Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
Applicant
NIKKISO CO., LTD.
Product Code
KOC · Gastroenterology, Urology
Decision Date
Jun 16, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5820
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use. This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.
Device Story
Disposable blood tubing lines for hemodialysis; used with NIKKISO DBB-06 Hemodialysis Delivery System. Components include tubing, drip chambers, infusion lines, pressure monitoring lines, ports, clamps, and filters. Functions: pump blood, capture debris, infuse fluids/medications, sample blood, monitor pressure. Used in hospitals and dialysis clinics by qualified operators. Provides extracorporeal access to patient blood. Output: physical blood circuit connectivity and pressure monitoring interface. Benefits: enables safe extracorporeal blood circulation during hemodialysis treatment.
Clinical Evidence
No clinical data submitted. Substantial equivalence supported by extensive non-clinical bench testing, including structural integrity, tensile strength, mechanical hemolysis, flow dynamics, and simulated treatment performance.
Indicated for adult patients with acute and chronic renal failure requiring hemodialysis. Not indicated for pediatric patients. Not for home use.
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.
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June 16, 2023
NIKKISO Co., Ltd. Fumiaki Kanai President & CEO MIC International 4-32-16 Ryogoku Sumida-ku, Tokyo 130-0023 JAPAN
Re: K230514
> Trade/Device Name: Blood Tubing Lines for Hemodialysis AL Series (Archloop); AL-ADC-E(U)06, AL-CDC-E(U)06 Blood Tubing Lines for Hemodialysis C18 Series; C18BDD-E(U)06, C18RDC-E(U)06, C18SFD-E(U)06 Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: Class II Product Code: KOC Dated: June 5, 2023 Received: June 7, 2023
Dear Fumiaki Kanai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-
information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices
(21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
## Gema Gonzalez -S
Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Enclosure
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### Indications for Use
510(k) Number (if known) K230514
Device Name BLOOD TUBING LINES FOR HEMODIAL YSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIAL YSIS C18 Series
#### Indications for Use (Describe)
This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediative patients. It is not for home use.
This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.
| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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## 5. 510(k) Summary
| 510(k) Number | K230514 | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Preparation Date | June 15th, 2023 | |
| Submitter | NIKKISO CO., LTD.<br>20-3, Ebisu 4-Chome, Shibuya-ku<br>Tokyo 150-6022, Japan | |
| Contact | Satoko Hina<br>Quality Assurance Department<br>Medical Division<br>NIKKISO CO., LTD.<br>20-3, Ebisu 4-Chome, Shibuya-ku<br>Tokyo 150-6022, Japan<br>Phone: +81-3-3443-3754<br>Fax: +81-3-3473-4965<br>Email: MedicalRA@nikkiso.co.jp | |
| Subject Device | Device Name:<br>BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop)<br>BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series<br>Device Classification Name: Accessories, Blood Circuit, Hemodialysis<br>Regulation Number:<br>21 CFR 876.5820<br>Regulation Description:<br>Hemodialysis system and accessories<br>Device Class:<br>Class II<br>Classification Product Code:<br>KOC<br>Regulation Medical Specialty: Gastroenterology/Urology<br>510(k) Review Panel:<br>Gastroenterology/Urology | |
| Device Description | The BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) includes arterial and<br>venous dialysis blood tubing.<br><br>The devices are packaged together for convenient use during hemodialysis procedures. They are<br>manufactured for application with the DBB-06 Hemodialysis Delivery System. The components<br>of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports,<br>clamps and filters which are used to pump blood, retain and capture blood debris, infuse<br>medications or fluids, sample blood as well as monitor pressure.<br><br>The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned<br>or reused. They are restricted for sale by or on the order of a physician.<br><br>The BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series is one part of a blood tubing<br>lines device for hemodialysis. The devices are packaged together for convenient use during<br>hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis<br>Delivery System. The devices are packaged sterile and labeled for single use only. These devices<br>cannot be cleaned or reused. They are restricted for sale by or on the order of a physician. | |
| Intended Use /<br>Indications for Use | This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and<br>chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is<br>not indicated for pediatric patients. It is not for home use.<br><br>This device is made up of disposable bloodlines intended to provide extracorporeal access to a<br>patient's blood during hemodialysis. It is the responsibility of the physician or other licensed<br>practitioner to ensure compatibility with the available configurations. | |
