SOLCART B

K072760 · B. Braun Medizintechnologie GmbH · KPO · Jan 29, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K072760
• Device Name: SOLCART B
• Applicant: B. Braun Medizintechnologie GmbH
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Jan 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Solcart B is intended for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.

Device Story

Solcart B is a non-refillable polypropylene cartridge containing dry sodium bicarbonate powder; used to prepare bicarbonate concentrate solution for hemodialysis. Device requires integration with a compatible B. Braun dialysis machine equipped with a specific holder for powder bicarbonate cartridges; must be used in conjunction with appropriate acid concentrate and AAMI-compliant water. The system facilitates the preparation of dialysate for clinical hemodialysis procedures. Healthcare providers (clinicians/nurses) operate the dialysis machine to deliver the prepared solution to the patient. The device supports the treatment of renal failure and intoxication by enabling the necessary chemical composition of the dialysate, which is essential for the removal of waste products and toxins from the patient's blood.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness supported by biocompatibility, functional performance, and stability testing.

Technological Characteristics

Non-refillable polypropylene cartridge containing dry sodium bicarbonate (USP/Ph. Eur. compliant). Designed for use with B. Braun dialysis machines featuring a dedicated powder bicarbonate cartridge holder. Requires external acid concentrate and AAMI-compliant water. No software or electronic components.

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® (K013724)

Submission Summary (Full Text)

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K072760 Page 1 of 2

1. September 19.

## 5. 510(k) Summary

| SUBMITTER: | B Braun Medizintechnologie GmbH<br>Schwarzenberger Weg 73-79<br>34212, Melsungen<br>Germany |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Tracy Maddock, Regulatory Affairs Analyst<br>B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| DEVICE NAME: | Solcart B |
| COMMON OR USUAL<br>NAME: | Sodium Bicarbonate for Hemodialysis |
| DEVICE<br>CLASSIFICATION: | Hemodialysis system and accessories<br>Class II, CFR Title 21 § 876.5820 |
| PREDICATE DEVICE: | Gambro BiCart® (K013724) |
| DESCRIPTION: | Solcart B consists of a powder concentrate used to prepare<br>bicarbonate concentrate solution for use in hemodialysis.<br>Solcart B is a non-refillable polypropylene cartridge<br>containing dry sodium bicarbonate [in compliance with<br>European Pharmacopoeia (Ph. Eur.) and United States<br>Pharmacopoeia (USP)] for hemodialysis. It must be used<br>together with a suitable acid concentrate and water meeting<br>the requirements of the Association for the Advancement of<br>Medical Instrumentation (AAMI).<br><br>Solcart B must only be used with B. Braun dialysis<br>machines provided with a holder for powder bicarbonate<br>cartridges. |
| INTENDED USE: | Solcart B is intended for use in bicarbonate hemodialysis<br>for acute and chronic renal failure, or acute intoxication<br>with dialyzable substances. |

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K072760 Page 2 of 2

## SUBSTANTIAL EQUIVALENCE:

The Solcart B cartridges have the same intended use and technological characteristics as the stated predicate device, the Gambro BiCart® cartridges (K013724). There are no differences between the predicate and the proposed device that raise new issues of safety and effectiveness. The proposed device has been subjected to biocompatibility testing, functional performance testing and stability testing to support safety and effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

JAN 29 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

B. Braun Medizintechnologie GmbH c/o Ms. Tracy Maddock Senior Regulatory Affairs Analyst B. Braun Medical, Inc. 901 Marcon Blvd. ALLENTOWN PA 18109

K072760 Re:

> Trade/Device Name: Solcart B Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: January 17, 2008 Received: January 22, 2008

Dear Ms. Maddock:

We have reviewed your Section 510() 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 yours,

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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## 4. Indications for Use Statement

Page 1 of 1

| 510(k) Number (if known): | K072760 |
|---------------------------|-----------|
| Device Name: | Solcart B |

Indications For Use:

Solcart B is intended for use in bicarbonate hemodialysis for acute and chronic renal failure, or acute intoxication with dialyzable substances.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancic Brogdon
(Division(Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number ***_***