GAMBRO CARTRIDGE BLOOD SETS

K070414 · Gambro Renal Products · FJK · Oct 12, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070414
• Device Name: GAMBRO CARTRIDGE BLOOD SETS
• Applicant: Gambro Renal Products
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Oct 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Gambro Cartridge® Blood Set is intended for single use in a hemodialysis treatment using the Phoenix and Centrysystem 3 Dialysis Delivery Systems. The Low Weight model is used when a low extra-corporeal blood volume is recommended. The Low Weight model with a priming volume of 75 ml is indicated for patients with body weight greater than 20 Kg and lower or equal to 40 Kg. The standard models with a priming volume ranging from 103 ml to 162 ml are indicated for patients with body weight greater than 40 Kg.

Device Story

Single-use sterile extracorporeal blood circuit (bloodlines) for hemodialysis; conveys blood from patient fistula to dialyzer and back. Comprises arterial and venous tubing sets with integrated cartridge. Used in clinical settings with Phoenix or Centrysystem 3 dialysis delivery systems; operated by trained healthcare professionals. Input: patient blood; Output: purified blood returned to patient. Facilitates extracorporeal circulation during dialysis treatment. Benefits patient by enabling safe, effective blood purification. Includes Low Weight model for pediatric/smaller patients requiring lower extracorporeal volume. Tubing utilizes DEHP-free plasticizer.

Clinical Evidence

Bench testing only. Testing included biocompatibility, flow rate, injection port validation, hemodialysis machine compatibility, mechanical hemolysis, expiration dating, connection strength, kink resistance, and clamping performance. No clinical data presented.

Technological Characteristics

Extracorporeal blood circuit; soft PVC tubing with DEHP-free plasticizer; latex-free injection plugs. Single-use, sterile, radiation-sterilized. Compatible with Phoenix and Centrysystem 3 dialysis machines. Includes various configurations (Single Needle, Double Needle, Low Weight).

Indications for Use

Indicated for hemodialysis patients using Phoenix or Centrysystem 3 delivery systems. Low Weight model (75 ml prime) for patients >20 kg and ≤40 kg. Standard models (103-162 ml prime) for patients >40 kg.

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

• Cobe Cartridge Blood Tubing Set

Submission Summary (Full Text)

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K070414 Page 1 of 4

Gambro Traditional 510(k)
Gambro Cartridge® Blood Set

# 5.0 510(K) SUMMARY

007 1 2 2007

| Submitter's Name | Gambro Renal Products |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 10810 West Collins Avenue<br>Lakewood, CO 80215 |
| Establishment<br>Number | 2087532 |
| Date of Submission | February 9, 2007 |
| Contact Person | Thomas B. Dowell, Regulatory Affairs Project Manager |
| Telephone Number<br>Fax Number | [phone]<br>[phone] |
| Name of the Device | Gambro Cartridge® Blood Set |
| Catalogue Numbers | 003409-400 Single Needle<br>003409-410 Single Needle (with prime line attached)<br>003410-500 Double Needle<br>003410-510 Double Needle (with prime line attached)<br>003410-710 Double Needle (with prime line attached with injection site)<br>003411-500 Double Needle (with longer patient line)<br>003412-500 Double Needle - Low Weight<br>003414-500 Double Needle (with extended dialyzer line)<br>003414-510 Double Needle (with extended dialyzer line and prime line<br>attached)<br>003415-510 Double Needle (with prime line attached)<br>003429-500 Single Needle Conversion Kit |
| 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: KOC<br>Regulation Number: 21 CFR 876.5820 |
| Identification of the<br>Legally Marketed<br>Device<br>(Predicate Device) | Cobe Cartridge Blood Tubing Set |

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K070914 Page 2 of 4

Traditional 510(k) Gambro Cartridge® Blood Set

## 510(k) SUMMARY, continued

The Gambro Cartridge® Blood Sets are single use sterile tubing sets Device Description employed in the Gambro 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) and they are commonly referred to as bloodlines. A Gambro Cartridge® Blood Set can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

