(27 days)
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.
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.
The provided text describes the Levelert II Fluid Level Sensor. However, it does not contain specific acceptance criteria or detailed study data as would be found in a comprehensive clinical or performance validation study report.
The text is a 510(k) summary for a medical device submission to the FDA, which focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions "performance testing," "EMI/EMC testing," "UL Safety testing," and "software verification and validation," but does not provide the results of these tests, the acceptance criteria, or the methodology.
Therefore, I cannot populate all sections of your request based solely on the provided text.
Here's an attempt to answer based on the available information, with significant gaps noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in the provided text) Presumably related to accurate fluid level sensing at pre-determined values. | "The performance testing... 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." |
| (Not explicitly stated in the provided text) Presumably related to electrical safety and electromagnetic compatibility. | "EMI/EMC testing, UL Safety testing... demonstrates substantial equivalence..." |
| (Not explicitly stated in the provided text) Presumably related to software functionality and reliability. | "Software verification and validation conducted on the Levelert II demonstrates substantial equivalence..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The text refers to "performance testing" but does not detail the number of units or test conditions.
- Data Provenance: Not specified. It can be inferred that testing was conducted by or on behalf of Smith & Nephew, Inc., Endoscopy Division, likely in the USA. The type of study (retrospective or prospective) is not applicable here as this is device performance testing rather than a clinical study with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable/Not specified. For a device like a fluid level sensor, ground truth for performance testing would typically be established by calibrated measurement tools (e.g., precise scales for weight, or volumetric measurements) rather than human expert interpretation.
4. Adjudication Method for the Test Set
- Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation or subjective assessment, which is not the primary focus of performance testing for this type of device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not mentioned. This type of study is more relevant for diagnostic imaging or interpretation tasks where human readers are involved. The Levelert II is a sensor, not an interpretive aid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance testing described ("performance testing, EMI/EMC testing, UL Safety testing and the software verification and validation") appears to be standalone algorithm/device performance testing. The device is a "stand-alone DC battery powered" unit, indicating its primary function is independent. The stated "signal operating room personnel" suggests an output for human users, but the core performance evaluation would be of the device's ability to accurately weigh and signal.
7. The Type of Ground Truth Used
- Not explicitly stated, but for a fluid level sensor, the ground truth would most likely be objective, quantitative measurements obtained through calibrated instruments (e.g., highly accurate scales to measure fluid weight, or precise volumetric measurements). It would not be expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This device is described as having a "load cell instead of a spring loaded circuit design" and incorporating a "microprocessor internally." While microprocessors contain software/firmware developed through engineering processes, the text does not indicate a machine learning model that would require a "training set" in the common sense (i.e., for AI/ML). The term "software verification and validation" is used, which refers to standard software development lifecycle testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as a "training set" for AI/ML is not indicated for this device based on the provided description. Software verification and validation would establish ground truth through functional specifications and test cases derived from engineering requirements.
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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: (978)749-1494 (978)749-1443 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three wing-like shapes stacked on top of each other.
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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): | 406012Comments of Children Comments of Children Comments of Children and Children William and Children Comments of Children William and Children Comments of Children------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
| --------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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
§ 880.2420 Electronic monitor for gravity flow infusion systems.
(a)
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.(b)
Classification. Class II (performance standards).