The CURLIN® 8000 ambulatory infusion pump system is indicated for use in home care and clinical settings for the controlled administration of prescribed medical fluids through clinically accepted routes of administration: intravenous, intra-arterial, subcutaneous, epidural, and perineural, to adult patients. The CURLIN® 8000 is not intended for use on pediatric patients. The pump is intended to deliver a variety of therapies (drugs and fluids) which have been approved for these routes of administration. Examples of the therapies, which may be delivered using the CURLIN® 8000 pump, include hydration, parenteral nutrition, anti-infectives, pain management, inotropes, chemotherapy, immune globulin, and biologics. The CURLIN 8000 is not indicated for the delivery of cellular blood products.

RxManager Enterprise Solution Software allows the user to create and manage pump configurations and therapy-based protocols to be used with the Curlin 8000 Ambulatory Infusion Pump.

Curlin Administration Sets are intended to be used with Curlin infusion pumps to deliver medication from a container to a patient.

Device Description

The CURLIN® 8000 Ambulatory Infusion Pump is a small, compact and light weight infusion delivery device that utilizes a curvilinear peristaltic pumping mechanism similar is design to the CADD®-Solis VIP Model 2120 but curvilinear to allow the pump to be more compact. The user activates the CURLIN® 8000 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 CURLIN® 8000 pump consists of components such as the user interface, sensors, communication ports, power ports, structural (housing) components, electronics, pumping mechanism, watchdog timer, pump battery and circuitry, real time clock, on-board memory, and pump log. Exterior surface components include the pump housing, platen (door assembly), LCD lens, keypad, and labels. Materials used for the construction of these components are widely used within the medical industry.

The CURLIN® 8000 pump is designed to deliver measured drug therapy to patients in homecare, infusion suites, oncology and other alternate site locations as appropriate. The pump also has applicability in the acute care market specifically in small hospitals (300 beds or less), Labor and Delivery Units, and other areas of the hospital where pain management is required.

The CURLIN® 8000 pump is designed to be used with CURLIN® 380-series administration sets, which provide a sterile pathway for the delivery of the infusate fluid from the infusion container (e.g., IV reservoir bag) to the distal connection, which connects to the patient's catheter / delivery site.

The Rx Manager Enterprise Solution (ES) pharmacy application, which consists of the Rx Manager, Admin Manager and Service Manager, incorporates a Dose Error Reduction System (DERS) software and intuitive workflows to support error prevention. The ES software subsystems are used by Pharmacy Staff, Biomed Staff, IT Staff and Moog Field Service Staff to achieve their specific needs. ES is architected to be scalable, i.e. it can run on a single desktop, many desktops in a campus-based server network, and can be advanced to multiple server-based topology. The applications utilize a common database manager software library along with secure connectivity to the database.

The associated accessories include:

Lockbox capable of mounting to a bar and accepting 500 mL bags and sets
Pole clamp that is tilt adjustable and is capable of mounting both horizontally and vertically to a bar and still allows the pump to be viewed in a vertical orientation
PCA Bolus Cable with 2-meter cable with Micro-B USB Plug
USB Data Cable with 2-meter cable with Micro-B USB Plug at one end and USB Type A pluq at the other end
Power AC Adapter cord with input voltage of 100 Vac to 240 Vac and Input line frequency range of 50 Hz to 60 Hz. Rated output voltage of 5.00 Vdc and rated output current of at least 3.0 A
Rechargeable Battery with 2 Lithium-Ion cells in a 1s2p configuration (2 cells in parallel) and rated for at least 23.4 Watt-Hours (3.6 Volts at 6.5 Amp-Hours)
Battery Charger that charges up to 4 battery packs simultaneously

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the Curlin 8000 Ambulatory Infusion System, RxManager Enterprise Solution Software, and Curlin 380-series Administration Sets. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria in a quantitative sense with reported performance metrics.

The document describes various performance tests and evaluations conducted, but it doesn't provide a table of acceptance criteria with corresponding reported device performance metrics in the format typically used for studies demonstrating diagnostic or predictive accuracy (e.g., sensitivity, specificity, AUC). Instead, the performance data section generally states that the device was verified and validated through testing and compliance with various standards.

However, I can extract information related to the performance studies and what was evaluated.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly provide a table of quantitative acceptance criteria alongside precise numerical reported device performance in the context of diagnostic accuracy, sensitivity, or specificity commonly found in AI/CADe study reports. Instead, it lists the types of performance testing and compliance with standards.

