BICART

K013724 · Gambro Renal Products · KPO · Jan 8, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K013724
• Device Name: BICART
• Applicant: Gambro Renal Products
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Jan 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Gambro BiCart® is indicated for use in a bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.

Device Story

Gambro BiCart® is a non-refillable, disposable cartridge containing dry sodium bicarbonate concentrate; used in conjunction with acid dialysis concentrate and water to prepare bicarbonate hemodialysis solution on-line. Device integrates with adapted, commercially available hemodialysis machines. Used in clinical settings for patients with acute/chronic renal failure or acute intoxication. Cartridge sizes vary to accommodate different treatment durations; functional principle remains identical to predicate devices. Healthcare providers install cartridge into dialysis machine; machine automatically prepares dialysate for treatment. Benefits include simplified on-line preparation of bicarbonate solution for hemodialysis.

Clinical Evidence

No clinical testing performed. Equivalence established via comparison of technological characteristics and chemical composition to predicate devices.

Technological Characteristics

Non-refillable polypropylene cartridge containing dry sodium bicarbonate (USP/European Pharmacopoeia grade). Designed for on-line preparation of 38 mEq/L bicarbonate dialysate. Storage below 40°C. No electronic components or software.

Indications for Use

Indicated for patients with acute or chronic renal failure, or acute intoxication with dialyzable substances requiring bicarbonate hemodialysis.

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 BiCart® System (K873155)
• Gambro BiCart® 720g (K940601)

Submission Summary (Full Text)

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GAMBRO Renal Products

510(k) Premarket Notification

# 510(k) Summary

K013724

8 2002 JAN

# BiCart®

Sodium Bicarbonate for Hemodialysis

Contact Information:

**GAMBRO** Renal Products

1845 Mason Avenue Daytona Beach, FL 32117 Phone: [phone] Fax: [phone] Contact: Fei Law

Prepared: November 5, 2001

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K15124
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Image /page/1/Picture/1 description: The image shows the logo for GAMBRO Renal Products. The logo consists of the word "GAMBRO" in bold, followed by the words "Renal Products" in a smaller, less bold font. There is a small circular graphic to the left of the word "GAMBRO."

510(k) Premarket Notification

### 510(k) Summary

| Name of the device: | Gambro BiCart® | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|--|--|
| Common Name: | Sodium Bicarbonate for Hemodialysis | | |
| Classification Name: | Dialysate Concentrate for Hemodialysis (Liquid or Powder)<br>per 21 CFR 876.5820. The Product/Classification Code is<br>KPO. | | |
| Predicate Devices: | Gambro BiCart® System<br>K873155 cleared 10/26/1987<br>Gambro, Inc.<br>Manufactured by Gambro Lundia AB | | |
| | Gambro BiCart® 720g<br>K940601 cleared 03/22/1994<br>C.G.H Medical, Inc.<br>Manufactured by Gambro Lundia AB | | |

#### Device Description:

Gambro BiCart® Sodium Bicarbonate for hemodialysis is a dry concentrate used to prepare bicarbonate concentrate solution for use in conventional hemodialysis.

The Gambro BiCart® is a non-refillable cartridge containing sodium bicarbonate, which enables on-line preparation of bicarbonate hemodialysis solution. It is used in conjunction with appropriate acid dialysis concentrate and water meeting Association for the Advancement of Medical Instrumentation (AAMI) guidelines. The resulting dialysate is used in conventional, commercially available hemodialysis machines/monitors which have been adapted to receive the cartridges.

#### Indications for Use:

Gambro BiCart® is indicated for use in a bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.

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MBRO Renal Products

510(k) Premarket Notification

## 510(k) Summary

#### Comparison to Predicate Devices:

The Gambro BiCart® Sodium Bicarbonate for Hemodialysis cartridges are equivalent to the Gambro BiCart® System (includes 650g BiCart®) and the Gambro BiCart® 720g which have been previously approved by the FDA under Premarket Notifications K873155 and K940601. This Premarket Notification is intended to add cartridge sizes to existing product offerings. The only functional difference between the different sizes is the quantity of sodium bicarbonate contained in the cartridge. The varying quantities of sodium bicarbonate provide for varying lengths of treatment. The resulting bicarbonate concentrations for all cartridge sizes are identical, and the resulting solution is used in exactly the same way.

| | Gambro BiCart™<br>System<br>K873155<br>cleared 10/26/1987 | Gambro BiCart™<br>120g<br>K940601<br>cleared 03/22/1994 | Gambro BiCart®<br>(various sizes,<br>including 650, 720,<br>and 1150g) |
|------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Manufacturer | Gambro Lundia AB | Gambro Lundia AB | Gambro Lundia AB |
| Indication for Use | Bicarbonate<br>hemodialysis for<br>acute and chronic<br>treatment of renal<br>failure | Bicarbonate<br>hemodialysis for<br>acute and chronic<br>treatment of renal<br>failure | To be used in<br>bicarbonate<br>hemodialysis<br>treatment for patients<br>suffering from acute |
| Indication included<br>in labeling | In cases of poisoning<br>by substances which<br>can be removed by<br>hemodialysis | In cases of poisoning<br>by substances which<br>can be removed by<br>hemodialysis | renal failure, chronic<br>renal failure, or acute<br>intoxication with<br>dialyzable substances |
| Disposable? | Yes | Yes | Yes |
| Sodium Bicarbonate<br>Grade | USP & European<br>Pharmacopoeia | USP & European<br>Pharmacopoeia | USP & European<br>Pharmacopoeia |
| Sodium Bicarbonate<br>Weight Spec. | Target (± 50g) | Target (± 50g) | Target (+30g) |
| Bicarbonate<br>Concentration | 38 mEq/L | 38 mEq/L | 38 mEq/L |
| Storage Conditions | Store below +40 °C<br>(+104 °F) | Store below +40 °C<br>(+104 °F) | Store below +40 °C<br>(+104 °F) |
| Housing Material | Polypropylene | Polypropylene | Polypropylene |

Comparing the proposed device to the predicate devices, its indication for use, technological characteristics, and chemical composition are identical. We therefore consider this device to be substantially equivalent to existing products in commercial distribution in the United States.

#### Performance Data

No clinical testing was performed.

No testing was necessary to determine equivalence to predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850

8 2002 JAN

Ms. Fei Law Quality Assurance Manager Gambro Renal Products 1845 Mason Avenue . DAYTONA BEACH FL 32117 Re: K013724

Trade/Device Name: Gambro BiCart® Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: November 5, 2001

Received: November 9, 2001

Dear Ms. Law:

We have reviewed your Section 510(k) premarket notification of intent to market the device we forenced 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 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 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.

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This letter will allow you to begin marketing your device as described in your 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:

| 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 advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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K013724 510(k) Number (if known):

Gambro BiCart® Device Name:

Indications For Use:

Gambro BiCart® is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Bragtim
(Division Sign-Off)
Division of Reproductive, Abidemás,
and Radiological Devices
510(k) Number. Kor

(Optional Format 3-10-98)

*Prescription Use*