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.

Device Description

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.

AI/ML Overview

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 <788>.	Particulate matter testing was conducted per USP <788>. 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 <788> 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.

Summary

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August 12, 2022

Smisson-Cartledge Biomedical LLC % Julie Stephens President/Consultant Regulatory Resources Group, Inc. 111 Laurel Ridge Dr. Alpharetta, Georgia 30004

Re: K202461

Trade/Device Name: ThermaCor® 1200 Disposable Sets for the ThermaCor® 1200 Rapid Thermal Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LGZ, FRN, FPA Dated: July 19, 2022 Received: July 20, 2022

Dear Julie Stephens:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mark J. Antonino, M.S. Acting Division Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202461

Device Name

ThermaCor® 1200 Disposable Sets for the ThermaCor® 1200 Rapid Thermal Infusion System

Indications for Use (Describe)

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, 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

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Smisson-Cartledge Biomedical LLC Traditional 510(k) # K202461 - ThermaCor® 1200 Disposable Sets

510(k) Summarv

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.

Submitted By:	Smisson-Cartledge Biomedical LLC487 Cherry Street - Third Street TowerMacon, GA 31201Phone: (478) 744-9992
Contact Person:	Julie Stephens, President/ConsultantRegulatory Resources Group, Inc. - Phone: (678) 513-0693

August 9, 2022 Date Submitted:

Device Name and Classification:

Trade/Proprietary Name:	ThermaCor® 1200 Disposable Sets for theThermaCor® 1200 Rapid Thermal Infusion System
Common Name:	Rapid thermal infusion system
Regulation Number:	21 CFR 880.5725
Regulation Name:	Infusion Pump
Regulatory Class:	II
Product Code:	LGZ, FRN, FPA

Note: ThermaCor® 1200 Rapid Thermal Infusion System is the current "trade/proprietary name" for Smisson-Cartledge Biomedical TIS-1200 Thermal Infusion System, which was the name used within the prior 510(k) # K052055.

Legally Marketed Predicate Device:

Smisson-Cartledge Biomedical TIS-1200 Thermal Infusion System - 510(k) # K052055

Reason for 510(k) Submission:

To obtain clearance for a component modification within the ThermaCor® 1200 Disposable Sets. The component modification is the addition of a Parylene coating to the heat exchanger. The heat exchanger is a component of the cassette within the ThermaCor® 1200 Disposable Sets used with the ThermaCor® 1200 Rapid Thermal Infusion System.

Device Description:

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Smisson-Cartledge Biomedical LLC Traditional 510(k) # K202461 - ThermaCor® 1200 Disposable Sets

510(k) Summarv

Indications for Use:

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 ●

Discussion of Indications for Use for ThermaCor® 1200 Disposable Sets:

The Indications for Use as proposed for the ThermaCor® 1200 Disposable Sets are same as the Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System. The ThermaCor® 1200 Disposable Sets are necessary to enable the ThermaCor® 1200 Rapid Thermal Infusion System to meet its Indications for Use.

The Indications for Use statement for the Smisson-Cartledge Biomedical ThermaCor® 1200 Rapid Thermal Infusion System did not change from the cleared 510(k) # K052055.

Discussion of Technological Characteristics:

The ThermaCor® 1200 Disposable Sets did not change technological characteristics from the cleared 510(k) # K052055 except for the addition of Parylene coating to the heat exchanger. The heat exchanger transfers heat to the fluids and is a component within the cassette. The cassette is then part of the Disposable Set that mounts onto the infusion pump unit. The addition of the Parylene coating did not change the performance of the Disposable Sets within the ThermaCor® 1200 Rapid Thermal Infusion System and demonstrated an improvement in the safety margin for potential aluminum ion leaching. The Disposable Sets are substantially equivalent to the Disposable Sets within the cleared 510(k) # K052055.

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Smisson-Cartledge Biomedical LLC Traditional 510(k) # K202461 - ThermaCor® 1200 Disposable Sets

510(k) Summarv

Summary of Testing:

The biocompatibility risk assessment was completed as directed by FDA quidance under ISO 10993 biocompatibility requirements. Biocompatibility testing completed included Cytotoxicity. Acute Systemic Toxicity, Intracutaneous Reactivity Test, Material Mediated Pyrogenicity Test, Sensitization, and Blood Contact testing per ASTM F756 and ISO 10993-6 and additional FDA requests. Based on risk assessment, performance and safety testing was conducted on the ThermaCor® 1200 Disposable Sets with Parvlene Coated Heat Exchangers for bond strength tests per ISO 8536-4, mechanical adhesion of the Parylene coating per ASTM D3359, particulate matter testing per USP <788>, and aluminum ion leaching verification testing. Performance verification testing was conducted with the ThermaCor® 1200 Rapid Thermal Infusion System to demonstrate maximum heat transfer equivalency of the Parylene Coated Heat Exchangers to previous versions of Heat Exchangers without Parylene coating.

Substantial Equivalence Conclusions:

The modification to the Smisson-Cartledge Biomedical ThermaCor® 1200 Disposable Sets [proposed] is substantially equivalent to the Disposable Cassette Sets within the cleared 510(k) # K052055 [predicate] in terms of indications for Use/Intended Use, technical characteristics, principles of performance and safety.

Regulation Number and Section

§ 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).