The Medela® Vario 8 and 18 Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from or burgiour from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.

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.

Additional indication Wound Healing: It is intended to be used to create localized topical negative pressure when used with the Chariker-Jeter® wound sealing kit to promote wound healing and drainage of fluids and infected materials from the wound into a disposable or reusable canister.

Device Description

This notification for the Medela® Vario suction pumps is for a change in labeling and to include additional indications (for the Medela® Vario 18 c/i only). There have been no significant modifications or design changes to the currently cleared and marketed Medela® Vario, 510(k) No. K983552.

The only modifications relate to a change from lead acid to NiMH batteries and a more v differentiated trade name - Medela® Vario 8 and Vario 18 instead of Medela® Vario only (the number reflects the flow rate - 8 1/min or 18 l/min).

The Medela® Vario powered suction pump 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 Medela® Vario.

It is an AC or 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 and a selfbleeding membrane vacuum regulator.

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 mmHg). The pump is marked "low flow - high vacuum".

The Medela® 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 (-413 mmHg). The pump is marked "low flow – medium vacuum".

The Medela® Vario 8 "low vacuum" suction pump has a suction capacity of 8 liters rne wiedola - 8 a.r.o o 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 depending on the pump application. An overflow protection device (hydrophobic filter), connection tubing, electric applibation: An oremon participant for the expanded indication of use for wound healing an accessory kit consisting of individually reviewed medical components.

AI/ML Overview

The provided text is a 510(k) summary for the Medela Vario Suction Pumps, specifically K061435. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics in the way a novel device might.

Based on the provided information, the “acceptance criteria” are implicitly met by demonstrating that the modified device (Medela Vario 8 and 18, including the 18 c/i) is substantially equivalent to previously cleared predicate devices (Medela Basic, Median, Dominant, Vario Suction Pumps K983552, and Versatile 1 Wound Vacuum System K042134) and that the modifications do not significantly affect the safety or effectiveness of the device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for device modifications and additional indications (for the Vario 18 c/i), explicit quantitative acceptance criteria for performance, typically found in a clinical study report for a new device, are not specified. Instead, the "acceptance criteria" are the demonstration of substantial equivalence and that changes do not negatively impact safety or effectiveness.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance
New indications for Medela Vario 18 c/i for wound healing are identical to cleared predicate.	The Medela® Vario 18 c/i Suction Pump's additional indication for wound healing is stated to be identical to that of the predicate device, the Blue Sky Medical Versatile 1 Wound Vacuum System (K042134). No quantitative performance metrics are provided for this comparison; it relies on the predicate's clearance.
Device construction and performance are identical to previously cleared predicate (K983552) for existing indications.	The Medela® Vario 8 and 18 suction pumps are stated to be "identical in construction and performance to the legally marketed device as submitted under FDA File Number K983552". The original Vario had existing indications for aspiration and removal of surgical fluids, tissue, gases, bodily fluids, or infectious materials from wounds, airway, or respiratory support system. Specific performance values mentioned for the device models include: - Vario 18 c/i: suction capacity 18 l/min, max vacuum -55 kPa (-413 mmHg), "low flow – medium vacuum" - Vario 18: suction capacity 18 l/min, max vacuum -75 kPa (-563 mmHg), "low flow - high vacuum" - Vario 8: suction capacity 8 l/min, max vacuum -9 kPa (-68 mmHg), "low flow - low vacuum" These align with the "performance" aspect but are not presented as a direct comparison against a specific numerical acceptance criterion for this submission, rather as descriptive specifications of the device.
Modifications (battery type, trade name) do not significantly affect safety or effectiveness.	"The only modifications relate to a change from lead acid to NiMH batteries and a a more differentiated trade name..." The submission concludes: "...the modifications mentioned above do 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)." No specific safety or effectiveness data for the new battery type is provided in this summary, implying it was deemed minor enough not to require extensive testing for this 510(k) summary.

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

The provided text does not describe a test set or data provenance in the context of clinical performance evaluation. This 510(k) relies on demonstrating substantial equivalence to predicate devices, not on new clinical data from a "test set." The statement "The Blue Sky Medical Versatile 1 Wound Vacuum System (K042134) is identical to the Medela® Vario 18 c/i suction pump. Therefore the indications for use can be adopted" implies that the equivalence itself is the basis, leveraging previous clearances.

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

This information is not applicable or provided in the given 510(k) summary. The submission focuses on device modifications and substantial equivalence to previously cleared devices, not on a study requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable or provided in the given 510(k) summary.

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

This information is not applicable or provided. The device in question 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

This information is not applicable or provided. The device is a medical pump, not an algorithm.

