PRISMATHERM II, ASTOLINE

K991159 · Stihler Electronic GmbH · BSB · Sep 3, 1999 · Hematology

Device Facts

• Record ID: K991159
• Device Name: PRISMATHERM II, ASTOLINE
• Applicant: Stihler Electronic GmbH
• Product Code: BSB · Hematology
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.9205
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Warm return blood flow

Device Story

Prismatherm II is a medical device designed to warm return blood flow. It functions as a blood warming system to maintain or achieve target temperatures for blood being returned to the patient. The device is intended for use in clinical settings by healthcare professionals. By regulating the temperature of the blood, the device helps prevent hypothermia or maintain thermal stability during procedures involving extracorporeal circulation or blood transfusion. The healthcare provider monitors the device output to ensure blood is delivered at the appropriate temperature, thereby supporting patient safety and physiological stability.

Indications for Use

Indicated for warming return blood flow in patients.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle 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 in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1398

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

K991159 Prismatherm II, Astoline Re : Trade Name: Regulatory Class : II Product Code: _ BSB Dated: June 3, 1999 Dated: June 7, 1999

## Dear Mr. Lanzillotto:

Beather reviewed your Section 510 (k) notification of intent to We have reviewed your Section 510(K) noctr.readers of the bearing for market the device referenced above and we nate
device is substantially equivalent (for the indications for device is substantially equivalent (ior the increases in interstate
use stated in the enclosure) to devices marketed in interstate use stated in the enclosure) to devices the enactment date of the commerce prior to May 28, 1976, chevices that have been Common Covice Amendments, or to devices chac have and reclassified in accordance with the provisay, therefore, Food, Drug, and Cosmetic Act (Acc). Tod may , on
market the device, subject to the general controls provisions
of the secures The general controls provisions of the Act The general controls provisions of the Act
The general controls provisions of the Act of the Act. The general controls provision, listing of
include requirements for annual registration, listing of include requirements for amual regrossion, and devices, good manufacturing pracesses,
prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II)
it may and also belocar class III (Premarket Approval), it may If your device is classified (See above) trass of and one of the may
(Special Controls) or class III (Premarket Approval), Existing major (Special Controls) or Class III (Fromas . Existing major be subject to such additional concretor. Enobeling in the Code of
regulations affecting your device can be found in the Code of
the County of Local Lines . Title 21 . Parts 8 regulations arrecting your devile 21, Parts 800 to 895.
Federal Regulations, Title 21, Parts 800 to assumes co Rederal Regulations, TITLE ZI, Farcs over compliance with
substantially equivalent determination assumes compliance with substantially equivalent dection for Medical Devices:
the Good Manufacturing Practice for Medical through p the Good Manufacturing Practice IOI Medibat Chrough periodic
(GMP) regulation (21 CFR Part 820) and that, through periodic (GMP) regulation (2) Crk Part Grow and Drug Administration (PDA) will
GMP inspections, the Food and Drug Administration (PDA) GMP inspections, the FOOD and Bray namply with the GMP
verify such assumptions. Failure to comply with addition verify such assumptions. Farmer compary action. In addition, FDA
regulation may result in regulatory action. In adevice in regulation may result in regarats , accerning your device in
may publish further announcements, this response to your this response to your may publish farister. Please note:
the Federal Register. Please in des the Federal Register. Fread institution sations 531 through premarket notification Submission actions 531 through 542 of

{1}------------------------------------------------

Page 2 - Mr. Lanzillotto

the Act for devices under the Electronic Product Radiation the Act for devices under the Brocessor as a regulations.

This letter will allow you to begin marketing your device as This letter will allow you co begin mailitication. The FDA
described in your 510(k) premarket of vour device to a lea described in your 510KF prematic no review to a legally
finding of substantial equivalence of your device to a for your finding of substantial equivalence of your six and marketed predicate device resures in a crains. In the market.

If you desire specific advice for your device on our labeling
If you desire accorded additionally 809 10 for in If you desire specific advice to fiture and additionally 809.10 for in
regulation (21 CFR Part 801 and additionally 809.10 for in regulation (21 CFR Parc bor and and contact the Office of
vitro diagnostic devices), please contact the for questi vitiro diagnostic devices), precibe oblionally, for questions on
Compliance at [phone]. Additionally, please contact Compliance at [phone]. Insur device, please contact
the promotion and advertising of your device, Also, please no the promotion and adverturing or your ac339. 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 information on your responsibility and acturers Assistance obtained from the Division of Smart [phone] or at at its toll-free number [phone] 02 (60)
its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Director and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

V

Enclosure

{2}------------------------------------------------

Abbreviated 510K

: :

03/30/99

## Stihler Electronic GMBH Prismatherm II

## INDICATIONS FOR USE

Page 4

510(k) Number (if known):

Device Name:

.

Prismatherm II

•

-

Indications for Use:

.............................................................................................................................................................................. patient ﺔ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ

Warm return blood flow

Contraindications: Warnings and Precautions

See Attached

Padutta Cisconetti

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) EASE DO NOT WRITE BELOW THIS LINE-CONTINGE ON PRODUCT POST - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

.

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________