(278 days)
The Volumetric Infusion Controller is intended for the delivery of general maintenance fluids and non-critical antibiotics to adult patients using gravity infusion in a clinical setting by a trained medical professional. The device is not intended to administer critical fluids, including high-risk medications.
The Volumetric Infusion Controller (VIC) is a gravity-based electronic infusion controller relying on head height to provide the delivery pressure necessary to meet the target infusion delivery rates. The drip chamber of an administration set is monitored by a vision system for drop growth. This information is used to provide feedback to the flow control valve to establish and maintain the target flow-rate without user intervention.
Here's an analysis of the acceptance criteria and study information for the Volumetric Infusion Controller, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Condition | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|
| Flow Rate Accuracy | |||
| Minimum 72 hour infusion at 10 mL/h and head height within operating range | The second hour is within ±20% of the programmed flow rate | -1.00 to -2.00% | Pass |
| The last hour of the infusions are within ±20% of the programmed flow rate | -0.80 to -1.80% | Pass | |
| Minimum 2 hour infusion at 25 mL/h and a head height simulated negative back pressure | The second hour is within ±20% of the programmed flow rate | -0.40 to -2.93% | Pass |
| 1L infusion at 300 mL/h and a head height within operating range | The second hour is within ±20% of the programmed flow rate | 5.56 to 6.42% | Pass |
| The last hour of the infusions are within ±20% of the programmed flow rate | 5.33 to 6.64% | Pass | |
| Maintenance of Set Flow Rate Despite Changes in Head Height (Increasing) | |||
| Increasing head height (50 to 200cm) at 10mL/h | • The device continues infusing and the accuracy does not exceed ±25%; or• The device alarms | -7.03 to -9.87% | Pass |
| Increasing head height (50 to 200cm) at 300mL/h | • The device continues infusing and the accuracy does not exceed ±25%; or• The device alarms | 6.23 to 6.27% (1 device alarmed) | Pass |
| Maintenance of Set Flow Rate Despite Changes in Head Height (Decreasing) | |||
| Decreasing head height (200 to 50cm) at 10mL/h | • The device continues infusing and the accuracy does not exceed ±25%; or• The device alarms | -10.57 to -13.17% | Pass |
| Decreasing head height (200 to 50cm) at 300mL/h | • The device continues infusing and the accuracy does not exceed ±25%; or• The device alarms | 4.01% (2 devices alarmed) | Pass |
| Reliability Analysis (Mean Time Between Failures - MTBF) | |||
| The devices performed the minimum number of infusion hours for the associated number of failures to establish MTBF $\ge$ 6 months with 90% confidence ($\ge$ 7596 hours for zero failures). | In order to pass with zero failures the number of infusion hours... would need to be $\ge$ 7596 hours. The actual number of infusion hours before discontinuing testing, with zero failures, was 7951 hours. | Pass | |
| Minimum number of infusion hours for associated number of failures (examples provided from table in text for context):0 failures: 7596 hours1 failure: 12816 hours2 failures: 17532 hours | 7951 hours (with zero failures) | Pass |
2. Sample size(s) used for the test set and the data provenance:
- Flow Rate Accuracy & Maintenance of Set Flow Rate despite changes in Head Height: The text does not explicitly state the number of devices or test runs/infusions used for each specific condition within these tests. However, the data provided shows a range of percentages for the "Test Results," implying multiple measurements were taken. The study was a bench test, conducted in accordance with IEC 60601-2-24:2012. The provenance is not specified, but it can be inferred to be from the manufacturer's testing (DEKA Research & Development). This would be prospective data collection.
- Reliability Analysis (MTBF): The test involved multiple devices ("devices are setup...continuously infusing solutions"). The actual number of infusion hours before discontinuing testing, with zero failures, was 7951 hours. The number of individual devices is not specified, nor is the cumulative number of "uses" for the 7951 hours. This is also prospective bench testing data.
- Other Testing (Electrical, EMC, Safety Control Mechanisms, Software, Human Factors): No specific sample sizes for these tests are provided in the summary. These are generally conducted as part of product development and validation, likely under controlled laboratory conditions, making them prospective bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The studies described are bench tests and human factors evaluations, not clinical studies involving expert medical interpretation of data for ground truth establishment in a diagnostic context.
- For the performance testing (flow rate, reliability), the "ground truth" is defined by the objective physical measurements and adherence to specified standards (e.g., IEC 60601-2-24). No human experts are used to establish ground truth in this context; rather, calibrated measurement equipment and predefined standards serve this purpose.
- For Human Factors testing, usability evaluation and human factors testing were conducted, which would typically involve end-users (e.g., medical professionals), but the number and qualifications of these individuals, or how "ground truth" (e.g., successful task completion) was established, are not detailed in this summary.
