(143 days)
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication
CADD®-Solis Infusion Pump, Model 2110
The CADD®-Solis 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. The pump is intended for therapies that require a continuous rate of infermittent bolus, and/or with patientcontrolled demand doses.
PharmGuard® Administrator Medication Safety Software
The PharmGuard® Administrator Medication Safety Software allows the use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis Infusion Pump.
CADD® Administration Set
The CADD® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container.
Wireless Communication Module (CM)
The Wireless Communication Module is intended to be used as an accessory to provide wireless capability and battery power to a CADD®-Solis Infusion Pump, Model 2110
The CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD®-Solis Infusion Pump, Model 2110, the Wireless Communication Module (CM), and the PharmGuard® Administrator Medication Safety Software, work together to provide wireless communication between the pump and the server and are similar to currently marketed products.
The CADD®-Solis Infusion Pump, Model 2110 has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump, Version 3.0 (K130394). The user activates CADD®-Solis Infusion Pump, Model 2110 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® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container. The Flow Stop feature is a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump. The Flow Stop is located on the set housing, which is attached to the pump.
The provided text is a 510(k) summary for the CADD®-Solis Ambulatory Infusion Pump with Wireless Communication. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific, novel acceptance criteria through a dedicated study with statistical endpoints. Therefore, many of the requested categories for a rigorous clinical or performance study involving AI or human readers are not applicable or cannot be extracted from this type of regulatory document.
However, I can extract information related to the performance testing and how the device's modifications are verified.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of specific acceptance criteria with corresponding performance metrics in a quantitative manner as one might expect from a statistically powered study. Instead, it states that "All the testing met the acceptance criteria." and "Device testing met pre-defined acceptance criteria and did not raise new or different question of safety or effectiveness." The criteria are largely described by adherence to relevant standards and a safety assurance case.
| Aspect of Performance | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| Overall System Safety & Effectiveness | The CADD-Solis Ambulatory Infusion Pump System is reasonably safe for use in its intended environment by its intended users; modifications do not raise new or different questions of safety and effectiveness. | Achieved through non-clinical testing. |
| Pump Firmware Update (Version 4.1) | Verified with software testing in accordance with IEC 62304:2006 (Medical device software life cycle process) and FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Met acceptance criteria. |
| Wireless Data Transmission (via CM) | Design Verification and Validation testing demonstrates the wireless data transmission as meeting the acceptance criteria and intended use. | Met acceptance criteria. |
| CM Accessory Power Performance | Performance of the CM accessory was verified and validated through bench testing, demonstrating a similar type of power source to the predicate's standalone rechargeable battery pack. | Met acceptance criteria. |
| PC Software Compatibility (Windows 8 support) | Verified with software testing in accordance with IEC 62304:2006 and FDA's software guidance. | Met acceptance criteria. |
| Multi-line Drug Names (Software Feature) | Verified with software testing in accordance with IEC 62304:2006 and FDA’s software guidance. Validated with Human Factors testing (enhancing ease of use). | Met acceptance criteria; validated for ease of use. |
| Profiles Function (Software Feature) | Verified with software testing in accordance with IEC 62304:2006 and FDA’s software guidance. Validated with Human Factors testing. | Met acceptance criteria; validated. |
| Daylight Savings Time Auto Adjust Feature (Software) | Verified with software testing in accordance with IEC 62304:2006 and FDA’s software guidance. | Met acceptance criteria. |
| Asset ID Feature (Software) | Verified with software testing in accordance with IEC 62304:2006 and FDA’s software guidance. Validated with Human Factors testing. | Met acceptance criteria; validated. |
| Administration Sets (Intrathecal Use) | Freedom from unacceptable neurotoxicological risk (established through GLP pre-clinical neurotoxicity studies), appropriate chemical characterization, and toxicology assessment. Biocompatibility studies in accordance with ISO 10993-1:2009. | Met acceptance criteria. |
| Basic Safety & Essential Performance of Infusion Pump | In accordance with IEC 60601-1. | Met acceptance criteria. |
| Human Factors / Usability Engineering | Effectiveness of use error related mitigations in accordance with FDA's "Applying Human Factors and Usability Engineering to Medical Devices" and IEC 62366-1:2007. | Conducted and validated. |
