(61 days)
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No
The device is a simple chemical solution used for calibrating conductivity meters and does not involve any computational or analytical processes that would utilize AI/ML.
No
The device is a solution used to calibrate and verify the accuracy of TDS (Total Dissolved Solids) meters, which in turn are used to check the conductivity of water in hemodialysis systems. It does not come into contact with the patient and is not directly involved in treating a medical condition.
No
The device is a calibration solution for conductivity meters, not a device used to diagnose a patient's medical condition. It's used to verify the accuracy of equipment.
No
The device description explicitly states the device consists of salts dissolved in de-ionized water and packaged in bottles, which are physical components, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The primary intended use is to verify and calibrate TDS (Total Dissolved Solids) meters used to test water from purification systems. This is a quality control function for equipment, not a diagnostic test performed on a biological sample from a patient.
- Contact with Patient: The description explicitly states that the solution "do[es] not come into contact with the patient." IVDs are typically used to analyze samples taken from a patient (blood, urine, tissue, etc.) to provide information about their health status.
- Nature of the Device: The device is a standard solution used to check the accuracy of a measuring instrument. While it's used in a healthcare-related setting (hemodialysis), its function is to ensure the proper operation of equipment, not to diagnose or monitor a patient's condition directly.
In summary, the device is a calibration standard for equipment used in a medical context, but it does not meet the definition of an In Vitro Diagnostic device as it is not used to test a biological sample from a patient for diagnostic purposes.
N/A
Intended Use / Indications for Use
This TDS Standard Solution is indicated for verifying the accuracy (calibration) of TDS (Total Dissolved Solids) meters. This standard solution should be used immediately before conductivity meters are used to determine the conductivity of water obtained from water purification systems used in hemodialysis. This solution is prepared from a mixture of salts comprised of 40% Sodium Bicarbonate, 40% Sodium Sufate, and 20% Sodium Chloride which is intended to mimic natural water systems. These solutions are used remotely from the water purification equipment, and do not come into contact with the patient.
Product codes (comma separated list FDA assigned to the subject device)
FKH
Device Description
The device consists of salts (Sodium Chloride, Sodium Bicarbonate and Sodium Sulfate) dissolved in de-ionized water. The solution is packaged into sealed polyethylene bottles.
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
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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)
VP-00020 Conductivity Values of 15ppm TDS Solutions. The purpose of this test was to validate that the value of the new device were correct. A Reference Conductivity meter was used and calibrated using Standard Reference Materials purchased from Cole-Palmer. The TDS value for (5) bottles were: 15.063 ppm, 15.032 ppm, 15.007 ppm, 14.988 ppm and 14.994 ppm. The value of the 15ppm TDS Solution was within the tolerances of the solution and the Reference Conductivity meter. This was considered acceptable as per the Validation Protocol.
VP-00021 Conductivity Values of 150ppm TDS Solutions. The purpose of this test was to validate that the value of the new device were correct. A Reference Conductivity meter was used and calibrated using Standard Reference Materials purchased from Cole-Palmer. The TDS value for (5) bottles were: 150.546 ppm, 150.480 ppm, 150.546 ppm, 150.876 ppm and 150.744 ppm. The value of the 150ppm TDS Solution was within the tolerances of the solution and the Reference Conductivity meter. This was considered acceptable as per the Validation Protocol.
VP-00022 Conductivity Values of 1500ppm TDS Solutions. The purpose of this test was to validate that the value of the new device were correct. A Reference Conductivity meter was used and calibrated using Standard Reference Materials purchased from Cole-Palmer. The TDS value for (5) bottles were: 1508.18 ppm, 1505.99 ppm, 1505.99 ppm, 1506.72 ppm and 14.994 ppm. The value of the 1500ppm TDS Solution was within the tolerances of the solution and the Reference Conductivity meter. This was considered acceptable as per the Validation Protocol.
