(278 days)
Not Found
No
The description mentions a "vision system" monitoring the drip chamber for drop growth, which is used for feedback control. While this involves image processing, the summary does not mention any AI, ML, or deep learning techniques being used for this process. The control mechanism appears to be based on direct feedback from the vision system to the flow control valve, rather than an AI/ML model making predictions or decisions.
No
The device is used for the delivery of general maintenance fluids and non-critical antibiotics, which are part of a therapeutic regimen, but the device itself does not directly perform a therapeutic action; it controls the delivery of fluids.
No
The device is described as an "Infusion Controller" intended for the delivery of "maintenance fluids and non-critical antibiotics." Its primary function is to control the flow rate of fluids into a patient, not to diagnose a condition.
No
The device description explicitly mentions hardware components like a "vision system" and a "flow control valve" which are integral to its function, indicating it is not software-only. The performance studies also include testing of electrical, hardware, and mechanical safety.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "delivery of general maintenance fluids and non-critical antibiotics to adult patients using gravity infusion." This describes a therapeutic or treatment function, not a diagnostic one.
- Device Description: The description focuses on controlling the flow rate of fluids being infused into a patient. It monitors the drip chamber and adjusts a valve to maintain a target flow rate. This is a mechanism for administering substances to the body, not for analyzing samples taken from the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such analysis.
The device is an infusion controller, which is a type of medical device used for administering fluids or medications to a patient.
N/A
Intended Use / 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.
Product codes
LDR
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
trained medical professional / clinical setting
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
- Flow rate accuracy: Conducted in accordance with IEC 60601-2-24:2012 under three test conditions: Minimum 72 hour infusion at 10 mL/h and head height within operating range, Minimum 2 hour infusion at 25 mL/h and a head height simulated negative back pressure, and 1L infusion at 300 mL/h and a head height within operating range. All conditions passed the acceptance criteria of the second hour being within ±20% of the programmed flow rate. For the 72-hour and 1L infusions, the last hour of infusions also met the ±20% criterion.
- 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). All conditions passed the acceptance criteria that the device continues infusing and the accuracy does not exceed ±25%; or the device alarms.
- Reliability analysis: Tested as Mean Time Between Failures (MTBF). The actual number of infusion hours before discontinuing testing, with zero failures, was 7951 hours, which exceeded the required 7596 hours to establish MTBF >= 6 months with 90% confidence.
- 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, including testing for immunity to proximity fields from RF wireless communications equipment.
- 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: Conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered a "Major" level of concern.
- 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.
- No clinical investigation was conducted.
Key Metrics
- Flow rate accuracy: ±10% volumetric delivery accuracy. Tested accuracy results ranged from -1.00% to -2.00% (72hr, 10mL/h), -0.80% to -1.80% (72hr, 10mL/h, last hour), -0.40% to -2.93% (2hr, 25mL/h), 5.56% to 6.42% (1L, 300mL/h), and 5.33% to 6.64% (1L, 300mL/h, last hour).
- Flow rate accuracy during head height changes: At 10mL/hr, increasing head height: -7.03% to -9.87%; decreasing head height: -10.57% to -13.17%. At 300mL/hr, increasing head height: 6.23% to 6.27%; decreasing head height: 4.01%.
- MTBF: 7951 hours of infusion time with zero failures.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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.
1
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
2
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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See PRA Statement below.
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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 & Development
340 Commercial Street
Manchester, NH 03101 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Perkins
Regulatory Affairs Project Manager
DEKA Research & Development Corporation
Phone: (603) 669-5139
Fax: (603) 624-0573
jperkins@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.
4
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 (Volumetric
Infusion Controller)
(K153760) | Assessment of Difference |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Characteristics | | | |
| Intended Use | Electronic infusion
controller designed to
regulate the infusion of
a wide variety of fluids
where gravity provides
adequate head pressure
to achieve the desired
flow rate. | 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. | Although the intended use
for the proposed device has
been modified to include
categories of fluids to be
used with the device,
intended users, and intended
environment, both devices
are indicated for use for the
purpose of controlling
delivery of fluids using
gravity infusion. Therefore,
we believe that the
differences in the
indications for use do not
raise new questions of safety
or effectiveness. |
| Drop counter | Beam break technology | Video camera and vision
processing | The predicate and proposed
devices are both drop
counters paired with a clamp
that allows for the control of
flow. The difference in the
method for counting drops
has been modified in the
proposed device based on
current technology. In
addition to counting drops,
the proposed device also
monitors the drop formation
and detects drops falling.
This difference between the
predicate and proposed
device does not raise safety
or effectiveness questions. |
| Volumetric | Yes | Same | N/A |
| Disposable to be
used with device | Dedicated IV
administration set | Baxter Healthcare 10
drop/mL
• 1C8109S (DEHP)
• 2H8401 (non-DEHP) | N/A |
| System Performance | | | |
| Volumetric
Delivery accuracy | ± 10% | ± 10% | N/A |
| Flow rate range
(for 10 drop/mL
set) | 30-500 mL/hr | 10-300 ml/hr | No new associated risk. |
| Flow rate range
(for 60 drop/mL
set) | 10-250 mL/hr | Not applicable – device is
only compatible with 10
drop/mL IV administration
sets. | 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 the
predicate device based on
one IV administration set
change was 72 hours. |
| Environmental Requirements | | | |
| Operating
temperature range | 10C to 40C | 15C to 30C | No new associated risk. |
| Operating non-
condensing
humidity range | 5% to 95% | 20% to 85% | No new associated risk. |
| Operating altitude
range | Unknown | Sea level to 2000m | Operating altitude for the
predicate device not known. |
| Physical Specification and Electrical Power Requirements | | | |
| Weight |