The Inessa System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Inessa System is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, and confirm commands from these devices. The Inessa System is intended for single patient, home use and requires a prescription. The Inessa System is indicated for use in individuals 6 years of age and greater.

Device Description

The Inessa System ("System") is intended for subcutaneous delivery of insulin at set and variable rates, bolus or basal. The Inessa System includes a skin-adhered Patch Pump that is programmed and controlled wirelessly by a handheld Controller. The System main components include: Patch Pump: a skin adhered, syringe pump type, designed for insulin delivery at set and variable basal and/or bolus doses. The Patch Pump includes two parts: Pump: a reusable part that includes motor, electronics, drive mechanism, and o rechargeable battery. Two Pumps are provided, one is charged (P2) while the other is in use (P1). Cartridge: a sterile disposable part that includes insulin Reservoir. o Controller: The System user interface is a handheld, Alternate Controller Enabled (ACE), providing instructions to the Pump and receiving information from the Pump using wireless Bluetooth Low Energy (BLE) communication. The System includes the following accessories: Inserter: disposable, for insertion of Soft Cannula and retraction of Insertion needle. Filling kit: disposable, for filling of the Cartridge. It includes Filling needle, Filling syringe and Vial adaptor . Charger: reusable, for charging the Pump and the Controller. Docker: reusable, docking station for pumps for charging and protecting the Pump when not in use. The System also includes a Bolus Calculator, accessible through the System Controller. Based on user inputs of blood glucose (current and targeted), carbohydrate intake (meals), patient's insulin characteristics (i.e., Insulin Duration of Action, Insulin Correction Factor, Insulin-to-Carbs Ratio), this feature calculates suggested and estimated values for: Correction Bolus (amount of insulin needed to correct elevated blood glucose (BG) ● level): . Meal Bolus (amount of insulin needed to cover carbohydrates in an upcoming meal); and "Insulin on Board" or "Bolus on Board" (estimation of how much Active Insulin (Al) . remains in the body from previous boluses).

AI/ML Overview

The provided text is a 510(k) summary for the Inessa System, an insulin pump. It details the device's classification, intended use, technological characteristics, and safety and performance data. However, it does not include information about a study that assesses the device's performance against specific acceptance criteria in the context of AI (Artificial Intelligence) or Diagnostic Accuracy.

The document focuses on demonstrating substantial equivalence to a predicate device (Omnipod DASH™ Insulin Management System) for regulatory clearance, primarily through engineering and safety testing (e.g., sterilization, biocompatibility, electrical safety, delivered volume accuracy, occlusion testing, human factors, and usability).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment related to AI or diagnostic accuracy, because this information is not present in the provided text.

The text does mention "automated insulin dosing software" as something the Inessa System can communicate with, but it does not describe any specific studies or acceptance criteria related to the performance of such AI/software in a diagnostic or prescriptive context. The "software verification and validation" mentioned refers to the general software within the device, not necessarily an AI component with specific diagnostic performance metrics.

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, 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.

December 20, 2023

Triple Jump Israel Ltd. Liron Hadar Regulatory Affairs Director 5 HaCarmel St., P.O.B. 205 Yokneam Illit, 2069203 Israel

Re: K230545

Trade/Device Name: Inessa System Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate Controller Enabled Infusion Pump Regulatory Class: Class II Product Code: QFG, NDC Dated: November 20, 2023 Received: November 20, 2023

Dear Liron Hadar:

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" (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).

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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 QS 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 and Part 809); 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-safetyreporting-combination-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).

Sincerely,

Joshua Balsam -S

Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

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510(k) Number (if known)

K230545

Device Name

Inessa System

Indications for Use (Describe)

The Inessa System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Inessa System is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, and confirm commands from these devices. The Inessa System is intended for single patient, home use and requires a prescription. The Indicated for use in individuals 6 years of age and greater.