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

This information is not applicable or provided. The submission relies on demonstrating hardware equivalence and previously cleared indications, not on clinical ground truth data for a novel performance claim.

8. The Sample Size for the Training Set

This information is not applicable or provided. There is no mention of a "training set" as this is not an AI/ML device.

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

This information is not applicable or provided.

Summary

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K061435

Medela AG. Laettichstrasse 4b. CH-6341 Baar, Switzerland Applicant: Contact Person: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 werner.frei@medela.ch Traditional 510(k) Submission for Medela® Vario 18 c/i Suction Pump

Section E - 510(k) Summary

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

This 510(k) summary for the Medela® Vario 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 +41 41 769 5151 ext. 228 Ph: +41 41 769 5100 Fax:

Contact Person Werner Frei Manager Requlatory Affairs

Date Summary Prepared: February 16, 2006

2 Name of Device

Trade Name:	Medela® Vario 8 and Vario 18Secretion & 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® Basic, Median, Dominant, Vario Suction Pumps, by Medela Inc. . K983552
Versatile 1 Wound Vacuum System, by Blue Sky Medical Group Incorporated . K042134

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Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Contact Person: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 werner.frei@medela.ch

Traditional 510(k) Submission for Medela® Vario 18 c/i Suction Pump

Device Description 4

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 mmHg). The pump is marked "low flow - high vacuum".

The Medela® 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 (-413 mmHg). The pump is marked "low flow – medium vacuum".

The Medela® Vario 8 "low vacuum" suction pump has a suction capacity of 8 liters rne wiedola - 8 a.r.o o maximum vacuum up to -9 kPa (-68 mmHg). The pump is marked "low flow - low vacuum".

Indications for use 5

These indications for use for the Medela® Vario 8 and 18 Suction Pumps are the identical to the ones mentioned for the original Medela® Vario Suction Pumps (K983552).

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Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Contact Person: Werner Frei. Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 werner.frei@medela.ch Traditional 510(k) Submission for Medela® Vario 18 c/i Suction Pump

Additional indication Wound Healing

It is intended to be used to create localized topical negative pressure when used with the Chariker-Jeter® wound sealing kit to promote wound healing and drainage of fluids and infected materials from the wound into a disposable or reusable canister.

Contraindications for Wound Healing Application

The Medela® Vario 18 c/i is contraindicated for the following reasons for Wound treatment:

Presence of Necrotic tissue
Untreated Osteomyeltitis
Malignancy (except terminal patients for quality of life issues) •
Untreated malnutrition
Use on exposed arteries, veins, or organs .

The Blue Sky Medical Versatile 1 Wound Vacuum System (K042134) is identical to the Medela® Vario 18 c/i suction pump.

Precautions

patients on anticogagulations or difficult hemostatis ◆
non-compliant patients .

General Precautions for all indications for use

Health care provider must evaluate patient to insure that use of the Medela® Vario 18 c/i to promote wound healing is an appropriate use for the patient.

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Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Werner Frei, Tel +41 (41) 769 51 51 ext. 228; Fax +41 (41) 769 51 00 Contact Person: werner.frei@medela.ch Traditional 510(k) Submission for Medela® Vario 18 c/i Suction Pump

Summary of Technological Characteristics 6

The Medela® Vario 8 and 18 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 a more differentiated trade name - Medela® Vario 8, 8c/i, 18 or 18 c/i instead of Medela® Vario only (the number reflects the flow rate - 18 I/min).

The Blue Sky Medical Versatile 1 Wound Vacuum System (K042134) is identical to the Medela® Vario 18 c/i suction pump. Therefore the indications for use can be adopted.

Conclusion 7

According to the FDA Guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device", the modifications mentioned above do 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 in accordance with this guidance document.

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

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol. The symbol is positioned inside a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the circle.

Public Health Service

APR -7 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medela AG % Mr. Scott Cohn 1101 Corporate Drive Mchenry, Illinois 60050

Re: K061435

Trade/Device Name: Medela Vario Suction Pumps Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: May 22, 2006 Received: May 24, 2006

Dear Mr. Cohn:

This letter corrects our substantially equivalent letter of June 8, 2006.

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 (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

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Page 2 - Mr. Scott Cohn

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.

This letter will allow you to continue 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 (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/dsma/dsmamain.html.

Sincerely yours.

for Natter
Mark N. Natter

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): KO61435

Device Name:

Medela Vario Suction Pumps

Indications For Use:

The Medela Vario 8 and 18 Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's air-way or respiratory support system, either during surgery or at the patient's bedside.

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 (includinc vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.

• Prescription Use (Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)
Division of General, Restorative,
Concurrenand Neurological Devices Evaluation (ODE)

510(k) Number	4061435
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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.