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

K242660 · Zevex, Inc. · FRN · Oct 3, 2024 · General Hospital

Device Facts

• Record ID: K242660
• Device Name: Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
• Applicant: Zevex, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Oct 3, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 and 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. User interface includes color LCD screen and keypad. Microprocessor-controlled operation; program stored in on-board memory. Used in home care, infusion suites, oncology, and acute care (small hospitals, Labor and Delivery). Operated by clinicians or patients. Rx Manager Enterprise Solution (ES) software provides Dose Error Reduction System (DERS) and therapy-based protocols; supports pharmacy, biomed, and IT staff workflows. Pump connects to Curlin 380-series administration sets for sterile fluid delivery. Accessories include lockbox, pole clamp, PCA bolus cable, USB data cable, AC adapter, and rechargeable Li-ion battery. Benefits include controlled, accurate medication delivery and error prevention via DERS.

Clinical Evidence

Bench testing only. No clinical studies were conducted. Biocompatibility testing per ANSI/AAMI/ISO 10993-7 (2008) + Amd 2019 was performed to validate EO and ECH residual levels for neonates (3.5kg body mass). Results: EO = 0.022mg/d and ECH = 0.171mg/d, both within acceptable limits.

Technological Characteristics

Curvilinear peristaltic pumping mechanism. Materials: standard medical-grade housing, platen, LCD lens, keypad. Power: AC adapter (100-240 Vac) or rechargeable Li-ion battery (23.4 Wh). Connectivity: USB ports for data/PCA bolus. Software: DERS-enabled Rx Manager ES. Sterilization: Ethylene oxide (EO) with extended aeration.

Indications for Use

Indicated for adult and pediatric patients in home care and clinical settings for controlled administration of prescribed medical fluids (e.g., hydration, parenteral nutrition, anti-infectives, pain management, inotropes, chemotherapy, immune globulin, biologics) via intravenous, intra-arterial, subcutaneous, epidural, or perineural routes. Not indicated 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

• CURLIN® 8000 Ambulatory Infusion System with Rx Manager Enterprise Solution Software (K232793)

Submission Summary (Full Text)

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October 3, 2024

Zevex, Inc. Santosh Bhagat Regulatory Affairs Manager 4314 Zevex Park Lane Salt Lake City, Utah 84123

Re: K242660

Trade/Device Name: Curlin 8000 Ambulatory Infusion System: Enterprise Solution (ES) Software: Curlin 380-series Administration Sets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, FPA Dated: August 28, 2024 Received: September 4, 2024

Dear Santosh Bhagat:

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"

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(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).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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,

# Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. 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

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### Indications for Use

Submission Number (if known)

K242660

Device Name

Curlin 8000 Ambulatory Infusion System;

Enterprise Solution (ES) Software;

Curlin 380-series Administration Sets

ndications 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 to adult and 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)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

Date: September 03, 2024

#### SUBMITTER I.

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

Telephone: [phone] Fax: [phone]

### Contact Person:

Santosh Bhagat Manager, 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

#### PREDICATE DEVICE III.

CURLIN® 8000 Ambulatory Infusion System with Rx Manager Enterprise Solution Software (K232793)

#### 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 to allow the pump to be more compact. The user activates the Curlin 8000 рыгомерка via a color LCD screen and keypad user interface. Commands are issued to the ra

toll free 800.970.2331

www.moogmedia

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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 be installed on one to many desktops in a campus-based server network. 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)

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- . Battery Charger that charges up to 4 battery packs simultaneously
#### INDICATIONS FOR USE V.

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 and 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 technological characteristics are identical to the original device as there were no changes made to the Curlin 8000 Ambulatory Infusion Pump. The only update was to add the pediatric population to the Indication for Use and Intended Use after testing to ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009) AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)] was completed.

#### PERFORMANCE DATA VII.

There are no technological changes made to the subject device and hence no new performance data was gathered. The only update was to add the pediatric population to the Indication for Use and Intended Use after testing to ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Includinq: Technical Corrigendum 1 (2009) AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)] was completed.

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| Device<br>Change | Risks | Verification/<br>Validation | Acceptance<br>Criteria | Summary<br>of Results |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Add pediatric<br>population to<br>indication of use<br>by fulfilling<br>requirements<br>specified in<br>ANSI/AAMI/ISO<br>10993-7<br>(2008)+Amd<br>2019 for EO and<br>ECH residuals | Post sterilization<br>exposure to EO<br>and ECH<br>Residuals | Full EO sterilization Cycle<br>with extended aeration<br>time was conducted for<br>Validation of EO/ECH<br>residuals under<br>simulated use extraction<br>method | Per ANSI/AAMI/ISO<br>10993-7 (2008) +<br>Amd 2019 for EO and<br>ECH residuals, for<br>neonates (3.5kg<br>body mass per CNC<br>guidelines):<br><br>EO<= 0.21mg/d<br><br>(Tolerable exposure<br>for EO = 0.30<br>mg/kg/d x 3.5 kg x<br>0.2) (ANSI/AAMI/ISO<br>10993-7<br>(2008)+Amd 2019,<br>Section G.6.3).)<br><br>ECH <= 0.19mg/d<br><br>(Tolerable exposure<br>for ECH = 0.27<br>mg/kg/d x 3.5 kg x<br>0.2) (ANSI/AAMI/ISO<br>10993-7<br>(2008)+Amd 2019,<br>Section H.4.1.2).) | Pass<br><br>EO =<br>0.022mg/d (<br>48 hrs)<br><br>ECH =<br>0.171mg/d<br>(48 hrs) |

# 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.

# VIII. SUBSTANTIAL EQUIVALENCE DISCUSSION SUMMARY

The technological characteristics are identical to the original device as there were no changes made to the Curlin 8000 Ambulatory Infusion Pump. The only update was to add the pediatric population to the Indication for Use and Intended Use after testing to ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009) AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)] was completed.

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| | Predicate | Subject |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | CURLIN Administration Sets<br>are intended to be used with<br>CURLIN infusion pumps to<br>deliver medication from a<br>container to a patient. | deliver medication from a<br>container to a patient. |
| Intended Use<br>(LS-61765) | The CURLIN 8000<br>ambulatory infusion system is<br>intended for use on adult<br>patients in Home Care and<br>Clinical settings to provide<br>the infusion of a broad range<br>of fluids and medications.<br>The pump will provide<br>infusion delivery through<br>accepted clinical routes of<br>administration.<br>For Home Care settings this<br>includes:<br>• intravenous • epidural<br>• subcutaneous • perineural<br>For Clinical (non-home care)<br>settings this includes:<br>• intravenous • epidural<br>• intra-arterial • perineural<br>• subcutaneous | The CURLIN 8000 ambulatory<br>infusion system is intended for<br>use on adult and pediatric<br>patients in Home Care and<br>Clinical settings to provide the<br>infusion of a broad range of<br>fluids and medications. The<br>pump will provide infusion<br>delivery through accepted<br>clinical routes of<br>administration.<br>For Home Care settings this<br>includes:<br>• intravenous • epidural<br>• subcutaneous • perineural<br>For Clinical (non-home care)<br>settings this includes:<br>• intravenous • epidural<br>• intra-arterial • perineural<br>• subcutaneous |

#### IX. CONCLUSIONS

Full EO sterilization Cycle with extended aeration time was conducted for validation of EO/ECH residuals under simulated use extraction. This testing indicated that the EO/ECH residual levels were below those required by ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009) AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]. The test

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results allowed for adding pediatric patients to the Indications for Use and Intended Use statements of the device.