(321 days)
K770232, BK910033
Not Found
No
The device description explicitly states "No software is used." and there are no mentions of AI, DNN, or ML.
No
The device is a blood/fluid warmer, which prepares blood and intravenous solutions for administration; it does not directly treat a disease or condition.
No
The device is a blood/fluid warmer, which functions to heat blood products and intravenous solutions prior to administration. It does not perform any diagnostic function.
No
The device description explicitly states that the device consists of hardware (warming device) and a disposable container, and that "No software is used."
Based on the provided information, the ThermaCyl™ blood/fluid warmer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to warm blood products and intravenous solutions prior to administration to a patient. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The device physically warms fluids flowing through it. It does not analyze or test biological samples to provide diagnostic information about a patient's condition.
- Lack of Diagnostic Function: There is no mention of the device being used to test blood, fluids, or any other biological material for the purpose of diagnosing a disease or condition.
- Performance Study: The performance study focuses on the safety of the warming process (hemolysis), not on the diagnostic accuracy of any test.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ThermaCyl™ device's function is purely to prepare fluids for administration, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
The ThermaCyI™ blood/fluid warmer is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in clinical environments.
Product codes
Not Found
Device Description
The ThermaCyl™ blood/fluid warmer consists of a warming device (hardware) and a container (disposable) designed for use with the hardware. The device is capable of warming blood products or intravenous fluids, flowing at rates of up to 500 mL/minute, to temperatures of as high as and including 42°C (in accordance with American Association of Blood Banks (AABB) Standards for Blood Banks and Transfusion Services).
Two types of disposables are available. A standard blood/fluid warming cuff for use with standard administration sets and a high flow blood/fluid warming cuff for use with mass infusion sets. The disposables are composed of the same materials used in the current Pharmaseal blood warming device disposable. They are designed to surround the aluminum cylinder of the warming device. The disposable is in direct contact with the cylinder. The cylinder is heated by means of electrical resistance. Blood products or intravenous fluids are heated as they flow through the bag. The temperature of the cylinder is accurately controlled by the device's electronics. The electrical requirements are designed in accordance with UL 2601. The device also meets the requirements of CSA 601. No software is used.
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
healthcare professionals in clinical environments.
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
A study was conducted to evaluate the hemolytic effects of the redesigned blood/fluid warmer. Whole blood, packed red blood cells and Adsol preserved red blood cells near outdate were tested. Percent hemolysis was evaluated before and after flow through the blood warming device at less than 100 mL/minute and at the highest flow rate possible for each type of blood. There was minimal or no hemolysis for all bloods and variables tested.
Key Metrics
Not Found
Predicate Device(s)
K770232, BK910033
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
V. Systems Division Regulatory Affairs
Baxter Healthcare Corporation Route 120 & Wilson Road Round Lake, Illinois 60073-0490 708.546.6311 Fax: 708.270.4668
Image /page/0/Picture/22 description: The image shows the word "Baxter" in a bold, stylized font. The word is black and appears to be slightly slanted to the right. The letter "B" is larger than the other letters and has a unique design with an extended top portion.
ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ
JUN 2 6 1996
510(k) Summary
Submitter
Baxter Healthcare Corporation I. V. Systems Division Route 120 and Wilson Road Round Lake, IL 60073
Contact
Jody Ann Gould, Ph.D. Phone: (708) 270 - 4014 Fax: (708) 270 - 4668
Date Prepared June 26, 1995
Trade/Proprietary Name ThermaCyl™ Blood/Fluid Warmer
Common/Usual Name Blood/fluid warmer
Classification Name Nonelectromagnetic blood or plasma warming device
Predicate Devices Pharmaseal DW 1000 Blood/Fluid Warmer
Description of Device
Alton Dean Blood Warmer
The ThermaCyl™ blood/fluid warmer consists of a warming device (hardware) and a container (disposable) designed for use with the hardware. The device is capable of warming blood products or intravenous fluids, flowing at rates of up to 500 mL/minute, to temperatures of as high as and including 42°C (in accordance with American Association of Blood Banks (AABB) Standards for Blood Banks and Transfusion Services).
Two types of disposables are available. A standard blood/fluid warming cuff for use with standard administration sets and a high flow blood/fluid warming cuff for use with mass infusion sets. The disposables are composed of the same materials used in the current Pharmaseal blood warming device disposable. They are designed to surround the aluminum cylinder of the warming device. The disposable is in direct contact with the
CONFIDENTIAL
ﺎ ﻳﻜﺴﺎ
1
Baxter Healthcare Corporation Route 120 & Wilson Road Round Lake, Illinois 60073-0490
cylinder. The cylinder is heated by means of electrical resistance. Blood products or intravenous fluids are heated as they flow through the bag. The temperature of the cylinder is accurately controlled by the device's electronics. The electrical requirements are designed in accordance with UL 2601. The device also meets the requirements of CSA 601. No software is used.
Statement of Intended Use
The ThermaCyI™ blood/fluid warmer is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in clinical environments.
Comparison of the Technological Characteristics of the New Device and the Predicate Devices
The ThermaCy]™ blood/fluid warmer is substantially equivalent to the Pharmaseal blood/fluid warmer (found substantially equivalent under K770232) and the Alton Dean blood/fluid warmer (found substantially equivalent under BK910033). A comparison of technological features follows:
| FEATURE | ALTON DEAN
BLOOD WARMER | BAXTER THERMACYL ™
BLOOD/FLUID WARMER | PHARMASEAL
BLOOD/FLUID WARMER
(DW-1000D) |
|---------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Maximum Flow Rate | > 500 mL/minute | 500 mL/minute | 200 mL/minute |
| Heating Method | Metal plate heated by electrical
resistance; disposable bag in
direct contact with plate | Metal cylinder heated by electrical
resistance; disposable bag in
direct contact with cylinder | Metal cylinder heated by electrical
resistance; disposable bag in direct
contact with cylinder |
| Temperature Control | Adjustable set point; internal
sensors | Thermistors (2 inlet; 2 outlet) | Three control thermostats |
| Alarm Description | Audible and visual alarms | Audible and visual alarms | Audible and visual alarms |
| Alarm Conditions | Temperature exceeds adjustable
set point (up to 39.5°C) | Thermistor temperature exceeds
42°C;
Thermistor pair's temperatures
differ by $\u2265$ 5°C | Temperature reaches over-
temperature thermostat range 41.7 -
44.7°C |
| Electronics | Microprocessor control | UL 2601 and CSA 601 | UL 551 |
Discussion of NonClinical Studies
A study was conducted to evaluate the hemolytic effects of the redesigned blood/fluid warmer. Whole blood, packed red blood cells and Adsol preserved red blood cells near outdate were tested. Percent hemolysis was evaluated before and after flow through the blood warming device at less than 100 mL/minute and at the highest flow rate possible for each type of blood. There was minimal or no hemolysis for all bloods and variables tested.