| Electrical and Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1, IEC 60601-1-12, IEC 60601-1-2, IEC 60601-1-6:2013, 2054 UL Standard for Safety Household and Commercial Batteries, IEC 62122, and "Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers." | Complies with listed standards. |
| Software Verification and Validation | Per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," and IEC 62304:2006. | Met acceptance criteria for V&V. |
| Cleaning and Disinfection Validation | Confirmed that the new accessories meet cleaning and disinfection requirements. | Met acceptance criteria. |
| Packaging and Shipping Verification | In accordance with ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems. | Conducted in accordance with the standard. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of a statistical study with a defined sample size (e.g., number of patients or cases). The testing performed is described as "non-clinical performance testing," "design verification and validation testing," and "software testing." Provenance is not applicable to this type of testing (e.g., no patient data is mentioned).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a 510(k) submission for an infusion pump and its accessories, not an AI/diagnostic device that relies on expert interpretation of data to establish ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI diagnostic tool and does not employ "human readers" in the context of interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (the infusion pump system and its software/accessories) in delivering medication and communicating data. The non-clinical performance testing, design verification, and validation studies serve this purpose. The document states that these tests demonstrate "the device is substantially equivalent to the legally marketed predicate device."
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Engineering specifications and design inputs: The device is tested against its own design requirements.
- Industry standards: Compliance with standards like IEC 60601-1, IEC 62304, ISO 10993-1, etc.
- Predicate device characteristics: The new device's performance characteristics are compared to those of the legally marketed predicate devices (K130394 and K040636) to demonstrate substantial equivalence.
- GLP (Good Laboratory Practice) pre-clinical studies: For the new intrathecal indication of the administration sets, studies were conducted to show freedom from unacceptable neurotoxicological risk.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as #8.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2017
Smiths Medical ADS, Inc. Breanna Fautsch Regulatory Affairs Specialist 6000 Nathan Lane North Minneapolis, Minnesota 55442
Re: K170982
Trade/Device Name: CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MEA, MRZ, FPA, PYR Dated: July 24, 2017 Received: July 20, 2017
Dear Ms. Fautsch:
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.
{1}------------------------------------------------
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 devicerelated 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 Industry and Consumer Education (DICE) at its toll-free 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tara A. Ryan -S
for Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K170982
Device Name
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; Pharm Guard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM)
Indications for Use (Describe)
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication
CADD®-Solis Infusion Pump, Model 2110
The CADD®-Solis 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. The pump is intended for therapies that require a continuous rate of infermittent bolus, and/or with patientcontrolled demand doses.
PharmGuard® Administrator Medication Safety Software
The PharmGuard® Administrator Medication Safety Software allows the use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis Infusion Pump.
CADD® Administration Set
The CADD® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container.
Wireless Communication Module (CM)
The Wireless Communication Module is intended to be used as an accessory to provide wireless capability and battery power to a CADD®-Solis Infusion Pump, Model 2110
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{3}------------------------------------------------
K170982 510(K) SUMMARY
| Manufacturer's Name: | Smiths Medical |
|---|---|
| Corresponding Official: | Breanna Fautsch, Regulatory SpecialistSmiths Medical ASD, Inc6000 Nathan Lane NorthMinneapolis, Minnesota 55442 |
| Telephone Number: | 763-383-3258 |
| E-mail: | Breanna.Fautsch@smiths-medical.com |
| Preparation Date: | August 25, 2017 |
| Trade Name: | CADD®- Solis Ambulatory Infusion Pump with Wireless CommunicationCADD®-Solis Infusion Pump, Model 2110PharmGuard® Administrator Medication Safety SoftwareCADD® Administration SetsWireless Communication Module (CM) |
| Common or Usual Name: | Infusion Pump |
| Regulation Name:Regulation Number:Product Code:Device Class: | Infusion Pump21 CFR 880.5725FRN - Infusion PumpMRZ - Infusion Pump AccessoriesFPA - Set, Administration, IntravascularPYR- Neuraxial Administration Set - Intrathecal deliveryClass II |
| Primary Predicate Device: | K130394 |
| Secondary Predicate Device: | K040636 |
Device Description
The CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD®-Solis Infusion Pump, Model 2110, the Wireless Communication Module (CM), and the PharmGuard® Administrator Medication Safety Software, work together to provide wireless communication between the pump and the server and are similar to currently marketed products.
