(297 days)
The CADD® -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0, 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).
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.
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 provided text describes the CADD®-Solis Ambulatory Infusion Pump, Model 2110, Version 3.0, and the CADD™-Solis Medication Safety Software, Version 3.1. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with reported performance metrics.
Here's a breakdown of the requested information based on the provided text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" or provide "reported device performance" against those criteria in a table format. Instead, it relies on demonstrating equivalence through design verification, software validation, and human-factors engineering studies, concluding that "All testing met pre-established specifications."
Instead of a typical acceptance criteria table for a diagnostic device, the document presents a comparison table between the new device and predicate devices for various characteristics and infusion specifications. This table essentially defines the design and functional characteristics that were evaluated for equivalence.
Since direct "acceptance criteria" and "reported performance" like sensitivity/specificity for a medical device are not specified for this infusion pump and software, I cannot create that table. However, I can infer from the comparison tables that the acceptance for this 510(k) submission primarily involved demonstrating that the new device's characteristics and performance are comparable to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical study or a dataset for evaluating an AI algorithm. The testing described is "design verification and software validation testing" and "human-factors engineering studies."
- Sample Size: Not applicable/not provided for a "test set" in the context of clinical performance evaluation. The testing would have involved engineering and software quality assurance methods.
- Data Provenance: Not applicable/not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is typically relevant for studies validating diagnostic algorithms or interpretations. For an infusion pump and its associated software, "ground truth" would be established through engineering specifications, regulatory standards, and functional testing protocols rather than expert consensus on medical findings.
- Number of Experts: Not applicable/not provided.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication Method
This is also typically relevant for studies involving human interpretation. For design verification and software validation of an infusion pump and software, adjudication methods (like 2+1, 3+1) are not typically used. Testing outcomes are usually determined by passing or failing pre-defined engineering and functional requirements.
- Adjudication Method: Not applicable/not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The document explicitly states: "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."
- Effect Size with AI vs. without AI assistance: Not applicable, as there was no MRMC study and the devices are an infusion pump and its safety software, not an AI diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: Yes, in a sense, as design verification and software validation would assess the device's inherent performance capabilities without direct human-in-the-loop performance measurement against a clinical outcome. However, this is not in the context of an "algorithm" in the way it's usually asked for AI diagnostic devices. The performance testing was of the "algorithm" of the pump's operating system and the software's functionality. The "Testing Conclusion" states: "All testing met pre-established specifications, and successfully demonstrated that the devices performed as intended."
7. Type of Ground Truth Used
The "ground truth" for this type of device would be based on:
- Engineering Specifications: Pre-defined functional requirements and performance parameters for mechanical, electronic, and software components.
- Regulatory Standards: Compliance with relevant national and international medical device standards.
- Functional Testing Protocols: Measured outputs and behaviors of the pump and software across various operating conditions.
8. Sample Size for the Training Set
This product is not described as an AI/ML device that requires a "training set" in the conventional sense (e.g., for image classification or prediction tasks). Therefore:
- Sample Size for Training Set: Not applicable/not provided.
9. How Ground Truth for the Training Set was Established
As this is not an AI/ML device requiring a training set with medical "ground truth":
- How Ground Truth for Training Set was Established: Not applicable/not provided.
Summary of Study that Proves the Device Meets Acceptance Criteria:
The study described is a combination of:
- Design Verification and Software Validation Testing: This rigorously evaluated the CADD®-Solis Version 3.0 Pump and the CADD™-Solis Medication Safety Software-Administrator and Point of Care against pre-established engineering specifications and software requirements. This type of testing ensures that the device and software function as intended and meet all design inputs.
- Human-Factors Engineering Studies: These studies assessed the usability and user interface of the device and software, ensuring that they can be operated safely and effectively by users.
