NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET
Applicant
Nipro Medical Corporation
Product Code
FJK · Gastroenterology, Urology
Decision Date
Sep 28, 2012
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.5820
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The NIPRO Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.
Device Story
Disposable blood tubing set for hemodialysis; provides extracorporeal blood access. Includes arterial line, venous line, removable priming set, and pre-attached transducer protectors. Used in clinical settings by healthcare professionals during dialysis procedures. Connects patient to dialysis machine; arterial line attaches to bottom of dialyzer, venous to top. Shorter tubing design minimizes priming volume and bio-hazardous waste; allows increased blood processing efficiency during treatment. Device is single-use, sterile, and prescription-only.
Clinical Evidence
No clinical testing performed. Substantial equivalence supported by bench testing, including package integrity, pressure leak, pump segment endurance, injection port durability, priming volume assessment, tensile testing, transducer protector strikethrough testing, clamp performance, and hemocompatibility.
Technological Characteristics
Disposable bloodline set; components include drip chambers, clamps, transducer protectors, luer locks, injection ports, and tubing (main, heparin, saline, pump segment). Materials are color-coded. Designed for compatibility with Fresenius 2008H, 2008K/K2, and 2008T machines. Sterile, single-use. No software or electronic components.
Indications for Use
Indicated for patients requiring hemodialysis to provide extracorporeal blood access. Compatible with Fresenius 2008H, 2008K/K2, and 2008T dialysis machines.
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
NIPRO Set - Blood Tubing Set with Transducer Protector and Priming Set (K072024)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for Nipro Medical Corporation. The logo consists of a stylized, abstract symbol on the left, resembling an infinity symbol or a stylized double helix. To the right of the symbol is the company name, "NIPRO," in bold, sans-serif font, with "MEDICAL CORPORATION" printed in a smaller font size below it.
3150 NW 107th Avenue Miami FL 33172 Tel: 305.599.7174 Fax: 305.592.4621
### 510(k) Summary:
Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protectors and Priming Set
### 807.92(a)(1)
Applicant: Establishment Reg.:
Contact Person:
Nipro Medical Corporation 1056186
SEP 28 2012
Jessica Oswald Regulatory Affairs Specialist
Date of summary preparation: February 22, 2012
### 807.92(a)(2)
Trade Name: Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protectors and Priming Set Common Name: Blood tubing line
Classification Name: set, tubing, blood, with and without anti-regurgitation valve Regulation Number: 21 CFR 876.5820
Panel: 78
Product Code: FJK
### 807.92(a)(3)
Legally marketed substantial equivalent device: K072024 - NIPRO Set - Blood Tubing Set with Transducer Protector and Priming Set.
### 807.92(a)(4)
Description of device:
The SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. One device package includes 1 arterial line (A226Y), 1 venous line (V813), 1 attached but removable priming set and two pre-attached Transducer Protectors.
The SLIMLINE is packaged sterile and labeled for single use only. There is no ability to clean and reuse this device. It is restricted for sale by or on the order of a physician.
### 807.92(a)(5)
Indications for Use:
The NIPRO Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.
