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.

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.

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.

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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the DEKA Infusion System and DEKA Administration Set. It primarily focuses on demonstrating substantial equivalence to a predicate device after a modification, specifically an increased maximum programmable flow rate and an update to tilt angle detection.

However, the document does not contain the detailed information required to answer your specific questions about acceptance criteria, the study proving the device meets the criteria, sample sizes, expert involvement, ground truth, or MRMC studies for an AI/ML-based device.

This document is for a mechanical/electrical infusion system that uses a camera for drop formation detection and flow rate measurement, not an AI/ML diagnostic or prognostic device that would involve a training set, test set, expert adjudication, or MRMC studies in the way your questions imply. The "Vision System Performance" mentioned is likely related to the camera's ability to accurately detect drops, not a complex AI model requiring extensive human-in-the-loop validation or ground truth established by multiple medical experts interpreting images.

Therefore, I cannot extract the requested information from this document. The questions you've asked are typical for the validation of Artificial Intelligence/Machine Learning (AI/ML) medical devices, particularly those involving image interpretation or complex diagnostic algorithms. This 510(k) summary does not describe such a device or its corresponding validation studies.

The closest aspects discussed are:

Acceptance Criteria for Flow Rate Accuracy: Mentioned as "± 10% nominally" and "± 25% under environmental limits of normal use." The document states "All tests met acceptance criteria."
Study Proving Device Meets Criteria: "Formal performance testing was conducted on all areas of the subject device that are impacted by its changes with respect to the predicate device."
Performance Data: "Flow Rate Accuracy," "Vision System Performance," "Stopping Flow," and "Device Handling Alarms" were tested.

But none of these provide the level of detail (sample size, expert ground truth, adjudication, MRMC) specific to AI/ML device validation that your questions are designed to elicit.

Summary

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)

Type of Use (Select one or both, as applicable)
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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 Development340 Commercial StreetManchester NH, 03101
Contact Person(s)	Paul Smolenski (primary), Rhianne Tallarico (secondary)Regulatory AffairsPhone: (603) 669-5139Fax: (603) 624-0573Email: psmolenski@dekaresearch.com,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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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 close together, but still distinct. The overall impression is one of strength and stability.

