(149 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 patient's bed-side.
Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal in either "constant" or "intermittent" mode.
The Medela Vario 8/18/ci suction pump is an AC or AC/DC-powered aspirator and incorporates in its medium sized housing a motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHg, a membrane vacuum regulator, an overflow protection device (hydrophobic filter) and connection tubing, an electric cord and an instruction manual.
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 Models Vario 18 "high vacuum" suction pump have 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 Model 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 (-375 mmHg). The pump is marked "low flow medium vacuum".
The Models Vario 8 "low vacuum" suction pump have 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.
This document describes the FDA's acceptance of the Medela Vario 8/18/ci Suction Pump. As such, it details testing and compliance with various standards but does not include a comparative study with a test set, ground truth established by experts, or any elements that involve analyzing performance against a specific set of criteria where the "device performance" would be distinct from simply meeting regulatory standards.
Therefore, many of the requested sections (2-8) cannot be answered from the provided text. The document focuses on showing substantial equivalence to a predicate device rather than a standalone performance study as would be seen for AI/ML devices or novel therapies.
Here's a summary of the information that can be extracted or inferred from the provided text, along with explanations for the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on demonstrating compliance with recognized voluntary standards and showing that the device's technical characteristics are substantially equivalent to a predicate device, with expanded specifications supported by testing. The "reported device performance" is essentially that the device met these standards and specifications.
| Acceptance Criterion (Standard / Specification) | Reported Device Performance (Compliance / Result) |
|---|---|
| Voluntary Standards & Risk Management | |
| ISO 14971:2007 (Risk Analysis) | Risk Analysis developed in accordance with ISO 14971:2007. |
| Software V&V (FDA Guidance for Software in Medical Devices) | Software verification and validation testing were conducted; considered "moderate" level of concern. |
| IEC 60601-1:2005 (3rd Ed) with US deviations (AAMI/ANSI ES60601-1:2005) (Electrical Safety) | Complies (tested). |
| IEC 60601-1-2: 2007 (Electromagnetic Compatibility) | Complies (tested). |
| EN ISO 10079-1: 2009 (Particular requirements for electrically powered suction equipment) | Complies (tested). |
| Performance Specifications | |
| Vacuum and flow measurements (compared to predicate) | Performance testing demonstrated vacuum levels and flow are identical to predicate specifications. |
| Operating times for AC/DC (battery) | Verified with different pump loads and battery types. Correct function of battery low indication confirmed. Reliability of charging/discharging verified at different ambient temperatures. |
| Endurance runtime for AC/DC | Confirmed to be at least the specified 2,600h. |
| Sound emission | Confirmed to be below the maximum specification. |
| Substantial Equivalence | |
| Indications for Use | Current device's indications are a subset of the predicate devices. |
| Environmental Use, User Interface, User Control, Visual Indicator, Accessories. | Identical or substantially similar (as detailed in the comparison table on pages 6-8). |
| Flow (liters/min) | Vario 8/8 c/i: 8 liters/min; Vario 18/18 c/i: 18 liters/min (identical to predicate). |
| Maximum vacuum (mmHg/kPa) | Vario 8/8 c/i: -68mmHg/-9kPa; Vario 18: -563mmHg/-75kPa; Vario 18 c/i: -413mmHg/-55kPa (identical to predicate). |
| Therapy modes | Vario 8/18: Continuous; Vario 8 c/i / 18 c/i: Continuous/intermittent (identical to predicate). |
| Power Source | Identical specifications to predicate. |
| Electrical Protection Type | Class II (identical to predicate). |
| IP-Protection | IP21 (predicate was IPX1 - this is a difference but deemed not to raise new safety/effectiveness issues). |
| Type (of electrical protection) | CF (predicate was BF for AC versions, CF for AC/DC versions - this is a difference but deemed not to raise new safety/effectiveness issues). |
| Operating/Storage Conditions (Temp, Humidity, Pressure) | Mostly identical or within acceptable ranges to predicate. |
| Weight, Dimensions, Housing Material | Identical to predicate. |
| Principles of Operation, Suction Aggregate Type, Flow Control, Vacuum Regulation Type, Vacuum Gauge Type | Identical to predicate. |
| Software (AC/DC models) | Complexity is low; two tasks handle motor on/off and rechargeable battery management (identical to predicate). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The testing described is primarily engineering and bench testing against standards and specifications, not clinical data with a "test set" in the context of device performance on patients or specific cases.