For example, under "Device Performance", it states:

"Performance testing of essential performance attributes to duration of therapy: Head height, Viscosity, Back-pressure"
"Reliability testing"
"Flow rate accuracy testing across all operating conditions"
"Alarm detection: Battery, Air in Line, Up and Down Stream Occlusion, Hardware and Software failures, Pump Unattended, Infusion Complete Alarms comply with IEC 60601-1-8"
"Ambulatory, Transportation, Environmental Conditions: Operating Temperature, Operating Altitude"

And in the "Substantial Equivalence Discussion Summary", there's a comparison table that includes some numerical specifications for the subject device and the predicate. While these are specifications, they implicitly act as "acceptance criteria" for the device's technical characteristics, and the "Comparison" column indicates whether these criteria were met (similar, same, or tighter specification).

Extracted from the "Substantial Equivalence Discussion Summary" comparison table:

Acceptance Criteria (from Predicate/Standard)	Subject Device Performance (CURLIN® 8000)
System delivery accuracy (nominal)	+/- 5% (>= 1mL/hr, >2.5mL bolus) +/- 15% (< 1mL/hr, <=2.5mL bolus)
Time to Occlusion Alarm (worst case)	0.1 mL/hr = < 360 min 1.0 mL/hr = < 25 min 25 mL/hr = < 2 min
Air-in-Line Settings	0.1 mL, 0.5 mL, 1 mL, 2 mL; "Off" reports accumulated over 4mL
Ingress Protection	IPX4
Display	Graphic Color LCD
Controls	Microprocessor
Internal clock	Yes
Air-in-line sensor	Yes
Occlusion sensor	Up and Down Sensor
History Log	Yes
Alarms & Alerts	Audible, LCD message for various conditions (e.g., Air-In-Line, Low Battery, Door Open, Down Occlusion)
KVO Rate	0.1 - 9.9 mL/h
Bag (Reservoir) volume	1 to 9,999 mL
Maximum PCA Bolus Amount	Basic program: 9.9 mL; RxM/PSP: 50 mL
Maximum Clinician Bolus	Basic Program: 10 mL; PSP Program: 50 mL
Maximum PCA Boluses per Hour	30 per hour
PCA Dose lockout time	2 minutes - 24 hours
Bolus Delivery Limit Methods	1-hour limit OR Max # of Boluses/hour
Programmable Delivery Rate - PCA	Basic infusion 10-125 mL/h; PSP 10-400 mL/h
Priming Methods	Gravity or Pump
Electrical Safety	Compliant with ANSI/AAMI 60601-1:2005/A1:2012
Electromagnetic compatibility	Compliant with IEC 60601-1-2:2014
Pump Size	5.5" H x 4.3" W x 2.75" D
Pump Weight	25 oz. with batteries
Power Sources	1.5V "C" cell Alkaline (2), Rechargeable battery pack, AC Adapter
Alkaline Battery Life	10 Hours @ 500 mL/h 30 Hours @ 125 mL/h 50 Hours @ 2 mL/h
Rechargeable Battery Life	10 Hours @ 500 mL/h 30 Hours @ 125 mL/h 85 Hours @ 2 mL/h
Operating Temperature	15°C (59°F) to 40°C (104°F)
Operating Relative Humidity	15% to 90%
Atmospheric Pressure	70 kPa to 106 kPa
Storage Temperature	-20°C (-4°F) to 60°C (140°F)
Storage Relative Humidity	15% to 93%
PC Software Compatibility	Windows 10
Protocol Programming	Yes
View/Print/Save Reports, Event Log, Rx viewing	Yes
Password Protected	Yes
Units/Concentration/Continuous/Demand Dose/Epidural Mode/New Patient/Program limits/Pump Module ID/Date/Time format programming	Yes
Parameters from Drug Library Mismatch	RxManager checks against preset limits and warns user
Free-flow Protection	Normally closed (after actuation) spring-biased clamping mechanism. Manually openable for priming.
Free-flow protection plunger	Pinches tubing when latch is opened to prevent free flow.
Administration Sets - Biocompatible	Yes
Administration Sets - Non-DEHP	Yes
Administration Sets - Latex free	Yes
Administration Sets - Prescription Only	Yes
Administration Sets - Non-pyrogenic	Yes
Administration Sets - Sterile	Yes
Administration Sets - Hospital or Home Use	Yes
Administration Sets - Air Eliminating Filter	Yes
Administration Sets - Materials of Construction	Tubing - PVC, Bag Spike - ABS, Outlet housing - Polycarbonate, Inlet housing - Polycarbonate

