LEVELERT II FLUID LEVEL SENSOR

K060123 · Smith & Nephew, Inc. · FLN · Feb 14, 2006 · General Hospital

Device Facts

• Record ID: K060123
• Device Name: LEVELERT II FLUID LEVEL SENSOR
• Applicant: Smith & Nephew, Inc.
• Product Code: FLN · General Hospital
• Decision Date: Feb 14, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2420
• Device Class: Class 2

Intended Use

The Smith & Nephew LEVELERT II Fluid Level Sensor is intended to weigh a bag of irrigation fluid and signal operating room personnel when a pre-determined amount of fluid remains.

Device Story

Levelert II is a stand-alone, DC battery-powered, non-rechargeable electronic monitor used in arthroscopic procedures. It functions by weighing a bag of irrigation fluid via an internal load cell. The device incorporates an internal microprocessor to process weight data against user-selected pre-determined thresholds. When the fluid level reaches the set limit, the device signals operating room personnel. This feedback allows clinicians to manage irrigation fluid supply during surgery, potentially preventing fluid depletion. The device is operated by OR staff; it replaces previous designs that utilized external power supplies and external microprocessors.

Clinical Evidence

Bench testing only. Performance, EMI/EMC, and UL safety testing, along with software verification and validation, were conducted to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Stand-alone, DC battery-powered, non-rechargeable electronic monitor. Features an internal load cell for weight sensing and an integrated microprocessor. User interface utilizes dome switches. Designed for use in arthroscopic procedures.

Indications for Use

Indicated for use in operating rooms to monitor irrigation fluid bag weight and alert personnel when fluid levels reach a pre-determined threshold during arthroscopic procedures.

Regulatory Classification

Identification

An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.

Predicate Devices

• Smith & Nephew Dyonics Levelert System (K912453)

Submission Summary (Full Text)

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060123

EXHIBIT F

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as

FEB 1 4 2006

required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

## Levelert II Fluid Level Sensor

Date Prepared: January 16, 2006

### A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810 USA

## B. Company Contact

Janice Haselton Sr. Regulatory Affairs Specialist Phone: [phone] [phone] Fax:

## C. Device Name

| Trade Name: | Levelert II |
|----------------------|------------------------------------------------------|
| Common Name: | Electronic Monitor |
| Classification Name: | Monitor, Electric for Gravity Flow Infusion Systems- |

#### D. Predicate Devices

The predicate device for the Levelert II is the current Smith & Nephew Dyonics Levelert System cleared in K912453.

#### Description of Device E.

The Levelert II is a irrigation fluid bag level sensing device designed to provide the user with fluid level feedback at pre-determined values. The pre-determined values are selected by the user. The Levelert II is a stand-alone DC battery powered, nonrechargeable device that is used in arthroscopic procedures.

#### F. Intended Use

The Smith & Nephew Levelert II Fluid Level Sensor is intended to weigh a bag of irrigation fluid and signal operating room personnel when a pre-determined amount of fluid remains.

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# KO60123

## G. Comparison of Technological Characteristics

The Levelert II has the same Indications for Use as the predicate device, utilizes the same operating principle, incorporates the same basic design, and is manufactured under a Quality System.

The differences between the Dyonics Levelert System and the Levelert II are the additional of a battery to power the device instead of an external power supply, the use of a load cell instead of a spring loaded circuit design, dome switches instead of an adjusting knob and incorporating the microprocessor internally instead of externally connecting to one.

## H. Summary Performance Data

The performance testing, EMI/EMC testing, UL Safety testing and the software verification and validation conducted on the Levelert II demonstrates substantial equivalence to the Dyonics Levelert System cleared in K912453. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy and that the Levelert II performs as well as the legally marketed device.

> Smith & Nephew, Inc Levelert H Page 166 of 166

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2006

Ms. Janice Haselton Senior Regulatory Affairs Specialist Smith & Nephew, Incorporated Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K060123

Trade/Device Name: Levelert II Fluid Level Sensor Regulation Number: 21 CFR 880.2420 Regulation Name: Electronic Monitor for Gravity Flow Infusion Systems Regulatory Class: II Product Code: FLN Dated: January 16, 2006 Received: January 18, 2006

Dear Ms. Haselton:

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 (1 var 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.

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Page 2 -- Ms. Janice Haselton

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvisor mat I DA 3 issualled or a bases and issues complies with other requirements Incan that I DA nas made a decemmand regulations administered by other Federal agencies. of the Act of ally I oderal banales is requirements, including, but not limited to: registration 1 ou must comply with and are labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF reful 007), abolity systems (QS) regulation (21 CFR Part 820); and if requirences as set forth in the quality sion 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) I mis letter will anow you to obja finding of substantial equivalence of your device to a premarket nothers on - 11 verice 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), If you desire specific at Compliance at [phone]. 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 may outum 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 vours,

yette y Michener Omp.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

| 510(k) Number (if known): | 406012<br>Comments of Children Comments of Children Comments of Children and Children William and Children Comments of Children William and Children Comments of Children<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Levelert II Fluid Level Sensor________________________________________________________________________________________________________________________________________________ Device Name:

Indications For Use:

The Smith & Nephew LEVELERT II Fluid Level Sensor is intended to weigh a bag of irrigation fluid and signal operating room personnel when a pre-determined amount of fluid remains.

Prescription Use _ x _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Custer Baker

A Auto Barcelogy General Hospital, 11 2 2018 19 10

964433

Smith & Nephew, Inc Levelert II Page 13 of 166