(15 days)
Not Found
No
The device is a standard solution for calibrating conductivity meters and does not involve any computational or analytical processes that would utilize AI/ML. The description focuses on the chemical composition and packaging of the solution.
No
The device is a calibration solution for conductivity meters, specifically for verifying or calibrating conductivity functions of dialysis-related equipment. It is explicitly stated that it "does not come in contact with the patient" and "is for In-Vitro Use Only." Therefore, it is not a therapeutic device that treats or prevents a disease.
No
Explanation: The device is a "Conductivity Standard Solution" used to calibrate conductivity meters and verify conductivity functions of dialysis-related equipment. It does not directly diagnose a patient's condition.
No
The device description clearly states it is a "salt-based liquid" packaged in "polyethylene bottles," indicating it is a physical product, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the solutions are used for the "calibration of conductivity cells together with conductivity meters" and to "verify or calibrate conductivity or calibrate conductivity functions of dialysis related equipment." This is a clear diagnostic purpose, as accurate conductivity measurements are crucial for ensuring the proper functioning of dialysis equipment, which directly impacts patient treatment.
- "In-Vitro Use Only": The statement "Conductivity Standard Solution is for In-Vitro Use Only" is a strong indicator of an IVD. In vitro diagnostics are tests performed on samples taken from the human body (or in this case, used to calibrate equipment that interacts with fluids that interact with the body) outside of the body.
- Calibration of Diagnostic Equipment: The primary function is to calibrate equipment used in a diagnostic or treatment process (dialysis). While the solution itself doesn't directly test a patient sample, it is essential for the accurate performance of equipment that does.
While the device description doesn't involve analyzing patient samples directly, its role in ensuring the accuracy of diagnostic/treatment equipment places it within the scope of IVDs. The fact that it's used "remotely from the hemodialysis machine or water purification equipment and do not come in contact with the patient" doesn't negate its IVD status, as its function is to support the accuracy of the diagnostic/treatment process.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FKH
Device Description
H&S - Conductivity Standard Solution is salt-based liquid produced by dissolving reagent grade salt in treated water and equilibrated to atmospheric CO2. The salt concentration determines the conductivity value. The solution is packaged in various size polyethylene bottles and sealed with a taper indicator seal and cap. The product label is added, and the device is placed in a clear plastic bag The product label contains instructions for use, warnings, and other safety information. H&S - Conductivity Standard Solution is available in of a range sizes, values and accuracies.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The manufacturing process of H&S-Conductivity Standard Solution is performed in accordance with the Quality System regulation as specified for medical devices. This quality program addresses the complete production process and post production auditing and customer notification, if needed. H&S - Conductivity Standard Solution is traceable to NIST (National Institute of Standards and Technology). H&S-Conductivity Standard Solution is not sterile and is not marketed as sterile. H&S - Conductivity Standard Solution presents no safety or hazard risk to other devices, personnel or the environment, when used in accordance with the directions outlined in remote meter user directions and the instructions for use.
Verification and validation of the performance specifications of the device was performed on production lots and samples of the two predicate devices. The test results demonstrated that the devices were well below the acceptance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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.
0
K041636
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Image /page/0/Picture/1 description: The image shows the logo for H&S Technical Services. The logo is black and white and features the letters H&S in a bold font on the left side. To the right of the letters is the text "Technical Services" in a smaller font. Below the letters is the text "A Specialized Products & Services Company" in an even smaller font.
