CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0

K130394 · Smiths Medical Asd, Inc. · MEA · Dec 9, 2013 · General Hospital

Device Facts

• Record ID: K130394
• Device Name: CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
• Applicant: Smiths Medical Asd, Inc.
• Product Code: MEA · General Hospital
• Decision Date: Dec 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CADD Solis Version 3.0 Pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled demand doses. The CADD™-Solis Medication Safety Software - Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis VIP Ambulatory Infusion Pump, CADD®-Solis Ambulatory Infusion Pump, or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The CADD™-Solis Medication Safety Software - Point of Care allows use of a computer to send therapy-based protocols developed by the CADD™-Solis Medication Safety Software - Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

Device Story

CADD-Solis Model 2110 Version 3.0 is an ambulatory infusion pump with a linear peristaltic mechanism; microprocessor-controlled; user-operated via color LCD and keypad. Inputs include programmed therapy protocols (therapy, qualifier, drug) created via CADD-Solis Medication Safety Software (Administrator/Point of Care). Software allows creation of therapy-based protocol libraries on servers or PCs; protocols transferred to pump via USB or portable media. Pump delivers medication at continuous rates, intermittent boluses, or patient-controlled demand doses. Used in hospital or outpatient settings by clinicians or patients. Output includes infusion delivery and therapy logs. Benefits include standardized medication delivery via protocol libraries, reducing programming errors. Software supports protocol management, CQI data collection, and drug ID verification.

Clinical Evidence

No clinical data. Bench testing, design verification, software validation, and human-factors engineering studies were performed. All testing met pre-established specifications.

Technological Characteristics

Linear peristaltic pump; microprocessor-controlled; color LCD (320x320 pixels); keypad interface. Power: 4 AA batteries, AC adapter, or rechargeable pack. Connectivity: USB port for protocol transfer. Materials: standard medical-grade housing. Software: protocol-based library system.

Indications for Use

Indicated for patients requiring intravenous, intra-arterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural, or subarachnoid infusion. Supports continuous, intermittent bolus, and patient-controlled demand dose therapies.

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

• CADD®-Solis VIP Ambulatory Infusion Pump, Model 2120, Version 2.0 (K111275)
• CADD®-Solis Ambulatory Infusion Pump, Model 2100 or 2110, Version 1.0 (K072144)

Reference Devices

• CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher)

Submission Summary (Full Text)

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K130394

#### 510(k) Summary

# DEC - 9 2013

#### DATE PREPARED: December 3, 2013

### I. GENERAL INFORMATION

| Applicant's Name<br>and Address: | Smiths Medical ASD, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula Cordero<br>Sr. Manager, Global Regulatory Affairs |
| Common/Usual<br>Name: | 1) Ambulatory Infusion Pump<br>2) Pump Communications System |
| Proprietary Name: | 1) CADD®-Solis Ambulatory Infusion Pump, Model 2110, Version 3.0<br>2) CADDTM-Solis Medication Safety Software, Version 3.1 |
| Equivalence Device<br>Comparison: | 1) CADD®-Solis Ambulatory Infusion Pump, Model 2100<br>or Model 2110, Version 1.0<br>2) CADD®-Solis VIP Ambulatory Infusion Pump, Model 2120,<br>Version 2.0<br>3) CADDTM-Solis Medication Safety Software Version 1.2<br>4) CADDTM-Solis Medication Safety Software Version 2.0 |

#### II. DEVICE DESCRIPTION

CADD® Solis Ambulatory Infusion Pump, Model 2110, Version 3.0

The CADD -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0 ("CADD"-Solis Version 3.0 Pump") has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump, Version 1.0 (K072144) and CADD -Solis VIP Ambulatory Infusion Pump, Version 2.0 (K111275). The user activates CADD® Solis Version 3.0 Pump via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory.

The CADD®-Solis Version 3.0 Pump consists of components, such as the user interface, sensors, communication ports, power ports, structural (housing) components, electronics, pumping mechanism, watchdog timer, pump battery and circuitry, real time clock, onboard memory, and pump log. The CADD® Solis Version 3.0 Pump exterior surface components include the pump housing, LCD lens, labels, and keypad, and the materials of construction for these components are widely used in the medical industry. The CADD -Solis Version 3.0 Pump is designed to be used with a CADD® Infusion Disposable, such as Medication Cassette Reservoir.

