DEKA Infusion System, DEKA Administration Set
Device Facts
| Record ID | K242693 |
|---|---|
| Device Name | DEKA Infusion System, DEKA Administration Set |
| Applicant | Deka Research and Development Corporation |
| Product Code | LDR · General Hospital |
| Decision Date | Oct 7, 2024 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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.
Device Story
DEKA Infusion System is a gravity-based infusion controller comprising an Infusion Controller and Administration Set. It uses an integrated camera to monitor drop formation within the drip chamber; a vision processing system calculates flow rate. The controller automatically adjusts a Flow Control Valve (FCV) against the administration set to maintain the target flow rate without manual intervention. Used in clinical settings under supervision of a qualified clinician. The system provides continuous delivery of maintenance fluids and antibiotics. Output includes flow rate monitoring and alarm notifications for system faults (e.g., tilt, shake, occlusion, flow errors). The device benefits patients by automating gravity-based infusion, reducing the need for manual flow adjustments. The subject device increases the maximum programmable flow rate from 300 to 600 mL/h and updates tilt angle detection performance.
Clinical Evidence
No clinical or animal study data was obtained. Substantial equivalence is supported by bench testing, including flow rate accuracy, vision system performance, flow stopping, and device handling alarms.
Technological Characteristics
Gravity-based infusion controller; uses camera-based vision processing for flow monitoring and an automated Flow Control Valve (FCV). Powered by AC or rechargeable lithium battery. IP42 ingress protection. Dimensions < 5.11" x 5.11" x 2.55". Weight < 450g. Single-channel. Complies with ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-1-8.
Indications for Use
Indicated for continuous delivery of general maintenance fluids and supported antibiotics to adult patients via peripheral IV site under clinician supervision. Contraindicated for high-alert medications, blood/blood products, pediatric/neonatal patients, pressurized infusate sources, and use during transport. Prohibited for patients with congestive heart failure, Eisenmenger's Syndrome/Patent Foramen Ovale, acute myocardial infarction, acute respiratory failure/distress, acute hemorrhage/shock, renal failure/dialysis, fluid restrictions, or need for aggressive resuscitation.
Regulatory Classification
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.
Predicate Devices
- DEKA Infusion System (K232316)
Submission Summary (Full Text)
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October 7, 2024
DEKA Research and Development Corporation Paul Smolenski Director of Regulatory Affairs 340 Commercial Street Manchester, New Hampshire 03101
Re: K242693
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: September 5, 2024 Received: September 9, 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/cdrb/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 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
# Juliane C. Lessard -S
Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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### Indications for Use
510(k) Number (if known) K242693
Device Name
DEKA Infusion System, DEKA Administration Set
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | <div> <input type="checkbox"/> <input type="checkbox"/> </div> |
|-------------------------------------------------|----------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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# K242693 510(k) Summary
This 510(k) Summary of safety and effectiveness information is prepared in accordance with the requirements of CFR Part 807.92.
# Submitter Information
| 510(k) Sponsor | DEKA Research and Development<br>340 Commercial Street<br>Manchester NH, 03101 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person(s) | Paul Smolenski (primary), Rhianne Tallarico (secondary)<br>Regulatory Affairs<br>Phone: (603) 669-5139<br>Fax: (603) 624-0573<br>Email: psmolenski@dekaresearch.com,<br>rtallarico@dekaresearch.com |
| Date Prepared | September 5, 2024 |
# 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)
The subject device is a modified version of the predicate DEKA Infusion System, cleared under K232316 on March 1, 2024. The subject device is substantially equivalent to the predicate DEKA Infusion System.
## Device Description
The subject device is a modified version of the predicate DEKA Infusion System. Updates have been made to the predicate device software to increase the maximum programmable flow rate (from 300 to 600 mL/h), update the labeling to reflect the increased maximum programmable flow rate and update the performance of tilt angle detection. The administration set is unchanged.
### 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.
### 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.
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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.
