The Accu-Chek Solo micropump system with interoperable technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Accu-Chek Solo micropump system is able to communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Accu-Chek Solo micropump system is intended for single patient, home use and requires a prescription. The Accu-Chek Solo micropump system is indicated for use in individuals 2 years of age and greater.

Device Description

The Accu-Chek Solo micropump is a portable programmable insulin pump, which adheres to the patient's skin. The patch is comprised of two connected parts: a disposable reservoir, in which the insulin is stored and a reusable pump, which includes the pumping mechanism and electronic components. The patch is controlled via a connected Device. The Accu-Chek Solo micropump is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as per your detailed request.

The document is a 510(k) premarket notification summary for the Accu-Chek Solo micropump system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Omnipod DASH Insulin Management System). While it lists various non-clinical tests performed (e.g., human factors, biocompatibility, sterility, electrical safety, software, cybersecurity, interoperability, and system reliability/safety testing), it does not provide specific acceptance criteria or detailed results that quantify device performance against those criteria.

Specifically, it lacks the following information crucial for your request:

A table of acceptance criteria and reported device performance: The document mentions "The Performance testing of the Accu-Chek Solo micropump System demonstrated that the device met all device specifications," but it does not specify what those specifications are beyond broad categories like "Accuracy of Insulin Delivery" with some general percentages (e.g., "±18% or better at 0.1 U/h" for basal rates). It doesn't present a clear table linking acceptance criteria to actual measured performance for various functionalities.
Sample sizes used for the test set and data provenance: Details on the number of samples/devices tested for the various non-clinical tests are not provided. There is no mention of a "test set" in the context of an AI/ML device or data provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish ground truth & qualifications: This information is completely absent, as the document doesn't describe a study involving expert assessment or ground truth labeling in the context of AI/ML performance.
Adjudication method for the test set: Not applicable based on the document's content.
MRMC comparative effectiveness study: The document does not describe any multi-reader multi-case study, nor does it discuss human reader improvement with or without AI assistance. This device is an insulin pump, not an AI-assisted diagnostic tool.
Standalone (algorithm only) performance: Not applicable, as this is a physical medical device (insulin pump) with software, not a standalone AI algorithm being evaluated for diagnostic or predictive performance.
Type of ground truth used: Given the device type, ground truth would relate to physiological parameters (e.g., actual insulin delivered, occlusion detection). While some performance metrics are mentioned (e.g., accuracy of insulin delivery, occlusion detection time), the specific "ground truth" methodology for establishing these values in testing is not detailed in the way one would describe for an AI/ML model (e.g., pathology, outcomes data).
Sample size for the training set: Not applicable. The document discusses software verification and validation testing, but it does not refer to a "training set" in the context of machine learning model development.
How ground truth for the training set was established: Not applicable.

The document primarily focuses on:

Substantial equivalence comparison to a predicate device.
Confirmation of various engineering and regulatory compliance tests (e.g., electrical safety, EMC, software V&V, cybersecurity, human factors, biocompatibility, sterility, insulin compatibility) without providing specific quantitative results for most acceptance criteria.
A brief mention of a "clinical study" for the insertion process of the cannula, stating its aim was to prove safety, robustness, and pain-freeness, but it does not provide study details (e.g., sample size, specific outcomes, or quantitative results against acceptance criteria).

Therefore, I cannot fulfill your request based on the provided text, as it describes a clearance for an insulin pump, not an AI/ML device requiring the typical performance evaluation metrics you've outlined.

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.

August 10, 2023

Roche Diabetes Care, Inc. Wolfgang Handel Regulatory Affairs Project Lead 9115 Hague Road Indianapolis, IN 46250-0457

Re: K213134

Trade/Device Name: Accu-Chek Solo micropump system with interoperable technology Regulation Number: 21 CFR 880.5730 Regulation Name: Alternate Controller Enabled Infusion Pump Regulatory Class: Class II Product Code: QFG Dated: February 10, 2023 Received: February 10, 2023

Dear Wolfgang Handel:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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) K213134

Device Name

Accu-Chek Solo micropump system with interoperable technology

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K213134 – Accu-Chek Solo micropump system with interoperable technology 510(k) Summary

Submitter Details [21 CFR 807.92(a)(1)]

Applicant Name:	Roche Diabetes Care, Inc.
Applicant Address:	9115 Hague Road Indianapolis, IN 46250-0457;United States
Applicant Contact Telephone:	+49 621 759 8331
Applicant Contact:	Mr. Wolfgang Handel
Correspondent Name	Roche Diabetes Care GmbH
Correspondent Address	9115 Hague Road Indianapolis, IN 46250-0457;United States
Correspondent Contact Telephone	+49 621 759 8331
Correspondent Contact	Mr. Wolfgang Handel
Correspondent Contact Email:	wolfgang.handel@roche.com
Applicant Contact Email	wolfgang.handel@roche.com

