(56 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use is for warming fluids, which is a purely physical process.
Yes
The device is intended for warming transfusions, infusions, fluids, and blood infusions, which are actions performed as part of medical treatment to maintain physiological function or alleviate discomfort.
No
The indications for use describe warming functions for fluids and blood, which are therapeutic or supportive actions, not diagnostic. There is no mention of analysis, detection, or assessment for medical conditions.
No
The provided 510(k) summary only includes the intended use and indications for use, which describe a device that warms fluids. This function inherently requires hardware components to perform the warming action. There is no information in the summary to suggest this is a software-only device controlling external hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended uses listed ("Warming transfusions, infusions, fluids," "Warming blood infusions and return blood flow") describe a device that acts on fluids before or during their administration to a patient, not on specimens taken from a patient for diagnostic purposes.
- There is no mention of analyzing biological samples. The description focuses on the physical process of warming fluids.
Therefore, this device falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
-
- Warming transfusions, infusions, fluids.
-
- Warming blood infusions and return blood flow.
Product codes
LGZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping wave-like shapes, which is the department's official emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 5 2002
Mr. Richard C. Lanzillotto NATS Corporation 30 Northport Road Sound Beach, New York 11789-1734
Re: K020060
Trade/Device Name: ASTOFLO Regulation Number: None Regulation Name: Blood and Infusion Warmer Regulatory Class: Unclassified Product Code: LGZ Dated: January 3, 2002 Received: January 8, 2002
Dear Mr. Lanzillotto:
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 vour 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
1
Page 2 - Mr. Lanzillotto
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
[signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Stihler Electronic GmbH ASTOFLO
INDICATIONS FOR USE
510(k) Number (if known):
KO2006D
ASTOFLO
Indications for Use:
Device Name:
-
- Warming transfusions, infusions, fluids.
Warming blood infusions and return blood flow. 2.
- Warming transfusions, infusions, fluids.
Contraindications:
Warnings and Precautions
- Caution To reduce the risk of electric shock, do not remove 1. cover. Refer servicing to qualified service personnel.
- Danger Risk of explosion if used in the presence of 2. flammable anesthetics.
- Warning Replace fuse as marked. 3.
- Grounding reliability can only be achieved when the 4. equipment is connected to a receptacle marked "Hospital Only".
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Pellicer Ceverido.
("Tivision Sign-Off) Division of Dental. Infection Control, and General Hospital Devic F10(k) Number_________________________________________________________________________________________________________________________________________________________________