# Substantial Equivalence Discussion
The table below compares the characteristics of the subject device to the predicate device.
| Characteristic | Predicate Device - K232316 | Subject Device | Equivalence |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| General | | | |
| Device<br>Classification<br>Regulation and<br>Product Code | 21 CFR 880.5725<br>Product Code: LDR | 21 CFR 880.5725<br>Product Code: LDR | No change |
| Class | II | II | No change |
| Characteristic | Predicate Device – K232316 | Subject Device | Equivalence |
| Intended Use | The DEKA Infusion System,<br>comprised of the DEKA Infusion<br>Controller and the DEKA<br>Administration Set, is intended<br>for continuous delivery through a<br>peripheral intravenous (IV) site<br>of general maintenance fluids<br>and supported antibiotics under<br>the supervision of a qualified<br>clinician. The DEKA Infusion<br>System is not intended to<br>administer high-alert<br>medications, blood, and blood<br>products. | The DEKA Infusion System,<br>comprised of the DEKA Infusion<br>Controller and the DEKA<br>Administration Set, is intended<br>for continuous delivery through a<br>peripheral intravenous (IV) site<br>of general maintenance fluids<br>and supported antibiotics under<br>the supervision of a qualified<br>clinician. The DEKA Infusion<br>System is not intended to<br>administer high-alert<br>medications, blood, and blood<br>products. | No change |
| Prescription or<br>Over the<br>Counter (OTC) | Prescription | Prescription | No change |
| Intended Patient<br>Population | Adults | Adults | No change |
| Environment of<br>Use | Under supervision of a qualified<br>clinician | Under supervision of a qualified<br>clinician | No change |
| Compatible<br>Administration<br>Set | DEKA Administration Set, 20<br>drop/mL (non-DEHP) | DEKA Administration Set, 20<br>drop/mL (non-DEHP) | No change |
| Supported<br>Infusates | Maintenance Fluids<br>Antibiotic – Aminoglycosides<br>Antibiotic - Carbapenems<br>Antibiotic - Cephalosporins<br>Antibiotic – Fluoroquinolone<br>Antibiotic - Nitroimidazole<br>Antibiotic – Penicillin | Maintenance Fluids<br>Antibiotic – Aminoglycosides<br>Antibiotic - Carbapenems<br>Antibiotic - Cephalosporins<br>Antibiotic – Fluoroquinolone<br>Antibiotic - Nitroimidazole<br>Antibiotic – Penicillin | No change |
| Applicable Standards | | | |
| Applicable<br>Standards | ISO 14971<br>IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-8 | ISO 14971<br>IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-8 | No change |
| Characteristic | Predicate Device – K232316 | Subject Device | Equivalence |
| Environmental Specifications | | | |
| Operating<br>Environment | Temperature: 15 °C to 40 °C<br>Relative Humidity: 15% to 90%,<br>non-condensing<br>Altitude: -300 m to 3000 m | Temperature: 15 °C to 40 °C<br>Relative Humidity: 15% to 90%,<br>non-condensing<br>Altitude: -300 m to 3000 m | No change |
| Storage<br>Environment | Temperature and Relative<br>Humidity:<br>-25 to 5 °C, with uncontrolled<br>humidity<br>5 to 35 °C, with up to 90% RH,<br>non-condensing<br>>35 to 70 °C, with a water vapor<br>partial pressure ≤ 50 hPa<br>Altitude: -300 m to 3000 m | Temperature and Relative<br>Humidity:<br>-25 to 5 °C, with uncontrolled<br>humidity<br>5 to 35 °C, with up to 90% RH,<br>non-condensing<br>>35 to 70 °C, with a water vapor<br>partial pressure ≤ 50 hPa<br>Altitude: -300 m to 3000 m | No change |
| Specified<br>Ingress<br>Protection<br>rating for<br>Intended Use<br>Environment | IP42 | IP42 | No change |
| Physical Characteristics | | | |
| Weight | < 450 g (not including power<br>supply and primed<br>Administration Set) | < 450 g (not including power<br>supply and primed<br>Administration Set) | No change |
| Physical<br>Dimension<br>Requirements | < 5.11" x 5.11" x 2.55" | < 5.11" x 5.11" x 2.55" | No change |
