(27 days)
Not Found
No
The description focuses on simple weight sensing and pre-set level signaling, with no mention of AI/ML terms or complex data processing.
No.
The device's intended use is to weigh irrigation fluid bags and signal fluid levels to operating room personnel, not to diagnose, treat, or prevent disease.
No
Explanation: The device is a fluid level sensor that weighs irrigation fluid and signals remaining amounts, which is a monitoring/measurement function, not a diagnostic one. It does not provide information about a patient's health status or disease.
No
The device description explicitly states it is a "stand-alone DC battery powered, nonrechargeable device," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Smith & Nephew LEVELERT II Fluid Level Sensor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "weigh a bag of irrigation fluid and signal operating room personnel when a pre-determined amount of fluid remains." This describes a device that monitors the physical quantity of fluid in a bag during a procedure.
- Device Description: The description reinforces this by stating it's a "fluid bag level sensing device designed to provide the user with fluid level feedback."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The Levelert II does not interact with or analyze any biological specimens.
The device's function is purely related to monitoring the volume of irrigation fluid used during a surgical procedure, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FLN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
I recescopy . 1983 Tag Bear Int Dan bonnan Road. Passe 14/4 (11/16)
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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1
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
the 3 of 2
2
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.
3
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
4
Indications for Use
| 510(k) Number (if known): | 406012
| Comments 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