The CADD®-Solis Infusion Pump, Model 2110 has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump, Version 3.0 (K130394). The user activates CADD®-Solis Infusion Pump, Model 2110 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.
{4}------------------------------------------------
The CADD® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container. The Flow Stop feature is a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump. The Flow Stop is located on the set housing, which is attached to the pump.
Intended Use
The CADD®- Solis Ambulatory Infusion Pump with Wireless Communication is intended to be used for patient care for adult and pediatric patients in multiple care areas, including but not limited to post-operative, trauma, critical care, oncology, and labor and delivery. 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.
Indications for Use Statement
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication
CADD®-Solis Infusion Pump, Model 2110
The CADD®-Solis 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. The pump is intended for therapies that require a continuous rate of infermittent bolus, and/or with patientcontrolled demand doses.
PharmGuard® Administrator Medication Safety Software
The PharmGuard® Administrator Medication Safety Software allows the use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis Infusion Pump.
CADD® Administration Set
The CADD® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container.
Wireless Communication Module (CM)
The Wireless Communication Module is intended to be used as an accessory to provide wireless capability and battery power to a CADD®-Solis Infusion Pump, Model 2110
Substantial Equivalence Discussion
The CADD®- Solis Ambulatory Infusion Pump with Wireless Communication (pump and accessories) covered by this submission is the result of modifications to the FDA cleared CADD-Solis Ambulatory Infusion Pumps, Model 2110 Version 3.0 (K130394), CADD-Solis Medication Safety Software Version 3.1 (K130394) and CADD® Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop (K040636).
The modifications include user interface updates to a software version 4.1 and the capability of the pump to support a new optional accessory device, the Wireless Communication Module (CM). The CM connects through the battery compartment on the CADD®-Solis Infusion Pump, Model 2110 in order to wirelessly connect the pump to the Smiths Medical PharmGuard® Server. The administration sets subject devices are the predicate devices with the exception of the indication which now includes intrathecal use when utilized with the CADD®-Solis Infusion Pump, Model 2110.
Comparison of Indications for Use Statements
The tables below identifies and provides comparative assessments of the indications for use between the CADD®-Solis Infusion Pump. Model 2110, PharmGuard® Administrator Medication Safety Software, and CADD® Administration Sets subject device and predicate as required per 21 CFR 807.92.
| Indications for Use – Infusion Pump | |
|---|---|
| Subject Device (K170982) | Predicate Device (K130394) |
| CADD®-Solis Infusion Pump, Model 2110 | The CADD®-Solis Ambulatory Infusion Pump, |
{5}------------------------------------------------
| Model2110, Version 3.0 | |
|---|---|
| CADD®-Solis Infusion Pump, Model 2110 | The CADD® -Solis Ambulatory Infusion Pump, Model |
| The CADD®-Solis Version 4.1 Pump is indicated for | 2110, Version 3.0, is indicated for intravenous, intra- |
| intravenous, intra-arterial, subcutaneous, intraperitoneal, | arterial, subcutaneous, intraperitoneal, in close proximity |
| in close proximity to nerves, into an intraoperative site | to nerves, into an intraoperative site (soft tissue, body |
| (soft tissue, body cavity/surgical wound site), epidural | cavity/surgical wound site), epidural space, or |
| space or subarachnoid space. The pump is intended for | subarachnoid space infusion. The pump is intended for |
| therapies that require a continuous rate of infusion, and/or | therapies that require a continuous rate of infusion, and/or |
| an intermittent bolus, and/or with patient-controlled | an intermittent bolus, and/or with patient-controlled |
| demand doses. | demand doses. |
The indications for use statements are identical.
