GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

K100364 · Gambro Renal Products, Inc. · FJK · Nov 3, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K100364
• Device Name: GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
• Applicant: Gambro Renal Products, Inc.
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: Nov 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Gambro Cartridge® Blood Set Low Weight-Low Volume is intended for single use in a hemodialysis treatment using the Phoenix® Dialysis Delivery System. The Low-Weight - Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight - Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 Kg.

Device Story

Single-use sterile extracorporeal blood tubing set; conveys blood from arterial-venous access to dialyzing filter and back to patient. Used in hemodialysis treatments with Phoenix® Dialysis Delivery System. Designed for patients requiring low extra-corporeal blood volume (40 ml priming volume). Operated by clinical staff in dialysis settings. Facilitates blood purification; ensures safe connection between hemodialyzers, vascular access, and perfusion lines.

Clinical Evidence

No clinical testing was required or performed. Safety and effectiveness supported by bench testing including integrity, flow rate, endurance, priming volume, tensile, and hemocompatibility testing.

Technological Characteristics

Single-use sterile tubing set; includes arterial and venous lines, injection ports, and pressure transducers. Materials tested for biocompatibility. Designed for compatibility with Phoenix® Dialysis Delivery System. 40 ml priming volume.

Indications for Use

Indicated for patients with body weight >15 kg and ≤20 kg requiring hemodialysis treatment where low extra-corporeal blood volume is recommended. Used with Phoenix® Dialysis Delivery System.

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 Cartridge® Blood Set Low Weight (K100364)

Submission Summary (Full Text)

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K100364

Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401

Gambro Cartridge® Blood S10(k)
Gambro Cartridge® Blood Șet
Low Weight – Low Volume

# NOV - 3 2010

## 510(K) SUMMARY

| Submitter's Name | Gambro Renal Products, Inc. |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 14143 Denver West Parkway, Suite 400<br>Lakewood, CO 80401 |
| Establishment<br>Registration Number | 2087532 |
| Date of Summary | February 8, 2010 |
| Telephone Number<br>Fax Number | [phone]<br>[phone] |
| Contact Person | Kae Miller, Regulatory Affairs Manager |
| Name of the Device | Gambro Cartridge® Blood Set Low Weight - Low Volume<br>Catalogue Number:<br>003422-520 |
| Common or Usual Name | Extracorporeal blood circuit for hemodialysis |
| 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 Device<br>(Predicate Device) | Gambro Cartridge® Blood Set Low Weight<br>Catalogue Number: 003412-500<br>Classification Name: Hemodialysis System and accessories<br>Device Class: II<br>Product Code: FJK<br>Regulation Number: 21 CFR 876.5820 |

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K100364

Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401

Traditional 510(k) Gambro Cartridge® Blood Set Low Weight - Low Volume

### 510(k) SUMMARY, continued

#### Device Description

The Gambro Cartridge® Blood Set Low Weight – Low Volume is single use sterile tubing set employed in the Gambro hemodialysis equipments extracorporeal circulation. It conveys the patient's blood from the arterial-venous access fistula to the dialyzing filter (arterial line) and back after purification (venous line) and it is commonly referred to as bloodline. A Gambro Cartridge® Blood Set Low Weight - Low Volume can be safely connected to hemodialyzers, vascular accesses and various perfusion lines, under the responsibility of the physician in charge.

#### Indications For Use

The Gambro Cartridge® Blood Set Low Weight-Low Volume is intended for single use in a hemodialysis treatment using the Phoenix® Dialysis Delivery System.

The Low-Weight - Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight - Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 Kg.

#### Assessment of non-clinical performance data

The non-clinical testing consisted of performance testing (bench) that included testing for integrity of the strength between connections (pressure leak testing), flow rate (endurance testing of the pump segment), endurance testing of injection ports (access sites), priming volume assessment, tensile testing of joints and materials of all tubing segments, pressure transducers testing, tubing clamps testing, hemocompatibility testing, kinking resistance testing, hemodialysis delivery system compatibility, and expiration date testing (materials biocompatibility, performance, packaging integrity testing).

#### Assessment of clinical performance data

No clinical testing was required or performed in support of this 510(K) submission.

#### Conclusion

The successful testing demonstrates the safety and effectiveness of the Gambro Cartridge® Blood Sets Low Weight – Low Volume 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/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three thick, curved lines representing its wings or feathers.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002

Ms. Kae Miller Regulatory Affairs Manager Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 LAKEWOOD CO 80401

## NOV - 3 2010

Re: K100364

Trade/Device Name: Gambro Cartridge® Blood Set Low Weight - Low Volume Regulation Number: 21 CFR §876.5820

Regulation Name: Hemodialysis system and accessories

Regulatory Class: II

Product Code: FJK

Dated: October 20, 2010 Received: October 21, 2010

Dear Ms. Miller:

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, Drive, 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. Please note: CDRH does not evaluate information related to contract liality warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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 on new with all the Act's requirements, including, but not limited to: registration and listing (21 CFP Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Hubert Lemon MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 Lakewood, Colorado 80401

Traditional 510(k) Gambro Cartridge® Blood Set Low Weight - Low Volume

#### Indications for Use

510(k) Number (if known):

NOV - 3 2010

Device Name: Gambro Cartridge® Blood Set Low Weight - Low Volume

Indications for Use:

The Gambro Cartridge® Blood Set Low Weight-Low Volume is intended for single use in a hemodialysis treatment using the Phoenix® Dialysis Delivery System.

The Low-Weight - Low Volume model is used when a low extra-corporeal blood volume is recommended. The Low Weight - Low Volume model with a priming volume of 40 ml is indicated for patients with a body weight greater than 15 kg and lower or equal to 20 Kg.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

Over-The-Counter Use AND/OR (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, Gastro-Renal, and
Urological Devices
510(k) Number K100364

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