- Substantial Equivalence Comparison: The submission primarily relies on demonstrating that the new devices are substantially equivalent to previously cleared predicate devices (CADD®-Solis Ambulatory Infusion Pump, Models 2100/2110 Version 1.0, and CADD®-Solis VIP Ambulatory Infusion Pump, Model 2120 Version 2.0; and CADD™-Solis Medication Safety Software Versions 1.2 and 2.0). The detailed comparison tables (pages 4-8 and 9-10 of the original document) highlight the similarities in intended use, technological characteristics, and performance features between the new and predicate devices.
The "Testing Conclusion" states: "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."
This indicates that the "acceptance criteria" were essentially the fulfillment of all design and software requirements and the demonstration of substantial equivalence to predicate devices through comprehensive non-clinical testing. No clinical studies were deemed necessary.
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510(k) Summary
DEC - 9 2013
DATE PREPARED: December 3, 2013
I. GENERAL INFORMATION
| Applicant's Nameand Address: | Smiths Medical ASD, Inc.1265 Grey Fox RoadSt. Paul, MN 55112 |
|---|---|
| Contact Person: | Paula CorderoSr. Manager, Global Regulatory Affairs |
| Common/UsualName: | 1) Ambulatory Infusion Pump2) Pump Communications System |
| Proprietary Name: | 1) CADD®-Solis Ambulatory Infusion Pump, Model 2110, Version 3.02) CADDTM-Solis Medication Safety Software, Version 3.1 |
| Equivalence DeviceComparison: | 1) CADD®-Solis Ambulatory Infusion Pump, Model 2100or Model 2110, Version 1.02) CADD®-Solis VIP Ambulatory Infusion Pump, Model 2120,Version 2.03) CADDTM-Solis Medication Safety Software Version 1.24) 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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| And Control Concession Company Controllera man and the many ha-100 0 000 000 000 0001 | |
|---|---|
CADD®-Solis Version 3.0, CADD*-Solis VIP Version 1.2, and CADD® Solis Version 1.0 Pump Comparison Table
| Characteristic | General Information | Subject DeviceCADD®-Solis Version 3.0 Pump | Predicate DeviceCADD®-Solis VIP Version 1.2 Pump | Predicate DeviceCADD®-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 numberand substantial equivalencedetermination date | ||||
| Pump model number | 2110 | 2120 | 2100 or 2110 | |
| Pump firmware version | 3.0 | 1.2 | 1.0 | |
| Product description | The CADD®-Solis Ambulatory InfusionPump. Model 2110, Version 3.0,provides measured drug therapy topatients in hospital or outpatientsettings. The pump can be programmedwith a protocol configuration consistingof a therapy, qualifier, and drug.Medication is delivered at a constantrate, and/or with a clinician bolus,and/or with a patient dose, and/or withprogrammed intermittent boluses. | The CADD®-Solis VIP (variableinfusion profile) Ambulatory InfusionPump, Model 2120, provides measureddrug therapy to patients in hospital,outpatient and homecare settings.The pump can be programmed with apump protocol configuration consistingof a therapy, qualifier, and drug. Thepump can deliver medication via patientcontrolled analgesia (PCA), continuous,intermittent, variable stepped rate, andtapered infusions. | The CADD®-Solis Ambulatory InfusionPump. Model 2100 or 2110, Version1.0, provides measured drug therapy topatients in hospital or outpatientsettings. The pump can be programmedwith a protocol configuration consistingof a therapy, qualifier, and drug.Medication is delivered at a constantrate, and/or with an intermittent bolus,and/or with a patient dose. | |
| Characteristic | Subject DeviceCADD®-Solis Version 3.0 Pump | DevicePredicate DeviceCADD®-Solis VIP Version 1.2 Pump | Predicate DeviceCADD®-Solis Version 1.0 Pump | |