| Number of<br>Channels | 1 | 1 | No change |
| Power<br>Requirements | 100-127/220-240 V AC,<br>Rechargeable Lithium Battery | 100-127/220-240 V AC,<br>Rechargeable Lithium Battery | No change |
| Battery Life | A fully charged new battery will<br>provide at least 8 hours of<br>battery life during normal<br>operation. | A fully charged new battery willprovide at least 8 hours of<br>battery life during normal<br>operation. | No change |
| Performance Characteristics | | | |
| Control<br>Mechanism | Video camera and vision<br>processing system with a flow<br>control valve | Video camera and vision<br>processing system with a flow<br>control valve | No change |
| Characteristic | Predicate Device - K232316 | Subject Device | Equivalence |
| Programmable<br>Flow Rate<br>Range | 10 to 300 mL/h in 1 mL/h<br>increments | 10 to 600 mL/h in 1 mL/h<br>increments | Different |
| Flow Rate<br>Accuracy | ± 10% nominally<br>± 25% under environmental<br>limits of normal use | ± 10% nominally<br>± 25% under environmental<br>limits of normal use | No change |
| Volume to be<br>Infused (VTBI) | 10 mL to 1300 mL in 1 mL<br>increments | 10 mL to 1300 mL in 1 mL<br>increments | No change |
| Time to reach<br>target Flow<br>Rate | < 5 minutes | < 5 minutes | No change |
| Time to detect<br>an Occlusion | < 5 minutes | < 5 minutes | No change |
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Programmable Flow Rate Range: The programmable flow rate range of the subject device has been verified through formal testing to meet acceptance criteria and does not raise new or different questions of safety or effectiveness. Increasing the maximum programmable flow rate from 300 to 600 mL/h does not introduce any new risks. The supported infusates remain applicable to the subject system at this range.
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| Characteristic | Predicate Device – K232316 | Subject Device | Equivalence |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Alarm Conditions | | | |
| Internal System<br>Fault<br>Conditions | • Low Battery<br>• Timeout<br>• Interruption of Infusion<br>• Tilt<br>• Shake<br>• Camera Blocked<br>• Invalid/Missing<br>Administration Set<br>• Prime Level<br>• Mean Flow Rate Error<br>• Cannot Start Flow<br>• No Flow<br>• Streaming (Free Flow)<br>• Retrograde Flow<br>• End of Infusion | • Low Battery<br>• Timeout<br>• Interruption of Infusion<br>• Tilt<br>• Shake<br>• Camera Blocked<br>• Invalid/Missing<br>Administration Set<br>• Prime Level<br>• Mean Flow Rate Error<br>• Cannot Start Flow<br>• No Flow<br>• Streaming (Free Flow)<br>• Retrograde Flow<br>• End of Infusion | No change |
#### Performance Data
Formal performance testing was conducted on all areas of the subject device that are impacted by its changes with respect to the predicate device. Predicate test methodologies were used to test the subject device. Performance data was used to establish substantial equivalence to the predicate device in terms of safety and effectiveness. The following areas of the system were tested.
- Flow Rate Accuracy ●
- Vision System Performance ●
- Stopping Flow ●
- Device Handling Alarms
All tests met acceptance criteria.
#### Animal and Clinical Studies
No animal study or clinical trial data was obtained in support of this submission.
#### Design Control
The DEKA Infusion System was specified and developed by DEKA. DEKA complies with the FDA Quality System Regulation as specified in 21 CFR 820, as well as ISO 13485:2016.
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# Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject system is substantially equivalent to the DEKA Infusion System cleared under K232316 with respect to the indications for use, treatment method, and technological characteristics.
