ASTOFLO PLUS

K082765 · Stihler Electronic GmbH · LGZ · Dec 18, 2008 · General Hospital

Device Facts

• Record ID: K082765
• Device Name: ASTOFLO PLUS
• Applicant: Stihler Electronic GmbH
• Product Code: LGZ · General Hospital
• Decision Date: Dec 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ASTOFLO PLUS warmer is used for 1. Warming transfusions, infusions. 2. Warming blood transfusions and return 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

ASTOFLO PLUS is a dry-heat fluid warmer for clinical use by trained healthcare professionals. Device consists of a control unit and a silicon sleeve warmer. Input: disposable fluid lines (up to 7.00 mm diameter) inserted into the sleeve. Operation: resistance heating system transfers heat via contact to the fluid lines; integrated sensors monitor sleeve temperature. Output: warmed fluids/blood; visual and audible alarms for unsafe conditions. The device mounts to IV poles or medical rails. Benefits: prevents patient hypothermia during fluid administration. Healthcare providers use the control unit to set/monitor temperature and respond to alarms.

Clinical Evidence

Bench testing only. Verification activities confirmed the system's ability to warm fluids, prevent cooling, and detect/alarm at unsafe operating conditions. Compliance with DIN EN60601-1, DIN EN60601-1-2, UL 2601-1, CAN/CSA-C22.2 No. 601.1-M90, ASTM F 2172-02, and IEC60601-2-16:1998 was verified.

Technological Characteristics

Dry-heat warming system; silicon tube sleeve warmer; resistance heating elements; integrated temperature sensors. Dimensions: approx 3.0 kg. Power: 22 VDC (from 115/230 VAC, 50/60 Hz). Connectivity: standalone control unit with display. Standards: ASTM F 2172-02, DIN EN60601-1, IEC60601-2-16.

Indications for Use

Indicated for warming transfusions, infusions, fluids, and blood return flow in patients requiring fluid therapy to prevent undesirable cooling.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Stihler Electronic GmbH, Blood Warmer Model ASTOFLO (K020060)
• Barkey GmbH + Co. KG, Blood Warmer Model Prismacomfort (K071909)

Submission Summary (Full Text)

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Kd827.65

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510(K) SUMMARY August 18, 2008

DEC 1 8 2008

#### SUBMITTER INFORMATION:

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. Micoch

#### DEVICE NAME:

Name: Blood and Infusion Warmer Proprietary Model: ASTOFI.O PLUS Classification: 2 Product Code: BSB Regulation: (864.9205) Warmer, Thermal, Infusion Fluid Warmer, Blood, Non-Electromagnetic

#### PREDICATE DEVICES:

Stihler Electronic GmbH, Blood Warmer Model ASTOFLO - K020060 Barkey GmbH + Co. KG, Blood Warmer Model Prismacomfort - K071909

#### DESCRIPTION:

The ASTOFLO PLUS is a modified version of the ASTOFLO covered by K020060. The ASTOFLO uses the closed water circuit where the temperature of the closed water circuit is controlled by sensors. ASTOFLO PI.US uses dry heat warming and the control the sleeve temperature with integrated sensors.

The ASTOFLO PLUS blood warmer is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Stihler ASTOFLO 510(K) Number 020060 and Barkey Prismacomfort 510(K) Number K071909. The ASTOFLO PLUS blood warmer is used to warm the transfusions, infusions, fluids and also return blood flow in the medical field. The ASTOFLO PLUS warmer consists of one control unit and one sleeve warmer. The control unit (ASTOFLO PLUS) controls the sleeve warmer made by Stihler and displays alarm and status messages.

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# K082765 Pr

The ASTOFLO PLUS warmer warms blood, infusions, fluids and return blood flow by means of a silicon tube heat exchanger, which covers the fluid lines used in the medical field nearly complete. The heat is transferred by the contact of the resistance heating system to the inserted disposable lines need in the medical field. The nearly complete enclosure of the disposable lines used in the medical field to be warmed ensures that there is good warmth conduction to the fluids and there are no temperature losses to the surroundings. The warmth produced by the sleeve warmer is therefore transferred to the disposable lines used in the medical field and may be used with any therapy choices. when heat loss may cause undesirable cooling of the patient.