VP-00030 Open Bottle Shelf Life. The purpose of this test was to validate that the new device would remain within specification for 60 days after the bottle was opened and tightly recapped. The three values 23.8 µS/cm, 229 µS/cm, and 2060 µS/cm were all found to be within tolerance after the bottle was opened for 60 days and then tightly resealed. This was considered acceptable as per the Validation Protocol.
VP-00073 Sealed Bottle Storage Shelf Life. The purpose of this test was to validate that the new device would remain within specification for 18 months days after the bottle was sealed. Five different batchs of 23.8 µS/cm were manufactured. The testing consisted of measuring bottles from throughout the bottling run. (5) bottles, one from the 1st 20% of the run, one from the 2nd 20% of the run, one from the 3rd 20% of the run, one from the 4th 20% of the run, and one from the last 20% of the run were measured at specified intervals over 18 months. The results showed that the solution remained in tolerance for 18 months. This was used to demonstrate that the batch had uniform properties thourghout the production. This was considered acceptable as per the Validation Protocol.
VP-00074 Sealed Bottle Storage Shelf Life. The purpose of this test was to validate that the new device would remain within specification for 18 months days after the bottle was sealed. Five different batchs of 229 µS/cm were manufactured. The testing consisted of measuring bottles from throughout the bottling run. (5) bottles, one from the 1st 20% of the run, one from the 2nd 20% of the run, one from the 3rd 20% of the run, one from the 4th 20% of the run, and one from the last 20% of the run were measured at specified intervals over 18 months. The results showed that the solution remained in tolerance for 18 months. This was used to demonstrate that the batch had uniform properties thourghout the production. This was considered acceptable as per the Validation Protocol.
VP-00075 Sealed Bottle Storage Shelf Life. The purpose of this test was to validate that the new device would remain within specification for 18 months days after the bottle was sealed. Five different batchs of 2060 µS/cm were manufactured. The testing consisted of measuring bottles from throughout the bottling run. (5) bottles, one from the 1st 20% of the run, one from the 2nd 20% of the run, one from the 3rd 20% of the run, one from the 4th 20% of the run, and one from the last 20% of the run were measured at specified intervals over 18 months. This was used to demonstrate that the batch had uniform properties thourghout the production. The results showed that the solution remained in tolerance for 18 months. This was considered acceptable as per the Validation Protocol.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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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August 5, 2019
Mesa Laboratories, Inc. Jamie Louie Senior Manager - Quality 12100 West 6th Avenue Lakewood. CO 80228
Re: K191496
Trade/Device Name: TDS Standard Solution Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FKH Dated: June 5, 2019 Received: June 5, 2019
Dear Jamie Louie:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Carolyn Y. Neuland, Ph.D. Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastro-Renal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191496
Device Name TDS Standard Solution
Indications for Use (Describe)
This TDS Standard Solution is indicated for verifying the accuracy (calibration) of TDS (Total Dissolved Solids) meters. This standard solution should be used immediately before conductivity meters are used to determine the conductivity of water obtained from water purification systems used in hemodialysis. This solution is prepared from a mixture of salts comprised of 40% Sodium Bicarbonate, 40% Sodium Sufate, and 20% Sodium Chloride which is intended to mimic natural water systems. These solutions are used remotely from the water purification equipment, and do not come into contact with the patient.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K191496
| Owner: | Mesa Laboratories, Inc.