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)
This information is not applicable and therefore not provided. "Ground truth" established by experts is typically for clinical data assessment (e.g., image interpretation, diagnosis), which was not part of this submission as per section 10 ("SUMMARY OF CLINICAL TESTS: Clinical testing was not required...").
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no test set requiring expert 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 device is a powered suction pump and 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
"Standalone" performance in this context refers to the device's ability to operate according to its specifications (e.g., flow, vacuum, battery life). The non-clinical tests described are indeed standalone tests of the device's physical and functional performance. It is not a standalone algorithmic performance as might be seen for an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests was established by published voluntary standards (e.g., ISO, IEC, EN ISO) for safety and performance, as well as the manufacturer's own internal specifications which were validated against the predicate device. There was no expert consensus, pathology, or outcomes data used to establish ground truth in this context.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product and does not involve a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 18, 2016
Medela AG % Ms. Adrienne Lenz Pathway Regulatory Consulting, LLC W324S3649 County Road E Dousman, Wisconsin 53118
Re: K153663
Trade/Device Name: Vario 8/18/ci Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: April 29, 2016 Received: May 2, 2016
Dear Ms. Lenz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153663
Device Name Vario 8/18/ci
Indications for Use (Describe)
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 patient's bed-side.
Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal in either "constant" or "intermittent" mode.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
MEDELA AG
VARIO 8/18/CI SUCTION PUMPS
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K153663
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: May 17, 2016
SUBMITTER:
Medela AG Lättichstrasse 4b 6341 Baar / Switzerland Phone +41 (0)41 769 51 51 Fax + 41 (0)41 769 51 00
PRIMARY CONTACT PERSON:
Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC T 262-290-0023
SECONDARY CONTACT PERSON:
Markus Bütler Vice President Quality Assurance Medela AG
DEVICE:
TRADE NAME: Vario 8/18/ci
COMMON/USUAL NAME: Powered Suction Pump
CLASSIFICATION NAMES: 21 CFR 878.4780 Powered Suction Pump
PRODUCT CODE: BTA
PREDICATE DEVICE(S):
K061205, K061435 Medela Vario 8/18/ci
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DEVICE DESCRIPTION:
The Medela Vario 8/18/ci suction pump is an AC or AC/DC-powered aspirator and incorporates in its medium sized housing a motor with a flat belt power transmission to the pistons and cylinders, an ON/OFF-switch, a vacuum gauge in kPa and mmHg, a membrane vacuum regulator, an overflow protection device (hydrophobic filter) and connection tubing, an electric cord and an instruction manual.
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 Models Vario 18 "high vacuum" suction pump have 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 Model 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 (-375 mmHg). The pump is marked "low flow medium vacuum".
The Models Vario 8 "low vacuum" suction pump have 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.
INTENDED USE:
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 patient's bedside.
Generally the Medela Vario 8/18/ci is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal in either "constant" or "intermittent" mode.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The Vario 8/18/ci Suction Pumps use the same fundamental technology as the predicate pumps. The Vario 8/18/ci indications for use is a subset of the predicate devices indications for use. Additional testing has also been conducted to support expanded specifications. The table
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below summarizes the key differences between the Vario 8/18/ci Pumps and the predicate devices.