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify a distinct "test set" sample size or data provenance in the context of an AI/CADe study for diagnostic performance. The studies mentioned are primarily engineering-focused verification and validation tests and human factors studies (e.g., electrical safety, EMC, device performance, biocompatibility). These types of tests do not typically involve patient "test sets" or data provenance in the same way as AI model validation would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable and is not provided in the document. The studies performed are not clinical or diagnostic accuracy studies that involve expert-established ground truth on medical images or patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable and is not provided. The document describes compliance with engineering standards and performance testing for a medical device (infusion pump and its software), not a diagnostic algorithm requiring adjudication of ground truth.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CADe devices that assist human readers in interpreting medical data, which is not the function of this infusion pump or its software. The software's function is for creating and managing pump configurations and therapy-based protocols (Dose Error Reduction System).

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, for the non-clinical performance of the device, the document implies standalone testing was performed to verify the device's adherence to engineering standards and specified performance metrics. This is not a standalone "algorithm only" in the sense of a diagnostic AI, but rather the pump's mechanical and software functions operating independently as designed.

For instance, the "Software verification and validation per FDA guidance" and "Device Performance" sections describe testing the pump's functions (e.g., flow rate accuracy, alarm detection, software integrity) without human intervention in the real-time execution of the primary functions once programmed. The software itself, as a Dose Error Reduction System, operates "standalone" in its ability to check dosing limits.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined in diagnostic AI studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. For the engineering and performance tests, the "ground truth" would be the expected or specified performance according to design requirements, recognized industry standards (e.g., IEC standards), and FDA guidance documents. Compliance with these established criteria serves as the "ground truth" for verification and validation.

For example:

Electrical Safety: Ground truth is compliance with IEC60601-1.
EMC: Ground truth is compliance with IEC 60601-1-2 Ed 4.1.
Device Performance (Flow Rate Accuracy, Alarms): Ground truth is compliance with specified accuracy ranges and alarm trigger conditions as defined by design and relevant guidance (e.g., FDA Guidance "Infusion Pumps Total Product Life Cycle").
Biocompatibility: Ground truth is compliance with ISO10993 series of standards.

8. The sample size for the training set

This information is not applicable and is not provided. The device (infusion pump and its software) does not use machine learning in a way that requires a "training set" of data for diagnostic or predictive model development. The software is a rule-based system for managing pump configurations and protocols.

9. How the ground truth for the training set was established

This information is not applicable, as there is no "training set" for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 17, 2024

Zevex, Inc. Christopher Dodge Director, Quality Assurance & Regulatory Affairs 4314 Zevex Park Lane Salt Lake City, Utah 84123

Re: K232793

Trade/Device Name: Curlin 8000 Ambulatory Infusion System: Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN Dated: April 17, 2024 Received: April 17, 2024

Dear Christopher Dodge:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Jake K. Lindstrom -S

Jake Lindstrom, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232793

Device Name Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets

Indications for Use (Describe)

RxManager Enterprise Solution Software allows the user to create and manage pump configurations and therapy-based protocols to be used with the Curlin 8000 Ambulatory Infusion Pump.

Curlin Administration Sets are intended to be used with Curlin infusion pumps to deliver medication from a container to a patient.

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)

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K232793 510(k) Summary

Date: May 16, 2024

SUBMITTER I.

Zevex, Inc. 4314 Zevex Park Lane Salt Lake City, Utah 84123

Telephone: (801) 264-1001 Fax: (801) 264-1051

Contact Person:

Christopher Dodge Director, Quality Assurance & Regulatory Affairs Cell Phone: (801) 560-7147

II. DEVICE

Proprietary / Trade Name: CURLIN® 8000 Ambulatory Infusion System with Rx Manager Enterprise Solution Software Common Name: Infusion Pump Classification Name: Pump, Infusion (21 CFR 880.5725) Regulatory Class: II Product Code: FRN

Proprietary / Trade Name: CURLIN® Administration Sets Common Name: Intravascular Administration Sets Classification Name: Set, Administration, Intravascular (21 CFR 880.5440) Regulatory Class: II Product Code: FPA

III. PREDICATE DEVICE

CADD®-Solis VIP Model 2120 (K111275) with CADD™-Solis Medication Safety Software

CADD® Administration Sets (K170982)

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DEVICE BRIEF DESCRIPTION IV.