### 807.92(a)(6)
Comparison of technological characteristics:
The SLIMLINE is substantially equivalent to the predicate device in the following technological characteristics -
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# K112628 20f3 page
| Item of<br>Comparison | | | |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SLIMLINE<br>Model # A226YV813 | Predicate<br>Model # A209YV803 | SE determination |
| Physical<br>characteristics: | Color-coded Components: drip<br>chambers, clamps, transducer<br>protectors, luer locks, luer lock<br>caps, injection ports and dialyzer<br>connections. | Same | |
| | Tubing: main tubing, heparin<br>line, saline pigtail and blood<br>pump segment | SE | Main tubing has been<br>shortened on the<br>SLIMLINE to minimize<br>priming volume and<br>bio-hazardous waste |
| Intended Use: | The NIPRO Set - SLIMLINE is a<br>disposable bloodline intended to<br>provide extracorporeal access to<br>the patient's blood during<br>Hemodialysis. It is compatible<br>with the Fresenius 2008H,<br>2008K/K2 and 2008T dialysis<br>machines. | The Nipro Set -<br>SLIMLINE is a<br>disposable bloodline<br>intended to provide<br>extracorporeal<br>access to the<br>patient's blood<br>during Hemodialysis.<br>The compatibility of<br>available<br>configurations is the<br>responsibility of the<br>physician in charge. | Machine models added<br>to the SLIMLINE<br>indications for use.<br>Removal of sentence<br>"The compatibility of<br>available configurations<br>is the responsibility of<br>the physician in charge" |
| | SLIMLINE will attach the arterial<br>line to the bottom of the dialyzer<br>and the venous to the top, with<br>the dialysate running cross-<br>current. | Arterial line attached<br>to the top, venous to<br>the bottom.<br>Dialysate is cross<br>current. | Blood and dialysate<br>filtering through the<br>dialyzer in opposite<br>directions |
| Operational<br>technique: | Priming set is provided pre-<br>attached and needs to be<br>removed and reattached before<br>recirculation | Priming set provided<br>in package but not<br>pre-attached. | Priming set provided<br>with arterial and<br>venous lines |
| | Dialyzer needs to be parallel to<br>machine module in order to<br>prevent kinking of bloodlines | Tubing length<br>sufficient to prevent<br>kinking | Kinking risks mitigated |
| Performance | (testing detailed below<br>807.92.b.1) | SE | Shorter tubing length of<br>SLIMLINE allows more<br>blood to be processed<br>during the same<br>treatment time. |
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### 807.92(b)(1)
Non-clinical tests submitted:
Bench testing was conducted to verify that the device is safe and effective for its intended use. Those tests include: Package integrity, Pressure leak (positive and negative), Endurance test of pump segment at Maximum flow rate and pressures of the dialysis machine, Pump segment performance, Endurance testing of any injection port after penetrated by 18G hypodermic needle, Priming volume assessment, Tensile testing of joints and materials of all tubing segment, ability of Transducer protector to withstand leakage when subjected to pressures up to 2 times the maximum labeled pressure (Strikethrough test), Performance test of the device's clamps, Hemocompatability test, Performance testing of tubing to resist kinking after repeated
clamping, particularly in the post pump tubing segment; these tests along with their associated results and conclusions are included in this submission.
### 807.92(b)(2)
Substantial equivalence was proven through bench testing. No clinical testing was required or performed in support of this 510k submission.
### 807.92(b)(3)
Conclusions drawn from non-clinical and clinical tests:
The results of the bench testing and the comparison of technological characteristics with the predicate device demonstrate that the SLIMLINE performs equivalent to the predicate device and is safe and effective when used as intended.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with stylized wings and tail feathers.
### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Jessica Oswald Regulatory Affairs Specialist Nipro Medical Corporation 3150 NW 107th Ave. MIAMI FL 33172
SEP 2 8 2012
Re: K112628
Trade/Device Name: Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set
Regulation Number: 21 CFR& 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II . Product Code: FJK Dated: August 28, 2012 Received: August 29, 2012
Dear Ms. Oswald:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have rovious your becared or 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 conimeres prior to May 20, 1977, ar eccordance with the provisions of the Federal Food, Drug, de noos that have boon rocaders of 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 may, dioroloro, maines of the Act include requirements for annual registration, listing of gences, 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 Trase oc advised that I Dr F unstallion that your device complies with other requirements of the Act that I DA has made a actorminations administered by other Federal agencies. You must Of any I cueral sundes that vegaranents, including, but not limited to: registration and listing Comply with an the Att 1 roques one and 1); medical device reporting (reporting of medical
{4}------------------------------------------------
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice-related advorse evone) (21 CFR Part 820); and if applicable, the electronic forth in are quarty by sions (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 IT you desire specific advice to: your avviro soffices/CDRH/CDRHOffices/ucm115809.htm for go to mip.nam.ida.gov/rtoout Drives. Health's (CDRH's) Office of Compliance. Also, please the Concertion be noos and reading by reference to premarket notification" (21CFR Part note the regulation entitled, "insoranants of receiverse 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 Tou may obtain other general mormances on J 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. Ticho
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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# Indications for Use
510(k) Number:_K112628
Device Name: Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set
Indications for Use:
The Nipro Set - SLIMLINE is a disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis.
Prescription Use _ > (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Herbert Hoover
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number. K112628
-4.1-
SLIMLINE
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.