4. Adjudication method for the test set:
- Not applicable. The reported studies are bench tests and engineering validations, not studies requiring adjudication of human-interpreted data. The results are based on objective measurements against pre-defined engineering and performance criteria.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a Volumetric Infusion Controller, not an AI-powered diagnostic tool that assists human readers/interpreters. The FDA letter explicitly states, "A clinical investigation was not conducted, as the bench testing and human factors testing is sufficient to show the product is substantially equivalent in performance for its intended use."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance tests described (Flow rate accuracy, Maintenance of set flow rate, Reliability analysis, Electrical/hardware/mechanical safety, EMC, Alarms, Software V&V) were all standalone (algorithm/device only) performance evaluations. The device's ability to accurately control fluid delivery and operate reliably was tested independent of human interaction for the core performance metrics. Human factors testing assessed the interaction of users with the device, but the device's technical performance itself was standalone.
- The "vision system" that monitors drop growth and controls the flow valve functions as an algorithm/device-only system once initialized, without continuous human intervention.
7. The type of ground truth used:
- Objective physical measurements against predefined engineering standards and specifications (e.g., mL/hr, percentage accuracy, hours of operation). For example, flow rate accuracy is measured against the programmed flow rate. The reliability is measured against a statistical model for MTBF.
8. The sample size for the training set:
- This device does not appear to involve a "training set" in the context of machine learning, which is typically associated with AI/ML algorithms that learn from data. While the device uses a "vision system" and "similar algorithms" for drop detection, the text does not describe a machine learning model that was "trained" on a dataset. It refers to the vision system as using "similar algorithms" to make distinctions, implying a rules-based or traditional image processing approach rather than a modern deep-learning "training" paradigm. Therefore, a training set as typically understood for AI/ML is not applicable here based on the provided information.
9. How the ground truth for the training set was established:
- As a training set for an AI/ML model is not indicated from the text, the method for establishing its "ground truth" is not applicable. The device's "vision system" relies on specific detection algorithms that are likely designed and validated by engineers based on physical principles of drop formation and optical detection, rather than being "trained" on labeled data.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2016
DEKA Research & Development Mr. Roger Leroux Regulatory Affairs Project Manager 340 Commercial St. Manchester, New Hampshire 03101
Re: K153760
Trade/Device Name: Volumetric Infusion Controller Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LDR Dated: September 1, 2016 Received: September 2, 2016
Dear Mr. Roger Leroux:
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 (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. 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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Volumetric Infusion Controller
Indications for Use (Describe)
The Volumetric Infusion Controller is intended for the delivery of general maintenance fluids and non-critical antibiotics to adult patients using gravity infusion in a clinical setting by a trained medical professional. The device is not intended to administer critical fluids, including high-risk medications.
| 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 K153760
This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR 807.92.
Submitter's Information
| 510(k) Sponsor: | DEKA Research & Development340 Commercial StreetManchester, NH 03101 |
|---|---|
| Contact Person: | Julie PerkinsRegulatory Affairs Project ManagerDEKA Research & Development CorporationPhone: (603) 669-5139Fax: (603) 624-0573jperkins@dekaresearch.com |
| Date of Preparation | December 28, 2015 |
|---|---|
| --------------------- | ------------------- |
Device Information
| Common/Usual Name: | Controller, Infusion, Intravascular, Electronic |
|---|---|
| Trade/Proprietary Name: | Volumetric Infusion Controller |
| Regulation Number: | 21 CFR 880.5725 |
| Regulation Name: | Infusion Pump |
| Regulatory Class: | Class II |
| Product Code: | LDR |
| Device Panel: | General Hospital |
Predicate Device
The Volumetric Infusion Controller is substantially equivalent to the DEKA Jr. Volumetric Infusion Controller, which was previously cleared under application K863204.
Device Description
The Volumetric Infusion Controller (VIC) is a gravity-based electronic infusion controller relying on head height to provide the delivery pressure necessary to meet the target infusion delivery rates. The drip chamber of an administration set is monitored by a vision system for drop growth. This information is used to provide feedback to the flow control valve to establish and maintain the target flow-rate without user intervention.
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The device is capable of operating from wall power or on battery power. The VIC comes with an AC power supply (120V or 240V). When unplugged, the device is capable of running an infusion for more than 8 hours powered by the internal rechargeable battery. The device also has a second battery powering a safety system capable of stopping the infusion and alarming in the case of a sudden power failure.
Indications for Use
The Volumetric Infusion Controller is intended for the delivery of general maintenance fluids and non-critical antibiotics to adult patients using gravity infusion in a clinical setting by a trained medical professional. The device is not intended to administer critical fluids, including high-risk medications.