| Indications for Use – Medication Safety Software | |
|---|---|
| Subject Device (K170982) | Predicate Device (K130394) |
| PharmGuard® Administrator Medication SafetySoftware | The CADD®-Solis Medication Safety Software,Version 3.1 |
| The PharmGuard® Administrator Medication SafetySoftware allows the use of a computer to create therapy-based protocol libraries to be used with the CADD®-SolisInfusion Pump. | 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®-SolisAmbulatory Infusion Pump, or CADD-Prizm® PCS IIAmbulatory Infusion Pump (software revision H orhigher).The CADD™-Solis Medication Safety Software- Point ofCare allows use of a computer to send therapy-basedprotocols develojed by the CADD™Solis MedicationSafety Software.- Administrator to the CADD -SolisAmbulatory Infusion Pump and CADD-Prizm® PCS IIAmbulatory Infusion Pump (software revision H orhigher). |
Discussion of Differences
The predicate device provides two statements, one for administrative users and one for point of care users to reflect the two separate software products. However, the subject device product and multiple user profiles within the software product. Therefore, a single indications statement is appropriate. There are no differences in the core language of the indications for use statements.
| Indications for Use – Administration Sets | |
|---|---|
| Subject Device (K170982)CADD® Administration Set | Predicate Device (K040636)CADD® Medication Cassette Reservoir with Flow StopCADD® Administration Set with Flow Stop |
| The CADD® Administration Set is designed for use withthe CADD® Infusion pumps (except CADD®-Micro) toallow medication delivery from a flexible container. | "The CADD® Medication Cassette Reservoir with Flow Stop is designed for use with the CADD® pumps (except CADD-Micro® and CADD-TPN®) for delivery of medications and fluids.""The CADD® Administration Set with Flow Stop is |
{6}------------------------------------------------
| designed for use with the CADD® pumps (except CADD-Microo and CADD-TPN) for delivery of medications andfluids." | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------- |
Both statements imply medication delivery and therefore are identical in purpose.
Comparison of Device Characteristics
The tables below identifies and provides comparative assessments of significant physical and performance characteristics between the CADD Solis Infusion Pump, Medication Safety Software, and Administration Sets subject device and predicate as required per 21 CFR 807.92.
Infusion Pump
| Attribute | Subject Device (K170982)CADD®-Solis Infusion Pump,Model 2110 | Predicate Device (K130394)The CADD®-SolisAmbulatory Infusion Pump,Model2110, Version 3.0 | Comparison |
|---|---|---|---|
| Manufacturer | Smiths Medical ASD – PumpPlexus Corp. – CM | Smiths Medical ASD | - |
| Pump Model Number | Model 2110 | Model 2110 | - |
| Pump Firmware version | Version 4.1 | Version 3.0 | See discussion ofdifferences (1) |
| Pump type/ principle ofoperation | Linear peristaltic | Linear peristaltic | Identical |
| Materials of construction | Same for subject and predicateCADD®-Solis Pumps | Same for subject and predicateCADD®-Solis Pumps | Identical |
| Display | Color display with 320 x 320pixels | Color display with 320 x 320pixels | Identical |
| Wireless capability | Yes, with installed CM | No | See discussion ofdifferences (2) |
| Power requirements | Rechargeable CMAC Adapter | 4 ("AA") batteriesAC adapterRechargeable battery pack | See discussion ofdifferences (3) |
| Pump packaging | Foam insert, hardboard box | Foam insert, hardboard box | Identical |
| CM Packaging | Foam insert, hardboard box | n/a | n/a |
| USB port | Yes | Yes | Identical |
| AC adapter | Yes | Yes | Identical |
| AC power cord | Yes | Yes | Identical |
| Remote dose cord | Yes | Yes | Identical |
| Pole mount adapter | Yes | Yes | Identical |
| Carrying pouch | Yes | Yes | Identical |