12100 West 6th Avenue
Lakewood, CO 80228
Phone: (303) 987-8000 FAX: (303) 987-8989 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jamie Louie, Director of Quality |
| Date: | July 11, 2019 |
| Device Name: | TDS Standard Solution |
| Trade Name: | TDS Standard Solution |
| Common Name: | Conductivity/TDS Calibrator Solution |
| Classification
Name: | Solution-Test Standard-Conductivity, Dialysis |
| Device
Classification: | Classification: II
Classification Panels: Gastroenterology/Urology
Regulation Number: 21 CFR § 876.5820,
Solution-Test Standard-Conductivity, Dialysis
Product Code 78 FKH |
| Predicate
Device(s): | Conductivity/TDS Calibrator Solution
Mesa Laboratories Inc
510(k) Number K033330
Cleared February 4, 2004 |
| Device
Description: | The device consists of salts (Sodium Chloride, Sodium
Bicarbonate and Sodium Sulfate) dissolved in de-ionized
water. The solution is packaged into sealed polyethylene
bottles. |
| Indications
for Use: | This TDS Standard Solution is indicated for verifying the
accuracy (calibration) of TDS (Total Dissolved Solids)
meters. This standard solution should be used
immediately before conductivity meters are used to
determine the conductivity of water obtained from water
purification systems used in hemodialysis. This solution is
prepared from a mixture of salts comprised of 40% Sodium
Bicarbonate, 40% Sodium Sulfate, and 20% Sodium
Chloride which is intended to mimic natural water systems. |
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These solutions are used remotely from the water purification equipment, and do not come into contact with the patient.
- The population requiring disalysis requires that the solutions General Description of used in the dialysis machine and during the preparation of solutions used in the hemodialysis setting be verified for the Diseases or Conditions proper conductivity. The hemodialysis industry uses conductivity meters to verify the proper conductivity. The Device will treat: new device is used to verify and calibrate these meters at conductivities near the new values of the device.
- Operational Use: Prior to operating the conductivity meter, the user draws the Conductivity/TDS Calibrator Solution into the meter or dips the meter sensor into the solution to verify the meter is reading the value of the solution. If meter does not read the correct value (within the tolerances of the solution and the meter), the user will calibrate the meter to read the correct value.
No components of the device come in contact with the patient or patient fluids.
The conductivity of the fluid is determined by the amount of Scientific Concepts that electrical current flow within the solution. The dissolved form the basis salts separate into positive and negative ions. The ions are of the Device: free to move and the movement resulting from a voltage difference will result in an electrical current.
Modifications to Predicate:
The following modifications were made from the predicate to the new device:
-
- Additional Values
-
- Use of two different salts
-
- Additional Values
The new device has conductivity values of 23.8 µS/cm. 229 µS/cm and 2060 uS/cm are added to the original seven values of the predicate.
2. Use of two additional salts
The new device uses sodium bicarbonate and sodium sulfate in addition to the sodium chloride used in the predicate device.
Technological The technological Characteristics are summarized in Characteristics: the table below.
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| Technological
Characteristic | Mesa Laboratories, Inc. Predicate
Device 2004 510(k) K033330 | Mesa Laboratories, Inc.
New Device 2019 510(k) K191496 |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Conductivity/TDS Calibrator Solutions
are a secondary standard solution used
for the calibration of conductivity/TDS
cells together with conductivity/TDS
measurement instruments. The
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 hemodialysis machine
or water purification equipment, and doot come into contact with the patient. | This TDS Standard Solution is indicated
for verifying the accuracy (calibration) of
TDS (Total Dissolved Solids) meters.
This standard solution should be used
immediately before conductivity meters
are used to determine the conductivity
of water obtained from water purification
systems used in hemodialysis. This
solution is prepared from a mixture of
salts comprised of 40% Sodium
Bicarbonate, 40% Sodium Sulfate, and
20% Sodium Chloride which is intended
to mimic natural water systems. These
solutions are used remotely from the
water purification equipment, and do not
come into contact with the patient. |
| User
Instructions | See attached label | See attached label |
| Appearance
Properties | Clear, Colorless Liquid
Specific Gravity: Approx. 1- 1.04 | Clear, Colorless Liquid
Specific Gravity: Approx. 1- 1.04 |
| Chemical
Properties | Odor: Odorless
Boiling Point: Approx. 100.1℃
Melting Point: Approx. -0.6-0ºC
Vapor Pressure: