(93 days)
Not Found
No
The device is a chemical solution used for calibration, and the description focuses on its chemical composition and stability, with no mention of AI or ML.
No.
The device is a calibrator solution used to verify the proper function of hemodialysis machines and water purification equipment, not to directly treat a patient.
No
This device is described as a "secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments." It is used to calibrate or verify the proper function of other measurement equipment, not to directly diagnose a patient's condition.
No
The device is a physical solution composed of salts and water, packaged in bottles. It is a tangible product, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the solutions are used for calibrating conductivity/TDS and pH measurement instruments, specifically those used with hemodialysis machines and water purification equipment. It explicitly states that the solutions are used "remotely from the hemodialysis machine or water purification equipment, and does 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 determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Lack of Patient Contact/Specimen Analysis: This device does not come into contact with the patient, nor is it used to analyze any human specimens. Its function is solely to calibrate other equipment.
Therefore, while it is a medical device used in the context of medical procedures (hemodialysis), it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Conductivity/pH Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments. The conductivity /TDS cells and instruments may be indicated for calibrating the conductivity and pH 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 does not come into contact with the patient.
Product codes
FKH
Device Description
The device consists of salts (Sodium Chloride, Sodium Phosphate Dibasic, and Potassium Phosphate Monobasic) dissolved in de-ionized water. The proportion of total salt determines the solution's conductivity. The proportions of Sodium Phosphate Dibasic and Potassium Phosphate Monobasic determine the solution's pH. The solution is packaged into sealed polyethylene bottles.
The performance specifications of the device are a pH value of pH 7.0 ± 0.03 pH units and a conductivity value of 14.00 mS/cm ± 0.03 mS/cm. The solution should maintain these values for 18 months stored in a sealed bottle. The solution should also maintain these values for 30 days within an opened but recapped bottle. There will be two bottle sizes of this solution, a 32-oz bottle and a 16-oz bottle.
The solution is composed of the following: Sodium Chloride (CAS Registry Number 7647-14-5), Sodium Phosphate Dibasic (CAS Registry Number 7558-79-4), Potassium Phosphate Monobasic (CAS Registry Number 7778-77-0), and De-ionized Water (CAS Registry Number 7732-18-5).
No components of the device come in contact with the patient.
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
Not Found
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 using N.I.S.T. SRM's (Standard Reference Materials) produced in accordance with instructions provided by N.I.S.T. and used as primary calibration standards.
- PQ-RM017 pH and Conductivity Solution Manufacturing Process: validated that the device could be produced to specification using the manufacturing process.
- PQ-RM018 pH and Conductivity Solution Open Bottle Stability: validated that the device would meet specifications after bottles are opened, exposed to air and then recapped several times. The test results demonstrate that the new device, like the predicate device, is within specification after 30 days of the bottle has been opened and then tightly recapped several times.
- PQ-RM019 pH and Conductivity Solution Storage Stability: validated that the device values remain within specification for 18 months. The test results demonstrate that the new device, like the predicate device, is projected to be within specification for 18 months.
- PQ-RM020 pH and Conductivity Solution Instrument Independence: validated that the device values are independent upon the type of measurement instrument. The test results demonstrate that the new device, like the predicate, conductivity measurements are independent upon the type of measurement instrument.
Conclusions: The results of the validations show that the conductivity of the new device when manufactured, prior to the expiration date, and after the bottle is opened and recapped for 30 days are the same as the predicate values. The tests also showed that different meters will measure the same conductivity values for the new device as the predicate.
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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K130100 page 1 of 4
MesaLabs
510(k) Summary
APR 1 8 2013
سر
| Owner: | Mesa Laboratories, Inc.
12100 West 6 th Avenue
Lakewood, CO 80228
Phone: (303) 987-8000 FAX: (303) 987-8989 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jamie Louie, Quality Manager |
| Date: | January 28, 2013 |
| Device Name: | Conductivity/pH Calibrator Solution |
| Common Name: | Combined Standard Solution |
| Device Classification: | Classification: II
Classification Panels: Gastroenterology
Regulation Number: 21 CFR § 876.5820,
Solution - Test Standard - Conductivity, Dialysis
Product Code FKH |
| Predicate Device(s): | Conductivity/TDS Calibrator Solution
Mesa Laboratories Inc
510(k) Number K033330
Cleared February 27, 2004 |
| Device Description: | The device consists of salts (Sodium Chloride, Sodium
Phosphate Dibasic, and Potassium Phosphate
Monobasic) dissolved in de-ionized water. The
proportion of total salt determines the solution's
conductivity. The proportions of Sodium Phosphate
Dibasic and Potassium Phosphate Monobasic
determine the solution's pH. The solution is packaged
into sealed polyethylene bottles.