| Lockbox | Yes | Yes | Identical |
| Medication cassettereservoir | Yes | Yes | Identical |
| Administration set | Yes | Yes | Identical |
| Extension set | Yes | Yes | Identical |
| Intermittent | Yes | Yes | Identical |
{7}------------------------------------------------
| (programmedintermittent bolus) | Yes | Yes | Identical |
|---|---|---|---|
| Continuous infusion | Yes | Yes | Identical |
| Continuous infusionwith Bolus (PCA) | Yes | Yes | Identical |
| Intermittent(programmedintermittent bolus) | Yes | Yes | Identical |
| Continuous infusion | Yes | Yes | Identical |
| Maximum clinicianbolus | 50 mL | 50 mL | Identical |
| Programmablemaximum delivery rate(continuous rate + bolus) | Yes500 mL/hour, with high flowdisposable | Yes500 mL/hour, with high flowdisposable | Identical |
| Patient controlled accessPCA (dosing) | Yes | Yes | Identical |
| Dose lockout time | Yes | Yes | Identical |
| Doses per hour limit | Yes | Yes | Identical |
| Delivery limit | Yes | Yes | Identical |
| Clinician bolus | Yes | Yes | Identical |
| Maximum clinicianbolus | 50 mL | 50 mL | Identical |
| Programmablemaximum delivery rate(continuous rate+bolus) | Yes500 mL/hour, with high flowdisposable | Yes500 mL/hour, with high flowdisposable | Identical |
| Medication SafetySoftware | Version 4.1 | Version 3.1 | Identical |
- (1) Pump Firmware Update: firmware version update to accommodate updates in software. This was verified with software testing in accordance with IEC 62304:2006 Medical device software life cycle process and the Agency's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- (2) Data Transmission: update in means of data transmission of USB to wireless connection using the CM optional accessory. Design Verification and Validation testing demonstrates the wireless data transmission as meeting the acceptance criteria and intended use as well as USB data transmission utilized in the predicate device.
- (3) Power Requirements: the CM accessory contains a rechargeable battery pack within the confines of the CM container, which provides a similar type of power source for the standalone rechargeable battery pack that is included as a cleared accessory for the predicate device. Performance of the CM accessory was verified and validated through bench testing.
| Attribute | Subject Device (K170982)PharmGuard® MedicationSafety Software | Predicate Device (K130394)The CADD®-SolisMedication Safety Software,Version 3.1 | Comparison |
|---|---|---|---|
| Manufacturer | Smiths Medical ASD | Smiths Medical ASD | Identical |
| PC software | Windows 2000, XP, VISTA, | Windows 2000, XP, VISTA, | See discussion of |
| compatibility | Windows 7, Windows 8Administrator only:Windows Server 2003,Server 2008, Server 2008R | Windows 7,Administrator only:Windows Server 2003,Server 2008, Server 2008R | differences (1) |
| Protocol programming | Yes | Yes | Identical |
| Multi-line drug names | Yes | No | See discussion ofdifferences (2) |
| Profiles function | Yes | No | See discussion ofdifferences (3) |
| View reports | Yes | Yes | Identical |
| Print reports | Yes | Yes | Identical |
| Save reports | Yes | Yes | Identical |
| Event log viewing | Yes | Yes | Identical |
| Rx (pumpHistory/SettingsViewing | Yes | Yes | Identical |
| CQI data collection andretrieval | Yes | Yes | Identical |
| Wt based programming(PCA mode) | Yes | Yes | Identical |
| BarCode printing | Yes | Yes | Identical |
| Password protected | Yes | Yes | Identical |
| Second nurseverification | Yes | Yes | Identical |
| Drug ID verification | Yes | Yes | Identical |
| Units programming | Yes | Yes | Identical |
| Concentrationprogramming | Yes | Yes | Identical |
| Demand Doseprogramming | Yes | Yes | Identical |
| Max patient weight(ranges) | Yes | Yes | Identical |
| Epidural Mode on/off | Yes | Yes | Identical |
| New patient feature | Yes | Yes | Identical |
| Program limits (soft andhard limits)programming | Yes | Yes | Identical |
