K032975 · Jms North America Corp. · FJK · Aug 16, 2004 · Gastroenterology, Urology
Device Facts
Record ID
K032975
Device Name
JMS BLOOD TUBING SETS
Applicant
Jms North America Corp.
Product Code
FJK · Gastroenterology, Urology
Decision Date
Aug 16, 2004
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5820
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The JMS Blood Tubing Sets with transducer protector and priming sets are disposable bloodlines intended to provide extracorporeal access to the patient's blood during hemodialysis.
Device Story
Disposable blood tubing sets; arterial and venous lines; used to transfer blood between patient vascular access and hemodialyzer. Components include drip chambers, infusion tubing, monitoring lines, ports, and pump segments. Used for pumping blood, capturing air/debris, infusing fluids/medications, blood sampling, and pressure monitoring. Operated by clinical staff in hemodialysis settings. Connects to various dialysis machines (e.g., Baxter, Fresenius, Althin). Facilitates extracorporeal circulation during hemodialysis treatment.
Clinical Evidence
Bench testing only. Compliance with AAMI/ANSI RD 17:1994 standard for hemodialyzer tubing sets and biocompatibility testing per ISO 10993.
Indicated for patients requiring hemodialysis for extracorporeal blood access via disposable bloodlines.
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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## 510(k) Summary of Safety and Effectiveness
#### Manufacturer and contact Information 1.
- 1.1 Manufacturer
JMS Singapore Pte Ltd 440 Ang Mo Kio Industrial Park 1 Singapore 569620
- 1.2 Sponsor
JMS North America Corperation 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 USA
- 1.3 Contact Information
Swee Cheau, Chong Manager of RA & QA JMS North America Corperation 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 Telephone: (510) 888-9090 Fax: (510) 888-9099
#### Device Classification Name 2.
Gastroenterology Devices Panel has classified Hemodialysis System and accessories as Class II. Reference 21 CFR 876.5820
#### 3. Predicate Device Name
JMS Blood Tubing Sets which are substantially equivalent to the following predicate devices which are legally marketed in market in intended use, design, safety and effectiveness:
- . Nipro® Blood Tubing Set (K001465)
- OFI Biomedica SpA Blood Tubing Set (K001971) .
- Nextron medical Technologies Blood Tubing Set (K852605) .
- Fresenius Blood Tubing Set (K001107) .
- Medisystems Blood Tubing Set (K953823) .
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#### Device Intended use 4.
The JMS Blood Tubing Sets are disposable bloodlines, intended to transfer blood from patients' vascular access system to the hemodialyzer through an arterial tubing, and from the hemodialyzer to the patient vascular system via a venous tubing. JMS Blood Tubing set is for Single use only.
#### Device Description 5.
The tubing sets that JMS intended to market include arterial and venous dialysis blood tubing as described in 21 CFR 876.5820. Various models of blood tubing sets are being manufactured for application with different dialysis machines, such as Baxter, Fresenius, Althin, etc.
All components of blood tubing set, including drip chambers, infusion tubing, monitoring lines, ports, and segments which are use to pump blood, retain and capture air and blood debris, infuse medications or fluid, sampling blood, pressure monitoring and making connections to other devices, are all included.
The materials used are mainly, polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), acrylonitrite butadiene styrene (ABS), and polycarbonate (PC).
#### Technological Characteristics and Substantial Equivalence 6.
The configuration, labeling, packaging, materials and mode of sterilizations of the subject device are similar to legally marketed predicate devices. The subject device and all other predicate devices are used for hemodialysis, which are labeled sterile, non-pyrogenic and for single use only. JMS Blood Tubing Set and predicate devices are all composed of various tube sizes, connectors and clamps for connection to all arterial or venous access system.
The JMS Blood Tubing Set complies with AAMI/ANSI RD 17 : 1994 standard for <Hemodialyzer Tubing set>. The JMS Blood Tubing Set has also been tested for its biocompatibility as accordance to ISO 10993.
JMS believes that the information provided in this submission clearly describes the JMS Blood Tubing Sets and demonstrates that they are substantially equivalent to the said predicate devices with regards to intended use, material, biocompatibility, and overall performance characteristics.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2004
Swee Cheau, Chong Manager of Regulatory Affairs & Quality Assurance JMS North America Corporation 22320 Foothill Blvd., Suite 350 HAYWARD CA 94541
Re: K032975
Trade/Device Name: JMS Blood Tubing Sets Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Codes: 78 FJK and KOC Dated: August 5, 2004 Received: August 9, 2004
Dear Ms. Chong:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(x) premained in substantially equivalent (for the indications referenced above and nave uctemined the actrose aredicate devices marketed in interstate for use stated in the enclosite) to regally management date of the Medical Device Ameralments, or to commerce prior to May 26, 1776, the enaoutions with the provisions of the Federal Food. Drug, devices that have been receasined in aoost require approval approval application (PMA). and Cosment Act (Act) that do not require approvine the general controls provisions of the Act. The Y ou may, utcrefore, market the devices, soloje requirements for annual registration, listing of general controls provisions of the free morals can and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classified (see above) into eting major regulations affecting your device can be It may be Subject to additional controls. - Emile - Sats 800 to 898. In addition, FDA may found in the Code of I ederal resgueening your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a bacean.
that FDA has made a determination that your device complies with other requirements of the Act that TDA has made a decertimation that Josener Federal agencies. You must of any rederal statutes and regulations annimating, but not limited to: registration and listing comply with an the Act STequirences, monday, good manufacturing practice requirements as sch
(21 CFR Parl 807); labeling (21 CFR Part 801); good manufacturing dia dia dia des (21 CFR Part 807), labelling (21 CFR Part 820); and 820); and If applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 and 1000; 1 forth in the quanty 35 stems (QD) regarding 531-542 of the Act); 21 CFR 1000-1050.
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### Pare 2
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your acence of your device of your device to a legaliyalize premarket notification - The FDA Inding of substantial of your device and this, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on on table good on the regulation
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advice, please contact the seculaci the Additionally, for questions on the promote the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please mote of test. Other general Office of Compliance at (301) 594-4057. Tass, part 807.97) you may obtain. Other general by reference to premarket notification (21 cc r x an or obtained from the Division of Small
information on your responsibilities under the Act may be obtained from the 1800) information on your responsibilites this reserved its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Associated analysmamain html Manufacturers, International and Coulsumer rissistance anno control of the comment.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# INDICATION FOR USE STATEMENT
| 510(k) Number: | K032975 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name : | JMS Blood Tubing Sets |
| Indication for use: | The JMS Blood Tubing Sets with transducer protector and<br>priming sets are disposable bloodlines intended to provide<br>extracorporeal access to the patient's blood during<br>hemodialysis. |
:
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrently of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (per 21 CFR 801-109) | <div></div> |
|---------------------------------------|----------------------|
| or | Over The-counter use |
| (Division Sign-Off) | <div></div> |
|---------------------------------------------------------------|-------------|
| Division of Reproductive, Abdominal, and Radiological Devices | <div></div> |
| 510(k) Number | K032975 |
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.
