MEDELA THOPAZ

K130210 · Medela AG · BTA · Mar 15, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130210
• Device Name: MEDELA THOPAZ
• Applicant: Medela AG
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Mar 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medela® THOPAZ Suction Pump is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Medela® THOPAZ Suction Pump is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. The Medela® THOPAZ Suction Pump is intended for use on patients in appropriate care settings.

Device Story

Medela THOPAZ is a powered suction pump for aspiration/removal of surgical fluids, tissue, gases, and infectious materials. Device provides thoracic drainage in pleural and mediastinal cavities. Used in clinical care settings for patients with pneumothorax, post-operative thoracic/cardiac conditions, or pleural injuries. Operates as a portable suction system; provides continuous or intermittent vacuum to facilitate drainage. Healthcare providers monitor output to manage patient fluid/gas removal. Benefits include effective drainage management for post-surgical or trauma patients.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Powered suction pump (Class II, 21 CFR 878.4780). Portable form factor. Intended for pleural and mediastinal drainage. Technology is identical to the predicate Medela THOPAZ (K080212).

Indications for Use

Indicated for patients requiring thoracic drainage in pleural and mediastinal cavities, including pneumothorax, post-operative cardiac or thoracic surgery, thorax injury, pleural effusion, and pleural 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® THOPAZ (K080212)
• Oasis™ Chest Drain (K043140)

Submission Summary (Full Text)

{0}------------------------------------------------

K130210

Image /page/0/Picture/1 description: The image shows the word "medela" in a bold, sans-serif font. To the right of the word is a stylized graphic of three leaves arranged in a triangular shape. The leaves are outlined in black and have a slightly textured appearance.

Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerl Annlicant Markus Bütler, Tel [phone]; Fax [phone] Contact Person [e-mail] Traditional 510(k) Submission for Medela® THOPAZ Suction Pump

MAR 1 5 2013

# Section 5 - 510(k) Summary

This 510(k) summary for the Medela® THOPAZ Suction Pump 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] Ph: Fax: [phone] Contact Person Markus Bütler VP QM and RA

Date Summary Prepared: January 18, 2013

#### Name of Device 2.

Medela® THOPAZ Trade Name: Secretion & Surgical Aspirator

Common Name: Powered Suction Pump

Classification Name: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) Classified Class II, per 21 CFR 878.4780

Product Code: BTA

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

• Medela® THOPAZ, K080212

· Oasis™ Chest Drain, K043140

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "medela" in a bold, sans-serif font. To the right of the word is a small graphic of three teardrop shapes arranged in a triangular pattern. The word and graphic are both in black and are set against a white background.

Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Markus Bütler, Tel [phone]; Fax [phone] Contact Person: [e-mail] Traditional 510(k) Submission for Medela® THOPAZ Suction Pump

The Medela® THOPAZ Suction Pump is equipped with the identical technology like other marketed devices. These technological features do not affect safety and effectiveness of the device or the application (pleural and mediastinal drainage).

#### 7. Conclusion

There are no differences in performance or technology which significantly affect the safety and effectiveness of the device or the application (pleural and mediastinal drainage). All conclusions are made by the decision making process according to the recommendations in the "510(k) SE Decision Making Process" document.

The Medela® THOPAZ suction pump has the identical intended uses and, where applicable, the identical technological characteristics and performance data as the predicate devices.

Based upon the information presented in this submission, it is proven that the proposed Medela® THOPAZ powered suction pump is substantially equivalent, safe and effective for the intended use.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird with three stylized wing or feather shapes.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Medela AG % Mr. Markus Bütler Vice President, Quality Management and Regulatory Affairs Laettichstrasse 4b Baar, Zug Switzerland CH-6341

March 15, 2013

Re: K130210

Trade/Device Name: Medela® THOPAZ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA Dated: January 18, 2013 Received: January 29, 2013

Dear Mr. Bütler:

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 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 (reporting of medical device-related 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.

{3}------------------------------------------------

### Page 2 - Mr. Markus Bütler

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 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, FOR

Peter.D.Rumm-S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) number (if known):n/a K130210

Device Name: Medela® THOPAZ

Indications for Use:

The Medela® THOPAZ Suction Pump is intended to be used for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials. The Medela® THOPAZ Suction Pump is indicated for all situations where chest drains are applied - especially for thoracic drainage in the pleural and mediastinal cavity in situations such as pneumothorax, after cardiac or thoracic surgery (post-operative), thorax injury, pleural effusion, pleural empyema or other related conditions. The Medela® THOPAZ Suction Pump is intended for use on patients in appropriate care settings.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -A

for MXM

(Division Sign-off) Division of Surgical Devices 510(k) Number K130210

-