PRISMAFLO II

K082758 · Stihler Electronic GmbH · KOC · Dec 19, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K082758
• Device Name: PRISMAFLO II
• Applicant: Stihler Electronic GmbH
• Product Code: KOC · Gastroenterology, Urology
• Decision Date: Dec 19, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PRISMAFLO II is for warming dialysis fluid and returning blood flow. Federal law restricts this device to sale by or on the order of a physician. It is intended to be used only by appropriately trained and qualified healthcare professionals and servicing staff in clinical environments.

Device Story

PRISMAFLO II is a water-free blood and dialysis fluid warmer; designed to prevent heat loss in return blood flow lines during hemodialysis or CRRT (Gambro Prismaflex/Prisma systems). Device consists of a control unit and a slotted, silicon sleeve warmer; sleeve encloses blood return lines (up to 7.00 mm diameter). Resistance heating system transfers warmth directly to the tubing; ensures maximum efficiency and prevents temperature loss. Control unit manages sleeve temperature; displays actual/set temperatures; provides visual/audible alarms and hardware-based cut-offs. Operated by trained healthcare professionals in clinical settings; mounted directly onto hemodialysis systems. Benefits patient by maintaining normothermia during extracorporeal blood circulation.

Clinical Evidence

Bench testing only. Verification activities confirmed the system's ability to prevent cooling of blood return lines on the Gambro Prismaflex CRRT system and validated the effectiveness of alarm/cut-off mechanisms under unsafe operating conditions. Compliance with safety standards DIN EN 60601-1, DIN EN 60601-1-2, UL 2601-1, CAN/CSA-C22.2 No. 601.1-M90, and ASTM F 2172-02 was demonstrated.

Technological Characteristics

Water-free resistance heating system; silicon sleeve warmer; control unit with electronic temperature monitoring. Dimensions: 3.9 kg. Power: 22 VDC (from 115/230 VAC, 50/60 Hz). Standards: DIN EN 60601-1, DIN EN 60601-1-2, UL 2601-1, CAN/CSA-C22.2 No. 601.1-M90, ASTM F 2172-02. Hardware-based alarms and cut-offs.

Indications for Use

Indicated for warming dialysis fluids and returning blood flow in patients undergoing hemodialysis or CRRT treatments using Gambro Prismaflex or Prisma systems.

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

• Stihler Electronic GmbH, Blood Warmer Model PRISMAFLO (K020103)
• Barkey GmbH + Co. KG, Blood Warmer Model Prismacomfort (K071909)

Submission Summary (Full Text)

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K082758
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## 510(K) SUMMARY August 15, 2008

# DEC 1 9 2008

## SUBMITTER INFORMATION: (Registration#: 9617473)

Stihler Electronic GmbH Julius-Holder-Strasse 36 D-70597 Stuttgart (Degerloch) Germany

## APPLICANT/FDA AGENT/CORRESPONDING OFFICIAL INFORMATION:

North American Technical Services (NATS) Corp 30 Northport Rd Sound Beach, NY 11789 Tel: [phone] Fax: [phone] Email: [e-mail] Contact: Stephen T. Mlcoch

DEVICE NAME:

Name: Blood Warmer Proprietary Model: PRISMAFLO II Classification: 2 Product Code: KOC Regulation: Gastroenterology - Urology Devices (21CFR876.5820)

## PREDICATE DEVICES:

Stihler Electronic GmbH, Blood Warmer Model PRISMAFLO - K020103 Barkey GmbH + Co. KG, Blood Warmer Model Prismacomfort-K071909

## DESCRIPTION:

The PRISMAFLO II is a modified version of the PRISMAFLO covered by K020103. The PRISMAFLO uses water in the heat transfer process. PRISMAFLO II is the same as PRISMAFLO except it is water free.

The PRISMAFLO II dialysis fluid and blood warmer is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Barkey Prismacomfort 510(K) Number K071909. The PRISMAFLO II blood warmer is used to warm the return blood flow line in order to replace heat lost to the atmosphere and effluent flow during a Prismaflex or PRISMA treatment. The PRISMAFLO II blood warmer consists of one control unit and one sleeve warmer. The control unit (Stihler PRISMAFLO II) controls the sleeve warmer and displays alarm and status messages.

