CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE

K111275 · Smiths Medical Asd, Inc. · FRN · Feb 1, 2013 · General Hospital

Device Facts

• Record ID: K111275
• Device Name: CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
• Applicant: Smiths Medical Asd, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Feb 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CADD®-Solis VIP Ambulatory Infusion Pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion. PCA (patient-controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patientcontrolled analgesia. Continuous delivery allows the infusion of drug/fluid at a constant, programmed rate. Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval. Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume. Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion. 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

Ambulatory infusion pump with linear peristaltic mechanism; microprocessor-controlled. Inputs: user-programmed therapy parameters via color LCD/keypad. Outputs: controlled drug/fluid delivery. Used in hospital, homecare, and outpatient settings by clinicians or patients. Software modules (Administrator/POC) manage therapy-based protocol libraries; allow protocol creation, editing, and download to pumps via USB. Enhances medication safety by enforcing programmed limits and protocols. Benefits: precise, programmable drug delivery across multiple clinical routes; reduces medication errors via standardized protocols.

Clinical Evidence

No clinical data; bench testing only. Verification and validation included electrical/mechanical safety (IEC 60601-1, IEC 60601-2-24), software validation, usability/human factors, and biocompatibility testing. All testing met pre-established specifications.

Technological Characteristics

Linear peristaltic pump; microprocessor-controlled. Powered by 4 AA batteries, AC adapter, or rechargeable battery pack. Features color LCD (320x320 pixels), USB connectivity, and real-time clock. Software-based protocol management. Materials are standard medical-grade housing/components. Sterilization not specified; infusion disposables are biocompatible.

Indications for Use

Indicated for patients requiring intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural, or subarachnoid infusion therapy. Supports continuous, intermittent, step, taper, and patient-controlled analgesia (PCA) delivery modes.

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 Ambulatory Infusion Pump (K072144)
• CADD-Prizm® VIP Ambulatory Infusion Pump (K960826)
• CADD™-Solis Medication Safety Software-Point of Care (K082783)
• CADD™-Solis Medication Safety Software-Administrator (K072144)

Submission Summary (Full Text)

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# KIII 275

#### 510(k) Summary

# FEB 0 1 2013

| DATE PREPARED | January 29, 2013 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| I. GENERAL INFORMATION | |
| Applicant's Name and<br>Address: | Smiths Medical ASD, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
| Contact Person: | Julie Tapper<br>Senior Regulatory Affairs Specialist |
| Common/Usual Name: | Ambulatory Infusion Pump<br>Pump Communications System |
| Proprietary Name: | CADD®-Solis VIP Ambulatory Infusion Pump<br>CADD™-Solis Medication Safety Software |
| Predicate Devices: | K072144, CADD®-Solis Ambulatory Infusion Pump<br>K960826, CADD-Prizm® VIP Ambulatory Infusion Pump<br>K082783, CADD™-Solis Medication Safety Software-Point of Care<br>K072144, CADD™-Solis Medication Safety Software-Administrator |

# II. DEVICE DESCRIPTION

#### CADD®-Solis VIP Ambulatory Infusion Pump

The CADD®-Solis VIP Ambulatory Infusion Pump ("Solis VIP Pump") has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump (K072144) and CADD-Prizm® VIP Ambulatory Infusion Pump (K960826). The user activates the Solis VIP 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 Solis VIP 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, on-board memory, and pump log. The Solis VIP 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 Solis VIP Pump is designed to be used with an infusion disposable, such as medication cassette reservoir.

The Solis VIP Pump provides measured drug therapy to patients in the hospital, homecare, and outpatient settings. The Solis VIP Pump is intended for therapies that require a Continuous. Intermittent. Tapering, or Step rates of infusion, and Patient Controlled Analgesia (including Clinician Bolus).

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## CADDTM-Solis Medication Safety Software-Administrator

The CADD™-Solis Medication Safety Software-Administrator ("Administrator") module allows the user to create, edit, and save therapy-based protocols and pump settings within user-defined protocol libraries. The system administrator user determines user access and library editing capabilities. Other Administrator module features include barcode printing, reports, and sending and receiving pump protocol information.

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

The CADD™-Solis Medication Safety Software-Point of Care ("POC") module allows the user to download therapy based protocols to the Solis Pump, and Prizm Pump (software revision H or higher) and send and receive pump settings via USB connection.

# III. INTENDED USE OF THE DEVICE

# CADD®-Solis VIP Ambulatory Infusion Pump

The CADD®-Solis VIP Ambulatory Infusion Pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

PCA (patient-controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patientcontrolled analgesia.

Continuous delivery allows the infusion of drug/fluid at a constant, programmed rate.

Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval.

Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume.

Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion.