Device Name [21 CFR 807.92(a)(2)]

Device Trade Name: Accu-Chek Solo micropump system with interoperable technology Common Name: Infusion pump Classification Names: Alternate Controller Enabled Insulin Infusion Pump Regulation Number: 880.5725 Class II Product Code: QFG

Legally Marketed Predicate Devices [21 CFR 807.92(a)(3)]

Predicate #: K191679 Predicate Trade Name: Omnipod DASH Insulin Management System with Interoperable Technology Product Code: QFG

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Device Description Summary [21 CFR 807.92(a)(4)]

Technology Description

The Accu-Chek Solo micropump System Patch Pump's technological characteristics are the same as those of its predicate devices. Same as its predicates, Accu-Chek Solo micropump is an external, portable insulin infusion pump controlled by a connected Device. Same as predicate device Accu-Chek Solo micropump System communication is by means of radio frequency. Same as predicate devices, Accu-Chek Solo micropump System insulin dispensing patch is worn on the user's skin.

Accu-Chek Solo micropump includes the same functions as the predicate devices.

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Intended Use/Indications for Use [21 CFR 807.92(a)(5)]

Prescription Use (Part 21 CFR 801 Subpart D)

Indications for Use Comparison [21 CFR 807.92(a)(5)]

The Accu-Chek Solo Micropump described in this substantially equivalent to the predicate device.

The Accu-Chek Solo Micropump System uses the same indications for use.

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Technological Comparison [21 CFR 807.92(a)(6)]

The Accu-Chek Solo micropump System uses the same technology and modes of operation as the predicate device.

The Accu-Chek Solo micropump System is a device that is substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness. The Performance testing of the Accu-Chek Solo micropump System demonstrated that the device met all device specifications. Therefore, the device is substantially equivalent to the predicate device.

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	Accu-Chek Solo micropump system with	Omnipod DASH Insulin Management System
	interoperable technology	With Interoperable Technology
Manufacturer	Roche Diabetes Care Inc.	Insulet Corporation
K number	K213134	K191679
Code	QFG	QFG
Indications for use	The Accu-Chek Solo micropump system withinteroperable technology is intended for thesubcutaneous delivery of insulin, at set andvariable rates, for the management ofdiabetes mellitus in persons requiringinsulin. The Accu-Chek Solo micropumpsystem is able to communicate withcompatible, digitally connected devices,including automated insulin dosingsoftware, to receive, execute, and confirmcommands from these devices. The Accu-Chek Solo micropump system is intended forsingle patient, home use and requires aprescription. The Accu-Chek Solomicropump system is indicated for use inindividuals 2 years of age and greater.	The Omnipod DASH Insulin ManagementSystem (the Pump) with interoperabletechnology is intended for subcutaneousdelivery of insulin at set and variable rates forthe management of diabetes mellitus inpersons requiring insulin.The Pump is able to reliably and securelycommunicate with compatible, digitallyconnected devices, including automated insulindosing software, to receive, execute andconfirm commands from these devices.The Pump is intended for single patient, homeuse and requires a prescription. The Pump isindicated for use with NovoLog, Humalog,Admelog, or Apidra U-100 insulin.
Contraindications	The micropump system should not be usedby children under 2 years of age or bypeople who regularly require less than 0.1U/h of basal insulin or by people who havean insulin sensitivity above 1.00 U : 200mg/dL. It is the responsibility of thehealthcare professional to decide whetherthe accuracy of the delivery rate is adequatefor the patient in question. ContinuousSubcutaneous Insulin Infusion (CSII) with themicropump system is not recommended oronly recommended with limitations for thefollowing groups of people:• People who are not able or willing toeither perform at least 4 blood glucosetests per day or use a continuousglucose monitoring (CGM) systemreliably.• People who are not able to be inregular contact with their healthcareprofessional.• People who do not understand what isrequired for insulin pump therapy orwho are not able to follow theinstructions for use of the micropumpsystem.• People who cannot be relied upon dueto drug addiction, substance abuse ormental illness.	Insulin pump therapy is not intended foranyone unable or unwilling to• Unable to perform at least four (4) bloodglucose tests per day• Unable to maintain contact with theirhealthcare provider• Unable to use the Omnipod DASH™ Systemaccording to instructions
	Accu-Chek Solo micropump system with interoperable technology	Omnipod DASH Insulin Management System With Interoperable Technology
	People who are exposed to high ambient temperatures on a regular basis People with skin that does not tolerate adhesive pads. People who often experience a cannula occlusion. People who are not able to notice either visual, accoustic or vibration alarms. This includes people with a combination of hearing loss, neuropathy, vision impairment or other concomitant physical limitations.
Pump design	Single use Reservoir, cannula and pump holder and resusable pump	Single-use on-body pump with wireless controller
Skin contact /	Pump holder with adhesive and Cannula	Pod with adhesive and Cannula
Administration sets	Soft cannulaInsertion depth: 6 and 9 mm	Soft cannulaInsertion depth: 6-7 mm
Reservoir/ cartridge lifetime	Up to 96 hours (or less, depend on the insulin type) restricted by drug labeling	Up to 72 hours
Reservoir /cartridge volume (deliverable)	200 units	200 units
Communication	Bluetooth low energy	Bluetooth low energy
Insulin Type and Brands	U100 Insulin Humalog Novolog Apidra Fiasp	U100 Insulin Humalog NovoLog Apidra Fiasp (K) Admelog
Min. basal rate	0.10 U/hr	0.05 U/hr
Max. basal rate	25 U/hr	30 U/hr
Min. bolus	0.2 Units	0.05
Max. bolus	35 Units	30 Units
Button press bolus	Yes (on pump)	Yes (on PDM)
Accuracy of Insulin DeliveryBasal rate(tested per IEC 60601-2-24))	±18% or better at 0.1 U/h±5% or better at 1.0 U/h	± 5% at rates ≥ 0.05 U/hr
Accuracy of Insulin DeliveryBolus(tested per IEC 60601-2-24 & FDA special controls)	±30 % or better at 0.2 U up to < 1.0 U±5% or better for 1.0 U up to 35.0 U	±5%
Occlusion	1 IU/h 3h 29 min0.1 IU/h 26h 53 min	1 IU/h 3 h0.05 IU/h 51 h

