(249 days)
Not Found
No
The document describes a standard infusion pump with a microprocessor and software for managing configurations and protocols. There is no mention of AI or ML capabilities in the device description, intended use, or performance studies. The software includes a Dose Error Reduction System (DERS), which is a rule-based system, not typically considered AI/ML.
No.
The device is an infusion pump system, which is used to administer therapies (drugs and fluids), but it does not directly provide a therapeutic effect itself.
No.
The device is an ambulatory infusion pump system designed for the controlled administration of prescribed medical fluids, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components such as a pumping mechanism, sensors, communication ports, power ports, structural components, electronics, battery, and a user interface with a color LCD screen and keypad. While the submission mentions software (RxManager Enterprise Solution Software), it is described as a separate component used to manage pump configurations and protocols, not the primary medical device itself. The core medical device is the physical infusion pump.
Based on the provided information, the CURLIN® 8000 ambulatory infusion pump system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "controlled administration of prescribed medical fluids through clinically accepted routes of administration: intravenous, intra-arterial, subcutaneous, epidural, and perineural, to adult patients." This describes a device used to deliver substances into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a mechanical and electronic pump designed to deliver fluids. It mentions components like a pumping mechanism, sensors, and a user interface for controlling delivery. This aligns with the function of an infusion pump, not an IVD device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device's purpose is to deliver therapy, not to analyze biological samples.
- Associated Accessories: The accessories listed (lockbox, pole clamp, cables, power adapter, battery, battery charger) are all consistent with the operation and use of an infusion pump for delivering fluids.
- Performance Studies: The performance studies described focus on aspects like software verification and validation, electrical safety, EMC, device performance (flow rate accuracy, alarm detection), human factors, and biocompatibility. These are relevant to the safety and efficacy of a medical device that delivers substances to a patient, not an IVD device that analyzes samples.
In summary, the CURLIN® 8000 is a medical device used for delivering fluids and medications to patients, which falls under a different regulatory category than In Vitro Diagnostic devices.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FRN, FPA
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intravenous, intra-arterial, subcutaneous, epidural, and perineural
Indicated Patient Age Range
Adult patients. Not intended for use on pediatric patients.
Intended User / Care Setting
Home care and clinical settings. Pharmacy Staff, Biomed Staff, IT Staff and Moog Field Service Staff for the ES software.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A safety assurance case was provided, as recommended by the FDA guidance document, Infusion Pumps Total Product Life Cycle. The 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 indications for use, system definition, operational description, patient populations, and use environments.
The supporting assurance arguments cover:
- 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.
Specific evidence included in the assurance case to demonstrate verification and validation for intended use and substantial equivalence:
- Software: Software verification and validation per FDA guidance for the "Content of Premarket Submissions for Device Software Functions" (June 2023) and FDA guidance document "Infusion pump total product life cycle”.
- Electrical Safety: Electrical safety evaluation performed per standards IEC60601-1 medical electrical equipment part1: General requirements for basic safety and essential performance.
- EMC: EMC evaluation performed to: IEC 60601-1-2 Ed 4.1: Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: electromagnetic disturbances - Requirements and tests. Susceptibility testing to 5G, WPT, EAS, NFC & Security Metal Detectors.
- Device Performance: Essential performance requirements verified through performance testing in accordance with intended use and FDA Guidance "Infusion Pumps Total Product Life Cycle” including:
- 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
- Ambient Conditions: Ambulatory, Transportation, Environmental Conditions (Operating Temperature, Operating Altitude)
- Human Factors: Human factors studies conducted following FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016), with intended user population, use environment, and use scenarios to simulate clinical conditions. Results demonstrate validation of the device per intended use.
- Biocompatibility: Test reports conducted per ISO10993 series of standards following Good Laboratory Practices. CURLIN® 380-series administration sets classified as external communicating, blood path indirect, prolonged use. Endpoints evaluated: Cytotoxicity (Non-cytotoxic), Sensitization (Non-sensitizer), Irritation or Intracutaneous Reactivity (Non-irritant), Acute systemic toxicity (Non-toxic), Material Mediated Pyrogenicity (Non-pyrogenic), Subacute/Subchronic toxicity (Non-Toxic), Hemocompatibility (Non-hemolytic).
Animal studies were deemed unnecessary.
Human clinical studies were deemed unnecessary.
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CADD®-Solis VIP Model 2120 (K111275), CADD® Administration Sets (K170982)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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).
1
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).
2
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
3
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
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)
5
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
6
- 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
7
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.