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

DEKA Infusion System

DEKA Administration Set

Indications for Use

DEKA Infusion System

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 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
DeviceClassificationRegulation andProduct Code	21 CFR 880.5725Product Code: LDR	21 CFR 880.5725Product Code: LDR	No change
Class	II	II	No change
Characteristic	Predicate Device – K232316	Subject Device	Equivalence
Intended Use	The DEKA Infusion System,comprised of the DEKA InfusionController and the DEKAAdministration Set, is intendedfor continuous delivery through aperipheral intravenous (IV) siteof general maintenance fluidsand supported antibiotics underthe supervision of a qualifiedclinician. The DEKA InfusionSystem is not intended toadminister high-alertmedications, blood, and bloodproducts.	The DEKA Infusion System,comprised of the DEKA InfusionController and the DEKAAdministration Set, is intendedfor continuous delivery through aperipheral intravenous (IV) siteof general maintenance fluidsand supported antibiotics underthe supervision of a qualifiedclinician. The DEKA InfusionSystem is not intended toadminister high-alertmedications, blood, and bloodproducts.	No change
Prescription orOver theCounter (OTC)	Prescription	Prescription	No change
Intended PatientPopulation	Adults	Adults	No change
Environment ofUse	Under supervision of a qualifiedclinician	Under supervision of a qualifiedclinician	No change
CompatibleAdministrationSet	DEKA Administration Set, 20drop/mL (non-DEHP)	DEKA Administration Set, 20drop/mL (non-DEHP)	No change
SupportedInfusates	Maintenance FluidsAntibiotic – AminoglycosidesAntibiotic - CarbapenemsAntibiotic - CephalosporinsAntibiotic – FluoroquinoloneAntibiotic - NitroimidazoleAntibiotic – Penicillin	Maintenance FluidsAntibiotic – AminoglycosidesAntibiotic - CarbapenemsAntibiotic - CephalosporinsAntibiotic – FluoroquinoloneAntibiotic - NitroimidazoleAntibiotic – Penicillin	No change
Applicable Standards
ApplicableStandards	ISO 14971IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-8	ISO 14971IEC 60601-1IEC 60601-1-2IEC 60601-1-6IEC 60601-1-8	No change
Characteristic	Predicate Device – K232316	Subject Device	Equivalence
Environmental Specifications
OperatingEnvironment	Temperature: 15 °C to 40 °CRelative Humidity: 15% to 90%,non-condensingAltitude: -300 m to 3000 m	Temperature: 15 °C to 40 °CRelative Humidity: 15% to 90%,non-condensingAltitude: -300 m to 3000 m	No change
StorageEnvironment	Temperature and RelativeHumidity:-25 to 5 °C, with uncontrolledhumidity5 to 35 °C, with up to 90% RH,non-condensing>35 to 70 °C, with a water vaporpartial pressure ≤ 50 hPaAltitude: -300 m to 3000 m	Temperature and RelativeHumidity:-25 to 5 °C, with uncontrolledhumidity5 to 35 °C, with up to 90% RH,non-condensing>35 to 70 °C, with a water vaporpartial pressure ≤ 50 hPaAltitude: -300 m to 3000 m	No change
SpecifiedIngressProtectionrating forIntended UseEnvironment	IP42	IP42	No change
Physical Characteristics
Weight	< 450 g (not including powersupply and primedAdministration Set)	< 450 g (not including powersupply and primedAdministration Set)	No change
PhysicalDimensionRequirements	< 5.11" x 5.11" x 2.55"	< 5.11" x 5.11" x 2.55"	No change
Number ofChannels	1	1	No change
PowerRequirements	100-127/220-240 V AC,Rechargeable Lithium Battery	100-127/220-240 V AC,Rechargeable Lithium Battery	No change
Battery Life	A fully charged new battery willprovide at least 8 hours ofbattery life during normaloperation.	A fully charged new battery willprovide at least 8 hours ofbattery life during normaloperation.	No change
Performance Characteristics
ControlMechanism	Video camera and visionprocessing system with a flowcontrol valve	Video camera and visionprocessing system with a flowcontrol valve	No change
Characteristic	Predicate Device - K232316	Subject Device	Equivalence
ProgrammableFlow RateRange	10 to 300 mL/h in 1 mL/hincrements	10 to 600 mL/h in 1 mL/hincrements	Different
Flow RateAccuracy	± 10% nominally± 25% under environmentallimits of normal use	± 10% nominally± 25% under environmentallimits of normal use	No change
Volume to beInfused (VTBI)	10 mL to 1300 mL in 1 mLincrements	10 mL to 1300 mL in 1 mLincrements	No change
Time to reachtarget FlowRate	< 5 minutes	< 5 minutes	No change
Time to detectan Occlusion	< 5 minutes	< 5 minutes	No change

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Image /page/8/Picture/0 description: The image shows the word "DEKA" in a bold, sans-serif font. The letters are all capitalized and appear to be connected or very close together. The overall design is simple and modern, with a focus on the geometric shapes of the letters.

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Image /page/9/Picture/0 description: The image shows the word "DEKA" in a bold, stylized font. The letters are all capitalized and appear to be connected or very close together. The overall design is modern and geometric, with a strong emphasis on the shape and form of the letters.

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 SystemFaultConditions	• Low Battery• Timeout• Interruption of Infusion• Tilt• Shake• Camera Blocked• Invalid/MissingAdministration Set• Prime Level• Mean Flow Rate Error• Cannot Start Flow• No Flow• Streaming (Free Flow)• Retrograde Flow• End of Infusion	• Low Battery• Timeout• Interruption of Infusion• Tilt• Shake• Camera Blocked• Invalid/MissingAdministration Set• Prime Level• Mean Flow Rate Error• Cannot Start Flow• No Flow• Streaming (Free Flow)• Retrograde Flow• 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.

Regulation Number and Section

§ 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).