K Number
K991160
Device Name
ASTOTHERM PLUS, ASTOTUBES, ASTOLINE
Date Cleared
1999-09-02

(148 days)

Product Code
Regulation Number
864.9205
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gentle heating of all transfusions and infusions close to the patient -Warm return blood flow
Device Description
Astotherm Plus, Astotubes, Astoline
More Information

Not Found

Not Found

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and intended use do not suggest AI/ML functionality.

Yes
The device is described as warming transfusions and infusions close to the patient, indicating its use in a medical context for patient care, which aligns with the definition of a therapeutic device.

No
The device description states its purpose as "Gentle heating of all transfusions and infusions close to the patient -Warm return blood flow," which is a therapeutic function, not diagnostic. A diagnostic device would typically identify a disease or condition.

No

The device description lists physical components ("Astotherm Plus, Astotubes, Astoline") which are hardware, indicating it is not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "Gentle heating of all transfusions and infusions close to the patient -Warm return blood flow." This describes a device that physically interacts with fluids being administered to a patient, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
  • Device Description: The device names (Astotherm Plus, Astotubes, Astoline) suggest components of a fluid warming system.
  • Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic results, which are hallmarks of IVD devices.

Therefore, this device falls under the category of a medical device used for patient treatment or support, not for in vitro diagnosis.

N/A

Intended Use / Indications for Use

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

Product codes

BSB

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 864.9205 Blood and plasma warming device.

(a)
Nonelectromagnetic blood or plasma warming device —(1)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.(2)
Classification. Class II (performance standards).(b)
Electromagnetic blood and plasma warming device —(1)Identification. 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.(2)
Classfication. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 864.3.

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

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

1

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 (301) 594-4692. Additionally, for questions on compriation and advertising of your device, please contact che office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

2

Stihler Electronic GMBH Astotherm Plus

Page 4

Abbreviated 510K 03/25/99

:

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

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)


Concurrence of CDRH, Office of Device Evaluation (ODE)

escription Use
'er 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________