#### 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).

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

The CADDIM 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

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

## VI. SUMMARY OF STUDIES

#### Performance Testing

Smiths Medical performed extensive verification and validation testing on the Solis VIP Pump and Administrator and POC software.

Testing was completed in accordance with FDA's draft guidance, Total Product Life Cycle-Infusion Pump - Premarket Notification [510(k)] Submissions, issued on April 23, 2010; and the General Principles of Software Validation; Final Guidance for Industry and FDA Staff, issued on January 11, 2002.

Also, testing was completed in accordance with FDA consensus standards, IEC 60601-1:1988 Medical electrical equipment - Part 1: General reguirements for safety, plus Amendment 1:1991. Amendment 2:1995 and Amendment 2 Corrigendum: 2005, and IEC 60601-2-24:1998 - Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers.

An overall summary of the performance testing was, as follows:

| Electrical and mechanical safety tests | Electromagnetic compatibility tests |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Solis VIP Pump software validation | Administrator and POC software validation |
| Usability/human factors validations for<br>the Solis VIP Pump and Administrator<br>and POC Software | Infusion disposable biocompatibility<br>testing, including extractables and<br>leachables |

#### Clinical Studies

Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Solis VIP Pump, and Administrator and POC software.

# 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 Solis VIP Pump, and Administrator and POC software were as safe and effective as the predicate devices.

#### VII. STATEMENT OF EQUIVALENCE

The Solis VIP Pump, and Administrator and POC software 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 Solis VIP Pump, and Administrator and POC software devices are substantially equivalent to the predicate devices.

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| ADD®-Solis VIP Ambulatory Infusion Pu | | | |
|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| evice name | CADD®- | ADD®-Solis Ambulatory Infusio Pump | CADD-Prizm® VIP Ambulator Smiths Mesical ASS |
| | | | |
| | | Smiths Medical ASD, K072144 (March 7, 2008) | |
| | | | |
| | | | |
| | | | |
| Tanufacturer Notification numbr Substantial equivalence Substantial Eguivalence Subscription EDATURES Pump Lym FEAT UREST Display | - Linear Peristaltic display with 320 x 320 pixe<br>Color | Linear Peristaltic olor display with 320 x 320 pixel | 32<br>Linear Peristalic Tonchromatics displayatriis Pixol, Dixplandisplanding Mariity Program Pixel, Mistrials EPS Portalian Provinsian Provinsia EPS Power Power Power Provinsian P |
| | | | |
| ower requiremen | | | |
| | 4AA Batteries AC Adapter echargeable Battery Pac<br>d | 4AA Batteries | |
| | No | No | Yes |
| | No | No | No |
| rinting capabilities Remote communications capabilities USB port PROGRAMMING FUNCTIONS | Yes | Yes | No |
| | | | |
| Step | Yes | No | No |
| ntermitten | Yes | No | Yes |
| aper | Yes | No | Yes (TPN |
| | Yes | Y es | Yes |
| ontinuous infusion ontinuous infusion with bolus (PC) | Yes | ਿੰਡ ਨੇੜੇ ਵਿੱਚ ਮੈਡ | Yes |
| ecurity | Yes | | Yes |
| | Yes | Y es | Y es |
| | Yes | Y es | Yes |
| | Yes | Yes | Yes |
| | Y es | Yes | Yes |
| | Yes | No | Yes |
| | ﺮ ،<br>Yes | Yes | Yes |
| | Yes | Yes | Y es |
| | | | |
| | Yes | Yes | Yes |
| | Yes | Yes | Yes |
| | Yes | Yes | Yes |
| | | | |
| CADD®-Solis VIP Ambulatory Infusion Pump | | | |
| Device name | CADD®-Solis VIP Ambulatory<br>Infusion Pump | CADD®-Solis Ambulatory Infusion<br>Pump | CADD-Prizm® VIP Ambulatory<br>Infusion Pump |
| No-battery alert | Yes | Yes | Yes |
| Pump in stop mode | Yes | Yes | Yes |
| High pressure | Yes | Yes | Yes |
| Power up fault | Yes | Yes | Yes |
| Low volume in medication reservoir | Yes | Yes | Yes |
| Cassette detachment | Yes | Yes | Yes |
| Upstream occlusion | Yes | Yes | Yes |
| Downstream occlusion | Yes | Yes | Yes |
| Air-in-line | Yes | Yes | Yes |
| Key stuck | Yes | Yes | Yes |
| <b>INFUSION SPECIFICATIONS</b> | | | |
| Minimum continuous delivery rate | 0 mL/hr | 0 mL/hr | 0 mL/hr |
| Maximum continuous delivery rate | 100 mL/hr in PCA<br>500 mL/hr in Continuous,<br>Intermittent, Taper, Step | 30 mL/hr | 30 mL/hr in PCA<br>350 mL/hr in Continuous,<br>Intermittent, TPN |
| Maximum patient bolus | 50 mL | 20 mL | 9.9 mL |
| Maximum clinician bolus | 50 mL | 20 mL | 20 mL |
| Reservoir volume | 1 to 9999 mL | 1 to 9999 mL | 1 to 9999 mL |
| Patient controlled access PCA (dosing) | Yes | Yes | Yes |
| Dose lockout time | Yes | Yes | Yes |
| Doses per hour limit | Yes | Yes | Yes |
| Delivery limit | Yes | Yes | Yes |
| Clinician bolus | Yes | Yes | Yes |
| Programmable maximum delivery rate<br>(Continuous rate + bolus) | Yes | Yes | Yes |