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# CADD"-Solis Medication Safety Software Version 3.1

The CADD™-Solis Medication Safety Software System consists of the Administrator and the Point of Care software applications. This software allows the user to create therapy-based protocol libraries to be used with the CADD®-Solis Ambulatory Infusion Pump, or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The CADD™-Solis Medication Safety Software System allows the user to:

- Create a protocol library on a server or on a PC. .
- Create multiple protocol libraries within the database. Each protocol library can . be designated and named for a particular area of each facility.
- Create multiple pump protocols within each protocol library. .
- Designate authorized users for each protocol library. . ●
- . Program a pump with a therapy-based set of protocols.

The CADD™-Solis Medication Safety Software System can be used in various system configurations, including:

- . The protocol library database can be located on a server with one or more Administrator PCs and one or more Point of Care PCs distributed on the network throughout the facility.
- . The protocol library database can be located on the Administrator PC and one or more Point of Care PCs distributed over the network throughout the facility.
- The Point of Care PC can be located separately from a network and the protocol . libraries can be imported using portable media.

## III. DEVICE INTENDED USE

### CADD® -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0

The CADD Solis Version 3.0 Pump is indicated for intravenous, intra-arterial. subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled demand doses.

### CADD"-Solis Medication Safety Software-Administrator

The CADD™ Solis Medication Safety Software - Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis VIP Ambulatory Infusion Pump, CADD®-Solis Ambulatory Infusion Pump, or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

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### CADD"-Solis Medication Safety Software-Point of Care

The CADD™ Solis Medication Safety Software - Point of Care allows use of a computer to send therapy-based protocols developed by the CADD™-Solis Medication Safety Software - Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

### IV. SUMMARY OF STUDIES

### Performance Testing

Smiths Medical performed design verification and software validation testing on the CADD -Solis Version 3.0 Pump. Software validation testing was performed on the CADD™ Solis Medication Safety Software-Administrator and CADD™ Solis Medication Safety Software-Point of Care. Human-factors engineering studies were also completed.

### Clinical Studies

Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the CADD®-Solis Version 3.0 Pump. CADD " Solis Medication Safety Software-Administrator and POC.

### Testing Conclusion

All testing met pre-established specifications, and successfully demonstrated that the devices performed as intended. The testing results allowed for a conclusion to be made that the CADD® -Solis Version 3.0 Pump, and CADD™ Solis Medication Safety Software-Administrator and POC were as safe and effective as the predicate devices.

### VII. STATEMENT OF EQUIVALENCE

The CADD®-Solis Version 3.0 Pump, and CADD™ Solis Medication Safety Software-Administrator and POC are substantially equivalent to the predicate devices, based on comparisons of the device classifications, intended use, and technological characteristics. Verification and validation tests confirmed the suitability of the devices for their intended uses. The test results did not raise new safety or performance questions, and confirmed that the CADD -Solis Version 3.0 Pump, and CADD" Solis Medication Safety Software-Administrator and POC devices are substantially equivalent to the predicate devices.

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CADD®-Solis Version 3.0, CADD*-Solis VIP Version 1.2, and CADD® Solis Version 1.0 Pump Comparison Table

