The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

The pump is intended for single patient, home use and requires a prescription.

The pump is indicated for use in individuals six years of age and greater.

Device Description

The Subject Device, Tandem Mobi insulin pump with interoperable technology (" Mobi pump", "the pump"), is an Alternate Controller Enabled (ACE) Infusion Pump intended for the infusion of insulin into a patient requiring insulin therapy. The Tandem Mobi insulin pump with interoperable technology ( "pump") is screenless and includes visual LED, sound and vibratory indicators to alert the user of the pump status. The Tandem Mobi insulin pump with interoperable technology system also includes: the t:connect mobile app (K203234) and a 2mL (200 insulin unit) Tandem Mobi cartridge and a compatible FDA cleared infusion set. The t:connect mobile app (" Mobile app") displays all information from, and is the primary controller of, the pump. Through the Mobile app, users will program all aspects of basal and bolus insulin delivery therapy including managing personal profiles, viewing pump and CGM data, and actively acknowledging all pump and mobile app alerts, alarms, reminders, notifications and messages. The t:connect mobile app will also be used to transmit historical pump and mobile app therapy data to the Tandem Cloud. The t:connect mobile app will be made available via the Apple® App Store for iOS compatible smartphones based on completed device verification and validation. The Tandem Mobi cartridge is a disposable insulin cartridge compatible only with the Tandem Mobi pump.

The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.

The pump may be used in combination with a compatible continuous glucose monitor (CGM) system, such as the Dexcom G6 Continuous Glucose Monitoring System (DEN170088). Use of CGM is optional.

AI/ML Overview

The provided document is a 510(k) summary for the Tandem Mobi insulin pump. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance data in the format requested.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with corresponding device performance metrics in the format you requested, such as sensitivity, specificity, or similar quantitative measures for an AI-driven diagnostic. Instead, it describes general non-clinical performance tests and states that the device "met specified requirements" or "performed as intended."

2. Sample size used for the test set and the data provenance

The document explicitly states: "No new clinical testing was performed to support this Traditional 510(k) Notification." Therefore, there is no test set of patient data from a clinical study to report on for the Tandem Mobi insulin pump itself. The evaluation relies on non-clinical performance tests and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since no new clinical testing was performed, the concept of "ground truth" derived from expert consensus on a test set is not applicable here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new clinical testing was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Tandem Mobi insulin pump is an Alternate Controller Enabled (ACE) Infusion Pump intended for insulin delivery, not a diagnostic device requiring human interpretation of medical images or data. Therefore, an MRMC study and the concept of "human readers improve with AI assistance" are not relevant to this device's evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a pump for insulin delivery. While it has "interoperable technology" connecting to a mobile app and potentially automated insulin dosing software, the document doesn't describe a standalone algorithm performance in the context of a diagnostic AI system. The "algorithm only" would likely pertain to the internal control logic of the pump or any integrated automated dosing algorithms (which are referenced as separate devices like Control-IQ technology). The evaluation here focuses on the pump as a system, including its communication capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the nature of the device (an insulin pump), the "ground truth" for its performance would typically involve:

Physiological measurements: Accurate insulin delivery, blood glucose control (as observed in predicate/reference device studies, not new studies for this 510k).
Engineering specifications: Meeting defined tolerances for flow rate, pressure, safety, etc. (evaluated in non-clinical tests).
System Integrity: Reliability of communication, software function, alarm systems, etc. (evaluated in non-clinical tests).

The summary indicates that Usability/Human Factors, Software Verification and Validation, Electrical Safety/EMC, Insulin Compatibility and Biocompatibility, and Sterilization and Shipping tests were performed. These tests use their own respective "ground truths" in the form of pre-defined requirements, standards (e.g., IEC 60601), or established safety profiles. For instance, in "Insulin Compatibility," the ground truth is that the insulin performs "as intended" in the device, presumably based on its known pharmacological properties and stability.

8. The sample size for the training set

Not applicable, as no new clinical testing or development of a new AI algorithm (in the diagnostic sense) is described. The device is a medical device leveraging established technology for insulin delivery.

9. How the ground truth for the training set was established

Not applicable.

Summary Regarding Acceptance Criteria and Study:

The document effectively communicates that the Tandem Mobi insulin pump's acceptance criteria are primarily based on non-clinical performance tests demonstrating compliance with relevant standards and guidelines, and its substantial equivalence to an existing predicate device (K203234, the t:slim X2 Insulin Pump with interoperable technology).

The "study that proves the device meets the acceptance criteria" consists of:

Usability/Human Factors validation testing: To ensure users can safely and effectively operate the device.
Software Verification and Validation: To confirm the software meets requirements and performs as intended, adhering to standards like IEC 62304 and FDA guidance. This includes cybersecurity evaluations.
Electrical Safety/EMC Testing: To ensure compliance with electrical safety and electromagnetic compatibility standards (e.g., IEC 60601).
Insulin Compatibility and Biocompatibility Testing: To confirm the device functions correctly with approved insulins and that materials are biocompatible.
Sterilization and Shipping Testing: To ensure the integrity of the device and its sterilization.
Special Controls Adherence: Demonstrating compliance with special controls established for the predicate and reference devices.

