(211 days)
The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician.
The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products.
The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.
The DEKA Infusion System, comprised of the DEKA Infusion Controller and DEKA Administration Set, is a gravity-based infusion controller. The Infusion Controller uses a Camera to view drop formation in an Administration Set Drip Chamber in order to measure flow rate. During an infusion, the Infusion Controller can adjust the Flow Control Valve (FCV) as necessary against the DEKA Administration Set to maintain the desired flow rate without user intervention.
The DEKA Administration Set is a single-use, non-DEHP intravascular administration set provided sterile. It is compatible with the DEKA Infusion Controller or can be used as a standalone administration set for performing manual gravity infusions.
This document describes the regulatory submission for the DEKA Infusion System and DEKA Administration Set, emphasizing their substantial equivalence to previously cleared devices. It outlines performance data related to device testing but does not contain information on studies proving the device meets acceptance criteria related to AI/human reader performance or ground truth established by experts for such studies.
Therefore, I will extract relevant information that is present and note the absence of information specifically requested for AI/human reader performance studies.
Here's the analysis based on the provided text:
Acceptance Criteria and Device Performance (as far as described for the hardware components):
| Acceptance Criterion (Implicit/Derived from Predicate Comparison) | Reported Device Performance (Subject Device) |
|---|---|
| DEKA Infusion System | |
| Device Classification Regulation and Product Code | 21 CFR 880.5725, Product Code: LDR |
| Class | II |
| Intended Use | Equivalent to predicate |
| Prescription or Over the Counter (OTC) | Prescription |
| Intended Patient Population | Adults |
| Environment of Use | Equivalent to predicate |
| Compatible Administration Set | DEKA Administration Set, 20 drop/mL (non-DEHP) (Equivalent to predicate) |
| Applicable Standards | ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304 (Identical) |
| Operating Environment Temperature | 15 °C to 40 °C (Wider, supported by testing) |
| Operating Environment Relative Humidity | 15 % to 90%, non-condensing (Wider, supported by testing) |
| Operating Environment Altitude | -300 m to 3000 m (Wider, supported by testing) |
| Specified Ingress Protection rating | IP42 (Higher, supported by testing) |
| Physical Weight | < 450 g (Similar) |
| Physical Dimension | < 5.11" x 5.11" x 2.55" (Similar) |
| Power Requirements | 100-127/220-240 V AC, Rechargeable Lithium Battery (Identical) |
| Control Mechanism | Video camera and vision processing system with a flow control valve (Identical) |
| Flow Rate Accuracy | ± 10% nominally, ± 25% under environmental limits of normal use (Identical) |
| Flow Rate Range | 10 mL/hr to 300 mL/hr in 1 mL/hr increments (Identical) |
| Volume to be Infused (VTBI) | 10 mL to 1300 mL in 1 mL increments (Functionality equivalent to reference device) |
| Time to reach target Flow Rate | < 5 minutes (Identical) |
| Time to detect an Occlusion | < 5 minutes (Longer, but equivalent safety/effectiveness demonstrated via risk management and performance testing) |
| Alarm Conditions | All listed alarms (Internal System Fault, Low Battery, Timeout, etc.) are present and equivalent. "End of Infusion" alarm is new, equivalent to reference device. |
| DEKA Administration Set | |
| Device Classification Regulation and Product Code | 21 CFR 880.5440, Product Code: FPA |
| Class | II |
| Intended Use | Equivalent to predicate |
| Sterility Assurance Level (SAL) | Labeled as sterile (equivalent to 10e-6) (Identical) |
| Applicable Standards | ISO 8536-4, ISO 10993 (Identical) |
| Drop Size | 20 drops/mL (Identical) |
| Components | Simpler list of components than predicate, plus a multi-lumen Flow Control Insert verified for safety/effectiveness. |
| Fluid Path Material | Non-DEHP PVC, medical grade silicone (Includes medical grade silicone in Flow Control Insert, supported by performance testing). |
| Patient Connector Type | Male Luer (Identical) |
| Single use? | Yes (Identical) |
| Priming Volume (approx.) | 13 mL (Equivalent) |
Study Details (based on provided text):
1. A table of acceptance criteria and the reported device performance:
- See table above. The acceptance criteria are implicitly defined by the substantial equivalence comparison to the predicate devices and relevant industry standards. Performance is reported as "identical," "similar," or "equivalent." Specific quantitative performance values are provided for flow rate accuracy, range, VTBI, and time to detect occlusion.