| Vario 8/18/ci | Vario 8/18/ci (K061205/ K061435) | |
|---|---|---|
| Indicationsfor Use | The Medela Vario 8/18/ci SuctionPumps are indicated for aspiration andremoval of surgical fluids, tissue(including bone), gases, bodily fluids(including vomit) or infectiousmaterials from a patient's airway orrespiratory support system, eitherduring surgery or at the patient'sbedside.Generally the Medela Vario 8/18/ci isintended to be used for a variety ofsuctioning procedures includingnasopharyngeal, tracheal, surgical,gastrointestinal in either "constant" or"intermittent" mode. | The Medela Vario 8/18/ci Suction Pumps areindicated for aspiration and removal ofsurgical fluids, tissue (including bone), gases,bodily fluids (including vomit) or infectiousmaterials from a patient's airway orrespiratory support system, either duringsurgery or at the patient's bedside.Generally the Medela Vario 8/18/ci isintended to be used for a variety of suctioningprocedures including nasopharyngeal,tracheal, surgical, gastrointestinal and thoracicdrainage (in combination with a water seal ordry seal chest drain) in either "constant" or"intermittent" mode. Especially for thoracicdrainage the Medela Vario 8 is indicated insituations such as pneumothorax, aftersurgery (post-operative), thorax injury, pleuraeffusion, pleuryempyem or other relatedconditions.The Medela Vario 18 c/i Suction Pump isindicated for patients who would benefit froma suction device particularly as the device maypromote wound healing. The device is alsoindicated for aspiration and removal ofsurgical fluids, tissue (including bone), gases,bodily fluids (including vomit) or infectiousmaterials from a patient's airway orrespiratory support system, either duringsurgery or at the patient's bedside. |
| Environment of Use | Professional healthcare facilityenvironment | Professional healthcare facility environment |
| User Interface | ||
| UserControl | On/off switch for Vario 18 / 8 versionsOn/off/intermittent switch for Varioc/i versionsVacuum regulator, press knob to turn | On/off switch for Vario 18 / 8 versionsOn/off/intermittent switch for Vario c/iversionsVacuum regulator, press knob to turn |
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| Vario 8/18/ci | Vario 8/18/ci (K061205/ K061435) | |||||
|---|---|---|---|---|---|---|
| VisualIndicator | Vacuum gaugeLED for battery operation | Vacuum gaugeLED for battery operation | ||||
| Accessories | Patient tubing connectors(with and without coupling pieces)Reusable lids, jars Disposable liners Disposable jars Connectors and Tubing Filters Foot Controls (vacuum) Clamp Holders Specimen cups Drainage valve | Patient tubing connectors (with andwithout coupling pieces)Reusable lids, jars Disposable liners Disposable jars Connectors and Tubing Filters Foot Controls (vacuum) Clamp Holders Specimen cups Drainage valve | ||||
| Flowliters/min | Vario 8 /Vario 8 c/i8liters/min | Vario 1818liters/min | Vario 18 c/i18liters/min | Vario 8 /Vario 8 c/i8 liters/min | Vario 1818 liters/min | Vario 18 c/i18liters/min |
| MaximumvacuummmHg/kPa | Vario 8 /Vario 8 c/i-68mmHg-9kPa | Vario 18-563mmHg-75kPa | Vario 18 c/i-413 mmHg-55 kPa | Vario 8 /Vario 8 c/i-68mmHg-9kPa | Vario 18-563mmHg-75kPa | Vario 18 c/i-413 mmHg-55 kPa |
| Therapymodes | Vario 8 andVario 18Continuous | Vario 8 c/i andVario 18 c/iContinuous/intermittent | Vario 8 and Vario 18Continuous | Vario 8 c/i and Vario 18c/iContinuous/intermittent | ||
| PowerSource | AC versions:230-240V, 50/60 Hz, 90 VA120V, 60 Hz, 70 VAAC/DC versions:100-240V, 50/60 Hz, 80 VA | AC versions:230-240V, 50/60 Hz, 90 VA120V, 60 Hz, 70 VAAC/DC versions:100-240V, 50/60 Hz, 80 VA | ||||
| ElectricalProtectionType | Class II | Class II | ||||
| IP-Protection | IP21 | IPX1 |
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| Vario 8/18/ci | Vario 8/18/ci (K061205/ K061435) | |
|---|---|---|
| Type | CF | Vario AC 8/ AC 18BFVario AC/DC 8 /ACDC 18 c/iCF |
| OperatingAmbientTemperatures | +5...+40°C | +5...+40°C |
| OperatingAmbientHumidity | 15...93% R.L. | 30...75% R.L. |
| OperatingPressure | 70 – 106 kPa | 70 – 106 kPa |
| StorageAmbientTemperatures | -25...+70°C | +5...+40°C |
| StorageAmbientHumidity | 15...93% R.L. | 20...95% R.L. |
