PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R

K071909 · Barkey GmbH & Co. KG · KOC · Oct 18, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K071909
• Device Name: PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R
• Applicant: Barkey GmbH & Co. KG
• Product Code: KOC · Gastroenterology, Urology
• Decision Date: Oct 18, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat loss to the atmosphere and effluent flow during a Prismaflex® treatment. Federal law restricts this device to sale by or on the order of a physian. It is intended to be used only by approriately trained and qualified healthcare professionals and servicing staff in clinical environments.

Device Story

Prismacomfort blood warmer warms return blood flow lines during Prismaflex® treatments; prevents patient cooling. System comprises Barkey autocontrol 3XPT controller and Barkey autoline XPT 4R sleeve warmer. Sleeve warmer, constructed of slotted silicon tube, wraps around blood return line; resistance heating transfers warmth to blood. Controller manages sleeve temperature, monitors performance, and triggers visual/audible alarms. Used in clinical environments by trained healthcare professionals. Device mounts to Gambro Prismaflex® system. Benefits patient by maintaining blood temperature during extracorporeal therapy.

Clinical Evidence

Bench testing only. Verification of system performance included testing the ability to prevent cooling of blood return lines on the Gambro Prismaflex CRRT system and verifying the ability to protect the patient via detection and alarming at unsafe operating conditions. Compliance with DIN EN 60601-1, DIN EN 60601-1-2, UL 2601-1/10.97, CAN/CSA-C22.2 No. 601.1-M90, and ASTM F 2172-02 was confirmed.

Technological Characteristics

Power: 24 VDC (derived from 115/230 VAC, 50/60 Hz). Components: Barkey autocontrol 3XPT controller, Barkey autoline XPT 4R sleeve warmer. Material: Slotted silicon tube (accommodates lines up to 6.55 mm diameter). Heating: Resistance heating system. Mounting: Rear holder for Gambro Prismaflex® system. Standards: DIN EN 60601-1, DIN EN 60601-1-2, UL 2601-1/10.97, CAN/CSA-C22.2 No. 601.1-M90, ASTM F 2172-02. Electronic control of temperature and alarms.

Indications for Use

Indicated for patients undergoing Prismaflex® system therapy where heat loss may cause undesirable cooling of the patient. Used to warm the return blood flow line to replace heat lost to the atmosphere and effluent flow.

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 prismaflo (K020103)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for Barkey, a company located in Germany. The logo features a stylized electrical plug symbol next to the company name in bold, black font. Below the logo is the company's address: Barkey GmbH & Co. KG, Gewerbestrasse 8, D-33818 Leopoldshoehe, Germany. The text "page 1 of 4" is handwritten at the top of the image.

| Date: | 2007-10-06 |
|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Barkey GmbH & Co. KG |
| Address: | Gewerbestrasse 8<br>D-33818 Leopoldshoehe<br>Germany |
| Contact: | Thomas Barkey |
| Telephone:<br>Fax:<br>mail: | [phone]<br>[phone]<br>[e-mail] |
| Common Product Name: | Blood Warming Device |
| Trade Name: | Prismacomfort blood warmer |
| Regulation Medical<br>Specialty (Panel): | Gastroenterology-Urology Devices<br>[21 CFR 876.5820] |
| Product Code: | KOC |
| Device Class: | 2 |
| Identification of<br>legally marketed predicate<br>device to which substantial<br>equivalence is claimed: | Stihler prismaflo<br>510(k) Number: K020103<br>Stihler Electronic GmbH<br>Julius-Hoelder-Strasse 36<br>D-70597 Stuttgart-Germany<br>[21 CFR 876.5820] |

OCT 1 8## 2.2 510(k) summary

**Address:**

[21 CFR 876.5820]

## 2007

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Image /page/1/Picture/1 description: The image shows the logo for Barkey, a company located in Germany. The logo features the company name in a bold, sans-serif font, with a stylized plug symbol to the left. Below the logo is the company's name, Barkey GmbH Et Co. KG, followed by their address: Gewerbestrasse 8, D-33818 Leopoldshoehe, Germany. The image also contains the text 'K071909 page 2 of 4' at the top.

