The "Conductivity Standard Solution - MeterCare" may be used to calibrate conductivity reference meters used to test the dialysate, dialysate concentrate and water treatment systems used with dialysate delivering systems. MeterCare is an Over-the-Counter product and needs no prescription. The product is for In Vitro use only.

Device Description

The "Conductivity Standard Solution – MeterCare" is a range of high accuracy conductivity standard solutions to calibrate conductivity meters used in dialysis to test the conductivity of dialysate of dialysis machines and water used in hemodialysis applications.

AI/ML Overview

The information provided focuses on the regulatory submission for a medical device (a conductivity standard solution) and its substantial equivalence to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria in a typical medical diagnostic or treatment context.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or cannot be extracted from the provided text for this type of device.

However, I can extract the relevant information regarding the acceptance criteria and the methods used to demonstrate the device's characteristics.

Here is the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy (Uncertainty)
Primary Solutions	±0.10%
Secondary Solutions	±0.15%
Composition	KCl, NaCl, 442 Natural Water (40% Sodium Sulfate, 40% Sodium Bicarbonate, 20% Sodium Chloride)
Intended Use	Used to calibrate conductivity meters for dialysate, dialysate concentrate, and water treatment systems in hemodialysis applications.
Safety and Effectiveness	Considered "safe and effective for the intended use and is substantially equivalent to the predicate device."

Note: The "acceptance criteria" here are implied by the stated uncertainties for the solutions. The primary method of demonstrating performance is through adherence to established standards and substantial equivalence to a predicate device, as opposed to a direct measure against a performance goal in a clinical trial.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. The "test set" in this context refers to the batches of the Conductivity Standard Solution - MeterCare that were manufactured and tested according to various standards, not a patient cohort or a set of clinical cases. The document does not specify the number of batches or individual samples tested.
Data Provenance: Not applicable in the context of clinical data. The device itself is a standard solution, and its performance is validated through metrological testing against recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. The "ground truth" for a conductivity standard solution is established by its chemical composition and precise manufacturing processes, which are then verified against metrological standards. There are no "experts" in the sense of clinical reviewers establishing a ground truth for diagnostic accuracy.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. The performance is determined through standardized laboratory measurements and comparison to metrological standards, not through expert adjudication of ambiguous cases.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: Not applicable. This device is a calibration standard, not an AI-powered diagnostic tool. There are no "human readers" in the context of interpreting results derived from this product in a diagnostic setting.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is a physical chemical standard, not an algorithm or software device.

7. The type of ground truth used

Type of Ground Truth: The ground truth for the "Conductivity Standard Solution - MeterCare" is based on:
- Metrological Standards: Adherence to established scientific and industry standards for conductivity and calibration, such as NIST Special Publication 260-142, IUPAC Standards for Conductivity, OIML Standards for Conductivity, ASTM D 1125-91, and ISO 7888.
- Chemical Composition and Manufacturing Process: The precise formulation of the solutions (e.g., KCl, NaCl, 442 Natural Water composition) and their accurate preparation to yield specific conductivity values with defined uncertainties.

8. The sample size for the training set

Sample Size: Not applicable. This is a manufactured product, not a machine learning algorithm.

9. How the ground truth for the training set was established

Ground Truth Establishment: Not applicable.

Summary

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IBP

SEP 1 7 2003

K032075

Page : 1 of : 3

510(k) Summery

Conductivity Standard Solution - MeterCare

1. Submitted by:

IBP Instruments GmbH Sutelstr. 7A 30659 Hannover Germany Phone +49 511 651647 +49 511 652283 Fax eMail pfingstmann@ibpmt.com Internet: www.ibpmt.com

1. Contact Person: Dipl. Ing Werner Pfingstmann
1. Date Prepared:

February 10, 2003

4. Product Classification:

Device Name:	Conductivity Standard Solution - MeterCare
Common Name:	Standard Solution Conductivity for Dialysis
Classification Name:	SOLUTION-TEST STANDARD-CONDUCTIVITY, DIALYSIS
Regulation Number:	876.5820
Product Class:	II
Product Code:	FKH
Panel:	Advisory Committee Gastroenterology

5. Predicate Device:

STANDARD SOLUTION OF KNOWN CONDUCTIVITY 510(k) Number: K851362

RNA MEDICAL CORP 21 CUMMINGS PARK SUITE 228 WOBURN, MA 01801

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510(k) Summery

K 032075

Page : 2 of : 3

6. Device Description

The Range of solution include:

Nominal Valueat 25°C	SaltComposition	UncertaintyPrimarysolutions	UncertaintySecondarysolutions
46.7 uS/cm	442	±0.10%	±0.15%
70 us/cm	KCl	±0.10%	±0.15%
150 uS/cm	KCl	±0.10%	±0.15%
229 uS/cm	442	±0.10%	±0.15%
445 uS/cm	442	±0.10%	±0.15%
700 uS/cm	442	±0.10%	±0.15%
1000 uS/cm	442	±0.10%	±0.15%
1417 uS/cm	KCl	±0.10%	±0.15%
2060 uS/cm	KCl	±0.10%	±0.15%
3900 uS/cm	KCl	±0.10%	±0.15%
12.50 mS/cm	NaCl	±0.10%	±0.15%
13.40 mS/cm	NaCl	±0.10%	±0.15%
14.00 mS/cm	NaCl	±0.10%	±0.15%
100 mS/cm	NaCl	±0.10%	±0.15%
140 mS/cm	NaCl	±0.10%	±0.15%
190 mS/cm	NaCl	±0.10%	±0.15%

442 Natural Water™ Standard Solutions

The 442™ is a trademark of the Myron L Instruments. The composition is a combination of salts mixed with deionized water and 40% Sodium Sulfate, 40% Sodium Bicarbonate and 20% Sodium Chloride.

7. Indication for use

The indication for use "Conductivity Standard Solution - MeterCare" is substantial identical to the predicate device

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510(k) Summery

8. Test:

The following standards were used in testing the Conductivity Standard Solution - MeterCare:

EN 1441 Risk Analysis Medical Devices (1997)
ISO/DIS 14971: Feb. 2000 Medical Devices Risk Management
ISO 10012-1: Quality assurance requirements for measuring equipment
NIST Special Publication 260-142 i Primary Standards and Standard Reference Materials for Electrolyte Conductivity
IUPAC Standards for Conductivity
OIML Standards for Conductivity
ASTM D 1125-91 Standard Test Methods for Electrical Conductivity and Resistivity of Water - ISO 7888

Water Quality; Determination of electrical conductivity

9. Conclusion:

It is concluded that the proposed "Conductivity Standard Solution -MeterCare" is safe and effective for the intended use and is substantially equivalent to the predicate device.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.'

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Food and Drive Arm 200 Cornorato Bour Rockville MD 20850

SEP 1 7 2003

IBP Instruments GmbH c/o Mr. Olaf Teichert TÜV Product Service GmbH 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891

Re: K032075 Trade/Device Name: IBP Conductivity Standard Solution - MeterCare, 32.x Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FKH Dated: September 2, 2003 Received: September 5, 2003

Dear Mr. Teichert:

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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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

to proceed to the market.

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Indications for Use Statement

510(k) Number K032075

Device Name: Conductivity Standard Solution - MeterCare

Indication for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

OR Over-the-Counter Use __

Kinneth Lyman

Regulation Number and Section

§ 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.