BLOOD TUBING SETS (STERILE FLUID PATH)

K080807 · Nxstage Medical, Inc. · FJK · Jul 18, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080807
• Device Name: BLOOD TUBING SETS (STERILE FLUID PATH)
• Applicant: Nxstage Medical, Inc.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Jul 18, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.

Device Story

Blood tubing sets facilitate extracorporeal procedures by connecting blood access devices to hemodialysis or hemofiltration machines and hemodialyzers/hemofilters. Components include air trap chambers, filters, injection sites, pump segments, heparin infusion lines, saline administration lines, pressure pillows, priming sets, and pressure monitoring lines (with/without transducer protectors). Used in clinical settings by healthcare professionals to manage blood flow during dialysis. The device provides a sterile fluid path for blood circulation, enabling the hemodialysis process to treat patients with renal failure.

Clinical Evidence

Bench testing only. Performance, verification, and validation testing were conducted to characterize the subject blood tubing sets and provide a basis of comparison to the predicate device. Results documented substantial equivalence.

Technological Characteristics

Sterile fluid path tubing sets for hemodialysis. Components include air trap chambers, filters, injection sites, pump segments, and pressure monitoring lines. Design and configuration are similar to the predicate device. No specific materials or software algorithms are described.

Indications for Use

Indicated for use with a medically prescribed hemodialyzer in patients undergoing extracorporeal procedures. Suitability of configuration determined by the physician in charge.

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

• Arterial-Venous Blood Tubing Sets (K953823)

Submission Summary (Full Text)

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K080807
Page 1 of 3

# NxStage Medical, Inc. Blood Tubing Sets Special 510(k) Device Modification

9045797

Michael Doyle

[phone]

[phone]

9616074

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

#### A. Submitter's Information:

Name:

NxStage Medical Inc.

JUL 1 8 2008

Address:

439 South Union Street, 5th Floor Lawrence, MA 01843

Manager, Regulatory Affairs

Av. Valle imperial No. 10523 Parque industrial Valle Sur Tijuana, B.C., Mexico 22180

FDA Establishment Owner/Operator Number:

Contact Person:

Phone: Fax:

Manufacturing Site:

FDA Establishment Registration Number:

Manufacturing/Sterilization Site:

Kawasumi Laboratories Co. Ltd. 55/26-27 m-13 Phaholyothin Rd. Km-46 Klong Nueng, Klong Luang Pratumtanee, Thailand

MEDIMEXICO, S. DE R.L. DE C.V.

FDA Establishment Registration Number:

Manufacturing/Sterilization Site:

Kawasumi Laboratories Co. Ltd. 48 Moo 8 Ratchasima-Chokchai Rd., Tambon Tha-ang, Amphur Chokchai, Nakhorn Rachasima, Thailand

FDA Establishment Registration Number: 9615908

9680437

Sterilization Site:

Steris Corporation Isomedix Services, Inc. 1000 S. Sarah Place Ontario, CA 91761

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K080807
Page 2 of 3

| FDA Establishment<br>Registration Number: | Contract sterilizer |
|-------------------------------------------|----------------------------------------------------------------------------------------------|
| Sterilization Site: | STERIS Corporation<br>Isomedix Service, Inc.<br>7685 St. Andrews Ave.<br>San Diego, CA 92154 |
| FDA Establishment<br>Registration Number: | Contract sterilizer |
| B. Device Name: | |
| Trade/Proprietary Name: | Blood Tubing Sets |
| Common/Usual Name: | Tubing sets |
| Classification Name: | Sets, Tubing, Blood, With and Without Anti-<br>Regurgitation Valve |
| Regulation Number: | 876.5820 |
| Product Code: | FJK |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology/Urology |

#### C. Substantial Equivalence/Predicate Devices:

The subject blood tubing sets are substantially equivalent to the following legally marketed predicate device, previously cleared by the FDA:

- · Arterial-Venous Blood Tubing Sets, K953823, September 23, 1996
## D. Device Description/Indications for Use:

Medisystems/NxStage blood tubing sets consist of a family of products which are used during extracorporeal procedures to provide a means to connect blood access devices to a hemodialysis or hemofiltration machine and a hemodialyzer or hemofilter. To facilitate a hemodialysis procedure, for example, the arterial and/or venous blood tubing sets may contain features such as air trap chambers, filters, injection sites, pump segments, heparin infusion lines, saline administration lines, pressure pillows, priming sets, and pressure monitoring lines with or without transducer protectors. Numerous product codes are produced to accommodate various manufacturer's dialysis machines, as well as differing clinical preferences and clinical procedures.

## Indications for use:

The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.

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K080807
Page 3 of 3

# NxStage Medical, Inc. Blood Tubing Sets Special 510(k) Device Modification

#### E. Technological Characteristics:

The subject device has the same technological characteristics and is similar in design and configuration as compared to the predicate device. The subject device is designed with similar components and features also used in the predicate device.

## F. Summary of Non-Clinical Test/Performance Testing - Bench

NxStage Medical, Inc. believes that the information and data provided in this submission clearly describes the subject device and demonstrates that the device is adequately designed for the labeled indications for use. Performance, verification and validation testing was conducted to characterize performance of the subject blood tubing sets to provide a basis of comparison to the predicate device as all features are not identical. Results of this testing have documented that the subject blood tubing sets are substantially equivalent to the predicate device and are suitable for the labeled indications for use.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael J. Doyle Manager, Regulatory Affairs NxStage Medical, Inc. 439 South Union Street 5th Floor LAWRENCE MA 01843

K080807 Re:

Trade/Device Name: Blood Tubing Sets (Sterile Fluid Path) Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Codes: FJK and KOC Dated: July 10, 2008 Received: July 11, 2008

Dear Mr. Doyle:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy 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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510(k) Number (if known):

K080807

Device Name: Blood Tubing Sets (Sterile Fluid Path)

Indications for Use:

The blood tubing sets are indicated for use with a medically prescribed hemodialyzer. The suitability of a particular configuration is the responsibility of the physician in charge.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X |
|-------------------------------------------------|---|
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices.

| 510(k) Number | K080807 |
|---------------|---------|
|---------------|---------|

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