Technological Characteristics
The Volumetric Infusion Controller (VIC) has similar technological characteristics as compared to the predicate device. Similar to the DEKA Jr. predicate device, the VIC is a drop counter paired with a clamp that allows for the control of flow. Both devices operate by counting drops and ensuring that they are falling at the correct rate to achieve the desired flow rate. The predicate device uses "beam break" technology to determine when a drop had fallen whereas the VIC uses a video camera and vision processing to monitor the drop formation and detect drops falling. Beam break uses two beams of known width and known distance apart and uses the time period these beams are broken to determine the height of the drop, which is used to estimate the actual size of the drop. The VIC method is robust as it is less susceptible to interference from splashing. The VIC vision system uses similar algorithms to make the distinction between drops falling from the spout in the drip chamber and splashes of fluid adhering to the sides of the drip chamber. In addition, by watching the drop form, the VIC can determine if drops are forming quickly enough to achieve the desired flow rate between drops falling providing more accurate and more reactive control especially at low flow rates where the drop rate can be as one drop per 36 seconds.
Risk analysis has been completed and potential hazards associated with the proposed device have been identified and mitigated. All potential risks were deemed acceptable after mitigation.
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Comparison to Predicate Device
| Characteristic | Predicate (DEKA Jr.)(K863204) | Proposed (VolumetricInfusion Controller)(K153760) | Assessment of Difference |
|---|---|---|---|
| General Characteristics | |||
| Intended Use | Electronic infusioncontroller designed toregulate the infusion ofa wide variety of fluidswhere gravity providesadequate head pressureto achieve the desiredflow rate. | The Volumetric InfusionController is intended for thedelivery of generalmaintenance fluids and non-critical antibiotics to adultpatients using gravity infusionin a clinical setting by atrained medical professional.The device is not intended toadminister critical fluids,including high-riskmedications. | Although the intended usefor the proposed device hasbeen modified to includecategories of fluids to beused with the device,intended users, and intendedenvironment, both devicesare indicated for use for thepurpose of controllingdelivery of fluids usinggravity infusion. Therefore,we believe that thedifferences in theindications for use do notraise new questions of safetyor effectiveness. |
| Drop counter | Beam break technology | Video camera and visionprocessing | The predicate and proposeddevices are both dropcounters paired with a clampthat allows for the control offlow. The difference in themethod for counting dropshas been modified in theproposed device based oncurrent technology. Inaddition to counting drops,the proposed device alsomonitors the drop formationand detects drops falling.This difference between thepredicate and proposeddevice does not raise safetyor effectiveness questions. |
| Volumetric | Yes | Same | N/A |
| Disposable to beused with device | Dedicated IVadministration set | Baxter Healthcare 10drop/mL• 1C8109S (DEHP)• 2H8401 (non-DEHP) | N/A |
| System Performance | |||
| VolumetricDelivery accuracy | ± 10% | ± 10% | N/A |
| Flow rate range(for 10 drop/mLset) | 30-500 mL/hr | 10-300 ml/hr | No new associated risk. |
| Flow rate range(for 60 drop/mLset) | 10-250 mL/hr | Not applicable – device isonly compatible with 10drop/mL IV administrationsets. | N/A |
| Time to target | Less than 5 minutes | Same | N/A |
| Operating | One IV administration | Up to 72 hours with a single | N/A - Assumed that the |
| duration | set change | IV administration set. | operation duration for thepredicate device based onone IV administration setchange was 72 hours. |
| Environmental Requirements | |||
| Operatingtemperature range | 10C to 40C | 15C to 30C | No new associated risk. |
| Operating non-condensinghumidity range | 5% to 95% | 20% to 85% | No new associated risk. |
| Operating altituderange | Unknown | Sea level to 2000m | Operating altitude for thepredicate device not known. |
| Physical Specification and Electrical Power Requirements | |||
| Weight | <340grams | <600grams (not includingpower supply and IVadministration set) | No new associated risk. |
| Physical Size | 2" x 2.5" x 6" | 3.94" x 2.76" x 7.09" | No new associated risk. |
| Power Supply | 6.25 VDC, 5 AA cells | 100-127/220-240 VAC,Rechargeable Lithium Battery | No new associated risk. |
| Alarms | |||
| Air in line | No | Same | N/A |
| Low battery | Yes | Same | N/A |
| Flow rate error | Yes | Same | N/A |
| Door open | Yes | Same | N/A |
| Drop sensor | Yes | Same | N/A |
| Occlusion | Yes | Same | N/A |
| Invalid IV Set | No | Yes | N/A |
| Reverse flow | No | Yes | N/A |
| Stream | No | Yes | N/A |
| No flow | No | Yes | N/A |
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The VIC and the predicate device are both intended for use for the purpose of controlling delivery of fluids using gravity infusion. The modification of the indications for use of the VIC from the predicate to include categories of fluids to be used with the device, intended users, and intended environment do not adversely affect the performance of the VIC.
