(15 days)
The Medela® Vario 8 and 18 Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from or burgiour from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
The Medela® Vario 18 c/i Suction Pump is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing. The device is also 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 patient's bedside.
Additional indication Wound Healing: It is intended to be used to create localized topical negative pressure when used with the Chariker-Jeter® wound sealing kit to promote wound healing and drainage of fluids and infected materials from the wound into a disposable or reusable canister.
This notification for the Medela® Vario suction pumps is for a change in labeling and to include additional indications (for the Medela® Vario 18 c/i only). There have been no significant modifications or design changes to the currently cleared and marketed Medela® Vario, 510(k) No. K983552.
The only modifications relate to a change from lead acid to NiMH batteries and a more v differentiated trade name - Medela® Vario 8 and Vario 18 instead of Medela® Vario only (the number reflects the flow rate - 8 1/min or 18 l/min).
The Medela® Vario powered suction pump 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 Medela® Vario.
It is an AC or 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 and a selfbleeding membrane vacuum regulator.
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 mmHg). The pump is marked "low flow - high vacuum".
The Medela® Vario 18 c/i "medium vacuum" suction pump has a suction capacity of 18 liters per minute and a maximum vacuum up to -55 kPa (-413 mmHg). The pump is marked "low flow – medium vacuum".
The Medela® Vario 8 "low vacuum" suction pump has a suction capacity of 8 liters rne wiedola - 8 a.r.o o 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 depending on the pump application. An overflow protection device (hydrophobic filter), connection tubing, electric applibation: An oremon participant for the expanded indication of use for wound healing an accessory kit consisting of individually reviewed medical components.
The provided text is a 510(k) summary for the Medela Vario Suction Pumps, specifically K061435. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics in the way a novel device might.
Based on the provided information, the “acceptance criteria” are implicitly met by demonstrating that the modified device (Medela Vario 8 and 18, including the 18 c/i) is substantially equivalent to previously cleared predicate devices (Medela Basic, Median, Dominant, Vario Suction Pumps K983552, and Versatile 1 Wound Vacuum System K042134) and that the modifications do not significantly affect the safety or effectiveness of the device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for device modifications and additional indications (for the Vario 18 c/i), explicit quantitative acceptance criteria for performance, typically found in a clinical study report for a new device, are not specified. Instead, the "acceptance criteria" are the demonstration of substantial equivalence and that changes do not negatively impact safety or effectiveness.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| New indications for Medela Vario 18 c/i for wound healing are identical to cleared predicate. | The Medela® Vario 18 c/i Suction Pump's additional indication for wound healing is stated to be identical to that of the predicate device, the Blue Sky Medical Versatile 1 Wound Vacuum System (K042134). No quantitative performance metrics are provided for this comparison; it relies on the predicate's clearance. |
| Device construction and performance are identical to previously cleared predicate (K983552) for existing indications. | The Medela® Vario 8 and 18 suction pumps are stated to be "identical in construction and performance to the legally marketed device as submitted under FDA File Number K983552". The original Vario had existing indications for aspiration and removal of surgical fluids, tissue, gases, bodily fluids, or infectious materials from wounds, airway, or respiratory support system. Specific performance values mentioned for the device models include: |
- Vario 18 c/i: suction capacity 18 l/min, max vacuum -55 kPa (-413 mmHg), "low flow – medium vacuum"
- Vario 18: suction capacity 18 l/min, max vacuum -75 kPa (-563 mmHg), "low flow - high vacuum"
- Vario 8: suction capacity 8 l/min, max vacuum -9 kPa (-68 mmHg), "low flow - low vacuum"
These align with the "performance" aspect but are not presented as a direct comparison against a specific numerical acceptance criterion for this submission, rather as descriptive specifications of the device. |
| Modifications (battery type, trade name) do not significantly affect safety or effectiveness. | "The only modifications relate to a change from lead acid to NiMH batteries and a a more differentiated trade name..." The submission concludes: "...the modifications mentioned above do not significantly affect the safety or effectiveness of the device (e.g. a significant change or modification in design, material, chemical composition, energy source or manufacturing process)." No specific safety or effectiveness data for the new battery type is provided in this summary, implying it was deemed minor enough not to require extensive testing for this 510(k) summary. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a test set or data provenance in the context of clinical performance evaluation. This 510(k) relies on demonstrating substantial equivalence to predicate devices, not on new clinical data from a "test set." The statement "The Blue Sky Medical Versatile 1 Wound Vacuum System (K042134) is identical to the Medela® Vario 18 c/i suction pump. Therefore the indications for use can be adopted" implies that the equivalence itself is the basis, leveraging previous clearances.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or provided in the given 510(k) summary. The submission focuses on device modifications and substantial equivalence to previously cleared devices, not on a study requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable or provided in the given 510(k) summary.
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
This information is not applicable or provided. The device in question is a powered suction pump, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or provided. The device is a medical pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable or provided. The submission relies on demonstrating hardware equivalence and previously cleared indications, not on clinical ground truth data for a novel performance claim.
8. The Sample Size for the Training Set
This information is not applicable or provided. There is no mention of a "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided.
§ 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.