Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets

K232793 · Zevex, Inc. · FRN · May 17, 2024 · General Hospital

Device Facts

• Record ID: K232793
• Device Name: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-Series Adminstration Sets
• Applicant: Zevex, Inc.
• Product Code: FRN · General Hospital
• Decision Date: May 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Compact, lightweight ambulatory infusion pump; utilizes curvilinear peristaltic mechanism; delivers fluids/drugs via sterile administration sets. Operated via color LCD screen and keypad; microprocessor-controlled. Used in home care, infusion suites, oncology, and small hospitals (≤300 beds) for pain management, hydration, nutrition, etc. RxManager Enterprise Solution (ES) software provides Dose Error Reduction System (DERS) and therapy-based protocols; supports pharmacy/biomed/IT workflows. Pump features include air-in-line/occlusion sensors, history logs, and rechargeable battery. Healthcare providers program therapy parameters; pump delivers measured therapy; output affects clinical decision-making by ensuring precise, error-reduced medication delivery.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included software testing per FDA guidance, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993), and human factors studies. Performance testing verified flow rate accuracy, alarm detection (air-in-line, occlusion, infusion complete), and battery reliability.

Technological Characteristics

Curvilinear peristaltic pump; microprocessor-controlled; color LCD interface. Materials: PVC tubing, ABS spike, polycarbonate housings. Connectivity: USB ports for data/PCA bolus. Power: AC adapter or rechargeable Li-ion battery. Software: DERS-enabled RxManager ES. Sterilization: Sterile administration sets. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993, ASTM F756.

Indications for Use

Indicated for adult patients in home care and clinical settings for controlled administration of prescribed fluids via intravenous, intra-arterial, subcutaneous, epidural, and perineural routes. Not for pediatric use. Not for cellular blood products.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• CADD®-Solis VIP Model 2120 (K111275)
• CADD® Administration Sets (K170982)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 12px;">☐</span> 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: [phone] Fax: [phone]

## Contact Person:

Christopher Dodge Director, Quality Assurance & Regulatory Affairs Cell Phone: [phone]

#### 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 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

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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 guidance<br>for the "Content of Premarket Submissions for Device<br>Software Functions" (June 2023) and FDA guidance<br>document "Infusion pump total product life cycle”. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | The electrical safety evaluation of the medical electrical<br>equipment was performed per standards IEC60601-1<br>medical electrical equipment part1: General<br>requirements for basic safety and essential performance |
| EMC | EMC evaluation of the medical electrical equipment was<br>performed to:<br>- IEC 60601-1-2 Ed 4.1: Medical electrical<br>equipment- Part 1-2: General requirements for<br>basic safety and essential performance -<br>Collateral standard: electromagnetic disturbances<br>- Requirements and tests<br>Susceptibility testing to 5G, WPT, EAS, NFC & Security<br>Metal Detectors |
| Device Performance | The essential performance requirements of the device<br>(including feeding sets) were verified through<br>performance testing in accordance with the intended<br>use of the device and in accordance with the FDA<br>Guidance "Infusion Pumps Total Product Life Cycle”<br>including:<br>• Performance testing of essential performance<br>attributes to duration of therapy:<br>Head height<br>Viscosity<br>Back-pressure<br>• Reliability testing<br>• Flow rate accuracy testing across all operating<br>conditions<br>• Alarm detection<br>Battery<br>Air in Line<br>Up and Down Stream Occlusion<br>Hardware and Software failures<br>Pump Unattended |

