H&S-CONDUCTIVITY STANDARD SOLUTION

K041636 · H & S Technical Services · FKH · Jul 2, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041636
• Device Name: H&S-CONDUCTIVITY STANDARD SOLUTION
• Applicant: H & S Technical Services
• Product Code: FKH · Gastroenterology, Urology
• Decision Date: Jul 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

H&S - Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters; which may include meters and cells used by the hemodialysis technician to verify or calibrate conductivity functions of dialysis equipment. These solutions are used remotely from the hemodialysis machine or water purification equipment and do not come in contact with the patient. Conductivity Standard Solution is for In-Vitro Use Only.

Device Story

H&S-Conductivity Standard Solution is a salt-based liquid; reagent grade salt dissolved in treated water; equilibrated to atmospheric CO2. Used as secondary standard for calibrating conductivity cells and meters in hemodialysis settings. Operated by hemodialysis technicians; used remotely from dialysis machines or water purification systems. Does not contact patients. Provides reference conductivity values for equipment verification. Benefits patient by ensuring accuracy of dialysis equipment conductivity functions.

Clinical Evidence

Bench testing only. Verification and validation performed on production lots and samples of predicate devices. Results demonstrated performance within acceptance specifications. Referenced standards include ANSI/AAMI/ISO 14971, ISO 10012-1, NIST SP 260-142, IUPAC, OIML, and ASTM D1125-95.

Technological Characteristics

Salt-based liquid solution; reagent grade salt in treated water; equilibrated to atmospheric CO2. Packaged in polyethylene bottles. Traceable to NIST. Standards: ANSI/AAMI/ISO 14971, ISO 10012-1, NIST SP 260-142, IUPAC, OIML, ASTM D1125-95, ISO 7888-85 E. Non-sterile.

Indications for Use

Indicated for use by hemodialysis technicians to calibrate conductivity cells and meters used in hemodialysis equipment. For in-vitro use only; not for patient contact.

Regulatory Classification

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.

Predicate Devices

• Conductivity Standard Solution - MeterCare (K032075)
• Conductivity TDS Calibrator Solution (K032326)

Submission Summary (Full Text)

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K041636
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JUL - 2 2004

1832 W Main St. 5te 119 esa, AZ #5201 [500] \$23.2446 01 1480; 317-4824 [phone] 12 8

## 510(k) Summary H&S-Conductivity Standard Solution

H&S-Conductivity Standard Solution

| 510(k) Summary: | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with requirements of 21 C.F.R § 807.92 | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitted by: | H&S Technical Services<br>1833 W Main St. Ste 119<br>Mesa AZ 85201<br>Phone: [phone]<br>Fax: [phone] | | |
| Contact Person: | John Hyte<br>Email: [e-mail] | | |
| Date Prepared: | February 18, 2004 | | |
| Product<br>Classification: | Device Name:<br>Common Name:<br>Classification Name:<br>Device Classification:<br>Regulation Number:<br>Product Code:<br>Panel: | H&S-Conductivity Standard Solution<br>Conductivity Standard Solution<br>Solution-Test Standard-Conductivity, Dialysis<br>II<br>21 CFR § 876.5820<br>FKH<br>GASTROENTEROLOGY | |
| Predicate Device: | Predicate Device 1 Name:<br>Manufacturer:<br>510(k) Number:<br><br>Predicate Device 2 Name:<br>Manufacturer:<br>510(k) Number: | Conductivity Standard Solution - MeterCare<br>IBP Instruments GmbH<br>Sutelstr. 7A<br>30659 Hanover<br>Germany<br>K032075<br><br>Conductivity TDS Calibrator Solution<br>Mesa Laboratories, Inc.<br>12100 West 6th Ave<br>Lakewood, CO 80228<br>K032326 | |