Type of Use (Select one or both, as applicable)

区Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY Triple Jump Israel Ltd.'s Inessa System K230545

Submitter

Triple Jump Israel Ltd. 5 HaCarmel St., P.O.B. 205 Yokneam Illit 2069203 Phone: +972 73 707 9070 Facsimile: +972 4 822 3787

Contact Person: Dr. Liron Hadar

Date Prepared:	November 15 , 2023
510(k) Number:	K230545
Name of Device:	Inessa System
Common or Usual Name:	Insulin Pump
Classification Name:	Alternate Controller Enabled Infusion Pump
Regulatory Class:	21 CFR 880.5730 - Class II
Product Code:	QFG

Predicate Device

Insulet Corporation Omnipod DASH™ Insulin Management System with interoperable technology (K191679)

Device Description

The System main components include:

Patch Pump: a skin adhered, syringe pump type, designed for insulin delivery at set and variable basal and/or bolus doses. The Patch Pump includes two parts:
- Pump: a reusable part that includes motor, electronics, drive mechanism, and o rechargeable battery. Two Pumps are provided, one is charged (P2) while the other is in use (P1).
- Cartridge: a sterile disposable part that includes insulin Reservoir. o

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Controller: The System user interface is a handheld, Alternate Controller Enabled (ACE), providing instructions to the Pump and receiving information from the Pump using wireless Bluetooth Low Energy (BLE) communication.
The System includes the following accessories:
Inserter: disposable, for insertion of Soft Cannula and retraction of Insertion needle.
Filling kit: disposable, for filling of the Cartridge. It includes Filling needle, Filling syringe and Vial adaptor
. Charger: reusable, for charging the Pump and the Controller.
Docker: reusable, docking station for pumps for charging and protecting the Pump when not in use.

The System also includes a Bolus Calculator, accessible through the System Controller. Based on user inputs of blood glucose (current and targeted), carbohydrate intake (meals), patient's insulin characteristics (i.e., Insulin Duration of Action, Insulin Correction Factor, Insulin-to-Carbs Ratio), this feature calculates suggested and estimated values for:

Correction Bolus (amount of insulin needed to correct elevated blood glucose (BG) ● level):
. Meal Bolus (amount of insulin needed to cover carbohydrates in an upcoming meal); and
"Insulin on Board" or "Bolus on Board" (estimation of how much Active Insulin (Al) . remains in the body from previous boluses).

Intended Use / Indications for Use

The Inessa System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The lnessa System is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, and confirm commands from these devices. The Inessa System is intended for single patient, home use and requires a prescription. The Inessa System is indicated for use in individuals 6 years of age and greater.

Summary of Technological Characteristics

The subject device and predicate device use similar operating principles to achieve the intended therapeutic effect. The subject device and predicate device are both insulin infusion pumps that include a software-controlled, programmable pump capable of both basal and bolus delivery of insulin. Both devices are wearable units, which are secured to the patient's skin with an adhesive patch. Both devices include bolus calculators with identical calculations and equations and similar operational specifications. The differences between subject Inessa System and the predicate Omnipod device do not raise any different questions about safety and effectiveness. Therefore, the Inessa System is substantially equivalent to its predicate.

