The Dominant 35 cfi Suction Pump is indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patients bedside. Generally the Dominant 35 c/i is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, gastrointestinal, wound and thoracic drainage (must be used only in combination with a chest drainage unit with a built in flow adjustment valve) in either "constant" or "intermittent" mode.

Device Description

The Dominant 35 c/i Powered Suction Pump is an advancement of the approved Medela® Basic 30 and Dominant 50 Series of Secretion and Surgical Aspirators, which are all based on the well-proven Medela pistoncylinder system.

The Dominant 35 c/i Powered Suction Pump provides the choice of two suction modes:

-Constant Suction (c) with a flow rate of 35 liters/min (high flow)
Intermittent Suction (i) with a flow rate of 8 liters/min (low flow) and default settings of 16 seconds ONTime / 8 seconds OFFTime.

The new Dominant 35 c/i is based on the Dominant 50 and has additionally fixed to it's housing a jar holder which quarantees that the iar is approximately 20 cm above patient level.

The Dominant 35 c/i is an AC-powered aspirator and incorporates an ACmotor with gearbox, pistons and cylinders, an operation panel, a vacuum gauge in kPa and mmHG, a self-bleeding membrane vacuum regulator, a safety device of polysulfone with overflow protection device and connection tubing, an electric cord and an instruction manual.

The standard version includes a mobile stand with fitting rails 10 x 25 mm and four antistatic castors, two with locking device. The internal and external foot "ON/OFF"-switches have been retained unchanged, but please note, that these switches are only active while working in the constant mode!

AI/ML Overview

The provided text describes a 510(k) submission for the Medela® Dominant 35 c/i Suction Pump, aiming to demonstrate substantial equivalence to predicate devices, rather than a study with specific acceptance criteria related to AI performance or detailed clinical efficacy.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding a study proving acceptance criteria for a device, particularly those referencing AI performance metrics, clinical trials, or expert adjudication, cannot be filled from the given text as this information is not present. The submission focuses on technological equivalence and intended use.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly state "acceptance criteria" in the context of numerical performance metrics for the Dominant 35 c/i. Instead, the submission aims to demonstrate that the new device is "substantially equivalent" to predicate devices, implying that its performance is at least comparable and that there are no new issues regarding safety and effectiveness.

The reported device performance features are:

Feature/Criterion	Reported Device Performance (Medela® Dominant 35 c/i)
Suction Modes	- Constant Suction (c) with a flow rate of 35 liters/min (high flow) - Intermittent Suction (i) with a flow rate of 8 liters/min (low flow) and default settings of 16 seconds ON-Time / 8 seconds OFF-Time
Technological Characteristics	Based on the Dominant 50, with an additional operation panel to choose constant or intermittent mode and change time settings in intermittent mode. Technology is identical to legally marketed (unmodified) devices.
Safety and Effectiveness	Concluded to be safe and effective for the intended use, based on technological characteristics being identical to predicate devices and not raising new aspects regarding safety and effectiveness.
Intended Use	Same as the predicate devices: aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from wounds or from a patient's airway or respiratory support system. Includes nasopharyngeal, tracheal, surgical, gastrointestinal, wound, and thoracic drainage.

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 in the document. The submission is a 510(k) for a powered suction pump, which typically relies on demonstrating equivalence to existing devices rather than new clinical trials with test sets in the context of AI or diagnostic performance studies.

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)

Not applicable. This information is not relevant to a 510(k) submission for a powered suction pump and is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No such study or adjudication method is mentioned.

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. The device is a powered suction pump, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a powered suction pump, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The submission focuses on demonstrating equivalence in mechanical performance and safety, not on diagnostic accuracy against a ground truth.