| Characteristic | General Information | Subject Device<br>CADD®-Solis Version 3.0 Pump | Predicate Device<br>CADD®-Solis VIP Version 1.2 Pump | Predicate Device<br>CADD®-Solis Version 1.0 Pump |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | | Smiths Medical ASD, Inc.<br>K130394, pending | Smiths Medical ASD, Inc.<br>K111275, February 1, 2013 | Smiths Medical ASD, Inc.<br>K072144, March 7, 2008 |
| 510(k) notification number<br>and substantial equivalence<br>determination date | | | | |
| Pump model number | | 2110 | 2120 | 2100 or 2110 |
| Pump firmware version | | 3.0 | 1.2 | 1.0 |
| Product description | | The CADD®-Solis Ambulatory Infusion<br>Pump. Model 2110, Version 3.0,<br>provides measured drug therapy to<br>patients in hospital or outpatient<br>settings. The pump can be programmed<br>with a protocol configuration consisting<br>of a therapy, qualifier, and drug.<br>Medication is delivered at a constant<br>rate, and/or with a clinician bolus,<br>and/or with a patient dose, and/or with<br>programmed intermittent boluses. | The CADD®-Solis VIP (variable<br>infusion profile) Ambulatory Infusion<br>Pump, Model 2120, provides measured<br>drug therapy to patients in hospital,<br>outpatient and homecare settings.<br>The pump can be programmed with a<br>pump protocol configuration consisting<br>of a therapy, qualifier, and drug. The<br>pump can deliver medication via patient<br>controlled analgesia (PCA), continuous,<br>intermittent, variable stepped rate, and<br>tapered infusions. | The CADD®-Solis Ambulatory Infusion<br>Pump. Model 2100 or 2110, Version<br>1.0, provides measured drug therapy to<br>patients in hospital or outpatient<br>settings. The pump can be programmed<br>with a protocol configuration consisting<br>of a therapy, qualifier, and drug.<br>Medication is delivered at a constant<br>rate, and/or with an intermittent bolus,<br>and/or with a patient dose. |
| Characteristic | Subject Device<br>CADD®-Solis Version 3.0 Pump | Device<br>Predicate Device<br>CADD®-Solis VIP Version 1.2 Pump | Predicate Device<br>CADD®-Solis Version 1.0 Pump | |
| Indications for use | The CADD®-Solis Ambulatory Infusion<br>Pump is indicated for intravenous, intra-<br>arterial, subcutaneous, intraperitoneal,<br>in close proximity to nerves, into an<br>intraoperative site (soft tissue, body<br>cavity/surgical wound site), epidural<br>space, or subarachnoid space infusion.<br>The pump is intended for therapies that<br>require a continuous rate of infusion,<br>and/or an intermittent bolus, and/or with<br>patient-controlled demand doses. | The CADD®-Solis VIP Ambulatory<br>Infusion Pump is indicated for<br>intravenous, intra-arterial,<br>subcutaneous, intraperitoneal,<br>perineural, surgical site, epidural space,<br>or subarachnoid space infusion.<br>PCA (patient-controlled analgesia)<br>delivery is used for therapies that<br>require a continuous rate of infusion,<br>patient-controlled demand doses, or<br>both, such as patient-controlled<br>analgesia.<br>Continuous delivery allows the<br>infusion of drug/fluid at a constant,<br>programmed rate.<br>Intermittent delivery allows the<br>infusion of a specific volume of<br>drug/fluid at a regular, programmed<br>interval.<br>Step delivery allows an incremental<br>increase in infusion rate to a specified<br>maximum infusion rate for a specified<br>total infusion volume.<br>Taper delivery allows a plateau rate of<br>infusion with the option of tapering at<br>the beginning and/or end and has a<br>programmable KVO rate at the end of<br>the infusion. | The CADD®-Solis Ambulatory Infusion<br>Pump is indicated for intravenous, intra-<br>arterial, subcutaneous, intraperitoneal,<br>in close proximity to nerves, into an<br>intraoperative site (soft tissue, body<br>cavity/surgical wound site), epidural<br>space, or subarachnoid space infusion.<br>The pump is intended for therapies that<br>require a continuous rate of infusion,<br>patient-controlled demand doses, or<br>both (such as patient-controlled<br>analgesia). | |
| System Features<br>Pump type/principle of<br>operation | Linear peristaltic | Linear peristaltic | Linear peristaltic | |
| Materials of construction-<br>Pump housing | Same for subject and predicate<br>CADD®-Solis Pumps | Same for subject and predicate<br>CADD®-Solis Pumps | Same for subject and predicate<br>CADD®-Solis Pumps | |
| Characteristic | Subject Device<br>CADD®-Solis Version 3.0 Pump<br>Color display with 320 x 320 pixels | Predicate Device<br>CADD®-Solis VIP Version 1.2 Pump<br>Color display with 320 x 320 pixels | Predicate Device<br>CADD®-Solis Version 1.0 Pump<br>Color display with 320 x 320 pixels | |
| Display<br>Available with gray keypad<br>(denoting general use) | Yes | Yes | Yes | |
| Available with yellow<br>keypad (denoting epidural<br>use) | Yes | No | Yes | |
| Remote dose cord supplied<br>with device | Yes | No | Yes | |
| Power requirements | 4 ("AA") batteries<br>AC adapter<br>Rechargeable battery pack | 4 ("AA") batteries<br>AC adapter<br>Rechargeable battery pack | 4 ("AA") batteries<br>AC adapter<br>Rechargeable battery pack | |
| Printing capabilities | No | No | No | |
| Remote communications<br>capabilities | No | No | No | |
| USB port | Yes | Yes | Yes | |
| Accessories | | | | |
| AC adapter | Yes | Yes | Yes | |
| AC power cord | Yes | Yes | Yes | |
| Remote dose cord | Yes | No | Yes | |
| Rechargeable power pack | Yes | Yes | Yes | |
| Polemount adapter | Yes | Yes | Yes | |
| Carrying pouch | Yes | Yes | Yes | |
| Lockbox | Yes | Yes | Yes | |
| Medication cassette<br>reservoir | Yes | Yes | Yes | |
| Administration Set | Yes | Yes | Yes | |
| Extension Set | Yes | Yes | Yes |…