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	Inessa System (Subject Device)	Omnipod DASH TM (K191679)	Comparison
	Device Description
Regulation andClassification	21 CFR 880.5730; Product Code QFG;Class II	21 CFR 880.5730; Product Code QFG; Class II	Identical
Intended Use /Indications forUse	The Inessa System is intended for thesubcutaneous delivery of insulin, at setand variable rates, for the management ofdiabetes mellitus in persons requiringinsulin. The Inessa System is able toreliably and securely communicate withcompatible, digitally connected devices,including automated insulin dosingsoftware, to receive, execute, and confirmcommands from these devices. TheInessa System is intended for singlepatient, home use and requires aprescription. The Inessa System isindicated use in individuals 6 years of ageand greater.	The Omnipod DASH Insulin Management System(the Pump) with interoperable technology isintended for subcutaneous delivery of insulin at setand variable rates for the management of diabetesmellitus in persons requiring insulin. The Pump isable to reliably and securely communicate withcompatible, digitally connected devices, includingautomated insulin dosing software, to receive,execute and confirm commands from thesedevices. The Pump is intended for single patient,home use and requires a prescription. The Pump isindicated for use with NovoLog®, Humalog®,Admelog®, or Apidra® U-100 insulin.	Similar
PrescriptionUse	Yes	Yes	Identical
Insulin Type	NovoLog or Humalog U-100 insulin	NovoLog or Humalog U-100 insulin	Identical
Pump Design	Reusable pump with disposable fillablereservoir, patient-activated cannulainsertion system, and wireless controller	Single-use, on-body linear piston pump withintegrated reservoir, patient-activated cannulainsertion system, and wireless controller	Similar
Principles ofOperation	Delivery of insulin (Bolus and Basal)programmed by the patient based onhealth care provider recommendations	Delivery of insulin (Bolus and Basal)programmed by the patient based on health careprovider recommendations	Identical
Accessories	Filling kit (sterile)• Inserter/needle retractor (pre-attached, sterile, single-use)• Docker• Charger	Filling kit (sterile)• Inserter/needle retractor (built-in, sterile,single-use)• Controller Charger	Similar
	Technological Characteristics
InsulinCartridgeVolume	60-210 U	85-200 U	Similar
Flow Rates andProfiles	• Basal: 0.05 – 30U/h in 0.05Uincrements• Bolus: 0.05 - 30U in 0.05Uincrements• Extended Bolus: 30 minutes to 8hours in 30-minute increments• 8 basal programs• 12 basal segments per program	• Basal: 0.05 – 30U/h in 0.05U increments• Bolus: 0.05 - 30U in 0.05U increments• Extended Bolus: 30 minutes to 8 hours in30-minute increments• 7 basal programs• 24 basal segments per program	Similar
InsulinDeliveryAccuracy	Bolus:• ± 5% for amounts ≥ 0.2U• ± 8% for amounts < 0.2UBasal*:• ± 5% at rates ≥ 1.0 U/h	Bolus:• ± 5% for amounts ≥ 1.0U• ± 0.05 units for amounts < 1.0UBasal:• ± 5% at all rates	Similar
	Inessa System (Subject Device)	Omnipod DASH™ (K191679)	Comparison
	* Basal delivery accuracy shall beassessed using the basal flow rateaveraged over 4h observation windows.
OcclusionDetection	Yes	Yes	Similar
Cartridge andCannulaLifespan	72 hours	72 hours	Identical
TemporaryBasal Option	Yes	Yes	Identical
BolusCalculator	Inputs:- Current and Target BloodGlucose (BG)- Insulin Correction Factor (ICF)- Carb Intake- Insulin-to-Carbs Ratio (ICR)- Duration of Insulin Action (DIA)	Inputs:- Current and Target Blood Glucose (BG)- Insulin Correction Factor (ICF)- Carb Intake- Insulin-to-Carbs Ratio (ICR)- Duration of Insulin Action (DIA)	Identical
	Calculations:- Prelim Correction Bolus- Prelim Meal Bolus- Final Correction Bolus- Final Meal Bolus- Total Bolus	Calculations:- Prelim Correction Bolus- Prelim Meal Bolus- Final Correction Bolus- Final Meal Bolus- Total Bolus	Identical
	Optional Features:- Reverse Correction- Extension of Meal and CorrectionBoluses- Bolus Limiting (Max Bolus)	Optional Features:- Reverse Correction- Extension of Meal and Correction Boluses- Bolus Limiting (Max Bolus)	Identical
	Specifications:- Max BG Input: 600 mg/dL- Min BG Input : 20 mg/dL- Duration of unavailable ActiveInsulin after RESET or unknownbolus: based on DIA (2-8 hrs)	Specifications:- Max BG Input: 600 mg/dL- Min BG Input : 50-70 mg/dL- Duration of unavailable Active Insulin afterRESET or unknown bolus: 8.5 hrs	Similar
Power Source	Rechargeable Lithium-Ion	Rechargeable Lithium-Ion for controller; silver oxidefor Pod	Similar
ControllerBattery Life	~ 2 days	~ 2 days	Identical
User Interface(UI)	Handheld touchscreen password-lockedmobile device	Handheld touchscreen password locked mobiledevice	Identical
UI VisualIndicators	- Time and date- Battery level - Controller- Battery level - Pump- Insulin level- Active basal rate- Bolus in progress- Delivery status- Alert and alarm- Communication status	- Time and date- Battery (PDM)- Insulin level- Active basal rate- Bolus in progress- Delivery status- Alert and alarm- Communication status	Similar
Alarms	Audible, visual, & vibration	Audible, visual, & vibration	Similar

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Safety and Performance Data

Safety Assurance Case:

A comprehensive Safety Assurance Case (SAC) was developed for the Inessa System in full conformance to AAMI TIR38:2019 - Medical device safety assurance case guidance. This SAC was performed to address the applied risk management process addressing all reasonably foreseeable hazards / hazardous situations have been effectively mitigated, providing evidence that the mitigation are adequate and that they will remain effective over the product's lifetime.

