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
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.
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)
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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<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: 480-517-4918<br>Fax: 480-517-4924 | | |
| Contact Person: | John Hyte<br>Email: jchyte@hstechsve.com | | |
| 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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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.
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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 | (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
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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
Page 1 of 1
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
