(51 days)
The Medela Vario 8/18/ci Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patients bedside.
Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal and thoracic drainage (in combination with a water seal or dry seal chest drain) in either "constant" or "intermittent" mode. Especially for thoracic drainage the Medela Vario 8 is indicated in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.
This notification for the Medela® Vario 8/18/ci Suction Pumps is for labeling change and to include additional indications. There have been no significant modifications or design changes to the currently cleared and marketed Medela® Vario, 510(k) No. K983552.
The Medela® Vario 8/18/ci Suction Pumps is a further innovative development of Medela's well-proven piston/cylinder system. With its QuatroFlex™ technology, the drive power is transferred to the four piston/cylinder modules by means of high-grade, flexible thin-films hinges. The required suction value is rapidly built-up. High suction performance and low weight are positive features of the Vario pump.
The Medela® Vario 8/18/ci is an AC or an AC/DC-powered portable aspirator and incorporates in its medium sized housing an AC respectively DC-motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHG, a self-bleeding membrane vacuum regulator, an overflow protection device (hydrophobic filter) and connection tubing, an electric cord and an instruction manual.
The Medela® Vario 18 "high vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -75 kPa (-563 mmHd). The pump is marked "low flow - high vacuum".
The Medela® Vario 18 "medium vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -50 kPa (-375 mmHq). The pump is marked "low flow - medium vacuum".
The Medela® Vario 8 "low vacuum" suction pump has a suction capacity of 8 liters per minute and a maximum vacuum up to -9 kPa (-68 mmHg). The pump is marked "low flow - low vacuum".
A variety of reusable and disposable accessories are available. A variety of disposables for thoracic drainage are also available.
The provided text is a 510(k) summary for the Medela® Vario 8/18/ci Powered Suction Pumps. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. However, this document does not contain specific acceptance criteria, study details, or performance data in the way a clinical study report would.
The core of this 510(k) summary is that the new device is substantially equivalent to legally marketed predicate devices, meaning it is considered as safe and effective as those devices because there are no significant modifications or design changes that would raise new aspects regarding safety and effectiveness. The only modifications noted are a change from lead acid to NiMH batteries and more differentiated trade names.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth are not present in this type of regulatory filing because they are typically not required when demonstrating substantial equivalence for minor modifications.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| No new aspects regarding safety and effectiveness compared to predicate device K983552. | The Medela® Vario 8/18/ci suction pumps are "identical in construction and performance" to the legally marketed device K983552. |
| (Implicit) Functionality: Suction capacity and maximum vacuum. | Medela® Vario 18 "high vacuum": Suction capacity of 18 liters per minute, maximum vacuum up to -75 kPa (-563 mmHg). |
| Medela® Vario 18 "medium vacuum": Suction capacity of 18 liters per minute, maximum vacuum up to -50 kPa (-375 mmHg). | |
| Medela® Vario 8 "low vacuum": Suction capacity of 8 liters per minute, maximum vacuum up to -9 kPa (-68 mmHg). | |
| (Implicit) Durability/Reliability (due to battery change) | Change from lead acid to NiMH batteries. Device is concluded to be "reliable, safe and effective." |
Explanation: The document states that the new device is "identical in construction and performance" to the predicate device (K983552) and that the modifications (battery type and naming) do not "significantly affect the safety or effectiveness." This implies that the device meets the performance and safety standards established for the predicate device. The specific acceptance criteria for these standards are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No sample size, test set details, or data provenance information (country, retrospective/prospective) are provided in this 510(k) summary. The submission relies on demonstrating substantial equivalence to already cleared devices rather than providing new clinical test data.
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. No new clinical test set requiring expert ground truth establishment is mentioned in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new clinical test set is mentioned.
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 does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a powered suction pump and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new ground truth was established for this submission, as it relies on substantial equivalence. The "ground truth" for its safety and effectiveness is the regulatory clearance of its predicate device(s).
8. The sample size for the training set
Not applicable. This device is a powered suction pump and does not involve an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a powered suction pump and does not involve an algorithm that requires a training set.
§ 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.