2. Sample sized used for the test set and the data provenance:
- The document states "Performance testing was conducted in order to verify and validate each subject device for its respective intended use." However, it does not provide specific sample sizes (e.g., number of devices, number of test runs) for these tests, nor does it explicitly mention data provenance (e.g., country of origin, retrospective/prospective for any study in the typical sense of a human-in-the-loop or AI performance study). The tests are described as nonclinical in nature, implying laboratory testing of the devices themselves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the document describes performance testing of a physical medical device (infusion system and administration set), not an AI-enabled diagnostic device requiring expert interpretation for ground truth. There is no mention of "experts" beyond the general statement "under the supervision of a qualified clinician" for device use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for the type of device and testing described. Adjudication methods are typically used in clinical studies involving human readers and interpretations of medical images or data.
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:
- This is not applicable as the DEKA Infusion System and Administration Set are hardware devices, not AI-enabled diagnostic software that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is not an algorithm for diagnostic interpretation. Its "control mechanism" uses a "Video camera and vision processing system with a flow control valve" to measure and control flow rates, which is an integrated system function, not a standalone AI algorithm for interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the hardware performance tests mentioned (e.g., flow rate accuracy, alarm conditions, electrical safety), the "ground truth" would be established by physical measurements, adherence to engineering specifications, and compliance with recognized industry standards (e.g., AAMI TIR101, IEC 60601 series, ISO 8536-4). It's not a medical "ground truth" like disease presence or absence.
8. The sample size for the training set:
* This is not applicable. There is no mention of an AI model or a "training set" in the context of this device's regulatory submission. The device uses "vision processing" for its function, but the approval is for the physical device, not an AI model that undergoes a typical training and validation regimen as seen in AI/ML submissions.
9. How the ground truth for the training set was established:
* This is not applicable. As there is no explicitly mentioned "training set" for an AI model for clinical interpretation, there is no ground truth establishment method described.
Summary of what is present and what is not:
- Present: Detailed comparison of the subject devices (DEKA Infusion System and DEKA Administration Set) to their respective predicate devices across various characteristics, including technical specifications, performance parameters (like flow rate, alarms), and adherence to relevant medical device standards. The document confirms that extensive nonclinical performance testing was conducted to support substantial equivalence.
- Not Present: Any information related to AI-specific study designs, human reader performance, expert consensus for ground truth in diagnostic interpretation, or sample sizes for clinical trials/test sets/training sets for AI models. This is consistent with the device being a hardware infusion system, not an AI-enabled diagnostic tool in the typical sense.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2024
DEKA Research and Development Paul Smolenski Regulatory Affairs 340 Commercial Street Manchester, New Hampshire 03101
Re: K232316
Trade/Device Name: DEKA Infusion System, DEKA Administration Set Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LDR, FPA Dated: January 31, 2024 Received: February 1, 2024
Dear Paul Smolenski:
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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Jake K. Lindstrom -S
Jake Lindstrom, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Summary
This 510(k) Summary of Safety and Effectiveness information is prepared in accordance with the requirements of 21 CFR Part 807.92.
Submitter Information
| 510(k) Sponsor | DEKA Research & Development340 Commercial StreetManchester, NH 03101 |
|---|---|
| Contact Person(s) | Paul Smolenski (primary), Lauren Blake (secondary)Regulatory AffairsPhone: (603) 669-5139Fax: (603) 624-0573psmolenski@dekaresearch.com, lblake@dekaresearch.com |
| Date Prepared | August 2, 2023 |
Proposed Device(s)
| Common/Usual Name: | Infusion Controller |
|---|---|
| Trade/Proprietary Name: | DEKA Infusion System |
| Classification Name: | Controller, Infusion, Intravascular, Electronic |
| Device Classification: | 880.5725 |
| Product Code: | LDR |
| Class: | II |
| Device Panel: | General Hospital |
| Common/Usual Name: | Intravascular Administration Set | |
|---|---|---|
| Trade/Proprietary Name: | DEKA Administration Set | |
| Classification Name: | Set, Administration, Intravascular | |
| Device Classification: | 880.5440 | |
| Product Code: | FPA | |
| Class: | II | |
| Device Panel: | General Hospital |
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Predicate Device(s)
DEKA Infusion System
The DEKA Infusion System is substantially equivalent to the DEKA Volumetric Infusion Controller, which was previously cleared under premarket application K153760 on October 3. 2016.
