(297 days)
No
The summary describes a standard infusion pump with a microprocessor and software for managing protocols, but there is no mention of AI or ML capabilities.
Yes
The device is an infusion pump designed to deliver medication to various anatomical sites, which directly contributes to therapy.
No
Explanation: The device is an infusion pump designed to deliver fluids and medications to a patient, which is a therapeutic function, not a diagnostic one. It does not identify or detect diseases or conditions.
No
The device description clearly details a physical infusion pump with hardware components (microprocessor, pumping mechanism, sensors, etc.) in addition to the software. While the submission also includes software components (Medication Safety Software), the primary device is a hardware-based infusion pump.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an infusion pump for delivering fluids into various anatomical sites. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details the components of an infusion pump, including a pumping mechanism, user interface, sensors, etc. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Reagents or test kits.
The device is clearly designed for the controlled delivery of substances into the body, which is a therapeutic function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for 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).
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).
Product codes
MEA, MEA, MRZ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Patients in hospital or outpatient settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
DEC - 9 2013
DATE PREPARED: December 3, 2013
I. GENERAL INFORMATION
| Applicant's Name
and Address: | Smiths Medical ASD, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula Cordero
Sr. Manager, Global Regulatory Affairs |
| Common/Usual
Name: | 1) Ambulatory Infusion Pump
2) Pump Communications System |
| Proprietary Name: | 1) CADD®-Solis Ambulatory Infusion Pump, Model 2110, Version 3.0
2) CADDTM-Solis Medication Safety Software, Version 3.1 |
| Equivalence Device
Comparison: | 1) CADD®-Solis Ambulatory Infusion Pump, Model 2100
or Model 2110, Version 1.0
2) CADD®-Solis VIP Ambulatory Infusion Pump, Model 2120,
Version 2.0
3) CADDTM-Solis Medication Safety Software Version 1.2
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.
1
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).
2
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.
3
| And Control Concession Company Controller
a man and the many ha
100 0 000 000 000 000
| 1 | |
|---|---|
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
CADD®-Solis Version 3.0 Pump | Predicate Device
CADD®-Solis VIP Version 1.2 Pump | Predicate Device
CADD®-Solis Version 1.0 Pump |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | | Smiths Medical ASD, Inc.
K130394, pending | Smiths Medical ASD, Inc.
K111275, February 1, 2013 | Smiths Medical ASD, Inc.
K072144, March 7, 2008 |
| 510(k) notification number
and substantial equivalence
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
Pump. Model 2110, Version 3.0,
provides measured drug therapy to
patients in hospital or outpatient
settings. The pump can be programmed
with a protocol configuration consisting
of a therapy, qualifier, and drug.
Medication is delivered at a constant
rate, and/or with a clinician bolus,
and/or with a patient dose, and/or with
programmed intermittent boluses. | The CADD®-Solis VIP (variable
infusion profile) Ambulatory Infusion
Pump, Model 2120, provides measured
drug therapy to patients in hospital,
outpatient and homecare settings.
The pump can be programmed with a
pump protocol configuration consisting
of a therapy, qualifier, and drug. The
pump can deliver medication via patient
controlled analgesia (PCA), continuous,
intermittent, variable stepped rate, and
tapered infusions. | The CADD®-Solis Ambulatory Infusion
Pump. Model 2100 or 2110, Version
1.0, provides measured drug therapy to
patients in hospital or outpatient
settings. The pump can be programmed
with a protocol configuration consisting
of a therapy, qualifier, and drug.
