(134 days)
No
The device description and intended use clearly describe a simple chemical solution used for calibration, with no mention of AI or ML technology.
No
The device is a calibrator solution used for the verification and calibration of other equipment, not for direct patient treatment or diagnosis.
No
The device is a calibrator solution used to verify the proper function of conductivity measurement functions in other equipment, not to diagnose a patient's condition.
No
The device description explicitly states the device "consists of salt dissolved in purified water" and is "packaged into sealed polyethylene bottles," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the solutions are used for calibrating and verifying the function of equipment (hemodialysis machines and water purification equipment). They are used "remotely from the equipment, and do not come into contact with the patient."
- Definition of IVD: An IVD is a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures. This device does not examine human specimens.
While the equipment being calibrated (hemodialysis machines and water purification equipment) is used in a medical context and directly impacts patient care, the calibrator solution itself is a tool for ensuring the accuracy of that equipment, not for diagnosing or monitoring a patient's condition directly through the analysis of their biological samples.
N/A
Intended Use / Indications for Use
Conductivity/TDS Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells and instruments. Conductivity/TDS cells and instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification equipment measurement functions. These solutions are used remotely from the equipment, and do not come into contact with the patient.
Product codes
78 FKH
Device Description
The device consists of salt dissolved in purified water. The proportion of salt determines the solution's conductivity. The solution is packaged into sealed polyethylene bottles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Validation of the performance of the device was performed on production lots by the Danish Institute of Fundamental Metrology. The test results by the demonstrated that the device exceeded the acceptance specifications by greater than one order of magnitude.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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FEB 27 2004
KD33330
Page 1 of 2
510(k) Summary
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|---|---|
| Submitter | Mesa Laboratories, Inc. |
| 12100 West 6 th Ave. | |
| Lakewood CO 80228 | |
| Contact Person | Todd Romero, QC Manager |
| Date Prepared | 15 October, 2003 |
| Name | Conductivity/TDS Calibrator Solution |
| Common Name | Solutions Test Standard-Conductivity, Dialysis |
| Device Classification | Classification: II |
| Classification Panels: Gastroenterology | |
| Regulation Number: 21 CFR § 876.5820 | |
| Predicate Device(s) | Standard Solution of Conductivity and Measurement |
| RNA Medical Corporation | |
| 510(k) Number K851362 | |
| Cleared June 12, 1985 | |
| Performance Standards | Performance standards have not been established by the FDA under section 514 of the Federal, Food, Drug and Cosmetic Act |
| Device Description | The device consists of salt dissolved in purified water. The proportion of salt determines the solution's conductivity. The solution is packaged into sealed polyethylene bottles. |
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KD33330191
Page 2 of 2
Conductivity/TDS Calibrator Solutions are a secondary standard solution used Conductivity? IDS Canorativity/TDS cells together with conductivity/TDS Indications for for the canoration of concurtivity/TDS cells and instruments may Use be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis, or for verifying proper function of hemodialysis machine or water purification lor verrrying proper ranchon of as These solutions are used remotely from the equipment measurement fulletions: from equipment, and do not come into contact with the patient. The Calibrator Solution is similar to the predicate device in that they are both Technological I ne Candrator Sonductivity measurement instruments and both obtain Characteristics used for ourlorating controlled quantity of salt dissolved in water. they are different in that the predicate device was only offered in one value of I ney are dirrerent indicated for calibrating one particular meter, while oondablivity and was was number of different values and can be used for any conductivity meter. Validation of the performance of the device was performed on production lots Nonclinical by the Danish Institute of Fundamental Metrology. The test results Performance by the Damonstrated that the device exceeded the acceptance specifications by greater than one order of magnitude. Conductivity/TDS Calibrator Solution is substantially equivalent to the legally Conclusion marketed Standard Solution of Conductivity and Measurement.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 27 2004
Mr. Todd Romero Quality Control Manager Mesa Laboratories, Inc. 12100 West 6th Avenue LAKEWOOD CO 80228
Re: K033330
Trade/Device Name: Conductivity/TDS Calibrator Solution Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FKH Dated: February 4, 2004 Received: February 5, 2004
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 (PMA), it may be subject to additional controls. Existing major regulations affecting your 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 Act's requirements, including, 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) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter whilanow you to ought that ing of substantial equivalence of your device to a legally prematication. "The Dr. "The Dr. " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " 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 at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division 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/dsma/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
Page 2
4
Indications for Use Statement
510(k) Number (if known): K033330
Device Name: Conductivity/TDS Calibrator Solution
Indications for Use:
Conductivity/TDS Calibrator Solutions are a secondary standard solution used for the Conductivity/TDS Callorator Sollations are a south conductivity/TDS measurement callbration of conductivity/TDS cells and instruments may be indicated for calibrating instruments. The conductivity I DS Cells and morelines and water purification
the conductivity measurement function of hemodialysis machines machine of the conductivity measurement function of hemodialysis naction of hemotialysis machine or water purification equipment measurement functions. These solutions are used remotely water purification equipment incasarement reneation equipment, and do not come into contact with the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
122222
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
(Optional Format 3-10-98)
"Confidential"
Prescription Use . (Per 21 CFR 801.109)
510(k) Number __