ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100

K060381 · Renal Solutions, Inc. · FKT · May 24, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060381
• Device Name: ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
• Applicant: Renal Solutions, Inc.
• Product Code: FKT · Gastroenterology, Urology
• Decision Date: May 24, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5600
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Allient Sorbent Hemodialysis System, including the SORB series and HISORB series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the Physician.

Device Story

Allient Sorbent Hemodialysis System; re-circulating sorbent hemodialysis system. Components: hemodialysis machine, SORB/HISORB series sorbent cartridges, single-use sterile blood tubing set, single-use disposable dialysate set, dialysate/infusate chemicals. Operation: blood pumped from patient access through dialyzer and returned to patient; sorbent technology regenerates dialysate. Used for acute and chronic uremic patients. Physician prescribes treatment; system manages hemodialysis process.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design controls and comparison of technological characteristics to the predicate device.

Technological Characteristics

Sorbent regenerated dialysate delivery system. Components include hemodialysis machine, sorbent cartridges, disposable blood tubing, and disposable dialysate sets. Operates via re-circulating sorbent hemodialysis principle. Materials, manufacturing, packaging, and sterilization processes are identical to the predicate device.

Indications for Use

Indicated for treatment of acute and chronic uremic patients requiring hemodialysis as prescribed by a physician.

Regulatory Classification

Identification

A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories (§ 876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.

Predicate Devices

• Allient Sorbent Hemodialysis System (K043574)

Submission Summary (Full Text)

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Ke6038/ page 1 of 2

## Summary of Safety and Effectiveness 510(k) Summary Allient® Sorbent Hemodialysis System

This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The accordance with the requirement have been provided in accordance with 21 CFR 807.92.

| Date | February 13, 2005 | MAY 24 2005 |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Common/Usual<br>Name | Sorbent Hemodialysis System | |
| Trade/Proprietary<br>Name | Allient® Sorbent Hemodialysis System | |
| Classification<br>Name & Device<br>Classification | System, Dialysate Delivery, Sorbent Regenerated, Class II | |
| Product Code | FKT | |
| 21 CFR<br>Reference | 876.5600 | |
| Owner/Operator | Renal Solutions Inc<br>770 Commonwealth Drive<br>Warrendale, PA 15086 | |
| Contact | David J. Vanella, Vice President Quality Assurance &<br>Regulatory Affairs<br>770 Commonwealth Drive<br>Warrendale, PA 15086<br>Phone: [phone]<br>e-mail: [e-mail] | |
| Predicate Device<br>Information | Allient Sorbent Hemodialysis System K043572 | |

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K060381 Page 2 of 2

## Device Description

The Allient Sorbent Hemodialysis System is intended for the treatment of THE Allent Oorbont Homoutients where hemodialysis is prescribed by the ohysician.

The Allient System functions as a traditional re-circulating sorbent hemodialysis system. Either single-needle or dual-needle access to the nemodialysis bystem . The system consists of the Allient hemodialysis machine, SORB™ series of sorbent cartridges, a single-use, sterile, disposable blood tubing set, a single-use disposable dialysate set, and various dialysate and infusate chemicals. The patient's blood is pumped from the access through a dialyzer and is returned to the patient.

The modified Allient Sorbent Hemodialysis has the following similarities to the Substantial The modified Allient dialysis which previously received 510(k) clearance: Equivalence

- have the same indicated use, ●
- use the same operating principles, .
- incorporate the same basic system design, .
- incorporates the same accessories and generic materials which are . manufactured, packaged, and sterilized using the same processes.

In summary, the Allient Sorbent Hemodialysis System (considering the in Summary, the Ainet within) is, in our opinion, substantially equivalent to the Allient Sorbent Hemodialysis System K043574.

Based on the comparison of technological characteristics to the Allient Conclusion Sorbent Hemodialysis System and certification to design controls, the modified device is substantially equivalent to the cleared Allient Sorbent Hemodialysis System (K043574). The modifications as described above have been evaluated in terms of both safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 2 4 2006

Mr. David J. Vanella Vice President, Quality Assurance & Regulatory Affairs Renal Solutions®, Inc. 770 Commonwealth Drive WARRENDALE PA 15086

Re: K060381

Trade/Device Name: Allient® Sorbent Hemodialysis System Regulation Number: 21 CFR §876.5600 Regulation Name: Sorbent regenerated dialysate delivery system for hemodialysis Regulatory Class: II Product Code: FKT Dated: April 26, 2006 Received: May 2, 2006

Dear Mr. Vanella:

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 arior 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 I tpp. o an 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.

Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. The logo is circular and contains the letters FDA in bold. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The image appears to be a scan of a document or a print of the logo.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease of advisod that i Dr. i setaily our device complies with other requirements of the Act or any For has made a decermination administered by other Federal agencies. You must comply with all r coclar surfies and regulations as 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 labeling (21 OF R Part 801); 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) I this letter will and w you'ls ought maing of substantial equivalence of your device to a legally premarket notification: "The slassification 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 11 you desire specific act 100 for your as 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" (21 Also, prease note the regulation 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. 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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K060381

## Indication's for Use

510(k) Number

K060381

Device Name:

Allient®Sorbent Hemodialysis System

Indications For Use:

The Allient Sorbent Hemodialysis System, including the SORB series and HISORB series of cartridges is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the Physician.

Prescription Use X (Per 21 CFR 801.109) AND/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)

Nancy C. Brogdon

and Radiological D 510(k) Number