# COMPARISION OF TECHNOLOGICAL CHARACTERISTICS v.

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K111275 510(k) Summar

Smiths Medical ASD, Inc

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| CADD TM-Solis Medication Safety<br>Software Administrator and POC<br>Device Name | CADDTM-Solis Medication Safety<br>Software (software update) | CADDTM-Solis Medication Safety<br>Software | |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Manufacturer | Smiths Medical ASD, Inc. | Smiths Medical ASD, Inc. | |
| 10(k) notification number<br>(substantial equivalence date) | K111275<br>(TBD) | K082783<br>(December 17, 2008) | K072144<br>(March 7, 2008) |
| <b>COMPATIBILITY</b> | | | |
| Pump compatibility | CADD®-Solis VIP Ambulatory<br>Infusion Pump, CADD®-Solis<br>Ambulatory Infusion Pump and<br>CADD-Prizm® PCS II 6101 (rev H<br>and higher) | CADD®-Solis Ambulatory Infusion<br>Pump and CADD-Prizm® PCS II 6101<br>(rev H and higher) | CADD®-Solis Ambulatory Infusion<br>Pump and CADD-Prizm® PCS II 6101<br>(rev H and higher) |
| Accessory compatibility | USB cable for the CADD®-Solis VIP<br>pump, and CADD®-Solis pump<br>21-6144 Interface cable/null modem<br>cable for CADD-Prizm® pump | USB cable for the CADD®-Solis<br>pump<br>21-6144 Interface cable/null modem<br>cable for CADD-Prizm® pump | USB cable for the CADD®-Solis<br>pump<br>21-6144 Interface cable/null modem<br>cable for CADD-Prizm® pump |
| PC software compatibility<br>Computer equipment | Windows 2000, XP, VISTA<br>RS232 serial port, USB, and CD-<br>ROM | Windows 2000, XP, VISTA<br>RS232 serial port, USB, and CD-<br>ROM | Windows 2000, XP, VISTA<br>RS232 serial port, USB, and CD-<br>ROM |

KI11275 510(k) Summary

Smiths Medical ASD, Inc

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

#### Febauary 1, 2013

Ms. Julie Tapper Senior Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 1265 Grey Fox Road ST. PAUL, MN 55112

Re: K111275

Trade/Device Name: CADD® -Solis VIP Ambulatory Infusion Pump and CADD™-Solis Medication Safety Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 21, 2013 Received: January 22, 2013

Dear Ms. Tapper:

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.

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Page 2 - Ms. Tapper

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 (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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours;

hor
Theth
Harshita.D.

Anthony D. Watson, B.S., M.S., M.B.A. 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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# SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification

CADD®-Solis VIP Ambulatory Infusion Pump CADD"-Solis Medication Safety Software

#### Indications for Use --

510(k) Number: K 111275

TAB 5 - Page 1 of 2

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# Device Name: CADD®-Solis VIP Ambulatory Infusion Pump

Indications for Use:

"The CADD®-Solis VIP Ambulatory Infusion Pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

PCA (patient-controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patientcontrolled analgesia.

Continuous delivery allows the infusion of drug/fluid at a constant, programmed rate.

Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval.

Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume.

Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion."

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The Counter Use _ OR Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Richard C. Chapman Date: 2013.02.01 13:20:30 -05'00'

#### (Division Sign-Off)

: vision of Anesthesiology, General Hespital rection Control, Dental Devices

510(k) Number:

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# SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification CADD -Solis VIP Ambulatory Infusion Pump CADD™-Solis Medication Safety Software

## Indications for Use --

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

#### Device Name: CADD" Solis Medication Safety Software - Administrator

Indications for Use:

"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)."

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ OR Per 21 CFR 801.109

# Device Name: CADD" Solis Medication Safety Software - Point of Care

Indications for Use:

"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)."

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ Per 21 CFR 801.109

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Richard C. Chapman Date: 2013.01.30 10:21:19 -05'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _

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