(321 days)
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.
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.
The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria in the context of medical image analysis or AI. Instead, it describes a Class II medical device for warming blood and fluids.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document discusses the ThermaCyl™ Blood/Fluid Warmer and compares its technological characteristics to predicate devices. It also briefly mentions a non-clinical study on the hemolytic effects of the device.
Here's the information that is present in the text:
Device Description and Performance (as mentioned):
- Device: ThermaCyl™ Blood/Fluid Warmer
- Purpose: Warms blood products or intravenous fluids prior to administration.
- Maximum Flow Rate: 500 mL/minute
- Maximum Temperature: Up to and including 42°C (in accordance with AABB Standards).
- Heating Method: Metal cylinder heated by electrical resistance; disposable bag in direct contact with cylinder.
- Temperature Control: Thermistors (2 inlet; 2 outlet).
- Alarm Conditions: Thermistor temperature exceeds 42°C; Thermistor pair's temperatures differ by ≥ 5°C.
- Electronics: Designed in accordance with UL 2601 and CSA 601. No software is used.
Non-Clinical Study on Hemolytic Effects:
A study was conducted to evaluate the hemolytic effects of the redesigned blood/fluid warmer.
- Test Subjects: Whole blood, packed red blood cells, and Adsol preserved red blood cells (near outdate).
- Test Condition: Blood flowed through the warming device at less than 100 mL/minute and at the highest flow rate possible for each blood type.
- Outcome Measured: Percent hemolysis before and after flow.
- Result: Minimal or no hemolysis for all bloods and variables tested.
This study describes a safety and performance aspect of the device (hemolysis) but does not present a formal "acceptance criteria" table or details relevant to statistical analysis of a diagnostic or AI device as your request implies.
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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
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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 DEANBLOOD WARMER | BAXTER THERMACYL ™BLOOD/FLUID WARMER | PHARMASEALBLOOD/FLUID WARMER(DW-1000D) |
|---|---|---|---|
| Maximum Flow Rate | > 500 mL/minute | 500 mL/minute | 200 mL/minute |
| Heating Method | Metal plate heated by electricalresistance; disposable bag indirect contact with plate | Metal cylinder heated by electricalresistance; disposable bag indirect contact with cylinder | Metal cylinder heated by electricalresistance; disposable bag in directcontact with cylinder |
| Temperature Control | Adjustable set point; internalsensors | 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 adjustableset point (up to 39.5°C) | Thermistor temperature exceeds42°C;Thermistor pair's temperaturesdiffer 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.
§ 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.