(29 days)
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.
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 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 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 provided text describes a 510(k) submission for the Curlin 8000 Ambulatory Infusion System, specifically focusing on the addition of a pediatric population to its intended use. The core of the study revolves around evaluating the levels of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals after sterilization, to ensure they are safe for pediatric patients.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance Limit (for neonates, 3.5kg body mass) | Reported Device Performance (48 hrs) | Result |
|---|---|---|---|
| Ethylene Oxide (EO) Residuals (Per ANSI/AAMI/ISO 10993-7 (2008) + Amd 2019, Section G.6.3) | <= 0.21 mg/d (Tolerable exposure for EO = 0.30 mg/kg/d x 3.5 kg x 0.2) | 0.022 mg/d | Pass |
| Ethylene Chlorohydrin (ECH) Residuals (Per ANSI/AAMI/ISO 10993-7 (2008) + Amd 2019, Section H.4.1.2) | <= 0.19 mg/d (Tolerable exposure for ECH = 0.27 mg/kg/d x 3.5 kg x 0.2) | 0.171 mg/d | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a sample size in terms of a specific number of individual devices tested. Instead, it refers to a "Full EO sterilization Cycle with extended aeration time" being "conducted for Validation of EO/ECH residuals under simulated use extraction method." This suggests a test was performed on one or more representative samples of the administration sets to measure the residuals.
- Sample Size: Not explicitly stated as a number of distinct units. The testing involved a "Full EO sterilization Cycle" on the administration sets.
- Data Provenance: The study is a prospective test conducted specifically to evaluate the device changes for the 510(k) submission. The country of origin of the data is not specified, but the submission is to the U.S. FDA, implying adherence to international and U.S. standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This type of study does not involve human experts establishing ground truth in the traditional sense. The "ground truth" here is based on established international standards (ANSI/AAMI/ISO 10993-7) for acceptable levels of sterilization residuals in medical devices, particularly for vulnerable populations like neonates. These standards are developed by multidisciplinary expert panels in the fields of biocompatibility and toxicology, but no specific number or qualification of experts establishing the ground truth for this particular test is mentioned because it refers back to the existing standard.
4. Adjudication Method for the Test Set:
Not applicable. This is a laboratory-based chemical analysis comparing measured values against predefined acceptable limits from an international standard, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This study is not an MRMC comparative effectiveness study, nor does it involve AI. It is a biological evaluation of material safety.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This study does not involve an algorithm.
7. The Type of Ground Truth Used:
The ground truth used is based on established international biological evaluation standards (ANSI/AAMI/ISO 10993-7) which define the maximum tolerable exposure limits for Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals, especially for sensitive populations like neonates.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" as this is not a machine learning or AI study.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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: (801) 264-1001 Fax: (801) 264-1051
Contact Person:
Santosh Bhagat Manager, Regulatory Affairs Cell Phone: (385) 256-8649
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
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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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| DeviceChange | Risks | Verification/Validation | AcceptanceCriteria | Summaryof Results |
|---|---|---|---|---|
| Add pediatricpopulation toindication of useby fulfillingrequirementsspecified inANSI/AAMI/ISO10993-7(2008)+Amd2019 for EO andECH residuals | Post sterilizationexposure to EOand ECHResiduals | Full EO sterilization Cyclewith extended aerationtime was conducted forValidation of EO/ECHresiduals undersimulated use extractionmethod | Per ANSI/AAMI/ISO10993-7 (2008) +Amd 2019 for EO andECH residuals, forneonates (3.5kgbody mass per CNCguidelines):EO<= 0.21mg/d(Tolerable exposurefor EO = 0.30mg/kg/d x 3.5 kg x0.2) (ANSI/AAMI/ISO10993-7(2008)+Amd 2019,Section G.6.3).)ECH <= 0.19mg/d(Tolerable exposurefor ECH = 0.27mg/kg/d x 3.5 kg x0.2) (ANSI/AAMI/ISO10993-7(2008)+Amd 2019,Section H.4.1.2).) | PassEO =0.022mg/d (48 hrs)ECH =0.171mg/d(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 Setsare intended to be used withCURLIN infusion pumps todeliver medication from acontainer to a patient. | deliver medication from acontainer to a patient. | |
| Intended Use(LS-61765) | The CURLIN 8000ambulatory infusion system isintended for use on adultpatients in Home Care andClinical settings to providethe infusion of a broad rangeof fluids and medications.The pump will provideinfusion delivery throughaccepted clinical routes ofadministration.For Home Care settings thisincludes:• intravenous • epidural• subcutaneous • perineuralFor Clinical (non-home care)settings this includes:• intravenous • epidural• intra-arterial • perineural• subcutaneous | The CURLIN 8000 ambulatoryinfusion system is intended foruse on adult and pediatricpatients in Home Care andClinical settings to provide theinfusion of a broad range offluids and medications. Thepump will provide infusiondelivery through acceptedclinical routes ofadministration.For Home Care settings thisincludes:• intravenous • epidural• subcutaneous • perineuralFor Clinical (non-home care)settings this includes:• intravenous • epidural• intra-arterial • perineural• 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.
§ 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).