The key takeaway is that for this 510(k) submission, the safety and effectiveness of the Tandem Mobi insulin pump are established through bench testing, engineering validation, and comparison to a legally marketed predicate device, rather than new clinical trials with patient-level data and AI performance metrics.

Summary

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July 10, 2023

Tandem Diabetes Care, Inc. Louise Focht Director, Regulatory Affairs 12400 High Bluff Drive San Diego, California 92130

Re: K223213

Trade/Device Name: Tandem Mobi insulin pump with interoperable technology Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate Controller Enabled Infusion Pump Regulatory Class: Class II Product Code: QFG Dated: October 14, 2022 Received: October 17, 2022

Dear Louise Focht:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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

Enclosure

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Indications for Use

510(k) Number (if known) K223213

Device Name

Tandem Mobi insulin pump with interoperable technology

Indications for Use (Describe)

The Tandem Mobi insulin pump with interoperable technology (the pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes melliting insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.

The pump is intended for single patient, home use and requires a prescription.

The pump is indicated for use in individuals six years of age and greater.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY K223213

Company	Tandem Diabetes Care, Inc12400 High Bluff DriveSan Diego, CA 92130
Prepared	June 9, 2023
Contact	Louise FochtDirector Regulatory Affairs+1 (858) 255 6363lfocht@tandemdiabetes.com
Trade Name	Tandem Mobi insulin pump with interoperable technology
Common Name	Ambulatory Insulin Pump
Classification Product Code	QFG
Classification Name	Alternate Controller Enabled Infusion Pump
Regulation Number	21 CFR 880.5730
Device Class	Class II
Predicate Device	K203234, t:slim X2 Insulin Pump with interoperabletechnology (with t:connect Mobile app)
Reference Device	K200467, Control-IQ TechnologyDEN180058, t:slim X2 Insulin Pump with InteroperableTechnology

I. Device Under Review

The Tandem Mobi ACE pump can be used for basal and bolus insulin delivery with or without a CGM or with any compatible interoperable automated dosing algorithm.

The pump may be used in combination with a compatible continuous glucose monitor (CGM)

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system, such as the Dexcom G6 Continuous Glucose Monitoring System (DEN170088). Use of CGM is optional.

Intended Use/Indications for Use II.

The pump is intended for single patient, home use and requires a prescription.

The pump is indicated for use in individuals six years of age and greater.

	Predicate Device (K203234)	Subject Device
Indications forUse/ Intended Use	The t:slim X2 insulin pump with interoperabletechnology (the Pump) is intended for thesubcutaneous delivery of insulin, at set andvariable rates, for the management of diabetesmellitus in persons requiring insulin. The Pumpis able to reliably and securely communicatewith compatible, digitally connected devices,including automated insulin dosing software, toreceive, execute, and confirm commands fromthese devices.The Pump is intended for single patient, homeuse and requires a prescription. The Pump isindicated for use with NovoLog or Humalog U-100 insulin.The Pump is indicated for use in individuals 6years of age and greater.	The Tandem Mobi insulin pump withinteroperable technology (the pump) is intendedfor the subcutaneous delivery of insulin, at set andvariable 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 useand requires a prescription.The pump is indicated for use in individuals sixyears of age and greater.
Prescription Use	Prescription is required.	SAME
Insulin Type	NovoLog or Humalog U-100 insulin	SAME
Infusion Set Type	Compatible, FDA cleared infusions sets witht:lock connectors manufactured for TandemDiabetes Care	SAME
Pump Type	An Alternate Controller Enabled Infusion Pump(under 21 CFR 880.5730)	SAME
CompatibleInteroperableDevices	Compatible with:• DEN170088: Dexcom G6 ContinuousGlucoseMonitoring System or other compatibleiCGM• K193483: Basal-IQ technology• K200467: Control-IQ technology	SAME
Communicationwith CompatibleInteroperableDevices	Bluetooth Low Energy (BLE)	SAME
Principles ofOperation	Delivery of insulin (Bolus and Basal)programmed by the patient based on health careprovider recommendations.	SAME
PumpTechnologicalCharacteristics	The Device is an ambulatory, battery operated,rate-programmable infusion pump designed forthe subcutaneous delivery of insulin, at set andvariable rates, for the management of diabetesmellitus in persons requiring insulin. The deviceincludes a disposable cartridge which is motordriven to deliver patient programmed basal ratesand boluses through an infusion set intosubcutaneous tissue.	SAME
Alarm Type	Visual, audible, and vibratory	SAME
Bolus Calculator	The Device contains a built-in bolus calculator.	SAME
Bolus and BasalInsulin Control	Yes	SAME
Display ofPrimary Glucoseand TherapyInformation	The Device can display Glucose and Therapyinformation and trends from the Pump andcompatible interoperable devices.	SAMEThe pump does not include a graphical userinterface. Instead, Primary Glucose and Therapyinformation and trends from the pump andcompatible interoperable devices are displayed inthe t:connect mobile app.
Use of t:connectMobile app	The t:connect mobile app is optional and its useis limited to the following:• View Pump therapy data, trends, alerts,alarms, notifications, and reminders as asecondary display.• Program Correction Boluses, BolusOverride, and Food (Standard) Boluses.• Terminate (Cancel or stop) all bolustypes regardless of origin of bolusrequest being made on the t:slim X2Insulin Pump or the t:connect mobileapp.• Update historical pump data to TandemCloud	SIMILARThe t:connect mobile app is not optional.In addition to functions of the t:connect mobileapp as described in the Predicate Device, thet:connect mobile app, when paired with TandemMobi insulin pump and running on a compatiblesmartphone, will be able to control all aspects ofpump therapy in the same manner as the PredicateDevice.
Sterilization	The pump is provided non-sterile.Cartridge provided sterile via Gamma Radiationto a Sterility Assurance Level (Sal) 10-6.	EQUIVALENTThe pump is provided non-sterile.Cartridge provided sterile via Ethylene Oxide Gasto a Sterility Assurance Level (Sal) 10-6.
Cartridge Lengthof Use	Every 2 or 3 days depending on insulin typeused	SIMILAREvery 3 days for compatible insulins

