GAMBRO QUICKSET BLOODLINES

K063290 · Gambro Renal Products · FJK · Jan 30, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K063290
• Device Name: GAMBRO QUICKSET BLOODLINES
• Applicant: Gambro Renal Products
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Jan 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

Device Story

Gambro QuickSet® Bloodlines are single-use sterile tubing sets for hemodialysis; they transport patient blood from vascular access to a dialyzer and return purified blood to the patient. The system consists of arterial and venous lines, chambers, and connectors. Operated by clinical staff in a hemodialysis setting, the device facilitates the extracorporeal circuit necessary for blood purification. The device is connected to hemodialyzers and vascular access points. By providing a sterile, reliable pathway for blood flow, the device enables effective hemodialysis treatment, directly supporting the removal of waste products and fluid management in patients with renal failure.

Clinical Evidence

Bench testing only. Testing included biocompatibility, sterilization validation, sterility, flow rate, injection port validation, machine compatibility, and mechanical hemolysis testing.

Technological Characteristics

Single-use sterile tubing sets. Materials: Soft PVC (with or without DEHP), SEBS (latex-free injection plugs). Components: Arterial/venous chambers (injection or blow molded), pinch/slide clamps. Sterilization: Radiation or ETO. Connectivity: Standard hemodialysis machine interfaces. Storage: 0°C to +30°C.

Indications for Use

Indicated for patients requiring hemodialysis treatment. Single-use sterile device for extracorporeal blood circulation.

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

• Gambro G Series Bloodline Sets for Hemodialysis
• Cobe Hemaflo™ Blood Tubing Sets

Submission Summary (Full Text)

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# 5.0 510(K) SUMMARY

| Submitter's Name | Gambro Renal Products | JAN 3 0 2007 |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Address | 10810 West Collins Avenue<br>Lakewood, CO 80215 | |
| Establishment<br>Number | 1713683 | |
| Date of Submission | October 31, 2006 | |
| Contact Person | Thomas B. Dowell, Regulatory Affairs Project Manager | |
| Telephone Number<br>Fax Number | [phone]<br>[phone] | |
| Name of the Device | Gambro QuickSet® Bloodlines | |
| Catalogue Numbers | 018430501: Gambro QuickSet® Post-pump arterial chamber<br>018440501: Gambro QuickSet® No arterial pressure monitoring<br>009445601: Gambro QuickSet® No arterial pressure monitoring<br>009558601: Gambro QuickSet® Pre-pump arterial chamber<br>009559601: Gambro QuickSet® Post-pump arterial chamber<br>009566601: Gambro QuickSet® Pre-pump pillow with post arterial<br>chamber<br>009558714: Gambro QuickSet® Pre-pump arterial chamber<br>009566714: Gambro QuickSet® Pre-pump pillow with post arterial<br>chamber | |
| Common or Usual<br>Name | Extracorporeal blood circuit for hemodialysers | |
| Classification Name | Classification Name: Hemodialysis system and accessories<br>Device Class: II<br>Product Code: FJK<br>Regulation Number: 21 CFR 876.5820 | |
| Identification of the<br>Legally Marketed<br>Device<br>(Predicate Device) | Gambro G Series Bloodline Sets for Hemodialysis<br>Cobe Hemaflo ^TM Blood Tubing Sets | |

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## 510(k) SUMMARY, continued

# Device Description

The Gambro medical lines QuickSet® are tubing sets (bloodlines) employed in the hemodialysis equipments extracorporeal circulation: they convey the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line). The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

# Comparison Table

| | PREDICATE<br>G Series Blood Line | PREDICATE<br>Hemaflo™ Blood Tubing Set | MODIFIED DEVICE<br>QuickSet® Bloodlines<br>[currently distributed] | MODIFIED DEVICE<br>QuickSet® Bloodlines<br>[new models] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Gambro G series blood lines are intended for use during hemodialysis in conjunction with an artificial kidney (hemodialyzer). The type of blood line for use is dependent upon the type of dialysis delivery system employed. | Cobe Hemaflo™ Disposable Blood Tubing Set is intended for use in hemodialysis treatment. | The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge. | The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge. |
| Currently in Distribution | NO | NO | YES | NO |

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Traditional 510(k) Gambro QuickSet® Bloodlines

| | PREDICATE | PREDICATE | MODIFIED | MODIFIED |
|----------------------|---------------------|-------------------|-------------------|-------------------|
| | G Series Blood Line | Hemaflo™ | DEVICE | DEVICE |
| | | Blood Tubing | QuickSet® | QuickSet® |
| | | Set | Bloodlines | Bloodlines |
| | | | [currently | [new models] |
| | | | distributed] | |
| | | | 009445601 | |
| | | | 009558601 | |
| Catalogue No. | Not applicable | Not applicable | 009559601 | 009558714 |
| | | | 018430501 | 009566714 |
| | | | 018440501 | |
| | | | 009566601 | |
| Arterial Chamber | Injection Molded | Injection Molded | Blow Molded | Injection Molded |
| Venous Chamber | Injection Molded | Injection Molded | Blow Molded | Injection Molded |
| | | | | |
| Clamps | Pinch & Slide | Slide | Pinch | Pinch |
| Blood tubing | Soft PVC material | Soft PVC material | Soft PVC material | Soft PVC material |
| material | with DEHP | with DEHP | with DEHP | with DEHP-free |
| | plasticizer | plasticizer | plasticizer | plasticizer |
| Injection plug | Latex | Latex | Latex-free | Latex-free |
| material | | | (SEBS) | (SEBS) |
| Packaging | Blister | Pouch | Pouch | Blister |
| | | | | |
| Quantity per box | 16 | 10 | 16 | 14 |
| Sterilization Method | ETO | Radiation | Radiation | Radiation |
| Expiration | 3 years | 3 years | 3 years | 3 years |
| Single Use | Yes | Yes | Yes | Yes |
| Storage | Between | Between | Between | Between |
| Temperature | 10°C (50°F) | 10°C (50°F) | 0°C (32°F) | 0°C (32°F) |
| | and | and | and | and |
| | +24°C (75°F) | +24°C (75°F) | +30°C (86°F) | +30°C (86°F) |

Description and Conclusion of Testing

### Nonclinical Testing:

The non-clinical testing consisted of performance testing (bench) that included biocompatibility testing, validation of the sterilization process, sterility testing, flow rate testing, validation of needle and needle-less system injection ports, compatibility testing with different hemodialysis machines, and testing for mechanical hemolysis.

### Conclusion:

The successful non-clinical testing demonstrates the safety and effectiveness of the Gambro QuickSet® Bloodlines when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Thomas B. Dowell Regulatory Affairs Project Manager GAMBRO Renal Products 10810 West Collins Avenue LAKEWOOD CO 80215

JAN 3 0 2007

Re: K063290

Trade/Device Name: Gambro QuickSet® Bloodlines Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: October 31, 2006 Received: November 1, 2006

Dear Mr. Dowell:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial anniversary from 1906-2006. The letters "FDA" are in large bold font in the center of the logo. The word "Centennial" is written in cursive below the letters "FDA".

Protecting and Promoting Public Health

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Page 2 -

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 (QS) 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 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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Indications for Use

510(k) Number (if known): K063290

Device Name: Gambro QuickSet® Bloodlines

Indications for Use:

The Gambro Medical lines QuickSet® Bloodlines are single use sterile medical devices intended to provide extracorporeal blood circuit for hemodialysis treatment. QuickSet® Bloodlines can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Nancy Brogdon

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number