8
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
for the "Content of Premarket Submissions for Device
Software Functions" (June 2023) and FDA guidance
document "Infusion pump total product life cycle”. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | The electrical safety evaluation of the medical electrical
equipment was performed per standards IEC60601-1
medical electrical equipment part1: General
requirements for basic safety and essential performance |
| EMC | EMC evaluation of the medical electrical equipment was
performed to:
- IEC 60601-1-2 Ed 4.1: Medical electrical
equipment- Part 1-2: General requirements for
basic safety and essential performance -
Collateral standard: electromagnetic disturbances - Requirements and tests
Susceptibility testing to 5G, WPT, EAS, NFC & Security
Metal Detectors |
| Device Performance | The essential performance requirements of the device
(including feeding sets) were verified through
performance testing in accordance with the intended
use of the device and in accordance with the FDA
Guidance "Infusion Pumps Total Product Life Cycle”
including:
• 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 |
9
| | Infusion Complete
Alarms comply with IEC 60601-1-8
• Ambulatory
• Transportation
• Environmental Conditions:
Operating Temperature
• Operating Altitude | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-----------------------|----------------------------------|
| Human Factors | Following FDA Guidance Applying Human Factors and
Usability Engineering to Medical Devices (February 3,
2016), the human factors studies were conducted with
the intended user population, use environment, and use
scenarios to simulate clinical conditions. Results of the
human factors testing demonstrate validation of the
device per the intended use. | | | |
| Biocompatibility | The biocompatibility test reports provided were
conducted per ISO10993 series of standards following
Good Laboratory Practices and the representative
product tested passed all acceptance criteria.
CURLIN® 380-series administration sets are classified
as external communicating, blood path indirect,
prolonged use and the following endpoints have been
evaluated: | | | |
| | Endpoint | Method | Standard
reference | Biological
Risk
Assessment |
| | Cytotoxicity | Cytotoxicity
Study Using the
ISO Elution
Method | ISO
10993-5 | Non-
cytotoxic |
| | Sensitization | ISO Guinea Pig
Maximization
Sensitization
Test | ISO
10993-10 | Non-
sensitizer |
| | Irritation or
Intracutaneous
Reactivity | ISO
Intracutaneous
Irritation Study
- Extract | ISO
10993-10 | Non-irritant |
| | Acute systemic
toxicity | ISO Acute
Systemic
Toxicity Study in
Mice | ISO
10993-11 | Non-toxic |
| Material Mediated
Pyrogenicity | USP Rabbit
Pyrogen Study,
Material
Mediated | USP,
General
Chapter
ISO
10993-11 | Non-
pyrogenic | |
| Subacute/Subchronic
toxicity | ISO Two Week
Toxicity Study in
the Rat,
Repeated
Parenteral
Administration
of Two Extracts | ISO
10993-11 | Non-Toxic | |
| Hemocompatibility | ASTM
Hemolysis
Study - Extract
Method | ASTM
F756
ISO
10993-4 | Non-
hemolytic | |
10
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.
11
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
2120 | Comparison |
|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)# | Subject Device | K111275 | NA |
| Manufacturer | Zevex, Inc. | Smiths Medical ASD, Inc. | NA |
| 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. | The CADD®-Solis VIP
Ambulatory Infusion Pump is
indicated for intravenous,
intraarterial,
subcutaneous,
intraperitoneal, perineural,
surgical site, epidural
space, or subarachnoid
space infusion.
PCA (patient-controlled
analgesia) delivery is used for
therapies that require a
continuous rate of infusion,
patient-controlled demand
doses, or both, such as patient
controlled analgesia.
Continuous delivery allows the
infusion of drug/fluid at a
constant, programmed rate.
Intermittent delivery allows
the infusion of a specific
volume of drug/fluid at a
regular, programmed interval.
Step delivery allows an
incremental increase in
infusion rate to a specified
maximum infusion rate for a
specified total infusion volume.
Taper delivery allows a plateau
rate of infusion with the option
of tapering at the beginning
and/or end and has a
programmable KVO rate at the
end of the infusion. | Due to the
limited use of
intraperitoneal
and
subarachnoid
routes of
delivery by
ambulatory
pump users,
the two
devices are
substantially
equivalent. |
| Type of Pump | Multi-therapy Infusion Pump | Multi-therapy Infusion Pump | Same |
| Pumping
Mechanism | Curvilinear Peristaltic | Linear Peristaltic | Specification
differences do
not impact |
| Device Name | CURLIN® 8000 | CADD®-Solis VIP Model
2120 | Comparison |
| | | | substantial
equivalence |
| Patient Population | Adult | Not specified | The subject
device is
equivalent to
the predicate
device for the
stated patient
population
that is
indicated for
use. |
| Delivery Modes | Continuous, TPN, PCA,
Intermittent, Variable | Continuous, PCA, Intermittent,
Step (Variable), Taper (TPN) | Same |
| System delivery
accuracy
(nominal) | +/- 5%
For rates at and above 1mL/hr
and bolus doses greater than
2.5mL
+/- 15%
For rates below 1mL/hr and
bolus doses at or less than
2.5mL | +/- 6%
10mL/hr and above and bolus
accuracy | Specification
differences do
not impact
substantial
equivalence |
| Time to Occlusion
Alarm mL/hr Rate
(worst case) | 0.1 mL/hr = 0.15
mL)
• Low sensitivity (>0.4 mL)
• Off: truly off, does not
sense air | Similar |
| Volume of air to
trigger an Air-in-
Line alarm | Single bubble reporting is
based on the chosen setting:
• 0.1 mL
• 0.5 mL
• 1 mL
• 2 mL
"Off" senses air and reports
accumulated air over 4 mL.
