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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

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.

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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.

• 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.

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The Medela Clario Home Care Pump is intended for use in the medical field for suctioning secretions, bodily fluids and foreign objects in the nasal, pharyngeal and tracheal areas.

The Medela CLARIO Suction Pumps are indicated for aspiration and removal of secretions, bodily fluids and foreign objects from a patient's airway or respiratory support system in the nasal, pharyngeal and tracheal areas.

The Clario suction pump consists of three parts: drive unit, SafetyChamber (valve block) and canister set.

The DC motor and gear, drive electronics, LED light (indicating battery status), the on/off switch and, in the AC/DC version, a rechargeable battery are housed in the drive unit.

The valve block is attached to the drive unit with a turning motion. Two valve discs in the block are responsible for building up the vacuum in the suction canister.

On the top of the valve block the vacuum level can be adjusted by the user by means of a rotating knob, selecting one of the three air bleeding orifice sizes.

The canister set consists of canister, lid and swimmer. The canister plugs directly into the valve block.

For operation off the mains supply a medical grade AC/DC adapter is included.

The provided text is a 510(k) summary for the Medela® CLARIO™ Home Care Pump, a powered suction pump. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and detailed study designs in the way that new, higher-risk devices might.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this document because it is not required for a 510(k) submission of this nature.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics with pass/fail thresholds. For a 510(k) for a device like this, the "acceptance criteria" is primarily demonstrating substantial equivalence to existing predicate devices in terms of intended use, technological characteristics, and safety/effectiveness. This is a qualitative assessment made by the FDA.
• Reported Device Performance: The document states: "The technology of the Clario Home Care Pump is identical to the predicate devices and there are no technical differences which would raise new aspects regarding safety and effectiveness." This is the core "performance" claim for a 510(k) in this context – its performance is equivalent to established, safe, and effective devices.

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

• Not Applicable / Not Provided: 510(k) submissions for devices like this typically rely on comparison to predicate devices, engineering analyses, and performance bench testing rather than clinical "test sets" with patient samples in the way a diagnostic AI might. No specific test set sample size or provenance is mentioned.

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

• Not Applicable / Not Provided: See point 2. There's no mention of a "test set" requiring ground truth established by experts.

4. Adjudication method for the test set

• Not Applicable / Not Provided: See point 2 and 3.

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

• No: This device is a powered suction pump, not an AI or imaging diagnostic device. MRMC studies are not relevant to this product.

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

• No: This device is a powered suction pump, not an algorithm or AI.

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

• Not Applicable / Not Provided: The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices and the demonstration that the new device is technologically equivalent, thus inheriting that "truth."

8. The sample size for the training set

• Not Applicable / Not Provided: This is not an AI or machine learning device requiring a training set.

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

• Not Applicable / Not Provided: See point 8.

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The Ardo Suction Pumps master and senator are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.

The Ardo Suction Pumps master and senator are high performance suction pumps with maintenance-free glass piston/cylinder technology and a modern, functional design. They are the successor models of the egnell compact suction pump operating on the same basic principles. The mechanical over-flow safety device in the lid jar and the bacterial filter protect the pump against contamination. The suction pump is connected to the collection jars by means of collapse-resistant suction tubing. A longer piece of patient tubing is also connected to the jar. The latter transports the fluids from the patient to the jar. However, the tubing does not contact the patients directly. When the suction pump is switched to the ON position, the circuits direct electrical current from the external AC power supply to the pump/motor assembly. The pump operates to evacuate air from the collection jar. The resulting subatmospheric condition causes air to flow upward from the patient suction tubing and into the jars. Vacuum can be set by turning the adjustment knob. The difference between the master and senator is the suction capacity (master: 45 liter/minute, senator: 30 liter/minute). All other features are substantially equivalent.

The provided text does not contain detailed information regarding acceptance criteria for device performance or a specific study that proves the device meets those criteria in the context of clinical or diagnostic accuracy. Instead, it describes a medical device, the Ardo Suction Pumps (master and senator), and its regulatory submission (510(k)).

The document states that the device was tested against recognized international standards for medical suction equipment and general safety:

• ISO 10079-1: Medical Suction Equipment Part 1: Electrically powered suction equipment
• ISO 10079-3: Medical Suction Equipment -- Part 1: Suction equipment powered from a vacuum or pressure source
• IEC 601-1: Medical Electrical Equipment -- Part 1: General requirements for safety

These standards typically define performance requirements (e.g., maximum vacuum pressure, flow rate, safety features) and testing methodologies for such devices. Therefore, the "acceptance criteria" are implied to be compliance with these standards, and the "study" is the testing performed against these standards.

Here's an attempt to answer your questions based only on the provided text, acknowledging that much of the requested information for AI/diagnostic devices is not applicable to this type of medical hardware submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states the device "was tested" against these standards, implying compliance, as the FDA granted 510(k) clearance based on these tests.

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

• This information is not explicitly stated. For a hardware device like a suction pump, "sample size" typically refers to the number of units tested, which is not detailed.
• Data provenance: Not applicable in the context of clinical data. The tests were likely conducted in a laboratory setting by the manufacturer or a third-party testing facility.

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

• This information is not applicable. The "ground truth" for a mechanical device is its adherence to engineering specifications and safety requirements defined by the standards. No clinical experts were involved in establishing a diagnostic ground truth for this type of device.

4. Adjudication method for the test set

• Not applicable. The tests against the standards are objective measurements, not subjective evaluations requiring adjudication.

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 is a medical hardware device, not an AI/diagnostic imaging system.

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

• Not applicable. This is a medical hardware device, not an algorithm. The device functions independently in its suction capacity.

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

• The "ground truth" for this device is based on engineering specifications and safety standards (ISO 10079-1, ISO 10079-3, IEC 601-1). Compliance with these standards confirms the device's functional and safety performance.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device; there is no "training set."

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

• Not applicable. There is no training set for this type of device.

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