The associated accessories include:

. Lockbox capable of mounting to a bar and accepting 500 mL bags and sets
. Pole clamp that is tilt adjustable and is capable of mounting both horizontally and vertically to a bar and still allows the pump to be viewed in a vertical orientation

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PCA Bolus Cable with 2-meter cable with Micro-B USB Plug .
. USB Data Cable with 2-meter cable with Micro-B USB Plug at one end and USB Type A pluq at the other end
Power AC Adapter cord with input voltage of 100 Vac to 240 Vac and . Input line frequency range of 50 Hz to 60 Hz. Rated output voltage of 5.00 Vdc and rated output current of at least 3.0 A
Rechargeable Battery with 2 Lithium-Ion cells in a 1s2p configuration . (2 cells in parallel) and rated for at least 23.4 Watt-Hours (3.6 Volts at 6.5 Amp-Hours)
. Battery Charger that charges up to 4 battery packs simultaneously

V. INDICATIONS FOR USE

The CURLIN® 8000 ambulatory infusion pump system is indicated for use in home care and clinical settings for the controlled administration of prescribed medical fluids through clinically accepted routes of administration; intravenous, intra-arterial, subcutaneous, epidural, and perineural, to adult patients. The CURLIN® 8000 is not intended for use on pediatric patients. The pump is intended to deliver a variety of therapies (drugs and fluids) which have been approved for these routes of administration. Examples of the therapies, which may be delivered using the CURLIN® 8000 pump, include hydration, parenteral nutrition, anti-infectives, pain management, inotropes, chemotherapy, immune globulin, and biologics. The CURLIN® 8000 is not indicated for the delivery of cellular blood products.

RxManager Enterprise Solution Software allows the user to create and manage pump configurations and therapy-based protocols to be used with the CURLIN® 8000 Ambulatory Infusion Pump.

CURLIN® Administration Sets are intended to be used with CURLIN® infusion pumps to deliver medication from a container to a patient.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

The CURLIN® 8000 Ambulatory Infusion System and the predicate device are both multi-therapy infusion pumps with dosing software that utilize disposable, sterile administration sets. Both devices infuse a broad range of fluids and medications via a peristaltic pumping mechanism and can operate in continuous, intermittent, variable TPN, or PCA mode. Both devices are indicated for use on adult patients in homecare, infusion suites, oncology and other alternate site locations as appropriate. Both devices provide infusion delivery through accepted clinical routes such as intravenous, intra-arterial, epidural, and subcutaneous

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infusions. Both devices operate with similar infusion parameters such as flow rate, flow accuracy, KVO rate, volume limit, and prime mode.

At a high level, the subject and predicate devices are based on the following same technological elements:

. Graphic Color Display
Microprocessor control
Internal clock ●
Air-in-Line Sensor
Occlusion Sensor ●
. History Log
Programmable Delivery Ranges ●
Security Features such as locked access levels and customizable access codes .
. Rechargeable Batteries

The following technological differences exist between the subject and predicate devices:

Volume of air to trigger an Air-in-Line alarm
Maximum PCA Boluses per Hour .
Programmable Delivery Rate for PCA .
PC Software Compatibility .

PERFORMANCE DATA VII.

A safety assurance case, as recommended by the FDA guidance document, Infusion Pumps Total Product Life Cycle, was provided for the subject device. The stated top-level claim of the assurance case is:

The Curlin 8000 Ambulatory Infusion System is adequately safe for its intended use.

The assurance case defines the device system, including the indications for use, system definition, operational description, patient populations, and use environments. The supporting assurance arguments cover the following attributes:

The top claim is supported by appropriate contextual information. ●
. Device requirements are adequate, and design is adequately verified and validated.
Device associated risks are completely identified and adequately mitigated. ●
CURLIN® 8000 is adequately reliable to ensure safety over its service life . when being used according to its intended use and context of use.

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The following specific evidence was included within the assurance case to demonstrate that the subject device is verified and validated for its intended use, and to demonstrate substantial equivalence to the predicate device.

Software	Software verification and validation per FDA guidancefor the "Content of Premarket Submissions for DeviceSoftware Functions" (June 2023) and FDA guidancedocument "Infusion pump total product life cycle”.
Electrical Safety	The electrical safety evaluation of the medical electricalequipment was performed per standards IEC60601-1medical electrical equipment part1: Generalrequirements for basic safety and essential performance
EMC	EMC evaluation of the medical electrical equipment wasperformed to:- IEC 60601-1-2 Ed 4.1: Medical electricalequipment- Part 1-2: General requirements forbasic safety and essential performance -Collateral standard: electromagnetic disturbances- Requirements and testsSusceptibility testing to 5G, WPT, EAS, NFC & SecurityMetal Detectors
Device Performance	The essential performance requirements of the device(including feeding sets) were verified throughperformance testing in accordance with the intendeduse of the device and in accordance with the FDAGuidance "Infusion Pumps Total Product Life Cycle”including:• Performance testing of essential performanceattributes to duration of therapy:Head heightViscosityBack-pressure• Reliability testing• Flow rate accuracy testing across all operatingconditions• Alarm detectionBatteryAir in LineUp and Down Stream OcclusionHardware and Software failuresPump Unattended