The DEKA Infusion System has a VTBI functionality that is substantially equivalent to that of the reference device, the QCore Sapphire Infusion Pump cleared on November 19, 2020 under premarket notification K192860.
DEKA Administration Set
The DEKA Administration Set is substantially equivalent to the Zyno Medical Administration Set, which was previously cleared under premarket application K120685 on September 7, 2012.
Device Description
DEKA Infusion System
The DEKA Infusion System, comprised of the DEKA Infusion Controller and DEKA Administration Set, is a gravity-based infusion controller. The Infusion Controller uses a Camera to view drop formation in an Administration Set Drip Chamber in order to measure flow rate. During an infusion, the Infusion Controller can adjust the Flow Control Valve (FCV) as necessary against the DEKA Administration Set to maintain the desired flow rate without user intervention.
DEKA Administration Set
The DEKA Administration Set is a single-use, non-DEHP intravascular administration set provided sterile. It is compatible with the DEKA Infusion Controller or can be used as a standalone administration set for performing manual gravity infusions.
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Indications for Use
DEKA Infusion System
The DEKA Infusion System is indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients through a peripheral intravenous (IV) site under the supervision of a qualified clinician.
Contraindications
The DEKA Infusion System is not indicated for delivery of high-alert medications, blood, and blood products. The DEKA Infusion System is not indicated for use with pediatric or neonatal patients. The DEKA Infusion System is not indicated for use with a pressurized infusate source. The DEKA Infusion System is not indicated for use during transport.
The DEKA Infusion System is not indicated for use with patients who have certain pre-existing medical conditions that put them at risk of complications from a gravity infusion. A list of conditions that would prohibit the use of the DEKA Infusion System can be found below.
- Congestive Heart Failure ●
- A combination of Eisenmenger's Syndrome and Patent Foramen Ovale ●
- Acute Myocardial Infarction ●
- Acute Respiratory Failure ●
- Acute Respiratory Distress Syndrome ●
- Acute Hemorrhage or Hemorrhagic Shock
- Other critical illnesses
- Renal Failure/Patients on dialysis ●
- Patients on fluid restrictions ●
- Patients in need of aggressive fluid resuscitation .
DEKA Administration Set
The DEKA Administration Set is indicated for gravity administration of general maintenance fluids and supported antibiotics approved for peripheral intravenous (IV) infusion to adult patients under the supervision of a qualified clinician. The DEKA Administration Set is indicated for single patient use only. The DEKA Administration Set is not indicated for administration of high-alert medications, blood, and blood products.
The DEKA Administration Set is compatible with the DEKA Infusion Controller or can be used as a stand-alone administration set for performing manual gravity infusions.
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Substantial Equivalence Discussion
The tables below compare the characteristics of the subject devices to their respective predicate devices.
