Who is the manufacturer of DEKA Infusion System, DEKA Administration Set?

Deka Research and Development filed the 510(k) submission for DEKA Infusion System, DEKA Administration Set (K232316).

What is the FDA product code for DEKA Infusion System, DEKA Administration Set?

LDR. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for DEKA Infusion System, DEKA Administration Set?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DEKA Infusion System, DEKA Administration Set?

DEKA Volumetric Infusion Controller (K153760); Zyno Medical Administration Set (K120685).

Who can help prepare an FDA 510(k) submission like DEKA Infusion System, DEKA Administration Set?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DEKA Infusion System, DEKA Administration Set

K232316 · Deka Research and Development · LDR · Mar 1, 2024 · General Hospital

Device Facts

Record ID	K232316
Device Name	DEKA Infusion System, DEKA Administration Set
Applicant	Deka Research and Development
Product Code	LDR · General Hospital
Decision Date	Mar 1, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

DEKA Infusion System is a gravity-based infusion controller comprising an electronic controller and a single-use administration set. The controller uses an integrated camera to monitor drop formation within the administration set's drip chamber to measure flow rate. A flow control valve (FCV) adjusts the tubing to maintain the desired flow rate without manual intervention. Used in clinical settings by qualified clinicians for continuous delivery of maintenance fluids and antibiotics. The system provides automated flow regulation, alarm monitoring (e.g., occlusion, low battery, system faults), and volume-to-be-infused (VTBI) functionality. Output is displayed to the clinician, who manages the infusion setup and monitoring. Benefits include automated, consistent gravity-based fluid delivery for adult patients, reducing the need for manual flow adjustments.

Clinical Evidence

No clinical or animal study data was obtained. Substantial equivalence is supported by bench testing, including flow rate accuracy (AAMI TIR101:2021), alarm condition response, integration testing, durability, battery performance, biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and human factors validation.

Technological Characteristics

Gravity-based infusion controller with camera-based vision processing and flow control valve. Administration set includes non-DEHP PVC tubing and medical-grade silicone flow control insert. Connectivity: Standalone. Power: Rechargeable lithium battery. Standards: ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, ISO 8536-4, ISO 10993. Ingress protection: IP42. Sterilization: Sterile (SAL 10e-6).

Indications for Use

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. Contraindicated for high-alert medications, blood, blood products, pediatric/neonatal patients, pressurized infusate sources, and use during transport. Contraindicated for patients with congestive heart failure, Eisenmenger's Syndrome/Patent Foramen Ovale, acute myocardial infarction, acute respiratory failure, acute respiratory distress syndrome, acute hemorrhage/shock, renal failure/dialysis, fluid restrictions, or need for aggressive fluid 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 Volumetric Infusion Controller (K153760)
Zyno Medical Administration Set (K120685)

Reference Devices

QCore Sapphire Infusion Pump (K192860)