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	Infusion CompleteAlarms comply with IEC 60601-1-8• Ambulatory• Transportation• Environmental Conditions:Operating Temperature• Operating Altitude
Human Factors	Following FDA Guidance Applying Human Factors andUsability Engineering to Medical Devices (February 3,2016), the human factors studies were conducted withthe intended user population, use environment, and usescenarios to simulate clinical conditions. Results of thehuman factors testing demonstrate validation of thedevice per the intended use.
Biocompatibility	The biocompatibility test reports provided wereconducted per ISO10993 series of standards followingGood Laboratory Practices and the representativeproduct tested passed all acceptance criteria.CURLIN® 380-series administration sets are classifiedas external communicating, blood path indirect,prolonged use and the following endpoints have beenevaluated:
	Endpoint	Method	Standardreference	BiologicalRiskAssessment
	Cytotoxicity	CytotoxicityStudy Using theISO ElutionMethod	ISO10993-5	Non-cytotoxic
	Sensitization	ISO Guinea PigMaximizationSensitizationTest	ISO10993-10	Non-sensitizer
	Irritation orIntracutaneousReactivity	ISOIntracutaneousIrritation Study- Extract	ISO10993-10	Non-irritant
	Acute systemictoxicity	ISO AcuteSystemicToxicity Study inMice	ISO10993-11	Non-toxic
Material MediatedPyrogenicity	USP RabbitPyrogen Study,MaterialMediated	USP,GeneralChapter<151>ISO10993-11	Non-pyrogenic
Subacute/Subchronictoxicity	ISO Two WeekToxicity Study inthe Rat,RepeatedParenteralAdministrationof Two Extracts	ISO10993-11	Non-Toxic
Hemocompatibility	ASTMHemolysisStudy - ExtractMethod	ASTMF756ISO10993-4	Non-hemolytic

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Animal Studies

Animal studies were deemed unnecessary to evaluate the substantial equivalence of the subject device with the predicate device.

Clinical Studies

Human clinical studies were deemed unnecessary to evaluate substantial equivalence of the subject device with the predicate device.

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VIII. SUBSTANTIAL EQUIVALENCE DISCUSSION SUMMARY

The non-clinical data support the safety of the device, and the hardware and software verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. The test results allowed for a conclusion to be made that the subject device is substantially equivalent to the predicate device.