DEKA Infusion System
| Characteristic | Predicate Device –DEKA VolumetricInfusion Controller(K153760) | Subject Device –DEKA InfusionSystem | Equivalence |
|---|---|---|---|
| General | |||
| DeviceClassificationRegulation andProduct Code | 21 CFR 880.5725Product Code: LDR | 21 CFR 880.5725Product Code: LDR | Identical |
| Class | II | II | Identical |
| Intended Use | The VolumetricInfusion Controller isintended for thedelivery of generalmaintenance fluids andnon- critical antibioticsto adult patients usinggravity infusion in aclinical setting by atrained medicalprofessional. Thedevice is not intendedto administer criticalfluids, including high-risk medications. | The DEKA InfusionSystem, comprised ofthe DEKA InfusionController and theDEKA AdministrationSet, is intended forcontinuous deliverythrough a peripheralintravenous (IV) site ofgeneral maintenancefluids and supportedantibiotics under thesupervision of aqualified clinician. TheDEKA Infusion Systemis not intended toadminister high-alertmedications, blood, andblood products. | Equivalent |
| Prescription orOver theCounter (OTC) | Prescription | Prescription | Identical |
| Characteristic | Predicate Device –DEKA VolumetricInfusion Controller(K153760) | Subject Device –DEKA InfusionSystem | Equivalence |
| IntendedPatientPopulation | Adults | Adults | Identical |
| Environment ofUse | In a clinical setting bya trained medicalprofessional | Under supervision of aqualified clinician | Equivalent |
| CompatibleAdministrationSet | Baxter Healthcare 10 drop/mLadministration set:• 1C8109S (DEHP)• 2H8401 (non-DEHP)Both administrationsets are FDA-cleared. | DEKA AdministrationSet, 20 drop/mL (non-DEHP) | Equivalent |
| ApplicableStandards | • ISO 14971• IEC 60601-1• IEC 60601-1-2• IEC 60601-1-6• IEC 60601-1-8• IEC 62304 | • ISO 14971• IEC 60601-1• IEC 60601-1-2• IEC 60601-1-6• IEC 60601-1-8• IEC 62304 | Identical |
| Environmental Specifications | |||
| OperatingEnvironment | Temperature: 15 °C to30 °CRelative Humidity: 20% to 85%, non-condensingAltitude: 0 m to 2000 m | Temperature: 15 °C to40 °CRelative Humidity: 15% to 90%, non-condensingAltitude: -300 m to3000 m | The subject device'swider operatingenvironment isequivalent in safety andeffectiveness, assupported throughperformance testing. |
| Characteristic | Predicate Device –DEKA VolumetricInfusion Controller(K153760) | Subject Device –DEKA InfusionSystem | Equivalence |
| SpecifiedIngressProtectionrating forIntended UseEnvironment | IPX2 | IP42 | The subject device'shigher ingress protectionrating is supportedthrough performancetesting. |
| Physical Specifications and Electrical Power Requirements | |||
| < 600 g (not includingpower supply and IVadministration set) | < 450 g (not includingpower supply andprimed AdministrationSet) | Similar weight | |
| PhysicalDimensionRequirements | 3.94" x 2.76" x 7.09" | < 5.11" x 5.11" x 2.55" | Similar dimensions |
| PowerRequirements | 100-127/220-240 VAC,Rechargeable LithiumBattery | 100-127/220-240 VAC,Rechargeable LithiumBattery | Identical |
| Performance Characteristics | |||
| ControlMechanism | Video camera andvision processingsystem with a flowcontrol valve | Video camera andvision processingsystem with a flowcontrol valve | Identical |
| Flow RateAccuracy | ± 10% nominally± 25% underenvironmental limitsof normal use | ± 10% nominally± 25% underenvironmental limits ofnormal use | Identical |
| Flow RateRange | 10 mL/hr to 300 mL/hrin 1 mL/hr increments | 10 mL/hr to 300 mL/hrin 1 mL/hr increments | Identical |
| Characteristic | Predicate Device –DEKA VolumetricInfusion Controller(K153760) | Subject Device -DEKA InfusionSystem | Equivalence |
| Volume to beInfused (VTBI) | None | 10 mL to 1300 mL in 1 mL increments | VTBI is not considered new technology. This functionality is equivalent to that of the reference device (K192860) and is supported through performance testing. |
| Time to reachtarget FlowRate | < 5 minutes | < 5 minutes | Identical |
| Time to detectan Occlusion | < 65 seconds | < 5 minutes | The subject device has a longer time to detect an Occlusion. Equivalent safety and effectiveness was demonstrated through risk management and performance testing. |