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## 510(k) Summary

| Device Description: | H&S - Conductivity Standard Solution is salt-based liquid produced by<br>dissolving reagent grade salt in treated water and equilibrated to<br>atmospheric CO2. The salt concentration determines the conductivity value.<br>The solution is packaged in various size polyethylene bottles and sealed<br>with a taper indicator seal and cap. The product label is added, and the<br>device is placed in a clear plastic bag The product label contains<br>instructions for use, warnings, and other safety information.<br>H&S - Conductivity Standard Solution is available in of a range sizes,<br>values and accuracies. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| Indications for Use: | H&S - Conductivity Standard Solutions are a secondary standard solution<br>used for the calibration of conductivity cells together with conductivity<br>meters; which may include meters and cells used by the hemodialysis<br>technician to verify or calibrate conductivity functions of dialysis<br>equipment.<br>These solutions are used remotely from the hemodialysis machine or water<br>purification equipment and do not come in contact with the patient.<br>Conductivity Standard Solution is for In-Vitro Use Only. |
| | |
| Performance<br>Specifications | The manufacturing process of H&S-Conductivity Standard Solution is<br>performed in accordance with the Quality System regulation as specified for<br>medical devices. This quality program addresses the complete production<br>process and post production auditing and customer notification, if needed.<br>H&S - Conductivity Standard Solution is traceable to NIST (National<br>Institute of Standards and Technology).<br>H&S-Conductivity Standard Solution is not sterile and is not marketed as<br>sterile.<br>H&S - Conductivity Standard Solution presents no safety or hazard risk to<br>other devices, personnel or the environment, when used in accordance with<br>the directions outlined in remote meter user directions and the instructions |
| Non-clinical<br>performance: | Verification and validation of the performance specifications of the device<br>was performed on production lots and samples of the two predicate<br>devices. The test results demonstrated that the devices were well below<br>the acceptance specifications.<br><br>The following standards were used or referenced in the development,<br>production and testing of the H&S - Conductivity Standard Solution:<br>ANSI/AAMI/ISO 14971A1: Jun 2003 Medical Devices - Risk<br>Management ISO 10012-1: Quality assurance requirements for measuring<br>equipment NIST Special Publication 260-142 Feb 2000<br>Primary Standards and Standard Reference Materials for<br>Electrolyte Conductivity IUPAC Standards for Conductivity OIML Standards for Conductivity ASTM Stand Test Methods D1125-95 Standard Test Methods for Electrical Conductivity and Resistively<br>of Water ISO 7888-85 E Water Quality: Determination of Electrical Conductivity FDA Quality System Regulations (QSR) 21 CFR § 820 |
| Technological<br>Characteristics: | H&S - Conductivity Standard Solution is similar to the predicate devices<br>in that they are all used for calibrating conductivity measurement<br>instruments and are salt-based liquid produced by dissolving reagent grade<br>salt in treated water and then equilibrated to atmospheric CO₂. The salt<br>concentration determines the conductivity value. The solutions are<br>packaged in various sizes of polyethylene bottles<br>They are different in that the predicate device manufacturers make ranges<br>common for use with their specific conductivity meters. II & S provides<br>ranges and salt compositions to meet a broader range of conductivity<br>meters available in the market place. |
| Conclusion: | It is concluded that the proposed "H&S-Conductivity Standard Solution"<br>is safe and effective for the intended use and is substantially equivalent to<br>the predicate devices.<br><br>This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 CFR § 807.92 |

for use.

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510(k) Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2004

H & S Technical Services c/o Ms. Laura Danielson Responsible Third Party Official 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

Re: K041636

Trade/Device Name: H&S - Conductivity Standard Solution Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FKH Dated: June 16, 2004 Received: June 17, 2004

Dear Ms. Danielson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectority promained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally many to the Medical Device American of to commerce prior to May 20, 1976, the enaocdance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvine controls provisions of the Act. The You may, uterelore, market the dovres, see courements for annual registration, listing of general controls provisions of the I let I let I labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classifica (sec above) into eting major regulations affecting your device can be It may be subject to adultional condois. Little 21, Parts 800 to 898. In addition, FDA may found in the Code of I odelar resguine in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- 3 issuance of a bevice complies with other requirements of the Act that FDA has Inade a decermination in administered by other Federal agencies. You must of ally Federal Statutes and regulations , including, but not limited to: registration and listing Comply with an the Act 3 requirements, morating.
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), labornig (21 CFR Part 820); and 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820, 1959 form in the quality systems (QD) regarming 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) This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA inding of substantial ogarractive 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
r the regulation If you desire specific advice for your device on our last age of the regulation number at the top of the letter.

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the production and and the regulation entitled, "Masbranding
Office of Compliance at [phone]. and and experience of this . Other seences Other of Compliance at (501) 594-057. Tass, promoted from the Division of Small by reference to premarket nonication (21 Or Act may be obtained firon the Division of Small
information on your responsibilities under the Act may be its the first worker (80 information on your responsibilities and consumer its its toll-free number [phone] or
Manufacturers, International and Consumer Assisstance at its consignation http:// Manufacturers, International and Collsumier in and Consumer of the mardsmamain.html.
[phone] or at its Internet address http://www.fda.gov/odch/dsmaldsmamain.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

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## Indications for Use

510(k) Number (if known):

K041636

Device Name: H&S -- Conductivity Standard Solution

Indications For Use:

"H&S - Conductivity Standard Solutions" are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters; which may include the odilibrator of conduction to verify or calibrate conductivity or calibrate conductivity functions of dialysis related equipment.

These solutions are used remotely from the hemodialysis machine or water purification equipment and do not come in contact with the patient. Conductivity Standard Solution is for In-Vitro Use Only.

ン 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)

- Nancy C. Bergson

ve. Abdominal, 510(k) Number

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