(77 days)
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No
The description focuses on basic level sensing and alarming, with no mention of AI/ML terms or functionalities.
No
The device is described as an "accessory safety device" that monitors fluid levels and sounds an alarm. It does not directly treat or diagnose a medical condition, which are characteristics of a therapeutic device.
No
Explanation: The device is described as 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 does not diagnose any medical condition or disease.
No
The description explicitly states the device is an "accessory safety device" that monitors levels in a "reservoir" and sounds an "alarm." This strongly implies the presence of hardware components (sensors, alarm mechanism, potentially a housing) that interact with the physical reservoir, making it more than just software.
Based on the provided information, the LevelSens device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as monitoring blood or saline levels in a reservoir and sounding an alarm. This is a monitoring and safety function related to the physical level of a substance, not a diagnostic test performed in vitro (outside the body) on a sample to determine a medical condition or state.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, chemicals, etc.)
- Providing diagnostic information about a patient's health.
The LevelSens is an accessory device designed to ensure a safe level of fluid in a reservoir, which is a non-diagnostic function.
N/A
Intended Use / Indications 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.
Product codes
74 DTW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.4340 Cardiopulmonary bypass level sensing monitor and/or control.
(a)
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.(b)
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.
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.
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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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)