| Indications for use | The CADD®-Solis Ambulatory InfusionPump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal,in close proximity to nerves, into anintraoperative site (soft tissue, bodycavity/surgical wound site), epiduralspace, or subarachnoid space infusion.The pump is intended for therapies thatrequire a continuous rate of infusion,and/or an intermittent bolus, and/or withpatient-controlled demand doses. | The CADD®-Solis VIP AmbulatoryInfusion Pump is indicated forintravenous, intra-arterial,subcutaneous, intraperitoneal,perineural, surgical site, epidural space,or subarachnoid space infusion.PCA (patient-controlled analgesia)delivery is used for therapies thatrequire a continuous rate of infusion,patient-controlled demand doses, orboth, such as patient-controlledanalgesia.Continuous delivery allows theinfusion of drug/fluid at a constant,programmed rate.Intermittent delivery allows theinfusion of a specific volume ofdrug/fluid at a regular, programmedinterval.Step delivery allows an incrementalincrease in infusion rate to a specifiedmaximum infusion rate for a specifiedtotal infusion volume.Taper delivery allows a plateau rate ofinfusion with the option of tapering atthe beginning and/or end and has aprogrammable KVO rate at the end ofthe infusion. | The CADD®-Solis Ambulatory InfusionPump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal,in close proximity to nerves, into anintraoperative site (soft tissue, bodycavity/surgical wound site), epiduralspace, or subarachnoid space infusion.The pump is intended for therapies thatrequire a continuous rate of infusion,patient-controlled demand doses, orboth (such as patient-controlledanalgesia). | |
| System FeaturesPump type/principle ofoperation | Linear peristaltic | Linear peristaltic | Linear peristaltic | |
| Materials of construction-Pump housing | Same for subject and predicateCADD®-Solis Pumps | Same for subject and predicateCADD®-Solis Pumps | Same for subject and predicateCADD®-Solis Pumps | |
| Characteristic | Subject DeviceCADD®-Solis Version 3.0 PumpColor display with 320 x 320 pixels | Predicate DeviceCADD®-Solis VIP Version 1.2 PumpColor display with 320 x 320 pixels | Predicate DeviceCADD®-Solis Version 1.0 PumpColor display with 320 x 320 pixels | |
| DisplayAvailable with gray keypad(denoting general use) | Yes | Yes | Yes | |
| Available with yellowkeypad (denoting epiduraluse) | Yes | No | Yes | |
| Remote dose cord suppliedwith device | Yes | No | Yes | |
| Power requirements | 4 ("AA") batteriesAC adapterRechargeable battery pack | 4 ("AA") batteriesAC adapterRechargeable battery pack | 4 ("AA") batteriesAC adapterRechargeable battery pack | |
| Printing capabilities | No | No | No | |
| Remote communicationscapabilities | 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 cassettereservoir | Yes | Yes | Yes | |
| Administration Set | Yes | Yes | Yes | |
| Extension Set | Yes | Yes | Yes | |
| Programming Functions | ||||
| Intermittent (programmedintermittent bolus) | Yes | Yes | No | |
| Continuous infusion | Yes | Yes | Yes | |
| Continuous infusion withbolus (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 DeviceCADD®-Solis Version 3.0 Pump | Predicate DeviceCADD®-Solis VIP Version 1.2 Pump | Predicate DeviceCADD®-Solis Version 1.0 Pump | |
| Maximum continuousdelivery rate | 100 mL/hr | 100 mL/hr in PCA mode500 mL/hr in Continuous, Intermittent, Taper, Step modes | 30 mL/hr | |
| Maximum bolus deliveryrate | 250mL with standard flow disposable500mL with high flow disposable | 250mL with standard flow disposable inPCA 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 maximumdelivery rate (continuousrate + bolus) | Yes500 mL/hour, with high flow disposable | Yes250 mL/hour, with standard flowdisposable | Yes175 mL/hour, with standard flowdisposable | |
| Patient-controlled accessPCA (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
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Medication Safety So
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| 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 numberand substantial equivalencedetermination date | K130394, pending | K111275. February 1, 2013 | K072144 (Administrator), March 7, 2008K082783 (Point of Care), December 17, 2008 | |
