NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS
K972206 · Nipro Medical Corp. · KOC · Nov 26, 1997 · Gastroenterology, Urology
Device Facts
Record ID
K972206
Device Name
NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS
Applicant
Nipro Medical Corp.
Product Code
KOC · Gastroenterology, Urology
Decision Date
Nov 26, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5820
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set is intended for use during hemodialysis to provide access to a patient's blood. When used in hemodialysis, they are part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.
Device Story
Kit containing arterial/venous blood tubing sets, disposable solution infusion set, and transducer/protector; used during hemodialysis procedures as part of artificial kidney system. Components facilitate extracorporeal blood circulation. Used in clinical settings by healthcare professionals; restricted to prescription use. Transducer/protector prevents contamination of dialysis machine pressure monitoring lines. Biocompatible materials ensure patient safety during blood contact. Kit configuration provides convenience for clinical setup.
Clinical Evidence
No clinical data. Biocompatibility testing performed on kit components including cytotoxicity, mutagenicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, implantation tests, pyrogenicity, and sensitization. Results confirm conformance to specifications.
Technological Characteristics
Kit components: PE, PVC, ABS, POM, PP, PEHD, PC. Transducer/protector: rigid PVC with 0.2 micron Gore membrane (PTFE/PP) or rigid PVC with PTFE and polyester. Sterile, single-use. No software or electronic components.
Indications for Use
Indicated for patients with renal failure or toxemic conditions requiring hemodialysis treatment to provide blood access.
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
Medisystems Corporation ReadySet™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors
Submission Summary (Full Text)
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K972206 PAGE 1 OF 3
Image /page/0/Picture/2 description: The image shows the logo for Nipro. The logo consists of a stylized infinity symbol to the left of the word "NIPRO" in bold, sans-serif font. The infinity symbol is made up of two interlocking loops, and the word "NIPRO" is in all caps.
CORPORATION 0877 N.W. 33rd Street Miami. Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454
# SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set
\$807.92 (a)(1)
Submitter:
Nipro Medical Corporation
Contact Person:
Luis Candelario General Manager
September 24, 1997
Date of Summary Preparation:
\$807.92 (a)(2)
| Trade Name: | Nipro® Blood Tubing Set for Hemodialysis<br>withTransducer Protectors and Priming Set |
|----------------------|---------------------------------------------------------------------------------------|
| Common Name: | Blood tubing set with priming set and transducer/protectors |
| Classification Name: | Blood access device and accessories (21 CFR<br>876.5540) |
\$807.92 (a)(3)
Legally Marketed Substantially Equivalent Devices:
Medisystems Corporation ReadySet™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors
8807.92 (a)(1)
Description of Device:
The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set that we intend to market includes the following three components: a Nipro® Arterial and Venous Blood Tubing Set for Hemodialysis; a Nipro® Disposable Solution Set ; and, a transducer/ protector. These devices are packaged together for convenient use during hemodialysis procedures.
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## page 2 - SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® Blood Tubing Set for Hemodialysis with Transducer/Protectors and Priming Set
The Arterial and Venous Blood Tubing Sets that we intend to include within the kits include various models of blood tubing sets are available for application with different dialysis machines. A series of 27 arterial line models (A001 - A021, A026, A029 -A032, and A035) and a series of 14 venous line models (V600 - V607, V609 - V613, and V616) have been described. The Disposable Solution Infusion Set that we intend to include in the kit will be one of the 4 types of designs: NNC-3L, NNC-3CL. NNC-3C. and NNC-3CS. A transducer/protector is also included in the kit.
The materials used for the components of the blood tubing sets include polyethylene (PE), polyvinylchloride (PVC), acrylonitrate butadiene styrene (ABS), polyoxymethylene (POM), polypropylene (PP), polyethylene high density (PEHD), and polycarbonate (PC). The materials used for the disposable solution infusion set include polyethylene (PE), polyvinylchloride (PVC), polypropylene (PP), and acrylonitrate butadiene styrene (ABS). The transducer/protector component of this kit is fabricated from either rigid PVC and a 0.2 micron Gore membrane (PTFE and polypropylene) or rigid PVC and PTFE and polyester.
8807.92 (a)(5)
The Blood Tubing Set for Hemodialysis with Transducer Protectors Intended Use: and Priming Set is intended for use during hemodialysis to provide access to a patient's blood. When used in hemodialysis, they are part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.
8807.92 (a)(6)
Comparison of Technical Characteristics:
The configuration of the subject device kit is similar to legally marketed devices from Medisystems Corporation. Labeling for the competitor's devices is similar to the subject device. According to the device names on the labeling, the intended use for the competitors' products is similar to that of the subject device. They are used for hemodialysis. All of the devices are labeled as sterile and for single use only. The devices are restricted to sale by or on the order of a physician. The blood tubing sets and disposable solution infusion sets are already cleared for market individually and demonstrated to be biocompatible according to necessary testing and prior clinical use. The transducer/protector is fabricated from identical materials to those contained in certain blood tubing set components. Transducer/protectors have also undergone biocompatibility testing and are similar to marketed components.
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## page 3 - SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set
- The following biocompatibility tests were performed on the components of \$807.92 (b)(1) the subject device kit: cytotoxicity, mutagenicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, implantation tests, pyrogenicity, and sensitization. Results indicate that the blood tubing sets conform to the appropriate specifications.
- The Nipro Disposable Blood Tubing Set for Hemodialysis and Disposable \$807.92 (b)(3) Solution Infusion Set have already been determined to be substantially equivalent to legally marketed devices. The transducer/protector is composed of materials identical to those contained in blood tubing set components and similar to marketed components.
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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
### NOV 26 1997
Mr. Luis Candelario General Manager Nipro Medical Corporation 10877 N.W. 33rd Street Miami, Florida 33172
Re: K972206 Nipro® Blood Tubing Set with Transducer Protectors and Priming Set for Hemodialysis Dated: August 27, 1997 Received: September 4, 1997 Regulatory Class: II
21 CFR §876.5820/Product code: 78 KOC
Dear Mr. Candelario:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions; or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 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 to proceed to the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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" (21 CFR 807.97). Other general
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Page 2 - Mr. Luis Candelario
information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Robert R. Setting/
Lillian W. Ph.D.
\$\xi\$
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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): K972206
Device Name: Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set
Indications for Use: The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set is intended for use during hernodialysis to provide access to a patient's blood. When used in hemodialysis, they are part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use J (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Robert L. Satterly/
(Division Sign-Off) -2-Division of Reproductive, Abdominal, ENT, and Radiological Devices (972206 510(k) Number_
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.
