(715 days)
The Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System is indicated for use over a full range of flow rates from slow feed to rapid, high flow infusion of: crystalloid, colloid, or blood product, including packed red blood cells [not in additive . solutions and stored up to 21 days with anticoagulants], as volume replacement for patients suffering from blood loss due to trauma or surgery; warmed fluid to rewarm patients after surgery or for hypothermia; warmed fluid for irrigation in urology procedures.
The ThermaCor® 1200 Disposable Sets are intended for use only with the Smisson-Cartledge Biomedical (SCB) ThermaCor® 1200 Rapid Thermal Infusion System. The Disposable Sets consist of configurations that include cassettes with tubing connectors, various patient lines, and supply lines capable of interfacing with intravenous (IV) bags or optional-use reservoir equipment. Use of the ThermaCor® 1200 Disposable Sets ensures the intended use of the ThermaCor® 1200 Rapid Thermal Infusion System is met. The ThermaCor® 1200 Disposable Sets are provided sterile, non-pyrogenic and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.
The Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System is a portable or pole-mounted device intended for use in the hospital emergency room (ER), operating room (OR), intensive care unit (ICU), and Labor and Delivery (L&D) environments.
The system consists of an infusion device and a compatible, single patient use sterile disposable set with supply lines capable of interfacing with intravenous (IV) bags or an optional reservoir. The ThermaCor® 1200 Infuser may be used with a Footswitch (optional accessory) to allow hands-free, user-controlled delivery.
The ThermaCor® 1200 Infuser can deliver flow rates from 10 mL per Hour to 1200 mL per Minute selectable in 10mL/hr in Slow mode and 20mL/min in Rapid mode at normothermic temperatures and is intended for continuous operation. The ThermaCor® 1200 Rapid Thermal Infusion System is driven by a volumetric pump capable of variable-rate continuous infusion up to approximately 100 Liters total volume per Cassette. The system is also capable of delivering discrete bolus infusions. The user can select Bolus Mode to deliver a fixed, predetermined bolus of up to 1 Liter at a default or adjustable rate. When connected to alternating current (AC) power, the ThermaCor® 1200 Infuser can deliver fluids warmed to body temperature under most conditions. The Infuser can also run on battery power (heating capabilities will be disabled) to allow transport of the patient. A lithium-ion battery pack provides the power backup.
This document describes the acceptance criteria and study proving the device meets these criteria for the ThermaCor® 1200 Disposable Sets for the ThermaCor® 1200 Rapid Thermal Infusion System (K202461).
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on a component modification (Parylene coating on the heat exchanger) within an existing device, emphasizing that this modification did not change the performance of the Disposable Sets. Therefore, the acceptance criteria are implicitly met by demonstrating equivalency to the previously cleared device without performance degradation, and by confirming the safety of the new coating.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance Statement |
|---|---|---|
| Biocompatibility | Meets ISO 10993 requirements for: Cytotoxicity, Acute Systemic Toxicity, Intracutaneous Reactivity Test, Material Mediated Pyrogenicity Test, Sensitization, and Blood Contact testing per ASTM F756 and ISO 10993-6. | Biocompatibility risk assessment completed as directed by FDA guidance. Biocompatibility testing was successfully completed for the listed criteria. |
| Mechanical Integrity | Adhesion of Parylene coating (to heat exchanger/cassette) to meet ASTM D3359. - The material (Parylene coating) maintains its mechanical integrity when subjected to relevant stresses. | Testing demonstrated adhesion of the Parylene coating per ASTM D3359. |
| Bond Strength | Bond strength of the Disposable Sets components to meet ISO 8536-4. | Bond strength tests were conducted per ISO 8536-4, with presumably satisfactory results. |
| Particulate Matter | Particulate matter levels to meet USP . | Particulate matter testing was conducted per USP . It is assumed the results met the specified criteria. |
| Aluminum Ion Leaching | Aluminum ion leaching should be within safe limits and demonstrate an improvement in the safety margin compared to previous versions. | Aluminum ion leaching verification testing was performed, demonstrating an improvement in the safety margin for potential aluminum ion leaching compared to previous versions. |
| Heat Transfer Equivalency | Maximum heat transfer of the Disposable Sets with Parylene Coated Heat Exchangers must be equivalent to previous versions (without Parylene coating) when used with the ThermaCor® 1200 Rapid Thermal Infusion System. | Performance verification testing was conducted and demonstrated maximum heat transfer equivalency of the Parylene Coated Heat Exchangers to previous versions without Parylene coating. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly specify the sample size for each individual test conducted (biocompatibility, mechanical integrity, bond strength, particulate matter, aluminum ion leaching, and heat transfer equivalency). However, it broadly states that "performance and safety testing was conducted on the ThermaCor® 1200 Disposable Sets with Parylene Coated Heat Exchangers" and "performance verification testing was conducted with the ThermaCor® 1200 Rapid Thermal Infusion System."
The provenance of the data is not explicitly stated (e.g., country of origin). The studies appear to be prospective as they were specifically conducted to evaluate the modified device for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission does not involve diagnostic imaging or clinical interpretation by experts to establish a "ground truth" in the traditional sense of AI/clinical studies. The ground truth here is based on objective measurements and established standards (e.g., ISO, ASTM, USP, FDA guidance for biocompatibility). Therefore, no "readers" or "experts" for ground truth establishment are applicable in this context. The testing was carried out in accordance with recognized industry standards and regulatory guidance.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study requiring human adjudication for ground truth (e.g., image interpretation). The "adjudication" is based on the results meeting predefined quantitative or qualitative standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not relevant for evaluating a material modification to an infusion system component. The submission focuses on the safety and functional equivalence of the modified component, not on human interpretive performance with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a medical hardware component (disposable set) and not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for evaluating the modified device stems from objective, quantitative, and qualitative measurements against established medical device standards and regulatory guidance.
- Biocompatibility: Conformance to ISO 10993 and ASTM F756 standards, and additional FDA requests, reflecting generally accepted scientific principles for material safety in contact with the body.
- Mechanical Integrity/Bond Strength: Conformance to ASTM D3359 and ISO 8536-4 standards.
- Particulate Matter: Conformance to USP standard.
- Aluminum Ion Leaching: Measured values demonstrating an improvement in safety margin compared to previous versions, implicitly against a predefined safety threshold.
- Heat Transfer Equivalency: Measurement comparing the performance of the new heat exchanger to the cleared predicate device, demonstrating equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm. The "training" for the device's design and manufacturing is derived from engineering principles, prior experience with the predicate device, and regulatory standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm in this context.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).