Sterility and Shelf Life Testing:

Sterilization has been fully validated per ISO 11137-1:2015/A2:2019, ISO 11137-2:2013, AAMI TIR33:2005, ISO 11737-1:2018 and ISO 11737-2:2019. The Inessa System's shelf life of 6 months has been fully validated through accelerated aging testing per ASTM 1980-21.

Biocompatibility Testing:

Full biocompatibility testing for the Inessa System was conducted in accordance with ISO 10993-1:2018 and FDA's Biocompatibility Guidance "Use of international standard ISO 10993-1, biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, Guidance for Industry and Food and Drug Administration Staff, September 2020."

Electrical Safety and EMC:

All appropriate testing for electrical safety, electromagnetic compatibility, immunity to radio frequency identification readers (RFID) immunity, and wireless coexistence was performed in accordance to ES 60601-1,IEC 60601-1-2, RTCA DO-160 Edition G:2010, AIM 7351731, and IEEE/ANSI C63.27-2021.

Pre-Clinical Bench Testing:

Complete bench verification and validation testing has been performed to demonstrate that the Inessa System's performance specifications are all adequately met. Specifically, the following tests were performed:

-Software Verification and Validation
-Delivered Volume Accuracy Testing
-Occlusion Testing
Insulin Stability and Bioidentity Testing -
-Lifetime Verification Testing
-Adhesive Peeling Force Testing
Particulate Matter Testing -
-Unintended Insulin Delivery Testing
-Pump Battery Empty Alarm Testing
System Reliability Verification -

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Clinical Testing:

On-Body Adhesive Testing and Human Factors and Usability Validation Testing were conducted. Adhesive testing results supported the safety and performance of the device's adhesion to patients throughout its intended use life. Human Factors and Usability Validation Testing demonstrated that all use-related risks are adequately mitigated across both child and adult patient user populations.

Special Controls

The Inessa System conforms to all special controls as required under 21 CFR 880.5730.

Conclusions

The Inessa System is substantially equivalent to the cleared Omnipod DASH™ predicate device (K191679). The subject device has the same intended use and substantially similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended therapeutic use of the device and do not raise different questions of safety and effectiveness. In addition, the minor technological differences between the Inessa System and its predicate device do not raise different questions of safety or effectiveness. Performance data demonstrate that the subject device is as safe and effective as the predicate device. Thus, the Inessa System is substantially equivalent.

Regulation Number and Section

§ 880.5730 Alternate controller enabled infusion pump.