The performance specifications of the device are a pH
value of pH 7.0 ± 0.03 pH units and a conductivity value
of 14.00 mS/cm ± 0.03 mS/cm. The solution should
maintain these values for 18 months stored in a sealed
bottle. The solution should also maintain these values |
Mesa Laboratories Inc - 510(k) submission for Combined Standard Solution Section 6 - 510(k) Summary (updated)
1
for 30 days within an opened but recapped bottle. There will be two bottle sizes of this solution, a 32-oz bottle and a 16-oz bottle.
The solution is composed of the following:
| Component | CAS
Registry
Number | Suppliers |
|-------------------------------------|---------------------------|-----------------------------------------------------------------|
| Sodium Chloride | 7647-14-5 | Rocky Mountain Reagents
VWR Scientific |
| Sodium Phosphate
Dibasic | 7558-79-4 | Rocky Mountain Reagents
Sigma-Aldrich Inc.
VWR Scientific |
| Potassium
Phosphate
Monobasic | 7778-77-0 | Rocky Mountain Reagents
VWR Scientific |
| De-ionized Water | 7732-18-5 | In-House using
Water De-ionizer |
No components of the device come in contact with the patient.
Indications Conductivity/pH Calibrator Solutions are a secondary for Use: standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments. The conductivity /TDS cells and instruments may be indicated for calibrating the conductivity and pH 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 does not come into contact with the patient. legion Charact
| Technological | The technological Characteristics are summarized in |
|---|---|
| the | |
| Characteristics: | table below. |
Mesa Laboratories Inc – 510(k) submission for Combined Standard Solution Section 6 - 510(k) Summary (updated)
・
2
K130100
| Technological
Specification | Mesa Laboratories, Inc. Predicate Device
2004 510(k) K033330 | Mesa Laboratories, Inc.
New Device 2013 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conductivity
Value | 100.0 millisiemen
14.0 millisiemen
13.4 millisiemen
150 microsiemen
1.0 microsiemen | 14.0 millisiemen |
| pH Value | Not Specified*
*Measured values ranged 5.1 pH to 7.0 pH | 7.0 pH |
| Accuracy | 100.0 millisiemen ±0.2 millisiemen @ 25°C
14.0 millisiemen ±0.02 millisiemen @ 25°C
13.4 millisiemen ±0.02 millisiemen @ 25°C
150 microsiemen ±2 microsiemen @ 25°C
1.0 microsiemen ±2 microsiemen @ 25°C | ±0.03 millisiemen @ 25°C
±0.03 pH @ 25°C |
| Salt
Composition
(amount) | 70. 0g/l NaCl
7.799g/l NaCl
7.443g/l NaCl
48.90mg/l NaCl
0.4915g/l NaCl | 4.08g/l NaCl
5.34 g/l Sodium Phosphate Dibasic
2.87 g/l Potassium Phosphate
Monobasic |
| Salt
Composition
(chemical) | NaCl (Sodium Chloride) | NaCl (Sodium Chloride)
Sodium Phosphate Dibasic
Potassium Phosphate Monobasic |
| Ingredients | Sodium Chloride (CAS # 7647-14-5)
Water (CAS # 7732-18-5) | Sodium Chloride (CAS # 7647-14-5)
Sodium Phosphate Dibasic (CAS #
7558-79-4)
Potassium Phosphate
Monobasic (CAS # 7778-77-0) Water
(CAS # 7732-18-5) |
| 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°C
Melting Point: Approx -0.6-0°C
Vapor Pressure: Trade/Device Name: Conductivity/pH Calibrator Solution Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FKH Dated: February 1, 2013 Received: February 20, 2013
Dear Ms. 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. 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 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
5
Page 2 - Ms. Jamie Louie
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K130100 510(k) Number (if known):
Conductivity/pH Calibrator Solution Device Name:
Indications For Use:
Conductivity/pH Calibrator Solutions are a secondary standard solution used for the calibration of conductivity/TDS cells together with conductivity/TDS and pH measurement instruments. The conductivity /TDS cells and instruments may be indicated for calibrating the conductivity and pH 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 does not come into contact with the patient.
Prescription Use (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) | |
|---|---|
| -------------------------------------------------------- | -- |
Benjamin R. Fisher:=5. J.J.
2013.04.18 11:51:41:41:404.00
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130100 510(k) Number _
Page 1 of 1
Mesa Laboratories Inc -510(k) submission for Combined Standard Solution Section 5 - Indications for Use
Page 5.1