8. The sample size for the training set

Not applicable. The device is a mechanical suction pump, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. (See #8)

Summary

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

Applicant: Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Contact Person: Bruno Gretler, Tel +41 (41) 769 51 51 ext. 247; Fax +41 (41) 769 51 00 bruno.gretler@medela.ch Traditional 510(k) Submission for Medela® Dominant 35 c/i Suction Pump

K043544 1/2

JAN - 7 2005

Section E - 510(k) Summary

Medela Powered Suction Pumps

Dominant 35 c/i

Sponsor's Name, Address and Contact Person 1

Sponsor: Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland +41 41 769 5151 ext. 228 Ph: Fax: +41 41 769 5100

Contact Person Wemer Frei Manager Regulatory Affairs

Date Summary Prepared: October 10, 2004

2 Name of Device

Trade Name:	Medela® Dominant 35 c/iSecretion & Surgical Aspirator
Common Name:	Powered Suction Pump
Classification Name:	PUMP, PORTABLE, ASPIRATION (MANUAL ORPOWERED)(Classified Class II, per 21 CFR Section 878.4780)

Name of the predicate Device(s) 3

Medela® Basic 30 & Dominant 50 Suction Pumps, by Medela Inc. . K021368
Aeros MobIvac III Aspirator, by Aeros Instruments, Inc. . K933902

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

Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Contact Person: Bruno Gretler, Tel +41 (41) 769 51 51 ext. 247; Fax +41 (41) 769 51 00 bruno.gretler@medela.ch Traditional 510(k) Submission for Medela® Dominant 35 c/i Suction Pump

K643544 2/2

4 Description of Device

The Dominant 35 c/i Powered Suction Pump provides the choice of two suction modes:

-Constant Suction (c) with a flow rate of 35 liters/min (high flow)
Intermittent Suction (i) with a flow rate of 8 liters/min (low flow) and default settings of 16 seconds ONTime / 8 seconds OFFTime.

The new Dominant 35 c/i is based on the Dominant 50 and has additionally fixed to it's housing a jar holder which quarantees that the iar is approximately 20 cm above patient level.

5 Intended Use of the Device

The Dominant 35 c/i is intended to be used for a variety of suctioning procedures including nasopharyngeal, tracheal, surgical, wound and thoracic drainage (must be used only in combination with a chest drainage unit with a built in flow adjustment valve). The intermittent suction mode is intended to be used for gastrointestinal suction procedures.

The pump is highly suitable for gastrointestinal suction procedures and for all routine suctioning procedures involving surgical and bodily fluids, gases, blood, secretions, tissue (including bone) and infectious materials in operating theatres, emergency rooms, physicians offices, at the patients bedside and is also to perform wound and thoracic drainage. A comprehensive range of accessories makes the Dominant 35 c/i ideally suited to a wide range of medical applications.

The intended uses and the indications of the Medela Dominant 35 c/i powered suction pump, are the same as the intended uses and indications for the predicate devices Medela Basic 30 and Dominant 50 suction pumps (K021368) and/or to the AEROS Moblvac III (K933902).

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

K043544 3/2

Summary of Technological Characteristics 6

The Dominant 35 c/i is based on the Dominant 50, with an additional operation panel to choose either constant or intermittent mode and -- if desired - to change the time settings in the intermittent mode.

The technology of the Dominant 35 c/i powered suction pump is identical to the legally marketed (unmodified) devices and there are no technical differences which would raise new aspects regarding safety and effectiveness.

Conclusion 7

Based upon the information presented above, it is concluded that the proposed Medela® Dominant 35 c/i powered suction pump is safe and effective for the intended use.

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

Image /page/3/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 symbol of three abstract human figures, represented by flowing lines, suggesting unity and collaboration. The symbol is a common representation of the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

Medela AG c/o Mr. Stefan Preiss TÜV Product Service, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55412

Re: K043544

Trade/Device Name: Dominant 35 c/i Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: December 21, 2004 Received: December 23, 2004

Dear Mr. Preiss:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to continer of the rights in accordance with the provisions of the Federal Food, Drug, de noos mat have been 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 r ou may ateresy interest 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 that x Driveral statutes and regulations administered by other Federal agencies. You must or any I 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 Of It Furt 607); adoling (21 (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.

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

Page 2 - Mr. Stefan Preiss

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 premaince 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 If you attire of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

Dominant 35 c/i Device Name:

Indications For Use:

X 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)

Muriam C. Provost
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page 1 of __

510(k) Number K043544

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.