LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070

K992857 · Rocky Mountain Research, Inc. · DTW · Nov 10, 1999 · Cardiovascular

Device Facts

• Record ID: K992857
• Device Name: LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
• Applicant: Rocky Mountain Research, Inc.
• Product Code: DTW · Cardiovascular
• Decision Date: Nov 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4340
• Device Class: Class 2

Intended Use

The LevelSens is an accessory safety device which monitors blood or saline levels in a reservoir and sounds an alarm when the level falls below a predetermined level. It is currently configured for intended use with either Rigid Polycarbonate or Flexible Polyvinyl chloride (PVC) reservoirs.

Device Story

LevelSens is an accessory safety device for monitoring fluid levels in blood or saline reservoirs. It detects fluid presence/absence and triggers an audible alarm when levels drop below a set point. Used in clinical settings to prevent air embolism or fluid depletion; operated by healthcare professionals. Provides real-time safety monitoring; alerts clinicians to intervene when fluid levels are insufficient. Benefits patients by reducing risks associated with reservoir depletion during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Accessory safety device; compatible with rigid polycarbonate or flexible polyvinyl chloride (PVC) reservoirs. Functions as a level monitor with integrated alarm system.

Indications for Use

Indicated for monitoring blood or saline levels in reservoirs to provide an alarm when levels fall below a predetermined threshold.

Regulatory Classification

Identification

A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

## NOV 1 0 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert W. Griffiths President Rocky Mountain Research, Inc. 825 North 300 West, Suite NE 500 Salt Lake City, UT 84103

Re : K992857 LevelSens - Flexible, Model 201110, LevelSens - Rigid, Model 201070. II (TWO) Requlatory Class: Product Code: 74 DTW August 18, 1999 Dated: August 25, 1999 Received:

Dear Mr. Griffiths:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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

## Page 2 - Mr. Robert W. Griffiths

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on. your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sog. L. Deee L. Tayeule.

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

Enclosure

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

## INDICATIONS FOR USE STATEMEN

K992857. 0(K) Number:

LevelSens ICE NAME:

## DICATIONS FOR USE:

The LevelSens is an accessory safety device which monitors blood or saline levels in a reservoir and sounds an alarm when the level falls below a predetermined level.

It is currently configured for intended use with either Rigid Polycarbonate or Flexible Polyvinyl chloride (PVC) reservoirs.

Que de
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

99285 510(k) Number.

Concurrence of CDRH, Office of Device Evaluation (ODE)

escription Use: X Per 21 CFR 801.109)