(149 days)
Not Found
No
The description focuses on mechanical and electrical components and standard software for device control, with no mention of AI or ML capabilities.
Yes
The device is indicated for aspiration and removal of surgical fluids, tissue, gases, and bodily fluids, which are actions taken to treat or improve a patient's condition.
No
Explanation: The device is a suction pump used for the aspiration and removal of fluids and materials from a patient's body. It is a therapeutic or clinical support device, not a diagnostic one. Its purpose is to perform a physical function (suctioning), not to identify or characterize a disease, condition, or health status.
No
The device description clearly outlines physical hardware components like a motor, pistons, cylinders, vacuum gauge, and connection tubing, indicating it is a physical medical device with some software control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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." This describes a procedure performed on the patient, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The description details a suction pump and its components, all of which are used for physical aspiration. There is no mention of reagents, test strips, or any components typically associated with in vitro diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as analyzing samples (blood, urine, tissue, etc.), providing diagnostic information, or using methods like immunoassays, molecular diagnostics, or clinical chemistry.
The Medela Vario 8/18/ci Suction Pump is a medical device used for therapeutic and procedural purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
BTA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's airway or respiratory support system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare facility environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests:
- 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.
- 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.
Clinical tests:
Clinical testing was not required to demonstrate the substantial equivalence of the Vario 8/18/ci suction pump to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061205, K061435 Medela Vario 8/18/ci
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(K) SUMMARY
MEDELA AG
VARIO 8/18/CI SUCTION PUMPS
4
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
5
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
6
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) | |
|---|---|---|
| Indications | ||
| for 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. | 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 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. | ||
| 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. | ||
| Environme | ||
| nt of Use | Professional healthcare facility | |
| environment | Professional healthcare facility environment | |
| User Interface | ||
| User | ||
| Control | On/off switch for Vario 18 / 8 versions | |
| On/off/intermittent switch for Vario | ||
| c/i versions | ||
| Vacuum regulator, press knob to turn | On/off switch for Vario 18 / 8 versions | |
| On/off/intermittent switch for Vario c/i | ||
| versions | ||
| Vacuum regulator, press knob to turn |
7
| Vario 8/18/ci | Vario 8/18/ci (K061205/ K061435) | |||||
|---|---|---|---|---|---|---|
| Visual | ||||||
| Indicator | Vacuum gauge | |||||
| LED for battery operation | Vacuum gauge | |||||
| LED 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 and | |||||
| without coupling pieces) | ||||||
| Reusable lids, jars Disposable liners Disposable jars Connectors and Tubing Filters Foot Controls (vacuum) Clamp Holders Specimen cups Drainage valve | ||||||
| Flow | ||||||
| liters/min | Vario 8 / | |||||
| Vario 8 c/i | ||||||
| 8 | ||||||
| liters/min | Vario 18 | |||||
| 18 | ||||||
| liters/min | Vario 18 c/i | |||||
| 18 | ||||||
| liters/min | Vario 8 / | |||||
| Vario 8 c/i | ||||||
| 8 liters/min | Vario 18 | |||||
| 18 liters/min | Vario 18 c/i | |||||
| 18 | ||||||
| liters/min | ||||||
| Maximum | ||||||
| vacuum | ||||||
| mmHg/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 |
| Therapy
modes | Vario 8 and
Vario 18
Continuous | | Vario 8 c/i and
Vario 18 c/i
Continuous/
intermittent | Vario 8 and Vario 18
Continuous | | Vario 8 c/i and Vario 18
c/i
Continuous/
intermittent |
| Power
Source | AC versions:
230-240V, 50/60 Hz, 90 VA
120V, 60 Hz, 70 VA
AC/DC versions:
100-240V, 50/60 Hz, 80 VA | | | AC versions:
230-240V, 50/60 Hz, 90 VA
120V, 60 Hz, 70 VA
AC/DC versions:
100-240V, 50/60 Hz, 80 VA | | |
| Electrical
Protection
Type | Class II | | | Class II | | |
| IP-
Protection | IP21 | | | IPX1 | | |
8
| Vario 8/18/ci | Vario 8/18/ci (K061205/ K061435) | |
|---|---|---|
| Type | CF | Vario AC 8/ AC 18 |
| BF |
Vario AC/DC 8 /ACDC 18 c/i
CF |
| Operating
Ambient
Temperatures | +5...+40°C | +5...+40°C |
| Operating
Ambient
Humidity | 15...93% R.L. | 30...75% R.L. |
| Operating
Pressure | 70 – 106 kPa | 70 – 106 kPa |
| Storage
Ambient
Temperatures | -25...+70°C | +5...+40°C |
| Storage
Ambient
Humidity | 15...93% R.L. | 20...95% R.L. |
| Storage
Pressure | 70 – 106 kPa | 70 – 106 kPa |
| Weight
[kg] | 7.7lbs (3.5kg) (AC-version)
9.3 lbs (4.2 kg) (AC/DC-Version with
NiMH Battery) | 7.7lbs (3.5kg) (AC-version)
9.3 lbs (4.2 kg) (AC/DC-Version with NiMH
Battery) |
| Dimensions
(hxwxd) | 15x7x11 inches / 380x170x285 mm | 15x7x11 inches / 380x170x285 mm |
| Housing
Material | Plastic material ABS | Plastic material ABS |
| Principles of Operation | | |
| Suction
aggregate
type | QuatroFlex™ AC or DC-Motor with flat
belt transmission to the four
piston/cylinder modules | QuatroFlex™ AC or DC-Motor with flat belt
transmission to the four piston/cylinder
modules |
| | Vario 8/18/ci | Vario 8/18/ci (K061205/ K061435) |
| Flow
control | To adjust the level of suction, the
regulator knob has to be pressed
inwards and turned in the desired
direction. The knob will be locked
when it's not pressed down to prevent
accidental adjustment. The tubing is
clamped and the user can use the
gauge to adjust the suction level.
When the desired vacuum is reached,
the knob can be released. | To adjust the level of suction, the regulator
knob has to be pressed inwards and turned
into the desired direction. The knob will be
locked when it's not pressed down to prevent
accidental adjustment. The tubing is clamped
and the user can use the gauge to adjust the
suction level. When the desired vacuum is
reached, the knob can be released. |
| Vacuum
Regulation
type | Mechanical regulator | Mechanical regulator |
| Vacuum
Gauge type | Analog vacuum gauge | Analog vacuum gauge |
| Software,
AC/DC
models
only | The complexity of the software is low;
only two tasks handle motor on/off
switch and rechargeable battery
management. | The complexity of the software is low; only
two tasks handle motor on/off switch and
rechargeable battery management. |
9
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
10
- . 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.