| Alarm Conditions | |||
| Internal SystemFaultConditions | Yes | Yes | Equivalent |
| Low Battery | Yes | Yes | Equivalent |
| Timeout | Yes | Yes | Equivalent |
| Interruption ofInfusion | Yes | Yes | Equivalent |
| Tilt | Yes | Yes | Equivalent |
| Shake | Yes | Yes | Equivalent |
| CameraBlocked | Yes | Yes | Equivalent |
| Invalid/MissingAdministrationSet | Yes | Yes | Identical |
| Characteristic | Predicate Device –DEKA VolumetricInfusion Controller(K153760) | Subject Device –DEKA InfusionSystem | Equivalence |
| AdministrationSet PrimeLevel | Yes | Yes | Equivalent |
| Mean FlowRate Error | Yes | Yes | Identical |
| Cannot StartFlow | Yes | Yes | Equivalent |
| No Flow | Yes | Yes | Equivalent |
| Streaming(Free Flow) | Yes | Yes | Equivalent |
| RetrogradeFlow | Yes | Yes | Equivalent |
| End of Infusion | No | Yes | Equivalent to ReferenceDevice (K192860) |
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DEKA Administration Set
| Characteristic | Predicate Device –Zyno MedicalAdministration Set(K120685) | Subject Device –DEKAAdministration Set | Equivalence |
|---|---|---|---|
| DeviceClassificationRegulation andProduct Code | 21 CFR 880.5440Product Code: FPA | 21 CFR 880.5440Product Code: FPA | Identical |
| Class | II | II | Identical |
| Characteristic | Predicate Device –Zyno MedicalAdministration Set(K120685) | Subject Device –DEKAAdministration Set | Equivalence |
| Intended Use | Zyno MedicalAdministration Set is adevice used toadminister fluids froma container to apatient's vascularsystem through aneedle or a catheterinserted into a vein. | The DEKAAdministration Set isintended for gravityadministration ofgeneral maintenancefluids and supportedantibiotics approved forperipheral intravenous(IV) infusion to adultpatients under thesupervision of aqualified clinician. TheDEKA AdministrationSet is intended forsingle patient use only.The DEKAAdministration Set isnot intended foradministration of high-alert medications,blood, and bloodproducts.The DEKAAdministration Set iscompatible with theDEKA InfusionController or can beused as a stand-aloneadministration set forperforming manualgravity infusions. | Equivalent |
| SterilityAssuranceLevel (SAL) | Labeled as sterile(equivalent to an SALof 10e-6) | Labeled as sterile(equivalent to an SALof 10e-6) | Identical |
| ApplicableStandards | • ISO 8536-4• ISO 10993 | • ISO 8536-4• ISO 10993 | Identical |
| Drop Size | 20 drops/mL | 20 drops/mL | Identical |
| Characteristic | Predicate Device –Zyno MedicalAdministration Set(K120685) | Subject Device –DEKAAdministration Set | Equivalence |
| Components | Tubing Protective spike cap Drip chamber with spike Air vent Slide clamp Pinch clamp Roller clamp Male Luer lock Protective Luer lock cap 0.22 or 1.2 micron filter Back-check valve Needleless Y-site | Tubing Protective spike cap Drip chamber with spike Air vent Slide clamp Roller clamp Flow Control Insert Male Luer lock Protective Luer lock cap | The subject device has a simpler list of components, which does not impact safety or effectiveness.The subject device also includes a multi-lumen Flow Control Insert, which has been verified for safety and effectiveness through performance testing. |
| Fluid Path Material | Non-DEHP PVC | Non-DEHP PVC, medical grade silicone | The subject device has a multi-lumen flow control insert made of medical grade silicone, which is a material typically used in industry. The safety and effectiveness of the Flow Control Insert is supported through performance testing. |
| Patient Connector Type | Male Luer | Male Luer | Identical |
| Single use? | Yes | Yes | Identical |
| Priming Volume (approx.) | 18 mL | 13 mL | Equivalent |
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Performance Data
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Performance testing was conducted in order to verify and validate each subject device for its respective intended use, and to establish substantial equivalence to the respective predicate device in terms of safety and effectiveness.
