JMS BLOOD TUBING SETS

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

Intended 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.

Technological Characteristics

Materials: PVC, PE, PP, ABS, PC. Configuration: arterial/venous tubing with drip chambers, connectors, clamps. Standards: AAMI/ANSI RD 17:1994, ISO 10993 (biocompatibility). Sterilization: Sterile. Single-use.

Indications for Use

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.

Predicate Devices

• 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)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

#### 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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

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 [phone]. Also, please mote of test. Other general Office of Compliance at [phone]. 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 [phone] 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 |