SOLCART B

K102194 · B. Braun Avitum AG · KPO · Apr 25, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K102194
• Device Name: SOLCART B
• Applicant: B. Braun Avitum AG
• Product Code: KPO · Gastroenterology, Urology
• Decision Date: Apr 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Solcart B Powder Dialysis Concentrate 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 1100g of dry sodium bicarbonate powder; used to prepare bicarbonate concentrate solution for hemodialysis. Device functions as a component of a hemodialysis system; must be used with compatible acid concentrate and AAMI-compliant water. Cartridge fits into specific holder adapters on B. Braun hemodialysis machines. Intended for clinical use by healthcare professionals. Powder formulation remains unchanged from predicate; larger cartridge size accommodates increased volume. Benefits patient by providing necessary bicarbonate concentrate for dialysis treatment.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including package and ship testing, and performance testing to demonstrate compatibility with B. Braun hemodialysis machines and stability of the 1100g cartridge.

Technological Characteristics

Non-refillable polypropylene cartridge containing 1100g sodium bicarbonate powder. Compliant with Ph. Eur. and USP standards. Designed for use with B. Braun hemodialysis machines equipped with specific cartridge holder adapters. 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

• Solcart B (K072760)

Submission Summary (Full Text)

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K102194 page 1 of 3

| 5. 510(k) SUMMARY | APR 2 5 2011 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE: | July 30, 2010 |
| APPLICANT: | B. Braun Avitum AG<br>Schwarzenberg Weg 73-79<br>34212 Melsungen Germany<br>Establishment Registration Number: 3002879653 |
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Blvd.<br>Allentown, PA 18109-9341<br>Telephone: [phone] |
| CONTACT: | Angela Caravella<br>Senior Regulatory Affairs Analyst<br>Telephone: [phone]<br>Facsimle: [phone]<br>E-Mail: [e-mail] |
| DEVICE NAME: | Solcart B |
| COMMON OR<br>USUAL NAME: | Sodium Bicarbonate for Hemodialysis |
| DEVICE<br>CLASSIFICATION: | Hemodialysis System and Accessories<br>Class II, CFR Title 21 § 876.5820<br>Product Code: KPO |
| CURRENTLY<br>MARKETED<br>DEVICE (PREDICATE): | Solcart B (K072760) |
| DESCRIPTION: | Solcart B consists of a powder concentrate used to<br>prepare bicarbonate concentrate solution for use in<br>hemodialysis. Solcart B is a non-refillable<br>polypropylene cartridge containing dry sodium<br>bicarbonate [in compliance with European<br>Pharmacopoeia (Ph. Eur.) and United States<br>Pharmacopoeia (USP)] for hemodialysis. It must be<br>used together with a suitable acid concentrate and |

water meeting the requirements of the Association

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for the Advancement of Medical Instrumentation (AAMI).

The Solcart B cartridge is designed to fit into cartridge holder adapters affixed to the hemodialysis machine. The 1100g cartridge may only be used with B. Braun hemodialysis machines for which the use of powder bicarbonate cartridges is a stated option and the machine is equipped with a holder for the bicarbonate cartridge.

#### INTENDED USE:

# SUBSTANTIAL EQUIVALENCE:

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

The Solcart B cartridge, containing 1100g sodium bicarbonate concentrate powder, has the same intended use and utilizes the same fundamental technology as the predicate device, the currently marketed Solcart B sodium bicarbonate concentrate powder in cartridges labeled to contain 650g and 760g and cleared for market in 510(k) K072760. The proposed Solcart B in the 1100g cartridge can be considered a line extension to the Solcart B 650g and 760g sodium bicarbonate cartridges.

The technological characteristics of the 1100g cartridge for the proposed Solcart B dialysis concentrate powder are equivalent to those of the existing 650g and 760g sodium bicarbonate cartridges. The Solcart B 1100g cartridge is the same as the predicate device in material composition and components. However, the proposed device has a larger body and a larger cartridge cap to accommodate the additional amount of Solcart B dialysis concentrate powder.

Because the powder concentrate has not changed in formulation, the proposed addition of 1100g sodium bicarbonate cartridge size does not pose a significant impact upon the fundamental technology of Solcart B, as identified within the Design Control Activities Summary.

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### NONCLINICAL TESTING:

The proposed device was subjected to package and ship tests to demonstrate the acceptability of the packing and shipping configuration. In addition, performance testing was conducted with the proposed Solcart B 1100g cartridge to demonstrate compatibility with B. Braun hemodialysis machines. The stability testing conducted on the Solcart B 1100g cartridge verifies that the product meets the defined specifications.

# CONCLUSION:

Verification and validation testing for the proposed Solcart B 1100g cartridge device are complete and all acceptance criteria have been met. The testing demonstrates that there are no differences between the predicate and the proposed devices that raise any new issues of safety or effectiveness.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

B. Braun Avitum AG c/o Ms. Angela Caravella Senior Regulatory Affairs Analyst B. Braun Medical, Inc. 901 Marcon Blvd. ALLENTOWN PA 18109-9341

APR 2 5 2011

. Re: K102194

Trade/Device Name: Solcart B Sodium Bicarbonate Powder Dialysis Concentrate, 1100g Cartridge Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: April 12, 2011 Received: April 15, 2011

Dear Ms. Caravella:

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. Please note: CDRH does not evaluate information related to contract liability 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Stukert Lemur 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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# 4. INDICATIONS FOR USE STATEMENT

Page of of _ -

K102194 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Solcart B Sodium Bicarbonate Powder Dialysis Concentrate, 1100g Cartridge

Indications For Use:

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

_X____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (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)

Aoym M. Khan

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102194