The method for counting drops has been modified in the proposed device based on current technology. The VIC proposed device uses a video camera and vision processing to monitor the drop formation and detect drops falling. The VIC method is robust as it is less susceptible to interference from splashing. The vision system uses similar algorithms to make the distinction between drops falling from the spout in the drip chamber and splashes of fluid adhering to the sides of the drip chamber. Based on demonstrable evidence provided in this 510(k), the device differences described within this submission do not affect the intended use, the fundamental technology or operating principles of the device, or raise safety or effectiveness issues. The changes to the technology allow for a robust system for monitoring and controlling flow rate.
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Performance Data
The following performance data are provided in support of the substantial equivalence determination.
- Flow rate accuracy Conducted in accordance with IEC 60601-2-24:2012 under three test . conditions.
| Condition | Acceptance Criteria | Test Results | Conclusion |
|---|---|---|---|
| Minimum 72 hourinfusion at 10 mL/hand head heightwithin operatingrange | The second hour is within ±20%of the programmed flow rate | -1.00 to -2.00% | |
| The last hour of the infusions arewithin ±20% of the programmedflow rate | -0.80 to -1.80% | Pass | |
| Minimum 2 hourinfusion at 25 mL/hand a head heightsimulated negativeback pressure | The second hour is within ±20%of the programmed flow rate | -0.40 to -2.93% | Pass |
| 1L infusion at 300mL/h and a headheight withinoperating range | The second hour is within ±20%of the programmed flow rate | 5.56 to 6.42% | |
| The last hour of the infusions arewithin ±20% of the programmedflow rate | 5.33 to 6.64% | Pass |
- . Maintenance of set flow rate despite changes in head height – Conducted under worst case conditions using the accuracy calculation method of IEC 60601-2-24:2012 at two flow rates (10 and 300 mL/h) with increasing (50 to 200cm) and decreasing head heights (200 to 50cm).
| Condition | Acceptance Criteria | Test Result | Conclusion |
|---|---|---|---|
| Increasing headheight (50 to 200cm) | • The device continuesinfusing and theaccuracy does notexceed ±25%; or• The device alarms | At 10mL/hr:-7.03 to -9.87%At 300mL/hr:6.23 to 6.27%(1 device alarmed) | Pass |
| Decreasing headheight (200 to 50cm) | • The device continuesinfusing and theaccuracy does notexceed ±25%; orThe device alarms | At 10mL/hr:-10.57 to -13.17%At 300mL/hr:4.01%(2 devices alarmed) | Pass |
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- . Reliability analysis – Tested as Mean Time Between Failures (MTBF). Devices are setup in nominal operating conditions and are continuously infusing solutions at flow rates that are changed each time the solution is resupplied. Between infusions, the devices are cleaned and disinfected according to the Instructions for Use. The total infusion time and the number of alarms are recorded over the course of the test.
| Acceptance Criteria | Test Result | Conclusion | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The devices performed the minimum number of infusion hours for the associated number of failures as shown in the table below | In order to pass with zero failures the number of infusion hours to establish MTBF $\ge$ 6 months with 90% confidence would need to be $\ge$ 7596 hours. The actual number of infusion hours before discontinuing testing, with zero failures, was 7951 hours. | Pass | ||||||||||||||||||
| Number of Failures Number of Uses Number of Hours 0 422 7596 1 712 12816 2 974 17532 3 1223 22014 4 1463 26334 |
- Electrical, hardware, and mechanical safety testing per AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
- Electromagnetic compatibility testing per 60601-1-2:2007. In addition, testing . for immunity to proximity fields from RF wireless communications equipment was conducted.
- Verification and validation of safety control mechanisms, alarms (per IEC ● 60601-1-8:2006), operating specifications (such as battery life), and environmental specifications
- . Software verification and validation testing - Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
- Human factors – Usability evaluation and human factors testing was conducted in accordance with IEC 62366-1:2015 and IEC 62366:2007 +A1:2014 as well as collateral standards of IEC 60601-1 with relevant human factors requirements.
The proposed device was tested to verify conformance with the design specifications and applicable industry standards. Validation and human factors evaluations for the VIC were conducted in simulated environments to ensure user needs and intended uses were met. A
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clinical investigation was not conducted, as the bench testing and human factors testing is sufficient to show the product is substantially equivalent in performance for its intended use.
Conclusion
The performance data included in this premarket notification demonstrate that the proposed device is substantially equivalent to the predicate 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).