "acceptance criteria" as defined by engineering standards and regulatory requirements for substantial equivalence:
Acceptance Criteria and Study for Medela AG Invia Ease Negative Pressure Wound Therapy (NPWT) System (K214112)
Based on the provided FDA 510(k) summary, the "acceptance criteria" are primarily defined by compliance with recognized engineering standards, biocompatibility, cybersecurity, usability, and functional performance benchmarks demonstrated through non-clinical testing, ensuring the device is substantially equivalent to its predicate. No clinical performance acceptance criteria or clinical studies are detailed, as they were not required for this 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
The document lists various non-clinical tests performed to demonstrate safety and effectiveness. The acceptance criteria are implicit in passing these tests and meeting the standards. "Reported device performance" implies the device successfully passed these tests.
| Acceptance Criteria Category/Test Type | Specific Acceptance Criterion (Implicit) | Reported Device Performance (as stated in document) |
|---|---|---|
| Risk Management | Compliance with ISO 14971: 2019 | Risk analysis performed in accordance with ISO 14971: 2019. |
| Electrical Safety | Compliance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Medical Electrical Equipment - Part 1: General requirements for Basic Safety and Essential Performance). | Meets IEC 60601-1 Standard. |
| Usability | Compliance with IEC 60601-1-6; 2013 (General requirements for basic safety and essential performance - Collateral standard: Usability) and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." | Usability testing conducted to validate use in acute, extended and home care settings in accordance with FDA guidance. |
| Alarm Systems | Compliance with IEC 60601-1-8: 2020 (General requirements, tests and guidance for alarm systems). | Subject device's approach to audio indicators uses more modern technology and meets IEC 60601-1-8 alarm standard for Low and Medium priority alarms. |
| Home Healthcare Environment | Compliance with IEC 60601-1-11:2015 (Requirements for medical electrical equipment and systems used in the home healthcare environment). | Test documentation provided (implied compliance). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2:2014 (Edition 4.0) (Electromagnetic Disturbances - Requirements and Tests), AIM Standard 7351731 Rev. 2.00 2017-02-23 (RF Identification Readers), and ANSI IEEE C63.27-2017 (Wireless Coexistence). | Meets IEC 6060-1-2 Standard. |
| Battery Safety | Compliance with IEC 62133-2 Edition 1.0 2017-02 (Safety requirements for portable sealed secondary cells, for use in portable applications - Part 2: Lithium systems). | Test documentation provided (implied compliance). |
| Medical Suction Equipment | Compliance with ISO 10079-1 Third Edition 2015-11-01 (Medical suction equipment Part 1: Electrically powered suction equipment). | Test documentation provided (implied compliance). |
| Radio Frequency (RF) Compliance | Compliance with FCC, 47 C.F.R. Part 15 Subparts B and C. | Test documentation provided (implied compliance). |
| Sterilization & Shelf-Life | Compliance with FDA Guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." | Information provided in accordance with FDA guidance. |
| Biocompatibility | Compliance with FDA Guidance document "Use of International Standard ISO 10993-1," and draft guidance "Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin." Specific tests: Cytotoxicity (ISO 10993-5), Intracutaneous reactivity (ISO 10993-10), Sensitization (ISO 10993-10). | Evaluation completed according to FDA Guidance. Canister and Tubing components were successfully evaluated for cytotoxicity, intracutaneous reactivity, and skin sensitization. |
| Software/Firmware | Compliance with FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" ("Moderate" level of concern). | Software/firmware verification and validation provided in accordance with FDA guidance. |
| Cybersecurity | Compliance with FDA Guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." | Cybersecurity evaluation performed according to FDA guidance. |
| Bench Performance Testing | Device meets specifications under conditions of Intermittent and Constant therapy modes with power supplied from both internal battery and external AC/DC adapter, and with each compatible dressing kit. Tests include: Vacuum Performance (with leak), Noise, Pump Endurance, Pump Tightness, IP Protection - IP22, Filter, Battery Run time, Display Stability, Transport Validation. | Bench testing conducted to check that specifications were met. The listed tests were performed, and the device demonstrated compliance. For instance, Max. vacuum: -200 mmHg / -27 KPa; Min. vacuum: -40 mmHg / -5.3 KPa. IP rating meets IP22. Battery provides sufficient life. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated in terms of individual units tested, but the document refers to various bench tests. For biocompatibility, testing was performed on "Canister" and "Tubing" components. For performance, it mentions "all Medela AG cleared dressing kits." Without specific numbers, it is assumed standard engineering and quality control sample sizes were used to establish statistical confidence in meeting acceptance criteria during manufacturing and validation.
- Data Provenance: The tests are explicitly non-clinical bench tests performed by Medela AG, a company based in Switzerland. The data would originate from their internal testing and validation processes. Given the nature of 510(k) non-clinical submissions, this data is inherently prospective in the sense that it was generated specifically for the regulatory submission to prove design and manufacturing parameters.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable as the document explicitly states, "Clinical testing was not needed to support substantial equivalence." Therefore, there was no test set requiring expert ground truth for clinical outcomes or diagnoses, as would be the case for AI/imaging devices. The "ground truth" for non-clinical tests is against engineering specifications and international standards which are established by consensus in their respective fields (e.g., electrical engineers for IEC 60601, toxicologists for ISO 10993).
4. Adjudication Method for the Test Set:
- None. As the study described is non-clinical bench testing to engineering specifications, there is no need for adjudication of human interpretation, which is typical for clinical studies involving multiple readers or subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No. An MRMC study is a clinical study format typically used for diagnostic devices (e.g., radiology AI). This device (Negative Pressure Wound Therapy System) is a treatment device, and no clinical studies were performed or required for its 510(k) clearance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Not applicable. This device is a physical medical device, not an AI algorithm. Its performance is inherent to its mechanical and software functions, which operate either independently or with human interaction (e.g., adjusting pressure). The performance is evaluated based on its functional output (e.g., vacuum pressure, alarm accuracy) rather than a diagnostic output.
7. The Type of Ground Truth Used:
- For the non-clinical tests, the "ground truth" is established by:
- Engineering Specifications: Designed performance parameters (e.g., vacuum levels, battery life, dimensions).
- International Standards: Published consensus standards for medical devices (e.g., IEC 60601 series for electrical safety, ISO 10993 for biocompatibility, ISO 14971 for risk management).
- Predicate Device Performance: Demonstrating substantial equivalence to the legally marketed predicate device (K172145) provides a comparative "truth" that the new device performs similarly in its core functions.
8. The Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" in device development refers to design iterations, and the "set" would be the prototypes and components tested during the design process. No specific "training set" is relevant for this type of regulatory submission.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. (See point 8). The "ground truth" for the device's design and manufacturing is established through adherence to Good Manufacturing Practices (GMP), design controls, and iterative testing against engineering requirements and established safety/performance standards.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.