Device Name	CURLIN® 8000	CADD®-Solis VIP Model2120	Comparison
510(k)#	Subject Device	K111275	NA
Manufacturer	Zevex, Inc.	Smiths Medical ASD, Inc.	NA
Indications forUse	The CURLIN® 8000 ambulatoryinfusion pump system isindicated for use in home careand clinical settings for thecontrolled administration ofprescribed medical fluidsthrough clinically acceptedroutes of administration:intravenous, intra-arterial,subcutaneous, epidural, andperineural, to adult patients.The CURLIN® 8000 is notintended for use on pediatricpatients. The pump is intendedto deliver a variety of therapies(drugs and fluids) which havebeen approved for these routesof administration. Examples ofthe therapies, which may bedelivered using the CURLIN®8000 pump, include hydration,parenteral nutrition, anti-infectives, pain management,inotropes, chemotherapy,immune globulin, and biologics.The CURLIN® 8000 is notindicated for the delivery ofcellular blood products.	The CADD®-Solis VIPAmbulatory Infusion Pump isindicated for intravenous,intraarterial,subcutaneous,intraperitoneal, perineural,surgical site, epiduralspace, or subarachnoidspace infusion.PCA (patient-controlledanalgesia) delivery is used fortherapies that require acontinuous rate of infusion,patient-controlled demanddoses, or both, such as patientcontrolled analgesia.Continuous delivery allows theinfusion of drug/fluid at aconstant, programmed rate.Intermittent delivery allowsthe infusion of a specificvolume of drug/fluid at aregular, programmed interval.Step delivery allows anincremental increase ininfusion rate to a specifiedmaximum infusion rate for aspecified total infusion volume.Taper delivery allows a plateaurate of infusion with the optionof tapering at the beginningand/or end and has aprogrammable KVO rate at theend of the infusion.	Due to thelimited use ofintraperitonealandsubarachnoidroutes ofdelivery byambulatorypump users,the twodevices aresubstantiallyequivalent.
Type of Pump	Multi-therapy Infusion Pump	Multi-therapy Infusion Pump	Same
PumpingMechanism	Curvilinear Peristaltic	Linear Peristaltic	Specificationdifferences donot impact
Device Name	CURLIN® 8000	CADD®-Solis VIP Model2120	Comparison
			substantialequivalence
Patient Population	Adult	Not specified	The subjectdevice isequivalent tothe predicatedevice for thestated patientpopulationthat isindicated foruse.
Delivery Modes	Continuous, TPN, PCA,Intermittent, Variable	Continuous, PCA, Intermittent,Step (Variable), Taper (TPN)	Same
System deliveryaccuracy(nominal)	+/- 5%For rates at and above 1mL/hrand bolus doses greater than2.5mL+/- 15%For rates below 1mL/hr andbolus doses at or less than2.5mL	+/- 6%10mL/hr and above and bolusaccuracy	Specificationdifferences donot impactsubstantialequivalence
Time to OcclusionAlarm mL/hr Rate(worst case)	0.1 mL/hr = < 360 min1.0 mL/hr = < 25 min25 mL/hr = < 2 min	0.1 mL/hr = ≤ 1200 min150 mL/hr = ≤ 90 min	Subject devicehas a tighterspecification
Air-in-LineSettings	Settings:• 0.1 mL• 0.5 mL• 1 mL• 2 mL• "Off": still senses air andreports accumulated over 4mL	Settings:• High Sensitivity (>0.15mL)• Low sensitivity (>0.4 mL)• Off: truly off, does notsense air	Similar
Volume of air totrigger an Air-in-Line alarm	Single bubble reporting isbased on the chosen setting:• 0.1 mL• 0.5 mL• 1 mL• 2 mL"Off" senses air and reportsaccumulated air over 4 mL.Accumulated air is related tothe amount of air delivered(per chosen setting) overvolume of fluid delivered.	Single bubble reporting isbased on the setting chosen:Low: single bubble>400microlitersHigh: single bubble> 150microlitersOff: does not report any airAccumulated air is related tovolume over time.• Accumulated air: greaterthan 1 mL air over 15minutes (nominal)	Specificationdifferences donot impactsubstantialequivalence
Device Name	CURLIN® 8000	CADD®-Solis VIP Model2120	Comparison
IngressProtection	IPX4 - Protection against watersplashing	IPX4 - Protection againstwater splashing	Same
Display	Graphic Color LCD	Color display with 320 x 320pixels	No impact inequivalence asthis changehas beenvalidated to beacceptableand equivalentfor theintended use
Controls	Microprocessor	Microprocessor	Same
	System Components/Features
