MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR

K061205 · Medela AG · BTA · Jun 21, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061205
• Device Name: MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR
• Applicant: Medela AG
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Jun 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

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 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.

Device Story

Portable AC or AC/DC-powered aspirator; utilizes QuatroFlex™ piston/cylinder technology with flexible thin-film hinges to generate vacuum. Inputs: electrical power; manual user settings for vacuum level. Outputs: controlled suction via tubing. Used in clinical settings (OR, bedside) by healthcare professionals. Features vacuum gauge, self-bleeding membrane regulator, and hydrophobic filter for overflow protection. Assists in fluid/tissue removal and thoracic drainage; aids clinical management of respiratory and surgical conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, performance, and technological similarity to legally marketed predicate devices.

Technological Characteristics

Powered suction pump; QuatroFlex™ piston/cylinder system with thin-film hinges; AC or AC/DC motor; flat belt power transmission; self-bleeding membrane vacuum regulator; hydrophobic filter; vacuum gauge (kPa/mmHg). NiMH battery. No software/algorithm.

Indications for Use

Indicated for aspiration/removal of surgical fluids, tissue, gases, bodily fluids, or infectious materials from airway or respiratory support systems. Used for nasopharyngeal, tracheal, surgical, gastrointestinal, and thoracic drainage procedures in constant or intermittent modes. Specifically indicated for thoracic drainage in patients with pneumothorax, post-operative conditions, thorax injury, pleural effusion, or empyema.

Regulatory Classification

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.

Predicate Devices

• Medela® Basic, Median, Dominant, Vario Suction Pumps (K983552)
• Medela® Dominant 35 c/i (K043544)

Submission Summary (Full Text)

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Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Werner Frei, Tel [phone] ext. 228; Fax [phone] Contact Person: werner [e-mail] Traditional 510(k) Submission for Medela® Vario Suction Pump

JUN 2 1 2006

KO61205

# Section E - 510(k) Summary

This 510(k) summary for the Medela® Vario 8/18/ci Powered Suction Pumps meets the requirements of 21 CFR 807.92.

# Sponsor's Name, Address and Contact Person 1

Sponsor: Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland [phone] ext. 228 Ph: [phone] Fax:

Contact Person Werner Frei Manager Regulatory Affairs

Date Summary Prepared: April 18, 2006

#### 2 Name of Device

| Trade Name: | Medela® Vario 8/18/ci<br>Secretion & Surgical Aspirator |
|----------------------|--------------------------------------------------------------------------------------------|
| Common Name: | Powered Suction Pump |
| Classification Name: | PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)<br>Classified Class II, per 21 CFR 878.4780 |
| Product Code: | BTA |

#### 3 Name of the predicate Device(s)

- Medela® Basic, Median, Dominant, Vario Suction Pumps, by Medela Inc. ● K983552
- Medela® Dominant 35 c/i, by Medela AG . K043544

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Medela AG. Laettichstrasse 4b. CH-6341 Baar. Switzerland Apolicant: Contact Person: Werner Frei, Tel [phone] ext. 228; Fax [phone] [e-mail] Traditional 510(k) Submission for Medela® Vario Suction Pump

### Device Description 4

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.

#### 5 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 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.

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Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Contact Person: Werner Frei, Tel [phone] ext. 228; Fax [phone] [e-mail] Traditional 510(k) Submission for Medela® Vario Suction Pump

### Summary of Technological Characteristics 6

The Medela® Vario 8/18/ci suction pumps are identical in construction and performance to the legally marketed device as submitted under FDA File Number K983552 there are no technical differences which would raise new aspects regarding safety and effectiveness.

The only modifications relate to a change from lead acid to NiMH batteries and more differentiated trade names - Medela® Vario 8 or Medela® Vario 18 instead of Medela® Vario only (the number reflects the different flow rates - 8 I/min or 18 I/min).

## 7 Conclusion

According to the FDA Guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device", the modification mentioned above does 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). All conclusions are made by the decision making process according this guidance document.

Based upon the information presented above and in this 510(k) submission, it is concluded that the proposed Medela® Vario 8/18/ci powered suction pump is reliable, safe and effective for the intended use.

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JUN 2 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medela AG c/o Werner Frei, Manager Regulatory Affairs Laettichstrasse 4b 6341 Baar Switzerland CH-6341

Re: K061205

Trade/Device Name: Medela Vario Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: April 18, 2006 Received: May 8, 2006

Dear Werner Frei:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hulut Lemern
Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

KOG1205 510(k) Number (if known):

Device Name:

Medela Vario

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 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.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Huker
Division Sign Off

Division of General, Restorative, and Neurological Devices

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510(k) Number K061205