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| | Infusion Complete<br>Alarms comply with IEC 60601-1-8<br>• Ambulatory<br>• Transportation<br>• Environmental Conditions:<br>Operating Temperature<br>• Operating Altitude | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------|----------------------------------|
| Human Factors | Following FDA Guidance Applying Human Factors and<br>Usability Engineering to Medical Devices (February 3,<br>2016), the human factors studies were conducted with<br>the intended user population, use environment, and use<br>scenarios to simulate clinical conditions. Results of the<br>human factors testing demonstrate validation of the<br>device per the intended use. | | | |
| Biocompatibility | The biocompatibility test reports provided were<br>conducted per ISO10993 series of standards following<br>Good Laboratory Practices and the representative<br>product tested passed all acceptance criteria.<br>CURLIN® 380-series administration sets are classified<br>as external communicating, blood path indirect,<br>prolonged use and the following endpoints have been<br>evaluated: | | | |
| | Endpoint | Method | Standard<br>reference | Biological<br>Risk<br>Assessment |
| | Cytotoxicity | Cytotoxicity<br>Study Using the<br>ISO Elution<br>Method | ISO<br>10993-5 | Non-<br>cytotoxic |
| | Sensitization | ISO Guinea Pig<br>Maximization<br>Sensitization<br>Test | ISO<br>10993-10 | Non-<br>sensitizer |
| | Irritation or<br>Intracutaneous<br>Reactivity | ISO<br>Intracutaneous<br>Irritation Study<br>- Extract | ISO<br>10993-10 | Non-irritant |
| | Acute systemic<br>toxicity | ISO Acute<br>Systemic<br>Toxicity Study in<br>Mice | ISO<br>10993-11 | Non-toxic |
| Material Mediated<br>Pyrogenicity | USP Rabbit<br>Pyrogen Study,<br>Material<br>Mediated | USP,<br>General<br>Chapter<br><151><br>ISO<br>10993-11 | Non-<br>pyrogenic | |
| Subacute/Subchronic<br>toxicity | ISO Two Week<br>Toxicity Study in<br>the Rat,<br>Repeated<br>Parenteral<br>Administration<br>of Two Extracts | ISO<br>10993-11 | Non-Toxic | |
| Hemocompatibility | ASTM<br>Hemolysis<br>Study - Extract<br>Method | ASTM<br>F756<br>ISO<br>10993-4 | Non-<br>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 Model<br>2120 | Comparison |
|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)# | Subject Device | K111275 | NA |
| Manufacturer | Zevex, Inc. | Smiths Medical ASD, Inc. | NA |
| Indications for<br>Use | The CURLIN® 8000 ambulatory<br>infusion pump system is<br>indicated for use in home care<br>and clinical settings for the<br>controlled administration of<br>prescribed medical fluids<br>through clinically accepted<br>routes of administration:<br>intravenous, intra-arterial,<br>subcutaneous, epidural, and<br>perineural, to adult patients.<br>The CURLIN® 8000 is not<br>intended for use on pediatric<br>patients. The pump is intended<br>to deliver a variety of therapies<br>(drugs and fluids) which have<br>been approved for these routes<br>of administration. Examples of<br>the therapies, which may be<br>delivered using the CURLIN®<br>8000 pump, include hydration,<br>parenteral nutrition, anti-<br>infectives, pain management,<br>inotropes, chemotherapy,<br>immune globulin, and biologics.<br>The CURLIN® 8000 is not<br>indicated for the delivery of<br>cellular blood products. | The CADD®-Solis VIP<br>Ambulatory Infusion Pump is<br>indicated for intravenous,<br>intraarterial,<br>subcutaneous,<br>intraperitoneal, perineural,<br>surgical site, epidural<br>space, or subarachnoid<br>space infusion.<br>PCA (patient-controlled<br>analgesia) delivery is used for<br>therapies that require a<br>continuous rate of infusion,<br>patient-controlled demand<br>doses, or both, such as patient<br>controlled analgesia.<br>Continuous delivery allows the<br>infusion of drug/fluid at a<br>constant, programmed rate.<br>Intermittent delivery allows<br>the infusion of a specific<br>volume of drug/fluid at a<br>regular, programmed interval.<br>Step delivery allows an<br>incremental increase in<br>infusion rate to a specified<br>maximum infusion rate for a<br>specified total infusion volume.<br>Taper delivery allows a plateau<br>rate of infusion with the option<br>of tapering at the beginning<br>and/or end and has a<br>programmable KVO rate at the<br>end of the infusion. | Due to the<br>limited use of<br>intraperitoneal<br>and<br>subarachnoid<br>routes of<br>delivery by<br>ambulatory<br>pump users,<br>the two<br>devices are<br>substantially<br>equivalent. |
| Type of Pump | Multi-therapy Infusion Pump | Multi-therapy Infusion Pump | Same |
| Pumping<br>Mechanism | Curvilinear Peristaltic | Linear Peristaltic | Specification<br>differences do<br>not impact |
| Device Name | CURLIN® 8000 | CADD®-Solis VIP Model<br>2120 | Comparison |
| | | | substantial<br>equivalence |
| Patient Population | Adult | Not specified | The subject<br>device is<br>equivalent to<br>the predicate<br>device for the<br>stated patient<br>population<br>that is<br>indicated for<br>use. |
| Delivery Modes | Continuous, TPN, PCA,<br>Intermittent, Variable | Continuous, PCA, Intermittent,<br>Step (Variable), Taper (TPN) | Same |
| System delivery<br>accuracy<br>(nominal) | +/- 5%<br>For rates at and above 1mL/hr<br>and bolus doses greater than<br>2.5mL<br>+/- 15%<br>For rates below 1mL/hr and<br>bolus doses at or less than<br>2.5mL | +/- 6%<br>10mL/hr and above and bolus<br>accuracy | Specification<br>differences do<br>not impact<br>substantial<br>equivalence |
| Time to Occlusion<br>Alarm mL/hr Rate<br>(worst case) | 0.1 mL/hr = < 360 min<br>1.0 mL/hr = < 25 min<br>25 mL/hr = < 2 min | 0.1 mL/hr = ≤ 1200 min<br>150 mL/hr = ≤ 90 min | Subject device<br>has a tighter<br>specification |
| Air-in-Line<br>Settings | Settings:<br>• 0.1 mL<br>• 0.5 mL<br>• 1 mL<br>• 2 mL<br>• "Off": still senses air and<br>reports accumulated over 4<br>mL | Settings:<br>• High Sensitivity (>0.15<br>mL)<br>• Low sensitivity (>0.4 mL)<br>• Off: truly off, does not<br>sense air | Similar |
| Volume of air to<br>trigger an Air-in-<br>Line alarm | Single bubble reporting is<br>based on the chosen setting:<br>• 0.1 mL<br>• 0.5 mL<br>• 1 mL<br>• 2 mL<br>"Off" senses air and reports<br>accumulated air over 4 mL.<br>Accumulated air is related to<br>the amount of air delivered<br>(per chosen setting) over<br>volume of fluid delivered. | Single bubble reporting is<br>based on the setting chosen:<br>Low: single bubble>400<br>microliters<br>High: single bubble> 150<br>microliters<br>Off: does not report any air<br>Accumulated air is related to<br>volume over time.<br>• Accumulated air: greater<br>than 1 mL air over 15<br>minutes (nominal) | Specification<br>differences do<br>not impact<br>substantial<br>equivalence |
| Device Name | CURLIN® 8000 | CADD®-Solis VIP Model<br>2120 | Comparison |
| Ingress<br>Protection | IPX4 - Protection against water<br>splashing | IPX4 - Protection against<br>water splashing | Same |
| Display | Graphic Color LCD | Color display with 320 x 320<br>pixels | No impact in<br>equivalence as<br>this change<br>has been<br>validated to be<br>acceptable<br>and equivalent<br>for the<br>intended 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…