III. Technological Characteristics Compared to Predicate Device K203234

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IV. Overview of Non-Clinical Performance Tests

Appropriate testing was performed to confirm the Subject Device met specified requirements and performed as intended. See summaries below.

Usability/Human Factors:

Human Factors validation testing was conducted to demonstrate intended users can effectively use the Subject Device for its intended purpose in its expected use environment.

Usability tasks were evaluated in accordance with ANSI AAMI HE 75 Human Factors Engineering- Design of Medical Devices, ANSI/AAMI/IEC 62366-1:2015 Medical devices -Part 1: Application of Usability Engineering To Medical Devices, and, Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices -February 3, 2016.

The results from the Human Factors Validation study demonstrate users can safely and effectively use the features of the Subject Device in expected use environment.

Software Verification and Validation:

Software development activities included establishing detailed software requirements. linking requirements with associated verification and validation activities, software code inspection, software code walkthrough, static code analysis, unit testing, and system level testing to ensure that the software conforms to user needs and intended use. Software verification and validation testing was carried out in accordance with ISO 14971:2019 Medical Devices - Application of Risk Management to Medical Devices, ANSI AAMI IEC 62304:2006/A1:2016 Medical Device Software - Software Life Cycle Processes, FDA guidance General Principles of Software Validation: Final Guidance for Industry and FDA Staff, Mobile Medical Applications -Guidance for Industry and Food and Drug Administration Staff, February 9, 2015, and FDA guidance Multiple Function Device Products: Policy and Considerations- Guidance for Industry and Food and Drug Administration Staff. July 29, 2020.

In addition, Cybersecurity evaluations were carried out in accordance with Content of Premarket Submissions for Management of Cybersecurity in Medical Devices- Guidance for Industry and Food and Drug Administration Staff.

The Subject Device software was verified and validated to meet acceptance criteria and

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performed as intended.

Electrical Safetv/ EMC:

Electrical and Electromagnetic Compatibility (EMC) Testing were performed according to applicable requirements set forth in IEC 60601 general standard. Results confirm the Subject Device met specified requirements.

Insulin Compatibility and Biocompatibility:

The Subject Device utilizes the same insulin as the Predicate Device. Insulin Compatibility Testing was performed to ensure the indicated insulin performed as intended in the Subject Device. In addition, biocompatibility of the Tandem Mobi sleeve accessory was performed and met the acceptance criteria. Results confirm the Subject Device met specified requirements.

Sterilization and Shipping:

Sterilization, packaging, storage and shipping testing was conducted to ensure the Subject device met the requirements. Results confirm the sterilization and shipping integrity of the system.

Special Controls:

Evaluation and adherence to the Special Controls of the Predicate Device (K203224) and Reference Devices (K200467 and DEN180085) demonstrate continued assurance of the safety and effectiveness of the Subject Device.

Clinical Testing:

No new clinical testing was performed to support this Traditional 510(k) Notification.

Conclusion:

The Subject Device serves the same function as the Predicate Device. Furthermore, the Subject Device performs insulin therapy functions that are the same as that of the Predicate Device. The required technical documentation provided in this Traditional 510(k) demonstrates the Subject Device is as safe and as effective as the Predicate Device. Therefore, the Subject Device has been evaluated to be substantially equivalent to the Predicate Device and does not raise new or different questions of safety or effectiveness.

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.