SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200

K052055 · Smisson-Cartledge Biomedical, LLC · LGZ · Oct 26, 2006 · General Hospital

Device Facts

• Record ID: K052055
• Device Name: SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
• Applicant: Smisson-Cartledge Biomedical, LLC
• Product Code: LGZ · General Hospital
• Decision Date: Oct 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Full range from slow feed to rapid, high flow infusion of: crystalloid, colloid, or blood product, including packed red blood cells, 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 Story

Portable tabletop/pole-mount volumetric infusion pump; used in ambulances, helicopters, ERs, and ORs. Inputs: IV bags or cardiotomy equipment via sterile single-use disposable cassette kit. Operation: continuous infusion (10 mL/hr to 1200 mL/min) or discrete bolus delivery (up to 1 L). Features: footswitch for hands-free start/stop; AC power for fluid warming; lithium-ion battery for transport (heating disabled). Output: controlled delivery of warmed or ambient fluids to patient. Healthcare providers use device to manage fluid resuscitation and temperature regulation; benefits include rapid volume replacement and hypothermia prevention.

Clinical Evidence

Bench testing only. Performance testing verified mechanical characteristics and infusion capabilities against predicate devices. Biocompatibility testing conducted per ISO-10993.

Technological Characteristics

Volumetric infusion pump; tabletop/pole-mount form factor. Materials: biocompatible (ISO-10993 compliant). Energy: AC power (heating enabled) and lithium-ion battery (transport mode). Sterilization: Ethylene Oxide (EO) for disposable components. Connectivity: standalone.

Indications for Use

Indicated for patients suffering from blood loss due to trauma or surgery requiring volume replacement (crystalloid, colloid, or blood products), patients requiring rewarming after surgery or for hypothermia, and patients requiring warmed irrigation fluid for urology procedures.

Regulatory Classification

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.

Predicate Devices

• Belmont Fluid Management System (FMS2000) (K032778, K032674, K992672, K983975, K972284)
• Smiths Level 1 H-1200 Fast Flow Fluid Warmer System (BK020043)

Submission Summary (Full Text)

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February 16, 2021

Smisson-Cartledge Biomedical LLC Julie Stephens Correspondent 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K052055

Trade/Device Name: Smisson-Cartledge TIS-1200 Thermal Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: LGZ, FRN, FPA

Dear Julie Stephens:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 10, 2017. Specifically, FDA is updating this SE Letter because FDA has identified an additional product code to more clearly categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact CAPT Alan Stevens, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, [phone], [e-mail].

Sincerely,

Alan M.
Stevens -S3

CAPT Alan Stevens Acting 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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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JAN 1 0 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Smisson-Cartledge Biomedical, LLC C/O Ms. Julie Stephens Consultant for Smisson-Cartledge Biomedical, LLC Regulatory Resources Group. Incorporated 111 Laurel Ridge Drive Alpharetta, Georgia 30004

Re: K052055

Trade/Device Name: Smisson-Cartledge TIS-1200 Thermal Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ, FRN Dated: October 18, 2006 Received: October 19, 2006

Dear Ms. Stephens:

This letter corrects our substantially equivalent letter of October 26, 2006.

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. 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.

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

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Page 2 - Ms. Julie Stephens

CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809] ), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K052055

Device Name: Smisson-Cartledge TIS-1200 Thermal Infusion System

Indications For Use:

Full range from slow feed to rapid, high flow infusion of:

- crystalloid, colloid, or blood product, including packed red blood cells, 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 .

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## Exhibit J - 510(k) SUMMARY

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 LLC<br>502 Mulberry Street, Second Floor<br>Macon, GA 31201<br>Phone: [phone] |
|---------------|-------------------------------------------------------------------------------------------------------------------|
|---------------|-------------------------------------------------------------------------------------------------------------------|

Contact Person: Julie Stephens, President/Consultant Regulatory Resources Group, Inc.

510(k) Number: K052055

Date Prepared: July 26, 2005

Device Name and Classification:

| Trade/Proprietary Name: | Smisson-Cartledge TIS-1200 Thermal Infusion System |
|-------------------------|----------------------------------------------------|
| Common Name: | Infusion Pump |
| Classification Name: | Infusion Pump |
| Product Code: | LGZ: FRN: FPA |

## Legally Marketed Predicate Device:

Belmont Fluid Management System (FMS2000) - 510(k) # K032778. K032674. K992672. K983975. K972284 Smiths Level 1® H-1200 Fast Flow Fluid Warmer System - 510(k) # BK020043

## Device Description:

The Smisson-Cartledge TIS-1200 Thermal Infusion System is a portable tabletop or polemount device intended for use in the ambulance, medical helicopter, hospital emergency room and operating room environments. (See Exhibits A and B for photographs and drawings) The system consists of an infusion device and a compatible single-use sterilized disposable set with supply lines capable of interfacing with intravenous (IV) bags or optional-use cardiotomy equipment. It also includes a footswitch to allow hands-free user-controlled stopping and starting of fluid delivery. The Smisson-Cartledge TIS-1200 Thermal Infusion System is a volumetric pump capable of continuous infusion (up to approximately 100 L at a rate of from 10 mL per hour to 1200 mL per minute) and discrete bolus delivery. When the system is set to Bolus mode, the user can select a predetermined delivery volume and a default or adjustable rate and deliver a fixed bolus of up to 1 L. When connected to alternating current (AC) power, the Smisson-Cartledge TIS-1200 Thermal Infusion System can deliver fluids at body temperature in certain modes. It can also be set to run on battery power with heating capabilities disabled to allow transport of the patient. A lithium-ion battery pack provides power backup. The unit (infusion pump) and Large Volume Reservoir Holder are provided non sterile. The Disposable Cassette Kit and Large Volume Reservoir are provided sterile, non-pyrogenic and are single-use only. They are sterilized by Ethylene Oxide (EO) sterilization method.

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## Exhibit J - 510(k) SUMMARY

## Indications for Use:

Full range from slow feed to rapid, high flow infusion of crystalloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery. Full range from slow feed to rapid, high flow infusion of warmed fluid to rewarm patients after surgery or for hypothermia. Full range from slow feed to rapid, high flow infusion of warmed fluid for irrigation in urology procedures.

## Similarities and Differences to the Predicate Devices:

## Similarities

The Smisson-Cartledge TIS-1200 Thermal Infusion System has the same basic mechanical characteristics to infuse and warm liquid products into a patient as the predicate devices, and the indications for use are the Belmont predicate device.

## Differences

The Smisson-Cartledge TIS-1200 Thermal Infusion System utilizes different materials from the predicate devices; however, the materials are biocompatible.

## Summary of Testing:

The Smisson-Cartledge TIS-1200 Thermal Infusion System has the same indications for use, principles of operation, and mechanical characteristics as the predicate devices that were previously cleared for market under a 510(k). These conclusions were verified in performance / bench testing as summarized within the 510(k).

The Smisson-Cartledge TIS-1200 Thermal Infusion System device differs only in its materials used. All biocompatibility testing, as required, complies with ISO-10993 "Biological Evaluation of Medical Devices".