| Brief Description: | The Prismacomfort blood warmer is substantially equivalent in safety andeffectiveness to the legally marketed (predicate)Stihler prismaflo (510(k) Number: K020103). The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat lost to the athmosphere and effluent flow during a Prismaflex® treatment. The Prismacomfort blood warmer consists of one controller and one sleeve warmer. The controller (Barkey autocontrol 3XPT) controls the sleeve warmer (Barkey autoline XPT 4R) and displays alarm and status messages. The Prismacomfort blood warmer warms the returning blood flow line by means of a silicon tube heat exchanger (applied part Barkey autoline XPT 4R) which covers the blood return flow line of the Gambro Prismaflex® system completely. The heat is transferred by the contact of the resistance heating system Barkey autoline XPT 4R to the inserted 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 device is intended for the Prismaflex® System and may be used with any of the Prismaflex® system therapy choices, when heat loss may cause undesirable cooling of the patient. |
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| Intended Use: | The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat loss to the atmosphere and effluent flow during a Prismaflex® treatment. <p>Federal law restricts this device to sale by or on the order of a physian.</p> <p>It is intended to be used only by approriately trained and qualified healthcare professionals and servicing staff in clinical environments.</p> |
| Summary of the technological characteristics of the Prismacomfort blood warmer: | The warmer is powerd with 24 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 Barkey autocontrol 3XPT. Below the on-off switch is a display temperature monitor. The temperature of the sleeve warmer, visual and audible alarms, and other performance characteristics of the sleeve warmer are controlled electronically. Like the blood warmer Stihler prismaflo (510(k) Number: K020103; Stihler Electronic GmbH, Julius-Hoelder-Strasse 36, D-70597 Stuttgart-Germany), the sleeve warmer Barkey autoline XPT 4R is constructed as a slotted enclosed silicon tube which can completely enclose inserted blood return flow lines of up to 6.55 mm diameter. The Prismacomfort weighs approx. 3.7kg and is equipped with a holder at the rear side of the control unit which allows mounting on hemodialysis system Gambro Prismaflex® system. Both products, the Prismacomfort and the Stihler prismaflo use sleeve warmers made of silicon. The flexibility of this material ensures a complete enclosure of the blood return flow line on Gambro Prismaflex® System. |

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Image /page/2/Picture/1 description: The image shows the logo for Barkey, a company located at Gewerbestrasse 8, D-33818 Leopoldshoehe, Germany. The logo features the company name in bold letters, with two electrical plug symbols on the left side. At the top of the image, there is a handwritten note that says "K071909 page 3 of 4".

Summary of Nonclinical Tests and Results:

The Prismacomfort blood warmer complies with the safety standards below and is therefore safe and effective 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 EN 60601-1-2
- . UL 2601-1/10.97
- . CAN/CSA-C22.2 No. 601.1-M90
- t ASTM F 2172-02

In order to verify performance of the Barkey Prismacomfort blood warmer in support of substantial equivalence, the following tests were carried out:

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

This shows that there are no new questions of safety and effectiveness for the Prismacomfort blood warmer as compared to the predicate device.

The predicate device (Stihler prismaflo (510(k) Number: K020103; Stihler Electronic GmbH, Julius-Hoelder-Strasse 36, D-70597 Stuttgart-Germany) has not been removed from the market at the initiative of the Commissioner of Food and Drugs or has not been determined to be misbranded or adulterated by a judicial order.

Conclusion: The Prismacomfort blood warmer is substantially equivalent to the Stihler prismaflo (510(k) Number: K020103; Stihler Electronic GmbH, Julius-Hoelder-Strasse 36, D-70597 Stuttgart-Germany, [21 CFR 876.5820]) which received 510(k) approval on April 24, 2002. Both systems have the same intended use, and are capable of heating blood return flow line on Gambro Prismaflex®system. Both systems as intended according to the specifications of the device. The Prismacomfort blood warmer is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Prismaflo(510(k) Number: K020103).

> The Prismacomfort blood warmer has the following similarities to the Prismaflo predicate device:

- have same intended use
- have same fundamental scientific technology and use the same operating priciple
- heating sleeves are constructed of identical materials
- both, the Prismacomfort and the Prismaflo give efficient heat to keep the blood return flow on Gambro Prismaflex® Systems warm.

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Barkey blood warmer Prismacomfort

Barkey GmbH & Co. KG Gewerbestrasse 8 D-33818 Leopoldshoehe Germany

The main differences between the Prismacomfort blood warmer and the predicate Prismaflo are the structure. Due to the fact that the Barkey Prismacomfort is consisting of one controller and one applied part (the sleeve warmer), the Prismflo is one complete system which means that the warming device is fix connected to the supply part (the controller).

The predicate device (Stihler prismaflo (510{k) Number: K020103; Stihler Electronic GmbH, Julius-Hoelder-Strasse 36, D-70597 Stuttgart-Germany) has not been removed from the market at the initiative of the Commissioner of Food and Drugs or has not been determined to be misbranded or adulterated by a judicial order

In summary the Prismacomfort, described in this conclusion is substantially equivalent to the predicate device Stihler Prismaflo (K020103).

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings or feathers. The eagle faces left within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 8 2007

Mr. Thomas Barkey Managing Director and Safety Officer Barkey GmbH Et Co. KG Gewerbestrasse 8 D-33818 Leopoldshoehe GERMANY

Re: K071909

Trade/Device Name: Prismacomfort blood warmer Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KOC Dated: October 6, 2007 Received: October 10, 2007

Dear Mr. Barkey:

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 (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.

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 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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Image /page/6/Picture/1 description: The image shows the logo for Barkey, along with their address. The address is Barkey GmbH & Co. KG, Gewerbestrasse 8, D-33818 Leopoldshoehe, Germany. The logo features the word "Barkey" in a bold, sans-serif font, with two electrical plug symbols stacked vertically to the left of the word.

2.1 Indications for Use

## Indications for Use

Kozilaoa 510(k) Number (if known): Device Name: Prismacomfort blood warmer Indications for Use: The Prismacomfort blood warmer is used to warm the return blood flow line in order to replace heat loss to the atmosphere and effluent flow during a Prismaflex® treatment.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Reiner

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