(35 days)
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Not Found
No
The summary describes a device that measures physical parameters (conductivity, temperature, pH, pressure) of a solution. There is no mention of AI, ML, image processing, or any data analysis techniques that would typically involve AI/ML. The device appears to be a standard measurement instrument.
No.
The device measures parameters of dialysate solution and water for hemodialysis systems, it does not directly treat a medical condition or perform a therapeutic function on a patient.
No
Explanation: The device measures parameters of dialysate solutions and water for hemodialysis systems, which are indicators of system performance, not of a patient's health or disease state. It is used to verify proper characteristics of fluids, not to diagnose a medical condition in a patient.
No
The device description is not found, but the intended use clearly describes a "Dialysis Meter" and "instrumentation system" which are hardware devices used to measure physical parameters (conductivity, temperature, pH, pressure). This indicates it is not a software-only device.
Based on the provided information, the 90XL Dialysis Meter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to measure the conductivity, temperature, pH, and pressure of the dialysate solution and water used in hemodialysis. These are physical and chemical properties of the fluids, not measurements performed on biological specimens (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Device Description (Not Found): While a detailed description is missing, the parameters measured (conductivity, temperature, pH, pressure) are consistent with analyzing the properties of fluids, not biological samples.
- No mention of biological specimens: The text focuses on the dialysate solution and water, which are external fluids used in the dialysis process. There is no mention of analyzing patient samples.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The 90XL Dialysis Meter's function is to ensure the quality and safety of the fluids used in the dialysis process, which is a different purpose than diagnosing or monitoring a patient's health status through analysis of their biological samples.
N/A
Intended Use / Indications for Use
The 90XL Dialysis Meter is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with hemodialysis delivery systems. Water purification specialists may also use the 90XL instrumentation system to verify proper characteristics of the purified water used in hemodialysis. These parameters are key indicators of system performance that require periodic monitoring and maintenance of respective hemodialysis systems.
Product codes
FIZ
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
hemodialysis professionals, Water purification specialists
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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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.
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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).
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§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Image /page/0/Picture/1 description: The image shows a circular logo with the words "Department of Health & Human Services" written around the edge of the circle. Inside the circle is an abstract image of an eagle. The eagle is facing to the left and has three lines coming out of its back.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2005
Mr. Todd Romero Quality Manager Mesa Laboratories, Inc. 12100 West 6th Avenue LAKEWOOD CO 80228
Re: K050812
Trade/Device Name: 90XL Instrumentation System Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FIZ Dated: March 25, 2005 Received: April 6, 2005
Dear Mr. Romero:
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 (Premarket 11 Joural), it may be subject to such additional controls. Existing major regulations affecting your I appro rary, it a 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I rease of a rise a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I cacial states and registring but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin hanketing your waters, your device of your device to a legally prematket notification. The I DA midnig of basisting 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), please If you desire specific advice tor your device to the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx
21 CFR 884.xxxx
21 CFR 892.xxxx | (Gastroenterology/Renal/Urology)
(Obstetrics/Gynecology)
ﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
(Radiology) | 240-276-0115
240-276-0115
240-276-0120
240-276-0100 |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Other | | |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation emitted, "Hiberation on your responsibilities under the Act from the 807.97). Tou May Outlin other general missistance at its toll-free number (800)
Division of Small Manufacturers, International and Consumer Assistance at its toll-free numb Drvision of Stilan Manufacturess, International outs outro://www.fda.gov/cdrh/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement 4.0
510(k) Number (if Known): Ko 50 & 10
Device Name: 90XL Instrumentation System
Indications for Use:
The 90XL Dialysis Meter is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with conductivity, temperature, pri, and pressure of the specialists may also use the 90XL
hemodialysis delivery systems. Water purification attracted in begodial hemodialysis delivery systems. We'll pullication spective water used in hemodialysis. These
instrumentation system to verify proper characteristics water used in hemodialys instrumentation system to Verty propen chat chat require periodic monitoring and
parameters are key indicators of system performance that require periodic monitoring and parameters are Rey multators of Systive hemodialysis systems.
Prescription Use X (Part 21 CFR 801 subpart D) And/Or
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hodgson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
"Confidential" (ﺩ)