#### Device Comparison Table

| | PREDICATE | MODIFIED DEVICE |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Cobe Cartridge Blood Tubing Set | Gambro Cartridge® Blood Set |
| Indication for Use | The Cobe Cartridge Blood Tubing Set<br>may be used with the following<br>hemodialysis devices: The Gambro<br>Dasco Phoenix; The Gambro Model Cx,<br>and the Cobe Centrysystem 3 (and 3+)<br>Systems. | The Gambro Cartridge® Blood Set is<br>intended for single use in a<br>hemodialysis treatment using the<br>Phoenix® and Centrysystem® 3<br>Dialysis Delivery Systems. The Low<br>Weight model is used when a low<br>extra-corporeal blood volume is<br>recommended. The Low Weight<br>model with a priming volume of 75<br>ml is indicated for patients with body<br>weight greater than 20 Kg and lower<br>or equal to 40 Kg. The standard<br>models with a priming volume<br>ranging from 103 ml to 162 ml are<br>indicated for patients with body<br>weight greater than 40 Kg. |
| Catalogue No. | Single Needle (SN):<br>003409-400<br>003409-410<br>Double Needle (DN):<br>003410-500<br>003410-510<br>003411-500<br>003414-500<br>Single Needle conversion kit (SNK):<br>003429-500<br>Double Needle Pediatric (P):<br>003412-500 | Single Needle (SN):<br>003409-400<br>003409-410<br>Double Needle (DN):<br>003410-500<br>003410-510<br>003411-500<br>003414-510<br>003414-500<br>003415-510<br>003410-710<br>Single Needle conversion kit (SNK):<br>003429-500<br>Double Needle Low Weight (LW):<br>003412-500 |
| | PREDICATE | MODIFIED DEVICE |
| | Cobe Cartridge Blood Tubing Set | Gambro Cartridge® Blood Set |
| Cartridge | Yes | Yes |
| Dialysis Machine<br>Compatibility (U.S.) | Phoenix and Centrysystem 3 | Phoenix and Centrysystem 3 |
| Clamps | Pinch | Pinch |
| Blood Tubing<br>Material | Soft PVC material | Soft PVC material with DEHP-free<br>plasticizer |
| Blood Tubing Length | Patient length:<br>SN: 198 cm<br>DN: from 183 cm to 244 cm<br>P: 183 cm | Patient length:<br>SN: 198 cm<br>DN: from 183 cm to 244 cm<br>LW: 183 cm |
| | Dialyzer length (venous):<br>SN: 46 cm<br>DN: from 46 cm to 53 cm<br>SNK: 46 cm<br>P: 46 cm | Dialyzer length (venous):<br>SN: 46 cm<br>DN: from 46 cm to 53 cm<br>SNK: 46 cm<br>LW: 46 cm |
| | Dialyzer length (arterial):<br>SN: 46 cm<br>DN: from 30 cm to 46 cm<br>SNK: 50 cm<br>P: 30 cm | Dialyzer length (arterial):<br>SN: 46 cm<br>DN: from 30 cm to 51 cm<br>SNK: 51 cm<br>LW: 30 cm |
| Blood Tubing<br>Thickness | Blood Pathway:<br>SN-DN: 1.16 mm<br>P: 1.62 cm | Blood Pathway:<br>SN-DN: 1.16 mm<br>SN-DN Connections to dialyzer<br>lines: 1.32 mm<br>LW: 1.63 mm |
| | Blood Pump segment:<br>SN-DN: 1.59 mm<br>P: 1.59 mm | Blood Pump segment:<br>SN-DN: 1.59 mm<br>LW: 1.59 mm |
| Priming Volumes | SN: 145 ml<br>DN: from 103 ml to 120 ml<br>SNK: 45 ml<br>P: 75 ml | SN: 162 ml<br>DN: from 103 ml to 119 ml<br>SNK: 45 ml<br>LW: 75 ml |
| Injection Plug<br>Material | Latex-free | Latex-free |
| Packaging | Pouch | Blister |
| Sterilization Method | Radiation | Radiation |
| Expiration | 3 years | 3 years |
| Single Use | Yes | Yes |
| Storage Temperature | -18°C (0°F) and 49°C (120°F) | -18°C (0°F) and 49°C (120°F) |

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K070 4/7 page 3 of 4

Gambro Cartridge® Blood Set

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KO70 4/4 P392 4 of 4

Traditional 510(k) Gambro Cartridge® Blood Set

### Description and Conclusion of Testing

#### Nonclinical Testing:

The non-clinical testing consisted of performance testing (bench) that included testing for biocompatibility, flow rate, validation of system injection ports (access sites), hemodialysis machine compatibility, mechanical hemolysis, expiration dating, integrity of the strength between connections, kink resistance, clamping of tubing and testing required by process to ensure compliance with other international standards applicable to extracorporeal blood circuit for hemodialysers.

#### Conclusion:

The successful non-clinical testing demonstrates the safety and effectiveness of the Gambro Cartridge® Blood Set 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/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or abstract human figure, composed of three curved lines.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# OCT 1 2 2007

Mr. Thomas B. Dowell Quality Systems Program Manager Gambro® Renal Products 10810 W. Collins Avenue LAKEWOOD CO 80215

Re: K070414

> Trade/Device Name: Gambro Cartridge® Blood Set Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: July 9, 2007 Received: July 10, 2007

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 Eederal Register.

Image /page/4/Picture/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" in it. The logo is black and white and has a star design at the bottom. The text is arranged in a circular fashion around the central FDA letters.

*Protecting and Promoting Public Health*

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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 (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. Hogdon

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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Traditional 510(k) Gambro Cartridge® Blood Set

Indications for Use

510(k) Number (if known): K070414

Device Name: Gambro Cartridge® Blood Set

Indications for Use:

The Gambro Cartridge® Blood Set is intended for single use in a hemodialysis treatment using the Phoenix and Centrysystem 3 Dialysis Delivery Systems. The Low Weight model is used when a low extra-corporeal blood volume is recommended. The Low Weight model with a priming volume of 75 ml is indicated for patients with body weight greater than 20 Kg and lower or equal to 40 Kg. The standard models with a priming volume ranging from 103 ml to 162 ml are indicated for patients with body weight greater than 40 Kg.

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)

Halut Peunand

(Division Si(i-Uff)
Page 17 of 57
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K070414