BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
K120823 · Fresenius Medical Care North America, Design Cente · FJK · Jun 15, 2012 · Gastroenterology, Urology
Device Facts
Record ID
K120823
Device Name
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
Applicant
Fresenius Medical Care North America, Design Cente
Product Code
FJK · Gastroenterology, Urology
Decision Date
Jun 15, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5820
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The set is intended for use with a prescribed hemodialyzer. The BVM Hemodialysis Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The set is intended for use with the Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module for monitoring patient blood volume during hemodialysis.
Device Story
Single-use, disposable arterial and venous bloodline set for extracorporeal hemodialysis circuits; transports blood from patient to hemodialyzer and back. Interfaces with Fresenius 2008 Series Hemodialysis Machines via pump rotor mechanism; includes transducer monitor lines for pressure monitoring and venous chamber for air detection. Designed for use with machines equipped with a Blood Volume Monitor (BVM) module. Facilitates blood volume monitoring during therapy; aids clinicians in managing patient fluid status and hemodialysis safety. Used in clinical settings by trained healthcare professionals.
Clinical Evidence
Bench testing only. No clinical data provided. Validation included biocompatibility, sterility, nonpyrogenicity, structural integrity (pressure/pull testing), connector performance, needle access port testing, transducer protector pressure testing, endurance testing, clamp testing, and usability evaluation.
Technological Characteristics
Materials: Polyvinyl chloride (PVC) and polypropylene (PP). Components: Arterial/venous lines, priming set, transducer protectors, venous chamber. Connectivity: Interfaces with Fresenius 2008 Series Hemodialysis Machines. Sterilization: Single-use, nonpyrogenic. Technology: Peristaltic pump interface, pressure monitoring, air detection.
Indications for Use
Indicated for acute and chronic hemodialysis patients requiring extracorporeal blood access. Intended for use with Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module for blood volume monitoring.
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
Nikkline Blood Tubing Lines with Transducer Protectors (K082719)
Submission Summary (Full Text)
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JUN 1 5 2012
Image /page/0/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized downward-pointing chevron made up of three stacked lines on the left. To the right of the chevron are the words "FRESENIUS MEDICAL CARE" in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
BVM Hemodialysis Blood Tubing Set Traditional 510(k) Notification
### 510(k) summary
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content in this 510(k) summary has been provided in conformance with 21 CFR Part 807.92
### A. Submitter's Information
| Name: | Fresenius Medical Care North America (FMCNA) |
|----------------------|----------------------------------------------|
| Address: | 920 Winter Street<br>Waltham, MA 02451-1457 |
| Phone: | (781) 699-4479 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, Senior Director |
| | Regulatory Affairs – Devices |
| Date of Preparation: | 3/16/2012 |
B. Device Name
| Trade Name: | Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors |
|------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Common Name: | Blood Tubing Sets (Sterile Fluid Path). |
| Product Code/Classification Panel: | FJK / Gastroenterology-Urology |
| Classification Name: | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve 21 CFR 876.5820 |
# C. Legally Marketed Predicate Device (unmodified devices)
Nikkline Blood Tubing Lines with Transducer Protectors (K082719)
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Image /page/1/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked on top of each other, with the top two pointing upwards and the bottom one pointing downwards. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
BVM Hemodialysis Blood Tubing Set Traditional 510(k) Notification
#### D. Device Description
The Fresenius Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors, Catalog number 03-2795-7 (BVM Bloodline) is designed to work with Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module.
The bloodline is a part of the extracorporeal circuit by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump segment of the bloodline interfaces with the pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit. The bloodline contains interfaces to the machine safety mechanisms to ensure proper operation. These include transducer monitor lines for arterial and venous pressure monitoring, as well as a venous chamber for the detection of air in the blood path.
#### ﻧﻨ Indications for Use
The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The set is intended for use with a prescribed hemodialyzer.
The BVM Hemodialysis Blood Tubing Set is intended for acute and chronic hemodialysis The set is intended for use with the Fresenius 2008 Series Hemodialysis therapy. Machines equipped with a BVM Module for monitoring patient blood volume during hemodialysis.
### F. Technological Characteristics
The BVM Bloodline and the Nikline Blood Tubing Lines with Transducer Protectors (K082719) have equivalent technological characteristics. The BVM Bloodline and the Nikkline share equivalent:
- . Intended Use - provides extracorporeal access during hemodialysis
- . Design/Configuration
- . Basic Scientific Technology - peristaltic pump, pressure monitoring capabilities, air capture chambers
- . Sterility - single use, nonpyrogenic
- Materials primary materials of polyvinyl chloride (PVC) and polypropylene (PP). .
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Image /page/2/Picture/15 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font.
BVM Hemodialysis Blood Tubing Set Traditional 510(k) Notification
### G. Performance Data
Testing was selected through the application of a risk management process, appropriate guidance documents and relevant standards. The results of the validation and verification testing have provided a sound basis for comparison to the predicate bloodline. The following are an example of some of the tests performed to support the determination of substantial equivalence:
- . Biological safety - biocompatibility testing
- Sterility and nonpyrogenicity testing
- . Structural integrity - pressure and pull testing
- Performance testing of connectors (hemodialyzer, vascular access device and . ancillary components) - pressure/dimensional
- Needle access ports- pressure testing after repeated use
- . Transducer protectors- pressure testing
- . Endurance testing of the complete bloodline using specified hemodialysis machines
- Clamp testing- ability to occlude and effects of repeated use ●
- Usability evaluation
## H. Conclusion
Based on a cumulative review of the verification and validation testing, the performance of the BVM Bloodline is substantially equivalent to the predicate Nikkline (K082719) and is safe and effective for its intended use.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with outstretched wings, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
# JUN 1 5 2012
Ms. Denise Oppermann Senior Director Regulatory Affairs, Devices Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451
Re: K120823
> Trade/Device Name: Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
Regulation Number: 21 CFR§ 876.5820
Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: March 16, 2012 Received: March 21, 2012
Dear Ms. Oppermann:
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 for doo barea in 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 I ou mayy aron's provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device 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 I tease of ac now a a determination that your device complies with other requirements of the Act that I Drives interes and regulations administered by other Federal agencies. You must or any I coordi statutes are reguirements, including, but not limited to: registration and listing Comply with an the 110. break and mart 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Tichner
Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked on top of each other, with the top two pointing upwards and the bottom one pointing downwards. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
BVM Hemodialysis Blood Tubing Set Traditional 510(k) Notification
Indication for use statement
510(k) Number (if known): K120823
Device Name:
Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
# Indications for Use:
The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis. The set is intended for use with a prescribed hemodialyzer.
The BVM. Hemodialysis Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The set is intended for use with the Fresenius 2008 Series Hemodialysis Machines equipped with a BVM Module for monitoring patient blood volume during hemodialysis.
XPrescription Use (Per 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)
Benjamine R. Fisher 15 JUNE 2012
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120823
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.
