ASTOTHERM PLUS, ASTOTUBES, ASTOLINE

K991160 · Stihler Electronic GmbH · BSB · Sep 2, 1999 · Hematology

Device Facts

• Record ID: K991160
• Device Name: ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
• Applicant: Stihler Electronic GmbH
• Product Code: BSB · Hematology
• Decision Date: Sep 2, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.9205
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Gentle heating of all transfusions and infusions close to the patient -Warm return blood flow

Device Story

Astotherm Plus, Astotubes, and Astoline are medical devices designed for the gentle heating of intravenous fluids, blood transfusions, and return blood flow. The system operates by warming fluids near the patient to maintain appropriate temperatures during infusion or transfusion procedures. It is intended for use in clinical settings by healthcare professionals. By ensuring fluids are at an appropriate temperature, the device helps prevent hypothermia during administration, potentially improving patient comfort and safety during clinical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fluid warming system consisting of the Astotherm Plus heating unit, Astotubes, and Astoline components. Designed for near-patient fluid heating. Operates as a medical device under 21 CFR Part 820 (GMP).

Indications for Use

Indicated for the gentle heating of all transfusions and infusions close to the patient and for warming return blood flow.

Regulatory Classification

Identification

A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration. An electromagnetic blood and plasma warming device is a device that employs electromagnetic radiation (radiowaves or microwaves) to warm a bag or bottle of blood or plasma prior to administration.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP -2 1999

Stihler Electronic GMBH C/O Mr. Richard C. Lanzillotto North American Technical Services Corporation 30 Northport Road Sound Beach, New York 11789-1734

Re : K991160 Astotherm Plus, Astotubes, Astoline Trade Name: Requlatory Class: II Product Code: BSB Dated: June 3, 1999 Received: June 9, 1999

Dear Mr. Lanzillotto:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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## Page 2 - Mr. Lanzillotto

This letter will allow you to begin marketing your device as first ited in your 510(k) premarket notification. The FDA described in your six (i) provivalence of your device to a legally Finding or bubboardains in a classification for your marketed predicate actros your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in regaradiagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compriation and advertising of your device, please contact che office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeathed from onemen [phone] or [phone] or at at Ics Coll Free namble (o://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Stihler Electronic GMBH Astotherm Plus

Page 4

Abbreviated 510K 03/25/99

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## INDICATIONS FOR USE

510(k) Number (if known):

Device Name:

Astotherm Plus, Astotubes, Astoline

Indications for Use:

Gentle heating of all transfusions and infusions close to the patient

-Warm return blood flow

Contraindications: Warnings and Precautions

See Attached

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Pulacia Accente

(Dision Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .

(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)

escription Use
'er 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________