| Biomed infusion pumpprogramming | Yes | Yes | Identical |
| Pump/Module IDStorage and retrieval | Yes | Yes | Identical |
| Date/Time format | Yes | Yes | Identical |
| Daylight Savings Timefeature | Yes | No | See discussion ofdifferences (4) |
| Asset ID Feature | Yes | No | See discussion ofdifferences (5) |
| Units programming | Yes | Yes | Identical |
| Concentration programming | Yes | Yes | Identical |
| Continuous rate programming | Yes | Yes | Identical |
| Demand dose programming | Yes | Yes | Identical |
Medication Safety Software
{8}------------------------------------------------
{9}------------------------------------------------
- (1) PC Software Capability: the subject device supports Windows 8 PC Software capability. This was verified with software testing in accordance with IEC 62304:2006 Medical device software life cycle process and the Agency's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- (2) Multi-line Drug Names: the subject device software updates to the pump allow for multiple lines of drug names to appear on the pump screen compared to the single line drug name capability of the predicate device pump. This change enhances ease of use as the user can see the full drug name instead of having to scroll through lines. This feature was verified with software testing in accordance with IEC 62304:2006 Medical device software - software life cycle process and the Agency's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. This feature was validated with Human Factors testing.
- (3) Profiles Function: the subject device software updates to the pump allow for user defined optional profiles to allow the user for easier organization stored on the pump. This feature was verified with software testing in accordance with IEC 62304:2006 Medical device software – software life cycle process and the Agency's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. This feature was validated with Human Factors testing.
- (4) Daylight Savings Time Auto Adjust Feature: the subject device can be configured to automatically update the time to account for daylight savings where the predicate device allows for manual entry of time adjustment only. This feature was verified with software testing in accordance with IEC 62304:2006 Medical device software software life cycle process and the Agency's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- (5) Asset ID Feature: the subject device has the optional feature of allowing the customer to set up an asset pump ID for each pump as a means of additional pump identification. This feature was verified with software testing in accordance with IEC 62304:2006 Medical device software - software life cycle process and the Agency's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. This feature was validated with Human Factors testing.
Administration Sets
The CADD® Administration Sets do not have any feature or function changes and are similar in design, function, and intended use to the predicate CADD® Administration Sets (K040636). The CADD® Administration Sets included in this submission may now be used to delivery medication to the intrathecal space as established through pre-clinical GLP neurotoxicity studies, chemical characterization and a toxicology assessment.
Conclusion
The differences in the indications for use statements and device characteristics are supported through non-clinical performance testing and do not raise new or different questions of safety and effectiveness.
Summary of Non-Clinical Performance Testing
A safety assurance case was provided for the CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD®-Solis Infusion Pump, Model 2110, the Wireless Communication Module (CM), and the
{10}------------------------------------------------
PharmGuard® Administrator Medication Safety Software, as recommended in the FDA guidance document, Infusion Pumps Total Product Life Cycle.