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 ASTOFLO PLUS. Above the on-off switch is a display temperature monitor. The temperature of the sleeve warmer visual and audible alarms and other performance characteristic of the sleeve warmer are controlled electronically. Like the blood warmer Stihler ASTOFLO and the Barkey Prismacomfort, the sleeve warmer Stihler ASTOFLO PLUS is constructed as a slotted enclosed silicon tube, which can completely enclose inserted bluod return flow lines of up to 7.00 mm diameter. The ASTOFLO Plus weighs approx 3.0 kg and is equipped with a holder at the rear side of the control unit, which allows mounting on i.v. poles and medical rails. All three products, the Stihler ASTOFLO PLUS, Barkey Prismacomfort and the Sticker ASTOFI.O use sleeve warmers made of silicon. The flexibility of this material ensures a nearly complete enclosure of the disposable lines used in the medical field.

#### INTENDED USE:

The ASTOFLO PLUS warmer is used for 1. Warming transfusions, infusions. 2. Warming blood transfusions and return 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.

#### SUMMARY OF NONCLINICAL TESTS AND DESIGN CONTROL ACTIVITIES:

The ASTOFLO PLUS blood, infusions, fluid and return blood flow warmer complies with the safety standards below and is therefore safe for the intended use. The device has been tested through validation and verification of specification of compliance with the following mandatory and voluntary standards has been made:

- DIN EN60601 I ●
- DIN EN60601-1-2 (All EMC and Immunity references) ●
- UL 2601-1/10.97 .
- � CAN/CSA-C22.2 No. 601.1-M90
- ASTM F 2172-02 (USA Standard for Blood and Fluid Warmers) .
- IEC60601-2-16:1998 (reference Standard for dialysate temperature) .

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In order to verify effective performance of the Stihler ASTOLFO PLUS blood, infusions and return blood flow warmer in support of substantial equivalence, the following tests were carried out successfully:

- Verify the ability of the system to warming fluids and to prevent cooling down of blood, . infusions and return blood flows used in all therapy choices of the medical field.
- Verify the ability of the system to protect the patient and to detect and alarm at unsafe i operating conditions.

This control activity shows that there are no new questions of safety and effectiveness for the ASTOFLO PLUS blood, infusions, fluid and return blood flow warmer as compared to both of the predicate devices including the modified device.

### CONCLUSION:

The ASTOFLO PLUS blood, infusions, fluid and return blood flow warmer is substantially equivalent to the Stihler ASTOFLO. ASTOFLO PLUS and ASTOFLO have the same intended use and are capable of heating blood, infusions. fluids and return flow line in the medical field. Both systems as intended according to the specifications of the device.

The ASTOFLO is the same as the ASTOFLO PLUS made by Stihler except the ASTOFLO PLUS consists of one control unit and one applied part (the slecve warmer), the ASTOFLO is one complete system which means that the warming device is fix connected to the supply part (the control unit). The ASTOFLO PLUS uses dry heat and ASTOFLO uses the closed water circuit.

The ASTOFLO PLUS is substantially equivalent to Barkey Prismacomfort. Note equivalence items:

- have same fundamental scientific technology and use the same operating principle, -
- heating sleeves are constructed of identical materials, •
- both the ASTOFLO PLUS and the Prismacomfort give efficient heat to keep blood return line warm.
- both the ASTOFLO PLUS and the Prismacomfort use the same structure. Both consist of one control unit and one applied port (the sleeve warmer).
- both the ASTOFLO PLUS and the Prismacomfort use the same principle of dry heat . warming and control the sleeve temperature with integrated sensors inside the sleeve.

(stihler /8046fm)

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

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

Stihler Electronic GmbH C/O Mr. Stephen T. Mlcoch North American Technical Services Corporation 30 Northport Road Sound Beach, New York 11789

JAN 1 0 2017

Re: K082765

Trade/Device Name: ASTOFLO PLUS Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: August 18, 2008 Received: September 22, 2008

Dear Mr. Mlcoch:

This letter corrects our substantially equivalent letter of December 18, 2008.

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 Parts 801 and 809 ); medical device reporting (reporting of

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Page 2 - Mr. Stephen T. Mlcoch

medical device-related 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 Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

Modified Device Name: ASTOFLO PLUS

Indications for Use: 1. Warming transfusions, infusions, fluids. 2. Warming blood transfusions and return blood flow.

Prescription Use X (Per 21 CFR 801.109)

Anthony Viner

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082765