Accumulated air is related to
the amount of air delivered
(per chosen setting) over
volume of fluid delivered. | Single bubble reporting is
based on the setting chosen:
Low: single bubble>400
microliters
High: single bubble> 150
microliters
Off: does not report any air
Accumulated air is related to
volume over time.
• Accumulated air: greater
than 1 mL air over 15
minutes (nominal) | Specification
differences do
not impact
substantial
equivalence |
| Device Name | CURLIN® 8000 | CADD®-Solis VIP Model
2120 | Comparison |
| Ingress
Protection | IPX4 - Protection against water
splashing | IPX4 - Protection against
water splashing | Same |
| Display | Graphic Color LCD | Color display with 320 x 320
pixels | No impact in
equivalence as
this change
has been
validated to be
acceptable
and equivalent
for the
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 | | |
| Air-In-Line | Audible, LCD message | Audible, LCD message | Same |
| Air-In-Line
Disabled | 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 |
| Infusion
Complete | Audible, LCD message | Audible, LCD message | Same |
| KVO Rate Too
High | Audible, LCD message | No | Subject device
warns while
predicate
device limits
programming
from 0-10
mL/hr |
| Low Bag Volume | Audible, LCD message | Audible, LCD message | Same |
| Pump
Maintenance Due | Audible, LCD message | Audible, LCD message | Same |
| Release/Remove
PCA Cord | Audible, LCD message | Audible, LCD message | Same |
| Handset
Unplugged | 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 key
is 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/h
INT: 0.1 – 500 mL/h
VAR: 0.1 - 500 mL/h
TPN: 10 – 500 mL/h
PCA Basic (non-Rx Manager) programming ranges:
Basal Rate: 0 or 0.1 - 10 mL/h
PCA PSP (Rx Manager) programming ranges
Basal Rate:
IV: 0 or 0.1 - 100 mL/h
SubQ: 0 or 0.1 – 10 mL/h
EPI: 0 or 0.1- 35 mL/h
PCA Bolus (Basic Program):
• Min: 0 when no patient bolus programmed 0.1 for mL
• Max: Max PCA Bolus Volume for (Basic) - All Routes: 10 mL
PCA Bolus (PSP Program):
• Min: 0 (OFF); 0.1 for mL
• Max: | CONT: 0.1 - 500 mL/h
INT: 0.1-500 mL/hr
VAR: 0.4- 500 mL/hr
TPN: 0.1-500 mL/hr
PCA Basal rate: 0-100 mL/hr
PCA (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 Model
2120 | Comparison |
| | SubQ route - 10 mL
equiv. | | |
| KVO | Yes (all non PCA modes) | Yes (all modes) | Same |
| KVO Rate | 0.1 - 9.9 mL/h | PCA: 0-0.1 mL/h
Other modes: 0 - 10 mL/h | Similar |
| Bag (Reservoir)
volume -
Programmed
value of volume
of available fluid
in drug container | 1 to 9,999 mL | 0 to 9,999 mL | Similar |
| Maximum PCA
Bolus Amount | Basic program: 9.9 mL
RxM/PSP programming: 50 mL | Maximum 50 mL | Same |
| Clinician Bolus | Yes | Yes | Same |
| Maximum
Clinician Bolus | Basic Program: 10 mL
PSP Program: 50 mL | 50 mL | Same |
| Maximum PCA
Boluses per Hour | 30 per hour | 60 per hour | Specification
differences do
not impact
substantial
equivalence |
| PCA Dose lockout
time | 2 minutes - 24 hours | 1 minute - 24 hours | Similar |
| Bolus Delivery
Limit Methods | 1-hour limit OR Max # of
Boluses/hour | 1-12-hour limit OR Max # of
Boluses/hour | Specification
differences do
not impact
substantial
equivalence |
| Programmable
Delivery Rate -
PCA | Basic infusion 10-125 mL/h
PSP 10-400 mL/h | 40 - 250 mL/h | Specification
differences do
not impact
substantial
equivalence |
| Priming Methods | Gravity or Pump | Gravity or Pump | Same |
| Accessories | | | |
| Administration
Sets | Yes | Yes | Same |
| AC adapter | Yes | Yes | Same |
| Remote Dose
Cord | Yes | Yes | Same |
| Reservoir
enclosure
(Lockbox) | Yes | Yes | Same |
| Pole Mount
Bracket | Yes | Yes | Same |
