(182 days)
Thermal Angel™ is an in-line intravenous fluid and blood warmer. Thermal Angel™ is indicated for use whenever parenteral introduction of normothermic fluids are desired or indicated, whether in field or clinical settings.
The Thermal Angel™ 200 Blood/Fluid Warmer consists of a single unit that is placed in-line between a standard IV drip set and a standard IV extension set. Thermal Angel™ is designed to warm blood, blood products and intravenous liquids at flow rates of up to and including 200 ml/min. Thermal Angel™ will deliver temperatures at 38°C. While the temperature will drop immediately after making major changes in flow rate, it will drop only a few degrees and return smoothly, and within seconds, to 38°C. Thermal Angel's™ fluid path is sterile and the entire unit is disposable after use. Blood, blood products or intravenous fluids travel through stainless steel tubing which is surrounded by a heating blanket and heated by means of electrical resistance. The temperature of the device is accurately controlled by the device's electronics. The electrical requirements are designed in accordance with UL 2601 and CSA 601.
The provided document is a 510(k) summary for the Thermal Angel™ 200 Blood/Fluid Warmer. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. It does not contain information about a study that assesses performance against acceptance criteria in the format typically used for AI/ML device evaluations.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study evaluating AI/ML performance.
However, I can extract information related to the device's technical specifications and general claims of achieving certain performance.
Here's an analysis based on the provided document, addressing the points where information is available or noting its absence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" for a study in the context of device performance as one might expect for an AI/ML device (e.g., target sensitivity, specificity). Instead, it focuses on demonstrating that its technological characteristics are comparable to predicate devices and that certain output parameters are achieved.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Flow Rate | Comparable to predicate devices, up to 200 ml/min. | Up to and including 200 ml/min. |
| Delivery Temperature | 38°C, with smooth return after flow changes. | Delivers temperatures at 38°C. Will drop a few degrees and return smoothly within seconds to 38°C after major flow rate changes. |
| Heating Method | Electrical resistance, similar to predicates. | Heating blanket covering stainless steel tubing; heated by electrical resistance. |
| Temperature Control | Accurate control. | DS1821S Temp Sensors, microprocessor control. |
| Safety Switch | Turns off at a specified temperature. | Safety switch turns off TA @ 41.0°C. |
| Hemolytic Effect | None or not clinically significant. | Studies will be conducted to evaluate prior to marketing. (Outcome not reported in this summary) |
| Electrical Requirements | In accordance with UL 2601 and CSA 601. | Designed in accordance with UL 2601 and CSA 601. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes a medical device (blood/fluid warmer), not an AI/ML system, and therefore does not refer to test sets for algorithm evaluation.
- The document mentions "studies will be conducted" regarding hemolytic effect, but details of these studies (sample size, data provenance) are not included in this 510(k) summary; only the intent is stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information pertains to AI/ML model development, which is not the subject of this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No such test set or adjudication process is mentioned for this type of device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical warmer and does not involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm component described for this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the context of AI/ML evaluation. For a physical device like a warmer, "ground truth" would refer to direct measurements of physical parameters (e.g., actual fluid temperature, flow rate, assessment of hemolysis in laboratory tests). The document only states the desired outcomes for these physical parameters (e.g., 38°C delivery temperature, none or not clinically significant hemolysis).
8. The sample size for the training set:
- Not applicable. No AI/ML training set is referenced.
9. How the ground truth for the training set was established:
- Not applicable. No AI/ML training set is referenced.
Summary of what the document does provide:
- Predicate Devices: The device is being compared to existing, legally marketed blood/fluid warmers (Augustine Medical Bair Hugger™, Level 1 Technologies, Inc. Hotline™, Baxter Thermacyl™).
- Technological Equivalence: The document primarily uses a comparison chart to demonstrate that the Thermal Angel™ 200 has similar technological characteristics (heating method, temperature control, alarms) to these predicate devices.
- Intended Use Equivalence: The intended use is stated to be the same as currently marketed devices.
- Future Studies Mentioned: It notes that nonclinical studies to evaluate the hemolytic effect will be conducted prior to marketing, with the acceptance criterion being "none or not clinically significant hemolysis." However, the results of these studies are not included in this summary.
In conclusion, this 510(k) summary is for a physical medical device and is primarily based on demonstrating substantial equivalence to predicate devices through a comparison of technical specifications and intended use, rather than a clinical performance study with defined acceptance criteria and statistical outcomes for an AI/ML component.
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KA984640
510 (k) Summary of Safety and Effectiveness
This 510 (k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. This device is a Class II device per 21 CFR 864.9205, nonelectromagnetic blood and plasma warming device; henceforth referred to as the Themal Angel™.
