(211 days)
No
The description mentions a camera and vision processing system to measure flow rate and adjust a valve, but it does not explicitly mention or imply the use of AI or ML algorithms for this processing or control. The control mechanism appears to be rule-based or algorithmic rather than learned.
Yes
The device is used for the continuous delivery of general maintenance fluids and supported antibiotics to patients through an IV site, which directly relates to patient treatment and health management.
No
The device is an infusion system designed for continuous delivery of fluids and antibiotics, and its purpose is to administer treatment, not to diagnose a medical condition.
No
The device description explicitly states it is comprised of a "DEKA Infusion Controller and DEKA Administration Set," which are physical hardware components. It also mentions a "Camera" and "Flow Control Valve" as part of the system.
Based on the provided information, the DEKA Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the continuous delivery of fluids and antibiotics to patients through an IV site. This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The device controls the flow rate of fluids being administered to the patient. It uses a camera to monitor drop formation for flow rate measurement, but this is for controlling the delivery, not for analyzing biological samples.
- Anatomical Site: The device interacts with a peripheral intravenous (IV) site, which is within the patient's body, not with a sample taken from the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test, examine, or analyze specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The DEKA Infusion System's purpose is to administer substances into the body.
N/A
Intended Use / 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.
Product codes
LDR, FPA
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.
Mentions image processing
Video camera and vision processing system with a flow control valve
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical (Camera)
Anatomical Site
Peripheral intravenous (IV) site
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Under the supervision of a qualified clinician.
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
Device Performance
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 and Cybersecurity
The subject device is considered to require an “Enhanced Documentation Level” per the 2023 guidance (equivalent to a “Major” level of concern in the 2005 guidance).
Software and Cybersecurity testing was conducted per ANSI AAMI IEC 62304:2006/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 Software Contained 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 Cybersecurity in Medical Devices, issued October 2, 2014
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, issued April 8, 2020
Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices 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
Reprocessing (DEKA Infusion System)
Testing followed the FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 17, 2015.
Biocompatibility (DEKA Infusion System and DEKA Administration Set)
Testing followed the FDA Guidance Documents, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued September 4, 2020, and ANSI AAMI ISO 10993-1:2018.
Electrical Safety (DEKA Infusion System)
Per IEC 60601-1:2020
EMC (DEKA Infusion System)
Per IEC 60601-1-2:2020
Alarms (DEKA Infusion System)
Per IEC 60601-1-8:2020
Sterility (DEKA Administration Set)
Testing followed:
FDA Guidance Document, Intravascular Administration Sets Premarket Notification Submissions [510(k)], issued July 11, 2008
FDA Guidance Document, Review of Sterility Information in Premarket Notification [510(k)] Submissions for Devices Labeled as Sterile, issued January 21, 2016
ISO 11135:2014
ISO 11607-1:2019
Device Performance (DEKA Administration Set)
Testing was conducted per ISO 8536-4:2019. In addition, the following functional areas were evaluated:
Performance after shipping or storage, and at limits of operating conditions
Infusion Controller/Administration Set integration
Animal and Clinical Studies
No animal study or clinical trial data was obtained in support of this premarket submission.
Key Metrics
Flow Rate Accuracy: +/- 10% nominally, +/- 25% under environmental limits of normal use.
Time to reach target Flow Rate:
§ 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).
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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"
1
(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).
2
Sincerely,
Jake K. Lindstrom -S
Jake Lindstrom, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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 & Development
340 Commercial Street
Manchester, NH 03101 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person(s) | Paul Smolenski (primary), Lauren Blake (secondary)
Regulatory Affairs
Phone: (603) 669-5139
Fax: (603) 624-0573
psmolenski@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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Image /page/6/Picture/0 description: The image shows the word "DEKA" in a stylized, bold, sans-serif font. The letters are all capitalized and black. The "K" has a unique design, with the right arm extending diagonally upwards and the left arm extending horizontally to the left, creating a sharp, angular appearance.
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 Volumetric
Infusion Controller
(K153760) | Subject Device –
DEKA Infusion
System | Equivalence |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | | |
| Device
Classification
Regulation and
Product Code | 21 CFR 880.5725
Product Code: LDR | 21 CFR 880.5725
Product Code: LDR | Identical |
| Class | II | II | Identical |
| Intended 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. | The DEKA Infusion
System, comprised of
the DEKA Infusion
Controller and the
DEKA Administration
Set, is intended for
continuous delivery
through a peripheral
intravenous (IV) site of
general maintenance
fluids and supported
antibiotics under the
supervision of a
qualified clinician. The
DEKA Infusion System
is not intended to
administer high-alert
medications, blood, and
blood products. | Equivalent |
| Prescription or
Over the
Counter (OTC) | Prescription | Prescription | Identical |
| Characteristic | Predicate Device –
DEKA Volumetric
Infusion Controller
(K153760) | Subject Device –
DEKA Infusion
System | Equivalence |
| Intended
Patient
Population | Adults | Adults | Identical |
| Environment of
Use | In a clinical setting by
a trained medical
professional | Under supervision of a
qualified clinician | Equivalent |
| Compatible
Administration
Set | Baxter Healthcare 10 drop/mL
administration set:
• 1C8109S (DEHP)
• 2H8401 (non-DEHP)
Both administration
sets are FDA-cleared. | DEKA Administration
Set, 20 drop/mL (non-DEHP) | Equivalent |
| Applicable
Standards | • 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 | | | |
| Operating
Environment | Temperature: 15 °C to
30 °C
Relative Humidity: 20
% to 85%, non-
condensing
Altitude: 0 m to 2000 m | Temperature: 15 °C to
40 °C
Relative Humidity: 15
% to 90%, non-
condensing
Altitude: -300 m to
3000 m | The subject device's
wider operating
environment is
equivalent in safety and
effectiveness, as
supported through
performance testing. |
| Characteristic | Predicate Device –
DEKA Volumetric
Infusion Controller
(K153760) | Subject Device –
DEKA Infusion
System | Equivalence |
| Specified
Ingress
Protection
rating for
Intended Use
Environment | IPX2 | IP42 | The subject device's
higher ingress protection
rating is supported
through performance
testing. |
| Physical Specifications and Electrical Power Requirements | | | |
| | 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.
| Device
Performance | 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 and
Cybersecurity | The subject device is considered to require an “Enhanced Documentation
Level” per the 2023 guidance (equivalent to a “Major” level of concern in
the 2005 guidance).
Software and Cybersecurity testing was conducted per ANSI AAMI IEC
62304:2006/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 Software
Contained 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 Cybersecurity
in Medical Devices, issued October 2, 2014 Cybersecurity in Medical Devices: Quality System Considerations and
Content of Premarket Submissions, issued April 8, 2020 Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber
Devices 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 Medical
Devices in Health Care Settings: Validation Methods and Labeling,
issued March 17, 2015. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Testing followed the FDA Guidance Documents, Use of International
Standard ISO 10993-1, "Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk management process", issued
September 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 International
Standard ISO 10993-1, "Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk management process", issued
September 4, 2020 and ANSI AAMI ISO 10993-1:2018. |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility | Testing followed:
FDA Guidance Document, Intravascular Administration Sets
Premarket Notification Submissions [510(k)], issued July 11, 2008 FDA Guidance Document, and Review of Sterility Information in
Premarket Notification [510(k)] Submissions for Devices Labeled as
Sterile, issued January 21, 2016 ISO 11135:2014 ISO 11607-1:2019 |
| Device
Performance | Testing was conducted per ISO 8536-4:2019. In addition, the following
functional areas were evaluated:
Performance after shipping or storage, and at limits of operating
conditions 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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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.