JUL - 2 2004
1832 W Main St. 5te 119 esa, AZ #5201 [500] $23.2446 01 1480; 317-4824 (480) 317-4974 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
submitted in accordance with requirements of 21 C.F.R § 807.92 | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitted by: | H&S Technical Services
1833 W Main St. Ste 119
Mesa AZ 85201
Phone: 480-517-4918
Fax: 480-517-4924 | | |
| Contact Person: | John Hyte
Email: jchyte@hstechsve.com | | |
| Date Prepared: | February 18, 2004 | | |
| Product
Classification: | Device Name:
Common Name:
Classification Name:
Device Classification:
Regulation Number:
Product Code:
Panel: | H&S-Conductivity Standard Solution
Conductivity Standard Solution
Solution-Test Standard-Conductivity, Dialysis
II
21 CFR § 876.5820
FKH
GASTROENTEROLOGY | |
| Predicate Device: | Predicate Device 1 Name:
Manufacturer:
510(k) Number:
Predicate Device 2 Name:
Manufacturer:
510(k) Number: | Conductivity Standard Solution - MeterCare
IBP Instruments GmbH
Sutelstr. 7A
30659 Hanover
Germany
K032075
Conductivity TDS Calibrator Solution
Mesa Laboratories, Inc.
12100 West 6th Ave
Lakewood, CO 80228
K032326 | |
1
510(k) Summary
| Device Description: | H&S - Conductivity Standard Solution is salt-based liquid produced by
dissolving reagent grade salt in treated water and equilibrated to
atmospheric CO2. The salt concentration determines the conductivity value.
The solution is packaged in various size polyethylene bottles and sealed
with a taper indicator seal and cap. The product label is added, and the
device is placed in a clear plastic bag The product label contains
instructions for use, warnings, and other safety information.
H&S - Conductivity Standard Solution is available in of a range sizes,
values and accuracies. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| 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 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. |
| | |
| Performance
Specifications | The manufacturing process of H&S-Conductivity Standard Solution is
performed in accordance with the Quality System regulation as specified for
medical devices. This quality program addresses the complete production
process and post production auditing and customer notification, if needed.
H&S - Conductivity Standard Solution is traceable to NIST (National
Institute of Standards and Technology).
H&S-Conductivity Standard Solution is not sterile and is not marketed as
sterile.
H&S - Conductivity Standard Solution presents no safety or hazard risk to
other devices, personnel or the environment, when used in accordance with
the directions outlined in remote meter user directions and the instructions |
| Non-clinical
performance: | Verification and validation of the performance specifications of the device
was performed on production lots and samples of the two predicate
devices. The test results demonstrated that the devices were well below
the acceptance specifications.
The following standards were used or referenced in the development,
production and testing of the H&S - Conductivity Standard Solution:
ANSI/AAMI/ISO 14971A1: Jun 2003 Medical Devices - Risk
Management ISO 10012-1: Quality assurance requirements for measuring
equipment NIST Special Publication 260-142 Feb 2000
Primary Standards and Standard Reference Materials for
Electrolyte Conductivity IUPAC Standards for Conductivity OIML Standards for Conductivity ASTM Stand Test Methods D1125-95 Standard Test Methods for Electrical Conductivity and Resistively
of Water ISO 7888-85 E Water Quality: Determination of Electrical Conductivity FDA Quality System Regulations (QSR) 21 CFR § 820 |
| Technological
Characteristics: | H&S - Conductivity Standard Solution is similar to the predicate devices
in that they are all used for calibrating conductivity measurement
instruments and are salt-based liquid produced by dissolving reagent grade
salt in treated water and then equilibrated to atmospheric CO₂. The salt
concentration determines the conductivity value. The solutions are
packaged in various sizes of polyethylene bottles
They are different in that the predicate device manufacturers make ranges
common for use with their specific conductivity meters. II & S provides
ranges and salt compositions to meet a broader range of conductivity
meters available in the market place. |
| Conclusion: | It is concluded that the proposed "H&S-Conductivity Standard Solution"
is safe and effective for the intended use and is substantially equivalent to
the predicate devices.
This summary of 510(k) safety and effectiveness information is being
submitted in accordance with the requirements of 21 CFR § 807.92 |
for use.
2
510(k) Summary
.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
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.
4
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 | (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 Additionally, for questions on the production and and the regulation entitled, "Masbranding
Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or
Manufacturers, International and Consumer Assisstance at its consignation http:// Manufacturers, International and Collsumier in and Consumer of the mardsmamain.html.
(301) 443-6597 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
5
Indications for Use
510(k) Number (if known):
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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