| Electrical Safety | | | |
| Electrical Safety | Compliant with ANSI/AAMI
60601-1:2005/A1:2012 | Compliant with IEC 60601-1 | Same |
| Device Name | CURLIN® 8000 | CADD®-Solis VIP Model
2120 | Comparison |
| Electromagnetic
compatibility | 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 pack
AC Adapter | 1.5V "AA" cell Alkaline (4)
Rechargeable battery pack
AC Adapter | Similar |
| Alkaline Battery
Life | 10 Hours @ 500 mL/h
30 Hours @ 125 mL/h
50 Hours @ 2 mL/h | 11 Hours @ 500 mL/h
37 Hours @ 125 mL/H
139 Hours @ 1 mL/h | Similar,
though
calculated at
different mL/h |
| Rechargeable
Battery Life | 10 Hours @ 500 mL/h
30 Hours @ 125 mL/h
85 Hours @ 2 mL/h | 10 Hours @ 500 mL/h
30 Hours @ 125 mL/H
67 Hours @ 1 mL/h | The subject
device battery
life is longer
for infusions
run at lower
rates |
| 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 |
| Atmospheric
Pressure | 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 Medication
Safety Software V 3.1 | Comparison |
| 510(k)# | Subject Device | K111275 | NA |
| PC Software
Compatibility | Windows 10 | Windows 2000, XP, VISTA,
Windows 7, Administrator
only: Windows Server 2003,
Server 2008, Server 2008R | Differences in
supported
Windows
Operating
Systems do
not raise
questions of
safety and
effectiveness |
| Protocol
Programming | Yes | Yes | Same |
| View Reports | Yes | Yes | Same |
| Print Reports | Yes | Yes | Same |
| Save Reports | Yes | Yes | Same |
| Event Log
Viewing | Yes | Yes | Same |
| Rx (pump
History/Settings
Viewing) | Yes | Yes | Same |
| Device Name | CURLIN® 8000 | CADD®-Solis VIP Model
2120 | Comparison |
| Password
Protected | Yes | Yes | Same |
| Units
programming | Yes | Yes | Same |
| Concentration
programming | Yes | Yes | Same |
| Continuous rate
programming | Yes | Yes | Same |
| Demand Dose
programming | Yes | Yes | Same |
| Epidural Mode
on/off | Yes | Yes | Same |
| New Patient
feature | Yes | Yes | Same |
| Program limits
(soft and hard
limits)
programming | Yes | Yes | Same |
| Pump/Module ID
Storage and
retrieval | Yes | Yes | Same |
| Date/Time format | Yes | Yes | Same |
| Parameters from
Drug Library
Mismatch | When a user enters a
parameter value, RxManager
checks that value against
preset hard and soft dosing
limits. If the value is not within
the limits, RxManager warns
the user there may be an error. | Therapy based customized
protocols with Hard and/or
Soft Maximum and Minimum
delivery rates
Visual alerts when soft limit
maximum is exceeded | Same |
| | Administration Sets | | |
| Device Feature | CURLIN® Administration
Sets | CADD® Administration
Sets | Comparison |
| 510(k)# | Subject Device | K170982 | NA |
| Free-flow
Protection | 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 Home
Use | Yes | Yes | Same |
| Air Eliminating
Filter | Yes | Yes | Same |
| Materials of
Construction | Tubing - PVC
Bag Spike - ABS
Outlet housing - Polycarbonate
Inlet housing - Polycarbonate | T Tubing - PVC
Bag Spike - ABS
Outlet housing -
Polycarbonate
Inlet housing - Polycarbonate | Same |
| Device Name | CURLIN® 8000 | CADD®-Solis VIP Model
2120 | Comparison |
| Administration Set Functionality | | | |
| Free-flow
protection | Normally closed (after
actuation) spring-biased
clamping mechanism. Manually
openable for priming. | Flow Stop free flow protection
device is part of the CADD®
cassette.
-Spring based clamping
mechanism.
-Manually openable for
priming. | Similar |
| Free-flow
protection
plunger | Pinches tubing when latch is
opened to prevent free flow. | Pinches tubing when latch is
opened to prevent free flow. | Same |
12
13
14
15
16
17
18
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.