(77 days)
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.
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The provided document is a 510(k) clearance letter from the FDA for a device called "LevelSens". This type of letter generally declares substantial equivalence to a predicate device based on performance testing but does not typically include detailed studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader studies as would be expected for AI/ML-based devices.
Therefore, the requested information cannot be fully provided from the given document as it pertains to a different type of medical device clearance.
However, based on the limited information available in the document, here's what can be inferred or stated about the device and the nature of its clearance:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the FDA 510(k) clearance letter. Such letters confirm substantial equivalence, which implies the device meets performance standards comparable to legally marketed predicate devices, but they do not typically detail the specific acceptance criteria or the reported performance data from testing.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. For a non-AI/ML medical device like LevelSens, performance testing would typically involve engineering tests to verify alarm thresholds, accuracy of level detection, and durability, rather than a "test set" in the context of AI/ML validation data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided and is generally not applicable to the clearance of a device like LevelSens. Ground truth as typically understood in AI/ML (e.g., expert consensus on image interpretation) is irrelevant for a device that monitors fluid levels.
4. Adjudication Method for the Test Set:
This information is not provided and is not applicable for this type of device clearance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided and is not applicable. MRMC studies are relevant for evaluating the impact of AI on human reader performance, which doesn't apply to a fluid level monitoring device.
6. Standalone Performance Study (Algorithm Only):
This information is not provided. While the device operates independently to monitor levels, the term "standalone performance" in the context of an "algorithm only" study typically refers to AI/ML device performance without human intervention, which is not relevant here.
7. Type of Ground Truth Used:
The concept of "ground truth" as typically used in AI/ML (e.g., pathology, expert consensus) is not applicable to this device. The "ground truth" for LevelSens would be the actual physical fluid level in the reservoir against which the device's measurement and alarm activation are compared.
8. Sample Size for the Training Set:
This information is not provided and is not applicable as LevelSens is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided and is not applicable as LevelSens is not an AI/ML device that requires a training set.
In summary, the provided document is an FDA 510(k) clearance letter for a fluid level monitoring device. It confirms that the device is substantially equivalent to a predicate device for its stated indications for use but does not contain the detailed study information typically requested for AI/ML devices, such as acceptance criteria tables, sample sizes for test/training sets, ground truth establishment, or multi-reader studies.
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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)
§ 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.