(a)
Identification. An alternate controller enabled infusion pump (ACE pump) is a device intended for the infusion of drugs into a patient. The ACE pump may include basal and bolus drug delivery at set or variable rates. ACE pumps are designed to reliably and securely communicate with external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) Evidence demonstrating that device infusion delivery accuracy conforms to defined user needs and intended uses and is validated to support safe use under actual use conditions.
(A) Design input requirements must include delivery accuracy specifications under reasonably foreseeable use conditions, including ambient temperature changes, pressure changes (
e.g., head-height, backpressure, atmospheric), and, as appropriate, different drug fluidic properties.(B) Test results must demonstrate that the device meets the design input requirements for delivery accuracy under use conditions for the programmable range of delivery rates and volumes. Testing shall be conducted with a statistically valid number of devices to account for variation between devices.
(ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration (
e.g., occlusions, air in line, etc.) within a clinically relevant timeframe across the range of programmable drug delivery rates and volumes. Hazard detection must be appropriate for the intended use of the device and testing must validate appropriate performance under the conditions of use for the device.(iii) Validation testing results demonstrating compatibility with drugs that may be used with the pump based on its labeling. Testing must include assessment of drug stability under reasonably foreseeable use conditions that may affect drug stability (
e.g., temperature, light exposure, or other factors as needed).(iv) The device parts that directly or indirectly contact the patient must be demonstrated to be biocompatible. This shall include chemical and particulate characterization on the final, finished, fluid contacting device components demonstrating that risk of harm from device-related residues is reasonably low.
(v) Evidence verifying and validating that the device is reliable over the ACE pump use life, as specified in the design file, in terms of all device functions and in terms of pump performance.
(vi) The device must be designed and tested for electrical safety, electromagnetic compatibility, and radio frequency wireless safety and availability consistent with patient safety requirements in the intended use environment.
(vii) For any device that is capable of delivering more than one drug, the risk of cross-channeling drugs must be adequately mitigated.
(viii) For any devices intended for multiple patient use, testing must demonstrate validation of reprocessing procedures and include verification that the device meets all functional and performance requirements after reprocessing.
(2) Design verification and validation activities must include appropriate design inputs and design outputs that are essential for the proper functioning of the device that have been documented and include the following:
(i) Risk control measures shall be implemented to address device system hazards and the design decisions related to how the risk control measures impact essential performance shall be documented.
(ii) A traceability analysis demonstrating that all hazards are adequately controlled and that all controls have been validated in the final device design.
(3) The device shall include validated interface specifications for digitally connected devices. These interface specifications shall, at a minimum, provide for the following:
(i) Secure authentication (pairing) to external devices.
(ii) Secure, accurate, and reliable means of data transmission between the pump and connected devices.
(iii) Sharing of necessary state information between the pump and any digitally connected alternate controllers (
e.g., battery level, reservoir level, pump status, error conditions).(iv) Ensuring that the pump continues to operate safely when data is received in a manner outside the bounds of the parameters specified.
(v) A detailed process and procedure for sharing the pump interface specification with digitally connected devices and for validating the correct implementation of that protocol.
(4) The device must include appropriate measures to ensure that safe therapy is maintained when communications with digitally connected alternate controller devices is interrupted, lost, or re-established after an interruption (
e.g., reverting to a pre-programmed, safe drug delivery rate). Validation testing results must demonstrate that critical events that occur during a loss of communications (e.g., commands, device malfunctions, occlusions, etc.) are handled appropriately during and after the interruption.(5) The device design must ensure that a record of critical events is stored and accessible for an adequate period to allow for auditing of communications between digitally connected devices and to facilitate the sharing of pertinent information with the responsible parties for those connected devices. Critical events to be stored by the system must, at a minimum, include:
(i) A record of all drug delivery
(ii) Commands issued to the pump and pump confirmations
(iii) Device malfunctions
(iv) Alarms and alerts and associated acknowledgements
(v) Connectivity events (
e.g., establishment or loss of communications)(6) Design verification and validation must include results obtained through a human factors study that demonstrates that an intended user can safely use the device for its intended use.
(7) Device labeling must include the following:
(i) A prominent statement identifying the drugs that are compatible with the device, including the identity and concentration of those drugs as appropriate.
(ii) A description of the minimum and maximum basal rates, minimum and maximum bolus volumes, and the increment size for basal and bolus delivery, or other similarly applicable information about drug delivery parameters.
(iii) A description of the pump accuracy at minimum, intermediate, and maximum bolus delivery volumes and the method(s) used to establish bolus delivery accuracy. For each bolus volume, pump accuracy shall be described in terms of the number of bolus doses measured to be within a given range as compared to the commanded volume. An acceptable accuracy description (depending on the drug delivered and bolus volume) may be provided as follows for each bolus volume tested, as applicable: Number of bolus doses with volume that is 250 percent of the commanded amount.
(iv) A description of the pump accuracy at minimum, intermediate, and maximum basal delivery rates and the method(s) used to establish basal delivery accuracy. For each basal rate, pump accuracy shall be described in terms of the amount of drug delivered after the basal delivery was first commanded, without a warmup period, up to various time points. The information provided must include typical pump performance, as well as worst-case pump performance observed during testing in terms of both over-delivery and under-delivery. An acceptable accuracy description (depending on the drug delivered) may be provided as follows, as applicable: The total volume delivered 1 hour, 6 hours, and 12 hours after starting delivery for a typical pump tested, as well as for the pump that delivered the least and the pump that delivered the most at each time point.
(v) A description of delivery hazard alarm performance, as applicable. For occlusion alarms, performance shall be reported at minimum, intermediate, and maximum delivery rates and volumes. This description must include the specification for the longest time period that may elapse before an occlusion alarm is triggered under each delivery condition, as well as the typical results observed during performance testing of the pumps.
(vi) For wireless connection enabled devices, a description of the wireless quality of service required for proper use of the device.
(vii) For any infusion pumps intended for multiple patient reuse, instructions for safely reprocessing the device between uses.