The FDA Guidance Documents, Infusion Pumps Total Product Life Cycle, issued December 2, 2014, and Intravascular Administration Sets Premarket Notification Submissions [510(k)], issued July 11, 2008 were followed.
| DevicePerformance | The following functional areas were evaluated:Flow rate accuracy (per AAMI TIR101:2021) Ability to stop flow Response to Alarm conditions Performance after shipping or storage, and at limits of operating conditions Infusion Controller/Administration Set integration Durability and reliability Battery performance |
|---|---|
| Software andCybersecurity | The subject device is considered to require an “Enhanced DocumentationLevel” per the 2023 guidance (equivalent to a “Major” level of concern inthe 2005 guidance).Software and Cybersecurity testing was conducted per ANSI AAMI IEC62304:2006/A1:2016 and the following FDA Guidance Documents:Content of Premarket Submissions for Device Software Functions,issued June 14, 2023 Guidance for the Content of Premarket Submissions for SoftwareContained in Medical Devices, issued May 11, 2005 Off-The-Shelf Software Use in Medical Devices, issued September 27,2019 Content of Premarket Submissions for Management of Cybersecurityin Medical Devices, issued October 2, 2014 Cybersecurity in Medical Devices: Quality System Considerations andContent of Premarket Submissions, issued April 8, 2020 Cybersecurity in Medical Devices: Refuse to Accept Policy for CyberDevices and Related Systems Under Section 524B of the FD&C Act,issued March 30, 2023 |
| Human Factors | The human factors validation followed the FDA Guidance Document,Applying Human Factors and Usability Engineering to Medical Devices,issued February 3, 2016, and the following standards:IEC 60601-1-6:2020 ANSI AAMI IEC 62366-1:2015+A1:2020 |
DEKA Infusion System
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| Reprocessing | Testing followed the FDA Guidance Document Reprocessing MedicalDevices in Health Care Settings: Validation Methods and Labeling,issued March 17, 2015. |
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| Biocompatibility | Testing followed the FDA Guidance Documents, Use of InternationalStandard ISO 10993-1, "Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process", issuedSeptember 4, 2020, and ANSI AAMI ISO 10993-1:2018. |
| Electrical Safety | Per IEC 60601-1:2020 |
| EMC | Per IEC 60601-1-2:2020 |
| Alarms | Per IEC 60601-1-8:2020 |
DEKA Administration Set
| Biocompatibility | Testing followed the FDA Guidance Document, Use of InternationalStandard ISO 10993-1, "Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process", issuedSeptember 4, 2020 and ANSI AAMI ISO 10993-1:2018. |
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| Sterility | Testing followed:FDA Guidance Document, Intravascular Administration SetsPremarket Notification Submissions [510(k)], issued July 11, 2008 FDA Guidance Document, and Review of Sterility Information inPremarket Notification [510(k)] Submissions for Devices Labeled asSterile, issued January 21, 2016 ISO 11135:2014 ISO 11607-1:2019 |
| DevicePerformance | Testing was conducted per ISO 8536-4:2019. In addition, the followingfunctional areas were evaluated:Performance after shipping or storage, and at limits of operatingconditions Infusion Controller/Administration Set integration |
Animal and Clinical Studies
No animal study or clinical trial data was obtained in support of this premarket submission.
Design Control
The DEKA Administration Set and DEKA Infusion Controller were specified and developed by DEKA. DEKA complies with the FDA Quality System Regulation as specified in 21 CFR 820, as well as to ISO 13485:2016.
Conclusion
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Image /page/16/Picture/0 description: The image shows the word "DEKA" in a bold, sans-serif font. The letters are all capitalized and black. The letters are closely spaced together, and the overall appearance is modern and industrial.
DEKA Infusion System
The DEKA Infusion System is substantially equivalent to the DEKA Volumetric Infusion Controller, cleared under premarket application K153760 on October 3, 2016. The differences summarized in this submission do not raise different questions of safety and effectiveness. The performance of the device is supported by DEKA's design control process which included nonclinical testing and risk management activities.
DEKA Administration Set
The DEKA Administration Set is substantially equivalent to the Zyno Medical Administration Set, cleared under premarket application K120685 on September 7, 2012. The differences summarized in this submission do not raise different questions of safety and effectiveness. The performance of the device is supported by DEKA's design control process which included nonclinical testing and risk management activities.
§ 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).