| Software revision level | 3.1 | 2.0 | 1.2 | |
| Summary ofchanges/rationale forsubmission | Updated medication safety softwareapplications to support intermittentbolus parameters in the CADD®-SolisPump Version 3.0. | Updated medication safety softwareapplications to support the five deliverymodes (PCA, continuous, intermittent,step, and taper) in the CADD®-Solis VIPPump. | Initial release. | |
| Indications for use | CADD™-Solis Medication SafetySoftware-AdministratorThe CADD™-Solis Medication SafetySoftware - Administrator allows use ofa computer to create therapy-basedprotocol libraries to be used with theCADD®-Solis VIP AmbulatoryInfusion Pump, CADD®-SolisAmbulatory Infusion Pump, or CADD-Prizm® PCS II Ambulatory InfusionPump (software revision H or higher). | CADD™-Solis Medication SafetySoftware-Administrator:The CADD™-Solis Medication SafetySoftware - Administrator allows use of acomputer to create therapy basedprotocol libraries to be used with theCADD®-Solis VIP Ambulatory InfusionPump, CADD®-Solis AmbulatoryInfusion Pump or CADD-Prizm® PCS IIAmbulatory Infusion Pump (softwarerevision H or higher). | CADD™-Solis Medication SafetySoftware-AdministratorThe CADD™-Solis Medication SafetySoftware - Administrator allows useof a computer to create therapy basedprotocol libraries to be used with theCADD®-Solis Ambulatory InfusionPump or CADD-Prizm® PCS IIAmbulatory Infusion Pump (softwarerevision H or higher). | |
| CADD™-Solis Medication SafetySoftware-Point of CareThe CADD™-Solis Medication SafetySoftware - Point of Care allows use ofa computer to send therapy-basedprotocols developed by the CADD™-Solis Medication Safety Software -Administrator to the CADD®-SolisAmbulatory Infusion Pump andCADD-Prizm® PCS II Ambulatory | CADD™-Solis Medication SafetySoftware - Point of Care:The CADD™-Solis Medication SafetySoftware - Point of Care allows use of acomputer to send therapy-basedprotocols developed by the CADD™.Solis Medication Safety Software -Administrator to the CADD®-SolisAmbulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion | CADD™-Solis Medication SafetySoftware - Point of CareThe CADD™-Solis Medication SafetySoftware - Point of Care allows use ofa computer to send therapy-basedprotocols developed by the CADD®-Solis Medication Safety SoftwareAdministrator to the CADD®-SolisAmbulatory Infusion Pump andCADD-Prizm® PCS II AmbulatoryInfusion Pump (software revision H orhigher). | ||
| CharacteristicGeneral Information | Version 3.1(software revision H or higher) | CADD -Solis Medication Safety Software: Version 2.0Pump (software revision H or higher) | Version 1.2 | |
| Pump compatibility | CADD®-Solis VIP AmbulatoryInfusion Pump. CADD®-SolisAmbulatory Infusion Pump andCADD-Prizm® PCS II 6101 (rev H andhigher) | CADD®-Solis VIP Ambulatory InfusionPump, CADD®-Solis AmbulatoryInfusion Pump and CADD-Prizm® PCSII 6101 (rev H and higher) | CADD®-Solis Ambulatory InfusionPump model 2100 and 2110, andCADD-Prizm® PCS II 6101 (rev Hand higher) | |
| Accessory compatibility | P/N 21-6144, Interface cable/nullmodem cable for CADD-Prizm® pumpUSB cable for the CADD®-Solis VIPpump, and CADD®-Solis pump | P/N 21-6144, Interface cable/nullmodem cable for CADD-Prizm® pumpUSB cable for the CADD®-Solis VIPpump, and CADD®-Solis pump | P/N 21-6144, Interface cable/nullmodem cable for CADD-Prizm®pumpUSB cable for the CADD®-Solispump | |
| PC software compatibility | Windows 2000, XP, VISTA,Windows 7Administrator only: Windows Server2003, Server 2008, Server 2008R | Windows 2000, XP, VISTA | Windows 2000, XPWindows 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/SettingsViewing | Yes | Yes | Yes | |
| CQI data Collection andRetrieval | 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).
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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."
§ 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).