The stated goal of the safety assurance case is:
- . The CADD-Solis Ambulatory Infusion Pump System is reasonably safe for use in its intended environment by its intended users
The assurance case defined the device system, including the indications for use, system definition, operational description, patient populations, and use environments. The supporting assurance arguments covered the following attributes:
The device is properly identified and defined
- · The process used to define new products and establish their requirements build a foundation for safe products
- · Clinical requirements define a safe system for the intended indications for use
- · Requirements are driven by applicable standards for the intended use, and markets of distribution are identified
The device design is adequately verified and validated
-
. The developmental processes used take the establish requirement them, resulting in safe products
The device risks are acceptably mitigated -
· Risk analysis process identifies and manages safety requirements by identifying all hazards to safety, causes of those hazards, controls to mitigate those hazards, and assessing the effectiveness of those controls
The device is adequately reliable to ensure its safety over its intended use life. -
· The production process results in the manufacturing of products which, when used alone or in combination, form a safe system
-
· The post-launch processes are in place to maintain safe products once they have been shipped to the customer
The following evidence was included in the assurance case:
Performance Test Summary - System verification activities for CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD®-Solis Infusion Pump, Model 2110, the Wireless Communication Module (CM), and the PharmGuard® Administrator Medication Safety Software, confirmed that the system modifications meets user needs and design inputs. All the testing met the acceptance criteria.
- The infusion pump basic safety and essential performance verification was completed in accordance with IEC . 60601-1 General requirements for basic safety and essential performance.
- . Human factors evaluations have been conducted to validate the effectiveness of use error related mitigations in accordance with the Agency's Guidance Document, "Applying Human Factors and Usability Engineering to Medical Devices" and IEC 62366-1:2007 Application of usability engineering to medical devices
- . Electrical and Electromagnetic Compatibility testing were conducted. The CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD@-Solis Infusion Pump, Model 21 10, the Wireless Communication Module (CM), and the PharmGuard® Administrator Medication Safety Software, complies with following standards:
- Electrical Safety per IEC 60601-1 and IEC 60601-1-12 O
- O EMC testing per IEC 60601-1-2
- IEC 60601-1-6:2013 Medical electrical equipment Part 1-6: General requirements for safety: usability O
- 2054 UL Standard for Safety Household and Commercial Batteries Second Edition; Reprint with O revisions through and including September 14, 2011
{11}------------------------------------------------
- IEC 62122 Secondary cells and batteries containing alkaline or other non-acid electrolytes Safety O requirements for portable sealed secondary cells, and for them, for use in portable applications
- Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio O Frequency Identification Readers" (catalog number 7351731)
- . Software Verification and Validation per the Agency's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" and IEC 62304:2006 Medical device software - software life cycle process
- . Cleaning and Disinfection Validation for the CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD®-Solis Infusion Pump. Model 2110, the Wireless Communication Module (CM), and the PharmGuard® Administrator Medication Safety Software, confirmed that the new accessories meets the cleaning and disinfection requirements.
- . GLP pre-clinical studies were completed to demonstrate each of the CADD® Administration Sets proposed for delivery of fluids to the epidural and subarachnoid spaces are free from unacceptable neurotoxicological risk.
- . A Chemical Characterization, Toxicological Risk Assessment, and in vivo and in vitro Biocompatibility studies were completed in accordance with ISO 10993-1:2009/ (R) 2013 Biological Evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
- . Packaging and Shipping verification was conducted in accordance with ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
Conclusion
The testing conducted demonstrates that the CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD®-Solis Infusion Pump, Model 2110, the Wireless Communication Module (CM), and the PharmGuard® Administrator Medication Safety Software with changes described meet the design requirements of the cleared predicate devices. Therefore, the CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD®-Solis Infusion Pump, Model 2110, the Wireless Communication Module (CM), and the PharmGuard® Administrator Medication Safety Software that is this submission is substantially equivalent to its predicate.
Clinical Tests
Not Applicable
Conclusions
The modifications pertain to the software update, additional communication module accessory, and expansion of the administration sets to include intrathecal delivery when used with the CADD® Infusion Pump. There are no changes the basic infusion pump technology. The modifications are supported by non-clinical testing.
The evaluation of the CADD®- Solis Ambulatory Infusion Pump with Wireless Communications for use, comparative evaluation to the predicate devices, K1310394 and K040636, and non-clinical performance testing demonstrate that the device is substantially equivalent to the legally marketed predicate device in as required per 21 CFR 807.92(3). Device testing met pre-defined acceptance criteria and did not raise new or different question of safety or effectiveness.
§ 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).