(72 days)
Not Found
No
The device is a conductivity standard solution used for calibrating meters, and the summary contains no mention of AI or ML.
No
This device is a conductive standard solution used to calibrate meters, not to directly treat or diagnose a medical condition.
No
The product is a standard solution used for calibrating conductivity meters, not for diagnosing medical conditions in patients. It is used to test dialysate and water treatment systems, which are components of medical procedures, but the solution itself does not provide a diagnosis.
No
The device description clearly states it is a "range of high accuracy conductivity standard solutions," which are physical substances, 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 solution is used to calibrate conductivity meters used to test dialysate, dialysate concentrate, and water treatment systems used with dialysate delivering systems. These are all substances that are used in the context of medical treatment (dialysis).
- "For In Vitro use only": This statement in the intended use is a strong indicator of an IVD. IVD products are designed to be used outside of the body.
- Device Description: The description reinforces the use in calibrating meters for testing dialysate and water used in hemodialysis applications. These are directly related to patient treatment.
- Predicate Device: The predicate device listed (K851362; STANDARD SOLUTION OF KNOWN CONDUCTIVITY) is also likely an IVD, as conductivity standards used in medical contexts are typically classified as such.
While the product is Over-the-Counter and doesn't require a prescription, this doesn't preclude it from being an IVD. Many IVDs are available over-the-counter (e.g., home pregnancy tests, blood glucose meters and strips).
The key factor is that the product is used to calibrate equipment that tests substances directly involved in patient treatment (dialysis). This places it within the scope of IVD regulation.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FKH
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.
The Range of solution include:
| Nominal Value
at 25°C | Salt
Composition | Uncertainty
Primary
solutions | Uncertainty
Secondary
solutions |
|--------------------------|---------------------|-------------------------------------|---------------------------------------|
| 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.
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)
Not Found
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
IBP
SEP 1 7 2003
Page : 1 of : 3
510(k) Summery
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
-
- Contact Person: Dipl. Ing Werner Pfingstmann
-
- 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
1
O
510(k) Summery
K 032075
Page : 2 of : 3
6. 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.
The Range of solution include:
| Nominal Value
at 25°C | Salt
Composition | Uncertainty
Primary
solutions | Uncertainty
Secondary
solutions |
|--------------------------|---------------------|-------------------------------------|---------------------------------------|
| 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 "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.
The indication for use "Conductivity Standard Solution - MeterCare" is substantial identical to the predicate device
2
.32c7.5
Image /page/2/Picture/1 description: The image shows a logo with the letters "IBP" in a stylized font. To the left of the letters is a black geometric shape that appears to be a stylized letter "I". The letters "IBP" are outlined in black and have a rounded, bubble-like appearance. The logo is simple and eye-catching.
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.'
3
Image /page/3/Picture/1 description: The image shows a black and white logo. The logo consists of a circle that is not fully complete, with a gap at the top. Inside the circle, there are three curved lines that resemble a bird in flight. The lines are parallel to each other and have a wave-like appearance.
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.
4
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.
5
Indications for Use Statement
510(k) Number K032075
Device Name: Conductivity Standard Solution - MeterCare
Indication for Use:
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.
(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