Medication is delivered at a constant
rate, and/or with an intermittent bolus,
and/or with a patient dose. |
| Characteristic | Subject Device
CADD®-Solis Version 3.0 Pump | Device
Predicate Device
CADD®-Solis VIP Version 1.2 Pump | Predicate Device
CADD®-Solis Version 1.0 Pump | |
| Indications for use | The CADD®-Solis Ambulatory Infusion
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 VIP Ambulatory
Infusion Pump is indicated for
intravenous, intra-arterial,
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 patient-controlled
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 Ambulatory Infusion
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,
patient-controlled demand doses, or
both (such as patient-controlled
analgesia). | |
| System Features
Pump type/principle of
operation | Linear peristaltic | Linear peristaltic | Linear peristaltic | |
| Materials of construction-
Pump housing | Same for subject and predicate
CADD®-Solis Pumps | Same for subject and predicate
CADD®-Solis Pumps | Same for subject and predicate
CADD®-Solis Pumps | |
| Characteristic | Subject Device
CADD®-Solis Version 3.0 Pump
Color display with 320 x 320 pixels | Predicate Device
CADD®-Solis VIP Version 1.2 Pump
Color display with 320 x 320 pixels | Predicate Device
CADD®-Solis Version 1.0 Pump
Color display with 320 x 320 pixels | |
| Display
Available with gray keypad
(denoting general use) | Yes | Yes | Yes | |
| Available with yellow
keypad (denoting epidural
use) | Yes | No | Yes | |
| Remote dose cord supplied
with device | Yes | No | Yes | |
| Power requirements | 4 ("AA") batteries
AC adapter
Rechargeable battery pack | 4 ("AA") batteries
AC adapter
Rechargeable battery pack | 4 ("AA") batteries
AC adapter
Rechargeable battery pack | |
| Printing capabilities | No | No | No | |
| Remote communications
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
reservoir | Yes | Yes | Yes | |
| Administration Set | Yes | Yes | Yes | |
| Extension Set | Yes | Yes | Yes | |
| Programming Functions | | | | |
| Intermittent (programmed
intermittent bolus) | Yes | Yes | No | |
| Continuous infusion | Yes | Yes | Yes | |
| Continuous infusion with
bolus (PCA) | Yes | Yes | Yes | |
| Characteristic | Subject Device CADD®-Solis Version 3.0 Pump | Predicate Device CADD®-Solis VIP Version 1.2 Pump | Predicate Device CADD®-Solis Version 1.0 Pump | |
| Step | No | Yes | No | |
| Taper | No | Yes | No | |
| Security | Yes | Yes | Yes | |
| Demand dose lockout | Yes | Yes | Yes | |
| Delivery limit | Yes | Yes | Yes | |
| Programmable titration limits | Yes | Yes | Yes | |
| Titration feature available while running | Yes | Yes | Yes | |
| Programmable maximum rate | Yes | Yes | Yes | |
| Cassette/disposable type supported | High flow and standard flow disposables | High flow and standard flow disposables | Standard flow disposables only | |
| Epidural mode | Yes | Yes | Yes | |
| Alarms | | | | |
| Low battery | Yes | Yes | Yes | |
| Depleted battery | Yes | Yes | Yes | |
| External power source low | Yes | Yes | Yes | |
| 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 | |
| Air-in-line | Yes | Yes | Yes | |
| Key stuck | Yes | Yes | Yes | |
| Infusion Specifications | | | | |
| Reservoir volume | 1 to 9999 mL | 1 to 9999 mL | 1 to 9999 mL | |
| Minimum continuous delivery rate | 0 mL/hr | 0 mL/hr | 0 mL/hr | |
| Characteristic | Subject Device
CADD®-Solis Version 3.0 Pump | Predicate Device
CADD®-Solis VIP Version 1.2 Pump | Predicate Device
CADD®-Solis Version 1.0 Pump | |
| Maximum continuous
delivery rate | 100 mL/hr | 100 mL/hr in PCA mode
500 mL/hr in Continuous, Intermittent, Taper, Step modes | 30 mL/hr | |
| Maximum bolus delivery
rate | 250mL with standard flow disposable
500mL with high flow disposable | 250mL with standard flow disposable in
PCA mode | 175mL with standard flow disposable | |
| Maximum patient bolus | 50 mL | 50 mL | 20 mL | |
| Maximum clinician bolus | 50 mL | 50 mL | 20 mL | |