Internal clock	Yes	Yes	Same
Air-in-line sensor	Yes	Yes	Same
Occlusion sensor	Up and Down Sensor	Up and Down Sensor	Same
History Log	Yes	Yes	Same
	Alarms & Alerts
Air-In-Line	Audible, LCD message	Audible, LCD message	Same
Air-In-LineDisabled	Audible, LCD message	Audible, LCD message	Same
Low Battery	Audible, LCD message	Audible, LCD message	Same
Empty Battery	Audible, LCD message	Audible, LCD message	Same
Door Open	Audible, LCD message	Audible, LCD message	Same
Down Occlusion	Audible, LCD message	Audible, LCD message	Same
Up Occlusion	Audible, LCD message	Audible, LCD message	Same
Backup Battery	Audible, LCD message	Audible, LCD message	Same
InfusionComplete	Audible, LCD message	Audible, LCD message	Same
KVO Rate TooHigh	Audible, LCD message	No	Subject devicewarns whilepredicatedevice limitsprogrammingfrom 0-10mL/hr
Low Bag Volume	Audible, LCD message	Audible, LCD message	Same
PumpMaintenance Due	Audible, LCD message	Audible, LCD message	Same
Release/RemovePCA Cord	Audible, LCD message	Audible, LCD message	Same
HandsetUnplugged	Audible, LCD message	Audible, LCD message	Same
Set Not Installed	Audible, LCD message	Audible, LCD message	Same
Unattended Pump	Audible, LCD message	Audible, LCD message	Same
Stuck Key	Audible, LCD message	Audible, LCD message	Same
Malfunction	Audible, LCD message	Audible, LCD message	Same
Invalid Key press	Yes:	Yes:	Same
	Audible alert when invalid keyis pressed
Device Name	CURLIN® 8000	CADD®-Solis VIP Model 2120	Comparison
		CADD®-Solis provides an optional feature which provides a confirmation sound with a valid keypress.
Improper flow of fluid alarm/sensor	No	No	Same
Temperature Sensor for the Infusate	No	No	Same
Pump Temperature Sensor	Yes (hot and cold)	Yes (hot)	Specification differences do not impact substantial equivalence
Tone Test	Audible and visual message	Audible	Similar
Security	Unused therapy modes can be blocked out, four access levels, tamper-proof lockbox, customizable access code	Cassette/keypad lock & three customizable security access levels: keypad code; clinician code; administrator code	Similar
Infusion Parameters
Programmable Delivery Ranges	CONT: 0.1 – 500 mL/hINT: 0.1 – 500 mL/hVAR: 0.1 - 500 mL/hTPN: 10 – 500 mL/hPCA Basic (non-Rx Manager) programming ranges:Basal Rate: 0 or 0.1 - 10 mL/hPCA PSP (Rx Manager) programming rangesBasal Rate:IV: 0 or 0.1 - 100 mL/hSubQ: 0 or 0.1 – 10 mL/hEPI: 0 or 0.1- 35 mL/hPCA Bolus (Basic Program):• Min: 0 when no patient bolus programmed 0.1 for mL• Max: Max PCA Bolus Volume for (Basic) - All Routes: 10 mLPCA Bolus (PSP Program):• Min: 0 (OFF); 0.1 for mL• Max:	CONT: 0.1 - 500 mL/hINT: 0.1-500 mL/hrVAR: 0.4- 500 mL/hrTPN: 0.1-500 mL/hrPCA Basal rate: 0-100 mL/hrPCA (Patient) Dose: 0-50 mL/hr	Within predicate ranges
		IV route - 50 mL equiv.EPI route - 25 mL equiv.
Device Name	CURLIN® 8000	CADD®-Solis VIP Model2120	Comparison
	SubQ route - 10 mLequiv.
KVO	Yes (all non PCA modes)	Yes (all modes)	Same
KVO Rate	0.1 - 9.9 mL/h	PCA: 0-0.1 mL/hOther modes: 0 - 10 mL/h	Similar
Bag (Reservoir)volume -Programmedvalue of volumeof available fluidin drug container	1 to 9,999 mL	0 to 9,999 mL	Similar
Maximum PCABolus Amount	Basic program: 9.9 mLRxM/PSP programming: 50 mL	Maximum 50 mL	Same
Clinician Bolus	Yes	Yes	Same
MaximumClinician Bolus	Basic Program: 10 mLPSP Program: 50 mL	50 mL	Same
Maximum PCABoluses per Hour	30 per hour	60 per hour	Specificationdifferences donot impactsubstantialequivalence
PCA Dose lockouttime	2 minutes - 24 hours	1 minute - 24 hours	Similar
Bolus DeliveryLimit Methods	1-hour limit OR Max # ofBoluses/hour	1-12-hour limit OR Max # ofBoluses/hour	Specificationdifferences donot impactsubstantialequivalence
ProgrammableDelivery Rate -PCA	Basic infusion 10-125 mL/hPSP 10-400 mL/h	40 - 250 mL/h	Specificationdifferences donot impactsubstantialequivalence
Priming Methods	Gravity or Pump	Gravity or Pump	Same
Accessories
AdministrationSets	Yes	Yes	Same
AC adapter	Yes	Yes	Same
Remote DoseCord	Yes	Yes	Same
Reservoirenclosure(Lockbox)	Yes	Yes	Same
Pole MountBracket	Yes	Yes	Same
Electrical Safety
Electrical Safety	Compliant with ANSI/AAMI60601-1:2005/A1:2012	Compliant with IEC 60601-1	Same
