The Medela THOPAZ Suction Pump is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery).

Generally the Medela THOPAZ is intended to be used in all situations where chest drains are applied - especially for thoracic drainage and in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.

Device Description

The Medela® THOPAZ pump is an innovative secretion aspirator intended to be used for thoracic drainage. Its well-proven membrane system guarantees maximum suction performance and quiet, dependable operation. Additional advantages of the Medela® THO-PAZ are: user friendliness, patient mobility, simple cleaning and integrated safety features. A comprehensive range of accessories makes the Medela® THOPAZ ideally suited for thoracic drainage while mobilizing the patient.

The Medela® THOPAZ suction pump is an AC/DC powered, maintenance-free aspirator which incorporates a DC-motor with membrane aggregate power actuation in its housing. A user friendly MMI (man machine interface) guides the user through first installation, change of settings, use, data transfer and alarm handling.

The Medela® THOPAZ suction pump has an electronic measuring and monitoring system with optical and acoustic status display. The device is a dry system, which means that no fluids are necessary for operation. Important information about the course of therapy is displayed digitally and as graphics in the display. These data can be transferred to a PC upon completion of the therapy.

The Medela® THOPAZ suction pump has a suction capacity of 5 liters per minute and a maximum vacuum up to -10 kPa (-75 mmHg). The pump is marked "low flow - low vacuum".

A variety of reusable and disposable accessories for thoracic drainage are available.

AI/ML Overview

The provided text, K080212 for the Medela® THOPAZ Suction Pump, is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and supporting research in the way a clinical trial for a novel drug or a complex AI diagnostic system might.

Therefore, many of the requested sections about explicit acceptance criteria, detailed study designs, sample sizes, ground truth establishment, and multi-reader comparative studies are not directly applicable or inferable from this type of regulatory document.

Here's an attempt to address your request based on the available information:

Acceptance Criteria and Device Performance Study for Medela® THOPAZ Suction Pump (K080212)

1. Table of Acceptance Criteria and Reported Device Performance

Based on the 510(k) summary, the primary "acceptance criteria" for this device are its performance characteristics and intended use being substantially equivalent to its predicate devices. The reported device performance is presented in terms of its specifications and how they align with the predicate.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Medela® THOPAZ Device Performance
Intended Use: For aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery), especially for thoracic drainage in conditions like pneumothorax, post-operative, thorax injury, pleura effusion, pleuryempyem.	Identical Intended Use: The Medela® THOPAZ Suction Pump is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery). Generally intended for all situations where chest drains are applied – especially for thoracic drainage and in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.
Technological Characteristics: Similar pump mechanism (e.g., membrane system), user interface, monitoring capabilities to predicate devices.	Similar Technological Characteristics: Incorporates a DC-motor with membrane aggregate power actuation. Features a user-friendly MMI (man machine interface) and an electronic measuring and monitoring system with optical and acoustic status display. The device is a "dry system." Digital and graphical display of therapy course data, transferable to PC. Stated to have "identical technology like other marketed devices" and that differences are "marginal and state of the art today."
Performance Data: Suction capacity, maximum vacuum, and flow rate comparable to predicate devices.	Specifics provided: Suction capacity of 5 liters per minute. Maximum vacuum up to -10 kPa (-75 mmHg). Described as "low flow – low vacuum." The document explicitly states, "The Medela® THOPAZ has the same performance characteristics as the predicate devices."
Safety and Effectiveness: Demonstrate that new device is as safe and effective as predicate devices.	Conclusion: "There are no differences in performance or technology which significantly affect the safety and effectiveness of the device or the application (thoracic drainage)." "proven that the proposed Medela® THOPAZ powered suction pump is substantially equivalent, safe and effective for the intended use."

2. Sample Size Used for the Test Set and Data Provenance

This is a 510(k) premarket notification, which primarily relies on comparison to predicate devices, not typically extensive clinical trials with "test sets" in the conventional sense of an AI or diagnostic study.

Sample Size for Test Set: Not applicable or not described in this document. The submission focuses on demonstrating equivalence through comparison of design, specifications, and performance to predicate devices (Medela® Vario 8/18/ci Suction Pumps, K061205, and Medela® Dominant 35 c/i Suction Pump, K043544).
Data Provenance: Not applicable in the context of a "test set" for a performance study. Any data supporting the device's technical specifications would typically come from internal engineering testing and validation based on design inputs, rather than external clinical data used for a diagnostic assessment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This type of submission does not involve a "ground truth" established by experts for a test set in the way a diagnostic study would. The safety and effectiveness are established by demonstrating substantial equivalence to already cleared devices.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication by multiple experts is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

Not applicable. MRMC studies are typically performed for diagnostic imaging devices or AI systems where human reader performance is being evaluated with and without AI assistance. This document is for a powered suction pump.

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

Not applicable. This device is a physical medical pump, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a diagnostic "ground truth." The "ground truth" in this submission is the established safety and effectiveness of the predicate devices, against which the new device is compared. Its performance characteristics (suction capacity, vacuum) are objective measurements.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable for the same reason as above.

Summary

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K080212

Section E - 510(k) Summary

This 510(k) summary for the Medela® THOPAZ Suction Pump meets the requirements of 21 CFR 807.92.

JUL 2 3 2008

Sponsor's Name, Address and Contact Person 1

Sponsor: Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland +41 41 769 5151 ext. 247 Ph: +41 41 769 5100 Fax:

Contact Person Bruno Gretler Manager Regulatory Affairs

Date Summary Prepared: January 24, 2008

2 Name of Device

Trade Name:	Medela® THOPAZSecretion & 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

3 Name of the predicate Device(s)

Medela® Vario 8/18/ci Suction Pumps, by Medela Inc. . K061205
Medela® Dominant 35 c/i Suction Pump, by Medela AG . K043544

E_510k_Summary_THOPAZ.doc

2008-01-24

Section E - 1 of 3

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ব Device Description

The Medela® THOPAZ suction pump has a suction capacity of 5 liters per minute and a maximum vacuum up to -10 kPa (-75 mmHg). The pump is marked "low flow - low vacuum".

A variety of reusable and disposable accessories for thoracic drainage are available.

5 Indications for use

The Medela® THOPAZ Suction Pump is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids or infectious materials from a patient's respiratory support system (after surgery).

Generally the Medela® THOPAZ is intended to be used in all situations where chest drains are applied - especially for thoracic drainage and in situations such as pneumothorax, after surgery (post operative), thorax injury, pleura effusion, pleuryempyem or other related conditions.

Summary of Technological Characteristics 6

The Medela® THOPAZ has the same performance characteristics as the predicate devices. These differences regarding type of aggregate and display are marginal and state of the art today. Other FDA approved devices using the same technology (aggregate and display).

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 (thoracic drainage).

E_510k_Summary_THOPAZ.doc

2008-01-24

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7 Conclusion

There are no differences in performance or technology which significantly affect the safety and effectiveness of the device or the application (thoracic 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.

E_510k_Summary_THOPAZ.doc

2008-01-24

Section E - 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular fashion around the eagle. The text is in all capital letters and is relatively small compared to the eagle symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL. 2 3 2008

Medela AG % Mr. Bruno Gretler Manager Regulatory Affairs Laettichstrasse 4b 6341 Baar Switzerland

Re: K080212

Trade/Device Name: Medela THOPAZ Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: July 10, 2008 Received: July 10, 2008

Dear Mr. Gretler:

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

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Page 2 - Mr. Bruno Gretler

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,

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millerson

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

510(k) Number (if known): Kc 80212

Device Name:

Medela THOPAZ

Prescription Use X (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)

Page 1 of 1

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 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.