Submitter:
Estill Medical Technologies. Inc. 17440 N. Dallas Parkway, Suite 100 Dallas, TX 75287
Contact:
Thomas L. Kistner, President Phone: (972) 818-1872 Fax: (972) 818-4329
Date Prepared: December 30, 1998
Trade/Proprietary Name: Themal Angel™ 200 Blood/Fluid Warmer
Classification Name: Warmer, blood, nonelectromagnetic
Predicate Devices: Augustine Medical Bair Hugger™ Blood/Fluid Warmer, Level 1 Technologies, Inc. Hotline™ Fluid Warmer, Baxter Thermacy|™ Blood/Fluid Warmer.
Description of device:
The Thermal Angel™ 200 Blood/Fluid Warmer consists of a single unit that is placed in-line between a standard IV drip set and a standard IV extension set. Thermal Angel™ is designed to warm blood, blood products and intravenous liquids at flow rates of up to and including 200 ml/min. Thermal Angel™ will deliver temperatures at 38°C. While the temperature will drop immediately after making major changes in flow rate, it will drop only a few degrees and return smoothly, and within seconds, to 38°C.
Thermal Angel's™ fluid path is sterile and the entire unit is disposable after use. Blood, blood products or intravenous fluids travel through stainless steel tubing which is surrounded by a heating blanket and heated by means of electrical resistance. The temperature of the device is accurately controlled by the device's electronics. The electrical requirements are designed in accordance with UL 2601 and CSA 601.
Statement of Intended Use:
The Thermal Angel™ 200 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
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in clinical and field environments.
Comparison of the Technological Characteristics of the New Device and the Predicate Devices:
The Thermal Angel™ 200 Blood/Fluid Warmer is substantially equivalent to the Augustine Medical Bair Hugger™ Blood/Fluid Warmer (K973741), the Baxter Thermacy™ Blood/Fluid Warmer (K770232) and the Level 1 Technologies, Inc. Hotline™ Fluid Warmer (K911383). A comparison of technological features are on the following page.
Discussion of Nonclinical Studies:
Studies will be conducted to evaluate the hemolytic effect of the new device prior to marketing. Percent hemolysis will be evaluated during flow, stop flow and highest flow rate possible conditions. Hemolysis must show to be none or not clinically significant before introduction into commerce.
Conclusion:
The Thermal Angel™ 200 Blood/Fluid Warmer has similar technological characteristics and the same intended use as devices currently on the market. Therefore, because of the similarities to the predicate devices, Estill Medical Technologies, Inc. believes this new device does not raise any new safety or effectiveness issues.
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| Comparison of Technological Features | ||||
|---|---|---|---|---|
| Features | Thermal Angel 200 | Bair Hugger Blood/Fluid Warmer | Baxter Thermacyl Blood/Fluid Warmer | Level I Technologies, Inc. Hotline Fluid Warmer |
| (k)# | Not yet assigned | K973741 | K770232 | K911383 |
| Heating Method | Heating blanket covering stainless steel tubing; heated by electrical resistance | Metal plate heated by electrical resistance | Metal cylinder heated by electrical resistance | Cirulating water heated by regulated resistance heater |
| Temperature Control | DS1821S Temp Sensors | Thermocouples | Thermistors (2 inlet; 2 outlet) | Water temp is displayed |
| Alarm | Visual; LED indicators | Audio/Visual | Audio/Visual | Audible |
| Alarm Conditions | Illumination: Red fading to dim or no light = no powerGreen fading to dim or no light = decrease in heat.Safety switch turns off TA @ 41.0*C | Temperature @ 32.0C; 43.0C 46.0*C | Temperature exceeds 42.0C or thermisters differ by 5.0C | Red "overtemperature" indicator illuminated alarm @ 41.0*C |
| Electronics | Microprocessor Control | PID Controlled | UL2601; CSA601 | Proportional controller |
| Operation | 12V Battery system | 120V-AC | ||
| Flow | TK0-200 ml/min | 0-500 ml/min | up to 500 ml/min | 5.0-50 ml/min |
| Infusion Temp. | 38*C | 42.0*C Max | Up to 42.0*C | 35.0C-39.0C |
.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Mr. Thomas L. Kistner President Estill Medical Technologies, Incorporated 17440 North Dallas Parkway 75287 Dallas, Texas
Re : K984640 Thermal Angel™ Trade Name: Requlatory Class: II Product Code: BSB Dated: April 5, 1999 Received: April 6, 1999
Dear Mr. Kistner:
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, Druq, 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 reqistration, 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. A 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.
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Page 2 - Mr. Kistner
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 ene regaración offication" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours, UND
imothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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| 510 (k) Number (if Known): | K984640 |
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| Device Name: | Thermal Angel™ |
| Indications for use: Thermal Angel™ is an in-line intravenous fluid and blood warmer. Thermal Angel™ is indicated for use whenever parenteral introduction of normothermic fluids are desired or indicated, whether in field or clinical settings. |
(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(Optional format 1-2-96) |
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K984640 |
|---|---|
| --------------- | --------- |
§ 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.