| Programmable maximum
delivery rate (continuous
rate + bolus) | Yes
500 mL/hour, with high flow disposable | Yes
250 mL/hour, with standard flow
disposable | Yes
175 mL/hour, with standard flow
disposable | |
| 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 | |
he CADD®-Solis Version 2.0 Pump is marketed solely outside of the United States at this time
4
5
Medication Safety So
6
7
8
| Characteristic | Version 3.1 | Version 2.0 | Version 1.2 | |
|---|---|---|---|---|
| General Information. | ||||
| Manufacturer | Smiths Medical ASD, Inc. | Smiths Medical ASD, Inc. | Smiths Medical ASD, Inc. | |
| 510(k) notification number | ||||
| and substantial equivalence | ||||
| determination date | K130394, pending | K111275. February 1, 2013 | K072144 (Administrator), March 7, 2008 | |
| K082783 (Point of Care), December 17, 2008 | ||||
| Software revision level | 3.1 | 2.0 | 1.2 | |
| Summary of | ||||
| changes/rationale for | ||||
| submission | Updated medication safety software | |||
| applications to support intermittent | ||||
| bolus parameters in the CADD®-Solis | ||||
| Pump Version 3.0. | Updated medication safety software | |||
| applications to support the five delivery | ||||
| modes (PCA, continuous, intermittent, | ||||
| step, and taper) in the CADD®-Solis VIP | ||||
| Pump. | Initial release. | |||
| Indications for use | 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-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-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 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 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 | 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 | 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). | ||||
| Characteristic | ||||
| General Information | Version 3.1 | |||
| (software revision H or higher) | CADD -Solis Medication Safety Software | |||
| : Version 2.0 | ||||
| Pump (software revision H or higher) | Version 1.2 | |||
| Pump compatibility | CADD®-Solis VIP Ambulatory | |||
| Infusion Pump. CADD®-Solis | ||||
| Ambulatory Infusion Pump and | ||||
| CADD-Prizm® PCS II 6101 (rev H and | ||||
| higher) | CADD®-Solis VIP Ambulatory Infusion | |||
| Pump, CADD®-Solis Ambulatory | ||||
| Infusion Pump and CADD-Prizm® PCS | ||||
| II 6101 (rev H and higher) | CADD®-Solis Ambulatory Infusion | |||
| Pump model 2100 and 2110, and | ||||
| CADD-Prizm® PCS II 6101 (rev H | ||||
| and higher) | ||||
| Accessory compatibility | P/N 21-6144, Interface cable/null | |||
| modem cable for CADD-Prizm® pump | ||||
| USB cable for the CADD®-Solis VIP | ||||
| pump, and CADD®-Solis pump | P/N 21-6144, Interface cable/null | |||
| modem cable for CADD-Prizm® pump | ||||
| USB cable for the CADD®-Solis VIP | ||||
| pump, and CADD®-Solis pump | P/N 21-6144, Interface cable/null | |||
| modem cable for CADD-Prizm® | ||||
| pump | ||||
| USB cable for the CADD®-Solis | ||||
| pump | ||||
| PC software compatibility | Windows 2000, XP, VISTA, | |||
| Windows 7 | ||||
| Administrator only: Windows Server | ||||
| 2003, Server 2008, Server 2008R | Windows 2000, XP, VISTA | Windows 2000, XP | ||
| Windows Server 2003 | ||||
| Computer equipment | RS-232 serial port, USB, and CD-ROM | RS232 serial port, USB, and CD-ROM | RS232 serial port, USB, and CD- | |
| ROM | ||||
| System Features | ||||
| Protocol Programming | Yes | Yes | Yes | |
| View Reports | Yes | Yes | Yes | |
| Print Reports | Yes | Yes | Yes | |
| Save Reports | Yes | Yes | Yes | |
| Event Log Viewing | Yes | Yes | Yes | |
| Rx (pump) History/Settings | ||||
| Viewing | Yes | Yes | Yes | |
| CQI data Collection and | ||||
| Retrieval | Yes | Yes | Yes | |
| Wt based programming | ||||
| (PCA mode) | Yes | Yes | Yes | |
| BarCode Printing | Yes | Yes | Yes | |
| Password Protected | Yes | Yes | Yes | |
| Second Nurse Verification | Yes | Yes | Yes | |
| Drug ID verification | Yes | Yes | Yes | |