| Predicate Device | 510(k) Number: | K082719 |
| | Device Name: | NIKKLINE BLOOD TUBING LINES WITH<br>TRANSDUCER PROTECTORS, MODELS<br>AV06A-P, AV06B-P, AV06C-P |
| | Applicant: | NIKKISO CO., LTD. |
| | Device Classification Name: | Accessories, Blood Circuit, Hemodialysis |
| | Regulation Number: | 21 CFR 876.5820 |
| | Regulation Description: | Hemodialysis system and accessories |
| | Device Class: | Class II |
| | Classification Product Code: | KOC |
| | Regulation Medical Specialty: | Gastroenterology/Urology |
| | 510(k) Review Panel: | Gastroenterology/Urology |
| Technological<br>Characteristics | The subject device and predicate device have substantially equivalent technological characteristics:<br>• Similar intended use including similar indication for use.<br>• Similar design and configuration.<br>• Same scientific technology and principles of operation. | |
| | The following are the only minor differences:<br>• EOG sterilization is adopted as the sterilization method.<br>• Newly adopted Styrenic thermoplastic elastomer (SEBS), Isoprene rubber (IR) and Methyl<br>Methacrylate Acrylonitrile Butadiene Styrene (MABS) as new materials.<br>• In addition to traditional transducer protection filters, PODs (Pressure monitor pod) are used<br>as a connection component to the pressure measurement unit.<br>• Compliance with the latest standards and guidance. | |
| FDA Guidance<br>Documents | The following FDA guidance documents were referenced in preparing this premarket notification:<br>• eCopy Program for Medical Device Submissions, issued April 2020<br>• Format for Traditional and Abbreviated 510(k)s, issued September 2019<br>• Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, issued June<br>2012<br>• Hemodialysis Blood Tubing Sets, issued April 2008<br>• Labeling: Regulatory Requirements for Medical Devices, issued August 1989<br>• Recommended Content and Format of Non-Clinical Bench Performance Testing Information<br>in Premarket Submissions, issued December 2019<br>• Shelf Life of Medical Devices, issued April 1991<br>• Submission and Review of Sterility Information in Premarket Notification (510(k))<br>Submissions for Devices Labeled as Sterile, issued January 2016<br>• Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part<br>1: Evaluation and testing within a risk management process", issued June 2016 | |
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# K230514
Page 3 of 4
| No. | Test Item | Report |
|-----|-----------------------------------------------------------|----------------------------------------|
| 1 | Sterilization Barrier System<br>Performance Test | TR-20210412-070442-16<br>(Appendix 24) |
| 2 | Blood Pathway Flow<br>Dynamics | TR-20210331-070442-01<br>(Appendix 25) |
| 3 | Colour Coding | VER-P301201-160<br>(Appendix 26) |
| 4 | Connectors to Haemodialyser | TR-20210412-070442-02<br>(Appendix 27) |
| 5 | Connectors to<br>Ancillary Components | TR-20210412-070442-15<br>(Appendix 28) |
| 6 | Connectors to<br>Vascular Access Device | TR-20210412-070442-03<br>(Appendix 29) |
| 7 | Mechanical Hemolysis | TR-20210412-070442-11<br>(Appendix 30) |
| 8 | Needle Access Ports | TR-20210412-070442-04<br>(Appendix 31) |
| 9 | Needleless Access Ports | TR-20210412-070442-05<br>(Appendix 32) |
| 10 | Blood Pathway Volume | TR-20210412-070442-06<br>(Appendix 33) |
| 11 | Structural Integrity | TR-20210412-070442-01<br>(Appendix 34) |
| 12 | Tensile Strength | TR-20210412-070442-13<br>(Appendix 35) |
| 13 | Transducer Protectors | TR-20210412-070442-10<br>(Appendix 36) |
| 14 | Dimensional and<br>Workmanship Analysis | TR-20211101-070442-01<br>(Appendix 37) |
| 15 | Peak Pressure Test of EOG<br>Sterile AL Series for DBB-06 | TR-20230104-070442-01<br>(Appendix 38) |
| 16 | Pump Segment Performance | TR-20221222-070442-01<br>(Appendix 39) |
| 17 | Air-capture Chamber Fill<br>Level | TR-20220707-210531-03<br>(Appendix 40) |
| 18 | Resist Kinking After Repeated<br>Clamping | TR-20220707-210531-02<br>(Appendix 41) |
| 19 | Tubing Compliance | TR-20220707-210531-01<br>(Appendix 42) |
| 20 | Simulated Treatment | TR-20230523-070442-01<br>(Appendix 43) |
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| Performance- Animal | No animal performance data is submitted in this Traditional 510(k). |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance-<br>Clinical | No clinical performance data is submitted in this Traditional 510(k). |
| Substantial<br>Equivalence | The subject devices are substantially equivalent to the predicate device when evaluating intended<br>use and technological characteristics. The subject devices have the same intended use as the predicate device. The subject devices and predicate device are substantially equivalent with only minor technological differences. These differences do not raise new questions of safety and effectiveness. |
| Conclusion | This comparison demonstrates that the subject devices are substantially equivalent to the predicate device. The subject devices are as safe and effective as the predicate device and will perform as intended. |
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.