Device Name	CURLIN® 8000	CADD®-Solis VIP Model2120	Comparison
Electromagneticcompatibility	Compliant with IEC 60601-1-2:2014	Compliant with IEC 60601-1-2	Same
Mechanical and Power Requirements:
Pump Size	5.5" H x 4.3" W x 2.75" D	5.0" H x 4.0" W x 1.6" D	Similar
Pump Weight	25 oz. with batteries	21 oz. with batteries	Similar
Power Sources	1.5V "C" cell Alkaline (2)Rechargeable battery packAC Adapter	1.5V "AA" cell Alkaline (4)Rechargeable battery packAC Adapter	Similar
Alkaline BatteryLife	10 Hours @ 500 mL/h30 Hours @ 125 mL/h50 Hours @ 2 mL/h	11 Hours @ 500 mL/h37 Hours @ 125 mL/H139 Hours @ 1 mL/h	Similar,thoughcalculated atdifferent mL/h
RechargeableBattery Life	10 Hours @ 500 mL/h30 Hours @ 125 mL/h85 Hours @ 2 mL/h	10 Hours @ 500 mL/h30 Hours @ 125 mL/H67 Hours @ 1 mL/h	The subjectdevice batterylife is longerfor infusionsrun at lowerrates
Operating Environment
Temperature	15°C (59°F) to 40°C (104°F)	15°C (59°F) to 40°C (104°F)	Same
Relative Humidity	15% to 90%	20% to 90%	Similar
AtmosphericPressure	70 kPa to 106 kPa	70 kPa to 106 kPa	Same
Storage Environment
Temperature	-20°C (-4°F) to 60°C (140°F)	-20°C (-4°F) to 60°C (140°F)	Same
Relative Humidity	15% to 93%	20% to 90%	Similar
Dose Error Reduction Software
Device Feature	CURLIN® Rx Manager	CADD®-Solis MedicationSafety Software V 3.1	Comparison
510(k)#	Subject Device	K111275	NA
PC SoftwareCompatibility	Windows 10	Windows 2000, XP, VISTA,Windows 7, Administratoronly: Windows Server 2003,Server 2008, Server 2008R	Differences insupportedWindowsOperatingSystems donot raisequestions ofsafety andeffectiveness
ProtocolProgramming	Yes	Yes	Same
View Reports	Yes	Yes	Same
Print Reports	Yes	Yes	Same
Save Reports	Yes	Yes	Same
Event LogViewing	Yes	Yes	Same
Rx (pumpHistory/SettingsViewing)	Yes	Yes	Same
Device Name	CURLIN® 8000	CADD®-Solis VIP Model2120	Comparison
PasswordProtected	Yes	Yes	Same
Unitsprogramming	Yes	Yes	Same
Concentrationprogramming	Yes	Yes	Same
Continuous rateprogramming	Yes	Yes	Same
Demand Doseprogramming	Yes	Yes	Same
Epidural Modeon/off	Yes	Yes	Same
New Patientfeature	Yes	Yes	Same
Program limits(soft and hardlimits)programming	Yes	Yes	Same
Pump/Module IDStorage andretrieval	Yes	Yes	Same
Date/Time format	Yes	Yes	Same
Parameters fromDrug LibraryMismatch	When a user enters aparameter value, RxManagerchecks that value againstpreset hard and soft dosinglimits. If the value is not withinthe limits, RxManager warnsthe user there may be an error.	Therapy based customizedprotocols with Hard and/orSoft Maximum and Minimumdelivery ratesVisual alerts when soft limitmaximum is exceeded	Same
	Administration Sets
Device Feature	CURLIN® AdministrationSets	CADD® AdministrationSets	Comparison
510(k)#	Subject Device	K170982	NA
Free-flowProtection	Yes	Yes	Same
Biocompatible	Yes	Yes	Same
Non-DEHP	Yes	Yes	Same
Latex free	Yes	Yes	Same
Prescription Only	Yes	Yes	Same
Non-pyrogenic	Yes	Yes	Same
Sterile	Yes	Yes	Same
Hospital or HomeUse	Yes	Yes	Same
Air EliminatingFilter	Yes	Yes	Same
Materials ofConstruction	Tubing - PVCBag Spike - ABSOutlet housing - PolycarbonateInlet housing - Polycarbonate	T Tubing - PVCBag Spike - ABSOutlet housing -PolycarbonateInlet housing - Polycarbonate	Same
Device Name	CURLIN® 8000	CADD®-Solis VIP Model2120	Comparison
Administration Set Functionality
Free-flowprotection	Normally closed (afteractuation) spring-biasedclamping mechanism. Manuallyopenable for priming.	Flow Stop free flow protectiondevice is part of the CADD®cassette.-Spring based clampingmechanism.-Manually openable forpriming.	Similar
Free-flowprotectionplunger	Pinches tubing when latch isopened to prevent free flow.	Pinches tubing when latch isopened to prevent free flow.	Same

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CONCLUSIONS IX.

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Curlin 8000 Ambulatory Infusion System is substantially equivalent to the CADD-Solis VIP Model 2120 Infusion System cleared under K111275 with respect to the indications for use, target populations, treatment method, and technological characteristics.

Regulation Number and Section

§ 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).