Related Devices

K242693 — DEKA Infusion System, DEKA Administration Set · Deka Research and Development Corporation · Oct 7, 2024
K153760 — Volumetric Infusion Controller · DEKA Research & Development · Oct 3, 2016
K172242 — DripAssist Plus · Shift Labs, Inc. · May 25, 2018
K150687 — DripAssist · Shift Labs · Oct 13, 2015
K030467 — GRAVITECH TM FLOW CONTROLLER PRIMARY SET/GRAVITECH FLOW CONTROLLER EXTENSION SET · Iv Medical, Inc. · Mar 14, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a white binder with red accents on the left side and top right corner. The binder has two silver rivets on the left side. In the center of the binder is a red Adobe Acrobat logo. The binder appears to be closed. For the best experience, open this PDF portfolio in Acrobat X or Adobe Reader X, or later. Get Adobe Reader Now! {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "DEKA" in a bold, sans-serif font. The letters are all capitalized and black. The letters are close together, and the overall impression is one of strength and stability. The background is white. # 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 | | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "DEKA" in a bold, sans-serif font. The letters are all capitalized and black. The letters are closely spaced together, creating a solid block of text. The background is white. ## 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. {6}------------------------------------------------ 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. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "DEKA" in a stylized, bold, sans-serif font. The letters are all capitalized and connected, creating a unified visual element. The color of the text is black, contrasting with the white background. # 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 | | | | | | < 600 g (not including power supply and IV administration set) | < 450 g (not including power supply and primed Administration Set) | Similar weight | | Physical Dimension Requirements | 3.94" x 2.76" x 7.09" | < 5.11" x 5.11" x 2.55" | Similar dimensions | | Power Requirements | 100-127/220-240 V AC, Rechargeable Lithium Battery | 100-127/220-240 V AC, Rechargeable Lithium Battery | Identical | | Performance Characteristics | | | | | | | | | | Control Mechanism | Video camera and vision processing system with a flow control valve | Video camera and vision processing system with a flow control valve | Identical | | Flow Rate Accuracy | ± 10% nominally ± 25% under environmental limits of normal use | ± 10% nominally ± 25% under environmental limits of normal use | Identical | | Flow Rate Range | 10 mL/hr to 300 mL/hr in 1 mL/hr increments | 10 mL/hr to 300 mL/hr in 1 mL/hr increments | Identical | | Characteristic | Predicate Device – DEKA Volumetric Infusion Controller (K153760) | Subject Device - DEKA Infusion System | Equivalence | | Volume to be Infused (VTBI) | None | 10 mL to 1300 mL in 1 mL increments | VTBI is not considered new technology. This functionality is equivalent to that of the reference device (K192860) and is supported through performance testing. | | Time to reach target Flow Rate | < 5 minutes | < 5 minutes | Identical | | Time to detect an Occlusion | < 65 seconds | < 5 minutes | The subject device has a longer time to detect an Occlusion. Equivalent safety and effectiveness was demonstrated through risk management and performance testing. | | Alarm Conditions | | | | | Internal System Fault Conditions | Yes | Yes | Equivalent | | Low Battery | Yes | Yes | Equivalent | | Timeout | Yes | Yes | Equivalent | | Interruption of Infusion | Yes | Yes | Equivalent | | Tilt | Yes | Yes | Equivalent | | Shake | Yes | Yes | Equivalent | | Camera Blocked | Yes | Yes | Equivalent | | Invalid/Missing Administration Set | Yes | Yes | Identical | | Characteristic | Predicate Device – DEKA Volumetric Infusion Controller (K153760) | Subject Device – DEKA Infusion System | Equivalence | | Administration Set Prime Level | Yes | Yes | Equivalent | | Mean Flow Rate Error | Yes | Yes | Identical | | Cannot Start Flow | Yes | Yes | Equivalent | | No Flow | Yes | Yes | Equivalent | | Streaming (Free Flow) | Yes | Yes | Equivalent | | Retrograde Flow | Yes | Yes | Equivalent | | End of Infusion | No | Yes | Equivalent to Reference Device (K192860) | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "DEKA" in a bold, stylized font. The letters are all capitalized and appear to be sans-serif. The overall impression is modern and industrial. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "DEKA" in a bold, sans-serif font. The letters are all capitalized and black. The letters are close together, and the overall effect is one of strength and stability. The background is white. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "DEKA" in a bold, stylized font. The letters are black and have a rounded, blocky appearance. The "K" in "DEKA" is designed with an arrow-like shape pointing to the left. {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "DEKA" in a bold, sans-serif font. The letters are all capitalized and black. The letters are close together, and the overall impression is one of strength and stability. The background is white. ### DEKA Administration Set | Characteristic | Predicate Device – Zyno Medical Administration Set (K120685) | Subject Device – DEKA Administration Set | Equivalence | |------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Classification Regulation and Product Code | 21 CFR 880.5440 Product Code: FPA | 21 CFR 880.5440 Product Code: FPA | Identical | | Class | II | II | Identical | | Characteristic | Predicate Device – Zyno Medical Administration Set (K120685) | Subject Device – DEKA Administration Set | Equivalence | | Intended Use | Zyno Medical Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein. | The DEKA Administration Set is intended 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 intended for single patient use only. The DEKA Administration Set is not intended 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. | Equivalent | | Sterility Assurance Level (SAL) | Labeled as sterile (equivalent to an SAL of 10e-6) | Labeled as sterile (equivalent to an SAL of 10e-6) | Identical | | Applicable Standards | • ISO 8536-4 • ISO 10993 | • ISO 8536-4 • ISO 10993 | Identical | | Drop Size | 20 drops/mL | 20 drops/mL | Identical | | Characteristic | Predicate Device – Zyno Medical Administration Set (K120685) | Subject Device – DEKA Administration Set | Equivalence | | Components | Tubing Protective spike cap Drip chamber with spike Air vent Slide clamp Pinch clamp Roller clamp Male Luer lock Protective Luer lock cap 0.22 or 1.2 micron filter Back-check valve Needleless Y-site | Tubing Protective spike cap Drip chamber with spike Air vent Slide clamp Roller clamp Flow Control Insert Male Luer lock Protective Luer lock cap | The subject device has a simpler list of components, which does not impact safety or effectiveness. The subject device also includes a multi-lumen Flow Control Insert, which has been verified for safety and effectiveness through performance testing. | | Fluid Path Material | Non-DEHP PVC | Non-DEHP PVC, medical grade silicone | The subject device has a multi-lumen flow control insert made of medical grade silicone, which is a material typically used in industry. The safety and effectiveness of the Flow Control Insert is supported through performance testing. | | Patient Connector Type | Male Luer | Male Luer | Identical | | Single use? | Yes | Yes | Identical…

DEKA Infusion System, DEKA Administration Set

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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DEKA Infusion System, DEKA Administration Set

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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