| StoragePressure | 70 – 106 kPa | 70 – 106 kPa |
| Weight[kg] | 7.7lbs (3.5kg) (AC-version)9.3 lbs (4.2 kg) (AC/DC-Version withNiMH Battery) | 7.7lbs (3.5kg) (AC-version)9.3 lbs (4.2 kg) (AC/DC-Version with NiMHBattery) |
| Dimensions(hxwxd) | 15x7x11 inches / 380x170x285 mm | 15x7x11 inches / 380x170x285 mm |
| HousingMaterial | Plastic material ABS | Plastic material ABS |
| Principles of Operation | ||
| Suctionaggregatetype | QuatroFlex™ AC or DC-Motor with flatbelt transmission to the fourpiston/cylinder modules | QuatroFlex™ AC or DC-Motor with flat belttransmission to the four piston/cylindermodules |
| Vario 8/18/ci | Vario 8/18/ci (K061205/ K061435) | |
| Flowcontrol | To adjust the level of suction, theregulator knob has to be pressedinwards and turned in the desireddirection. The knob will be lockedwhen it's not pressed down to preventaccidental adjustment. The tubing isclamped and the user can use thegauge to adjust the suction level.When the desired vacuum is reached,the knob can be released. | To adjust the level of suction, the regulatorknob has to be pressed inwards and turnedinto the desired direction. The knob will belocked when it's not pressed down to preventaccidental adjustment. The tubing is clampedand the user can use the gauge to adjust thesuction level. When the desired vacuum isreached, the knob can be released. |
| VacuumRegulationtype | Mechanical regulator | Mechanical regulator |
| VacuumGauge type | Analog vacuum gauge | Analog vacuum gauge |
| Software,AC/DCmodelsonly | The complexity of the software is low;only two tasks handle motor on/offswitch and rechargeable batterymanagement. | The complexity of the software is low; onlytwo tasks handle motor on/off switch andrechargeable battery management. |
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SUMMARY OF NON-CLINICAL TESTS:
The Vario 8/18/ci suction pump complies with voluntary standards for electrical safety, electromagnetic compatibility, and powered suction pumps. The following data were provided in support of the substantial equivalence determination:
- . Risk Analysis developed in accordance with ISO 14971: 2007.
- . Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since prior to mitigations of hazards, failure of the software could lead to minor injury, such as pain or engorgement.
- . Electrical safety and electromagnetic compatibility testing per IEC 60601-1:2005 (3rd Edition) with US deviations per AAMI/ANSI ES60601-1:2005 standard and IEC 60601-1-2: 2007 standards, respectively
- . Performance testing demonstrating compliance with EN ISO 10079-1: 2009 Particular requirements for the safety of electrically powered suction equipment
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- . Vacuum and flow measurements: Performance testing to determine the vacuum levels and flow of the pump as compared to its specifications, which are identical to those of the predicate version of the Vario 8/18/ci pumps.
- . Verification of operating times of the Vario AC/DC, if it is powered by battery only. The operating times were checked with different pump loads and battery types. The correct function of the battery low indication was also confirmed. The function is dependent on the antecedent pump settings / work load. The dependency was checked at worst case conditions, therefore completely different pump loads/settings were chosen for each test run. Verification of the reliability of the charging/discharging process in different ambient temperatures was also completed.
- . Confirmation of the endurance runtime of the Vario AC/DC is at least the specified 2,600h.
- . Confirmation that the sound emission of the pumps is below the maximum specification.
SUMMARY OF CLINICAL TESTS:
Clinical testing was not required to demonstrate the substantial equivalence of the Vario 8/18/ci suction pump to its predicate device.
CONCLUSION:
The differences between the Vario 8/18/ci suction pumps and its predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended.
From the results of nonclinical testing described, Medela AG concludes that the Vario 8/18/ci suction pumps are substantially equivalent to the legally marketed predicate device.
§ 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.