Search Results

The Medela® INVIA Wound Therapy is indicated to help promote wound healing, through means including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressures, particularly for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

The Medela® INVIA Liberty pump is an innovative suction pump to help promote wound healing. Its well-proven membrane system guarantees maximum suction performance and quiet, dependable operation. Additional advantages of the Medela® INVIA Liberty are: user friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® INVIA Liberty ideally suited for Negative Pressure Wound Therapy (NPWT).

The Medela® INVIA Liberty suction pump is an AC/DC powered, maintenance-free aspirator for Negative Pressure Wound Therapy which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) guides the user through first installation, change of settings, use, data transfer and alarm handling.

The Medela® INVIA Liberty suction pump has an electronic measuring and monitoring system with optical and acoustic status display. It is a "medium vacuum" suction pump and has a suction capacity of 5 liters per minute and a maximum vacuum up to -27 kPa (-200 mmHg). The pump is marked "low flow - medium vacuum".

A variety of reusable and disposable accessories to help promote wound healing are available.

The Medela® INVIA Wound Therapy device, specifically the INVIA Liberty suction pump, was cleared through a Traditional 510(k) submission, asserting substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone clinical study with detailed performance metrics.

Therefore, the input document does not contain the full set of information requested because it describes a 510(k) submission for substantial equivalence rather than a study testing against acceptance criteria. A 510(k) submission primarily demonstrates that a new device is as safe and effective as a legally marketed predicate device, often relying on comparison of technological characteristics and performance data, rather than a clinical trial with specific performance targets.

Here's an analysis of the provided text in the context of your request:

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

• No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission focuses on demonstrating "identical performance characteristics" and "identical technology" to predicate devices.
• The document states: "The Medela® INVIA Liberty suction pump has the identical intended uses and, where applicable, the identical technological characteristics and performance data as the predicate devices."
• Performance information mentioned is descriptive:
  • "maximum suction performance"
  • "quiet, dependable operation"
  • "suction capacity of 5 liters per minute"
  • "maximum vacuum up to -27 kPa (-200 mmHg)."
  • "marked 'low flow - medium vacuum'"
  • These are descriptions of the device's capabilities, not specific acceptance criteria from a study with corresponding results.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• No test set or associated sample size is mentioned. The submission is a regulatory filing for substantial equivalence, not a report of a specific study that used a test set to evaluate performance metrics against acceptance criteria.

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)

• Not applicable. As there is no mention of a test set, there is no discussion of experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set is described.

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 a powered suction pump and the submission does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This device is a physical medical device (suction pump) used for wound therapy, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. No specific "ground truth" as a reference standard for performance evaluation is mentioned, as the submission focuses on equivalence to existing devices based on technical characteristics.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so no training set is relevant.

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

• Not applicable. No training set is relevant.

In summary: The provided document is a 510(k) summary for a powered suction pump, intended to demonstrate substantial equivalence to predicate devices. It does not describe a performance study with defined acceptance criteria, test sets, or ground truth establishment in the manner typically associated with device performance evaluation against specific metrics, especially for AI/ML devices. The "study" mentioned is the 510(k) submission process itself, where the device's design and technical specifications are compared to similar already-approved devices.

Ask a specific question about this device

The ERBEJET® 2 System is intended for the cutting and dissection of soft tissue in neurosurgery and soft tissue such as the liver, kidney, etc. within the abdomen, including Total Mesorectal Excision (TME), in open as well as endoscopic surgery.

The ERBEJET® 2 System delivers pressurized normal saline solution (0.9% saline solution for irrigation) to cut and dissect soft tissue. The ERBEJET® 2 Unit together with its accessories is an active invasive surgical product. The sterile normal saline solution is the "cutting medium" which is projected under pressure through a nozzle. The pressure is generated by a sterile single-use double piston Pump Cartridge and is controlled by means of a Footswitch. The Footswitch has a "ReMode" button that allows the user to switch between two established or "set" programs during the surgical procedure. The ERBEJET® 2 Unit has a display screen that allows the user to adjust the desired pressure settings using effect levels (1 to 80). The user may use the BASIC program that comes preprogrammed or set up to nine additional personalized programs. The cutting medium is isolated from the pressure generation Unit (i.e. the ERBEJET® 2 Unit) except at the sterile Pump Cartridge. A range of Applicators with a nozzle diameter of 120 µm is available for a wide range of applications. An integrated suction function (i.e. the Suction Module, Model ESM 2 which is separate and optional) can be used with the Unit and is adjustable up to -12 psi. Settings for the suction are adjusted on the display screen of the ERBEJET® 2 Unit.

The ERBEJET® 2 System is intended for cutting and dissecting soft tissue in neurosurgery and within the abdomen (e.g., liver, kidney), including Total Mesorectal Excision (TME), in both open and endoscopic surgery.

Acceptance Criteria and Device Performance:

The provided document asserts that the ERBEJET® 2 System is substantially equivalent to its predicate devices (ERBE Helix Hydro-Jet™ System, K033590; K022613; K012464) based on performance testing and comparison of characteristics. The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device, particularly regarding "performance (i.e., the pressure and volume flow)." The study indicates that the performance of the proposed device is "substantially equivalent" to the predicate.

Study Details:

The provided information focuses on demonstrating substantial equivalence to a predicate device rather than an independent clinical trial with specific acceptance criteria in the traditional sense (e.g., statistical endpoints for efficacy). The primary study performed is a comparison and performance testing against the predicate device.

1. Sample Size and Data Provenance:

   • There is no mention of a "test set" in terms of patient data. The evaluation appears to be based on engineering and bench testing of the device itself and its components.
   • The data provenance would be internal testing conducted by ERBE Elektromedizin GmbH for the ERBEJET® 2 System and historical data for the predicate device. The country of origin for the proposed device's manufacturer is Germany (ERBE Elektromedizin GmbH).

2. Number of Experts and Qualifications for Ground Truth:

   • This type of evaluation (substantial equivalence for a device modification) does not typically involve experts establishing ground truth for a test set in the same way as, for example, an AI diagnostic device.
   • User feedback is mentioned as a driver for some design changes (e.g., pressure range, applicator dimensions), implying input from surgical professionals, but their number and specific qualifications are not detailed as formal "experts" for ground truth establishment.

3. Adjudication Method:

   • Not applicable in the context of this substantial equivalence submission, which relies on a comparison of technical specifications and performance data.

4. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

   • No. This type of study is typically for evaluating diagnostic or interpretive devices where human readers provide assessments. The ERBEJET® 2 System is a surgical instrument.

5. Standalone (Algorithm Only) Performance Study:

   • No. The device is a surgical instrument, not an algorithm. Its performance is evaluated through output measurements (pressure, flow) and mechanical characteristics.

6. Type of Ground Truth Used:

   • The "ground truth" here is the established performance and safety profile of the legally marketed predicate device. The proposed device is deemed acceptable if its performance and safety characteristics are substantially equivalent, or improved without raising new safety or effectiveness concerns. This is based on standardized measurements and engineering verification/validation.

7. Sample Size for Training Set:

   • Not applicable as this is not a machine learning or AI-driven device.

8. How Ground Truth for Training Set Was Established:

   • Not applicable.

Ask a specific question about this device