(149 days)
Not Found
Not Found
No
The provided 510(k) summary contains no information about the device description, image processing, or any mention of AI, DNN, or ML.
Yes
The intended use, "Warm return blood flow," describes a physiological effect designed to benefit the patient, which aligns with the definition of a therapeutic device.
No
The "Intended Use / Indications for Use" states "Warm return blood flow," which describes a therapeutic or functional purpose, not a diagnostic one. Diagnostic devices are used to identify or detect a disease or condition.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, it is highly unlikely that this device is an IVD.
Here's why:
- Intended Use: The intended use "Warm return blood flow" describes a function related to circulating blood within a patient's body, not analyzing samples in vitro (outside the body).
- Lack of IVD-specific information: The document is missing key information typically found in descriptions of IVD devices, such as:
- Device Description: IVDs would describe how they analyze samples (e.g., reagents used, detection methods).
- Input Imaging Modality: While not all IVDs use imaging, many do (e.g., microscopy).
- Anatomical Site: IVDs analyze samples from an anatomical site, but the device itself doesn't typically interact with one in the way a therapeutic or diagnostic device used on the body would.
- Performance Studies/Metrics: IVDs require rigorous performance studies demonstrating their accuracy in analyzing samples.
The intended use "Warm return blood flow" suggests a device likely used in procedures involving blood circulation, such as dialysis or cardiopulmonary bypass. These are not typically classified as IVDs.
Therefore, based on the limited information provided, this device is almost certainly not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Warm return blood flow
Product codes (comma separated list FDA assigned to the subject device)
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): 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.
Not Found
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.
Not Found
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).
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 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 (301) 594-4692. Additionally, please contact Compliance at (301) 334-4022. 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 (301) 443-6597 or at at its toll-free number (600) 650 2011 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 _________________________________________________________________________________________________________________________________________________________