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The PRISMAFLO II blood warmer warns the returning blood flow line by means of a silicon tube heat exchanger which covers the blood return flow line of the Gambro Prismaflex or Prisma system completely. The heat is transferred by the contact of the resistance heating system to the inscried blood return line. The complete enclosure of the returning blood flow line to be warmed ensures that there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the return blood flow at maximum efficiency.

The sleeve warmer is powered with 22 VDC which is derived from 115 VAC (or where required 230 VAC). 50/60 Hz power supply and is controlled by an on-off switch on the front panel of the control unit Stihler PRISMAFLO II. Above the on-off switch is a display temperature monitor showing actual and set temperature. The temperature of the sleeve warmer and other performance characteristics of the sleeve warmer are controlled electronically, visual and audible alarms as well as cut-offs are hardware realized. Like the blood warmer Barkey Prismacomfort, the sleeve warmer PRISMAFLO II is constructed as a slotted enclosed silicon tube, which can completely enclose inserted blood return flow lines of up to 7.00 mm diameter. The PRISMAFLO II woighs approx 3.9 kg and is equipped with a holder at the rear side of the control unit, which allows mounting on hemodialysis system Gambro Prismatlex and Prisma system. Both products, the PRISMAFLO II and the Barkev Prismacomfort use sleeve warmers made of silicon. The flexibility of this material ensures a nearly complete enclosure of the blood return flow line on Gambro Prismallex and Prisma system.

Only the water free operation of the PRISMAFLO II differs to the PRISMAFLO.

## INTENDED USE:

The PRISMAFLO II is for warming dialysis fluid and returning blood flow.

Federal law restricts this device to sale by or on the order of a physician. It is intended to be used only by appropriately trained and qualified healthcare professionals and scrvicing staff in clinical environments.

## SUMMARY OF NONCLINICAL TESTS AND DESIGN CONTROL ACTIVITIES:

The PRISMAFLO II blood warmer complies with the safety standards below and is therefore safe for the intended use. The device has been thoroughly tested through validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made:

- ◆ DIN EN 60601-1
- DIN EN60601-1-2 �
- UL 2601-1/10.97 �
- . CAN/CSA-C22.2 No. 601.1-M90
- ASTM F 2172-02 (USA Standard for Blood and Fluid Warmers) .

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In order to verify effective performance of the Stihler PRISMAFLO II blood warmer in support of substantial equivalence, the following tests were carried out successfully:

- Verify the ability of the system to prevent cooling down of blood return lines on Gambro Prismaflex CRRT system.
- Verify the ability of the system to protect the patient and to detect and alarm at unsafe operating conditions.

This control activity shows that there are no new questions of safety and effectiveness for the PRISMAFLO II blood warmer as compared to the predicate devices.

## CONCLUSION:

The PRISMAFLO II blood warmer is substantially equivalent to the Barkey Prismacomfort, Both systems have the same intended use and are capable of heating blood return flow line on Gambro Prismaflex system. Both systems are the same according to the specifications of the device. Both use a water free heat reference to initiate the heat transfer process.

The PRISMAFLO II is the same as the PRISMAFLO made by Stihler cxccpt for the water free operation. The water free modification is safe and effective per the controlled design process and equivalence to the predicate device.

(stihler /8047fm)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2008

Stihler Electronic GmbH c/o Mr. Stephen T. Mlcoch FDA Agent & Corresponding Official North American Technical Services Corp. 30 Northport Road SOUND BEACH NY 11789-1734

. Re: K082758 Trade/Device Name: PRISMAFLO II Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II

> Product Code: KOC Dated: December 8, 2008 Received: December 10, 2008

Dear Mr. Mlcoch:

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.

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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (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 Biometrics' (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/odrh/industry/support/index.html.

Sincerely yours.

Jorgu M. Zhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

Special 510(K) Number:

K082758

Modified Device Name:

PRISMAFLO II

Indications for Use:

For warming dialysis fluids and returning blood flow.

Prescription Use X (Per 21 CFR 801.109)

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

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Concurrence of CDRH Office of Device Evaluation (ODE)

Heleen

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices K082758
510(k) Number