| Characteristic | CADD "-Solis Medication Safety Software" | Version 3.1 | Version 2.0 | Version 1.2 |
| General Information | ||||
| Programming Features | ||||
| Bolus Programming | Yes | Yes | Yes | |
| Concentration Programming | Yes | Yes | Yes | |
| Continuous Rate Programming | Yes | Yes | Yes | |
| Demand Dose Programming | Yes | Yes | Yes | |
| Demand Dose Lockout programming | Yes | Yes | Yes | |
| Max Patient Weight (ranges) | Yes | Yes | Yes | |
| Epidural Mode on/off | Yes | Yes | Yes | |
| PRN Patient Feature | Yes | Yes | Yes | |
| Program Limits (Soft and Hard Limits) programming | Yes | Yes | Yes | |
| Low Med Infusion Pump programming | Yes | Yes | Yes | |
| Pump/Module ID Storage Retrieval | Yes | Yes | Yes | |
| Date/Time Format | Yes | Yes | Yes | |
| Report/Alarm/Messages/Features | ||||
| Pump Setting Reports | Yes | Yes | Yes | |
| Continuous Quality Indicator Reports | Yes | Yes | Yes | |
| Bolus Limits Exceeded | Yes | Yes | Yes | |
| Rate Limits Exceeded | Yes | Yes | Yes | |
| Defective Alarms/Messages | Yes | Yes | Yes | |
| User Customizable | Yes | Yes | Yes | |
| Config bar code scan incorrect | Yes | Yes | Yes | |
| Pump/Module Power Status | Yes | Yes | Yes |
CADD™-Solis Medication Safety Software Version 3.1, Version 2.0, and Version 1.2 Comparison Tabl
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Image /page/11/Picture/0 description: The image shows a logo for the Department of Health and Human Services - USA. The logo consists of a symbol with three curved lines and the text "DEPARTMENT". The image is black and white and appears to be a scan of a document.
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
December 9, 2013
Smiths Medical ASD, Incorporated Ms. Julie Tapper Sr. Regulatory Affairs Specialist 1265 Grey Fox Road St. Paul, MN 55112
Re: K130394
Trade/Device Name: CADD® - Solis Ambulatory Infusion Pump, Model 3.0 CADD® - Solis Medication Safety Software, Version 3.1 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA, MEA, MRZ Dated: November 4, 2013 Received: November 5, 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer for
Erin 1. Keith, M.S. Acting 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) K130394
Device Name
The CADD &-Solis Ambulatory Infusion Pump, Model2110, Version 3.0
Indications for Use (Describe)
The CADD® -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0, is indicated for intravenous, intreasterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an insue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is interapies that require a continuous rate of infusion, and/or an internittent bolus, and/or with patient-controlled demand doses.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Kathleen E. Fit
Digitally signed by Kathleen E. Fitzgerald DN: c=US, o=U.S. Govemment, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=0010093027, cn=Kathleen E. Fitzgerald Date: 2013.12.05 11:30:39 -05'00'
FORM FDA 3881 (9/13)
PSC Publishing Serviors (1011 413-6720 F
: *
... ...
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
- : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K130394
Device Name
The CADD®-Solis Medication Safety Software, Version 3.1
Indications for Use (Describe)
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 Infision Pump, CADD®-Solis Ambulatory Infusion Pump, or CADD-Prizen® 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 develojed by the CADD™Solis Medication Safety Software.- Administrator to the CADD-Solis Ambulatory Infision Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
Image /page/15/Figure/12 description: This image shows a document with the heading "FOR FDA USE ONLY". It contains the signature of Kathleen E. Fitzgerald, along with a digital signature block that includes details such as the DN, date, and time of signing (2013.12.05 11:31:46 -05'00'). The document is identified as FORM FDA 3881 (9/13).
Page 1 of 2
16
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."