Similarities / Differences from Candidate Device to Predicate Device

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	Accu-Chek Solo micropump system with		Omnipod DASH Insulin Management System
	interoperable technology		With Interoperable Technology
detection time Basaldelivery---averagetime to occlusiondetection
Occlusiondetection time Basaldelivery---Maximumtime to occlusiondetection	1 IU/h0.1 IU/h	7h 45 min71h	1 IU/h0.05 IU/h	5.5 h80 h
Occlusiondetection timeBolusaverage time toocclusion detection	25 IU	1 min 11 sec	5 IU	33 min
Occlusiondetection timeBolusmaximum time toocclusion detection	25 IU	5 min 16 sec	5 IU	35 min

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Non-Clinical & Clinical Testing Summary and Conclusions [21 CFR 807.92(b)]

Design verification and validation testing was performed to ensure the Accu-Chek Guide Solo diabetes manager Blood Glucose monitoring system met design specifications and requirements. Testing is summarized below:

Human Factors

Validation of the device system was performed in accordance with FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" dated February 3, 2016 and IEC 62366-1, in which safety critical tasks were identified, safeguards identified and implemented, then tested for their residual risk. The System validation demonstrated that the device is validated for its intended use.

Biocompatibility

Verification testing completed in accordance with ISO 10993 and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" dated September 4, 2020

Part 1: Evaluation and Testing Within a Risk Management Process
Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
Part 5: Tests for in vitro cytotoxicity
Part 6: Tests for local effects after implantation
Part 7: Ethylene Oxide Sterilization Residuals
Part 10: Tests for irritation and skin sensitization
Part 11: Tests for systemic toxicity
Part 17: Establishment of allowable limits for leachable substances
Part 18: Chemical Characterizations of Materials.

Sterility

The sterile parts are sterilized with Ethylenoxid. For the process the ISO 11135 was considered. The tests for the sterile barrier include the requirements of ISO 11607

Insulin Compatibility and Stability

The insulin compatibility was tested with NovoLog. Apidra, Fiasp and Humalog U-100 insulin. Therefore in vitro tests were performed which shows that the tested insulins are compatible with the Accu-Chek Solo micropump.

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Safety, Electrical Safety, Essential Performance and Electromagnetic Compatibility (EMC)

Safety, Electrical Safety, and EMC testing were conducted in accordance with

IEC 60601-1 for Basic Safety and Essential Performance
IEC 60601-1-2 for Electromagnetic Disturbances
IEC 60601-1-6 for Usability
IEC 60601-1-8 for Alarms
IEC 60601-1-11 for Systems Used in the Home Healthcare Environment.

Software

Software verification and validation testing was conducted and documentation provided in accordance with

IEC 62304

– FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005

Cybersecurity

Cybersecurity Analysis and testing was conducted and documented in accordance with – FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" dated October 2, 2014.

Interoperability

An approach was shared on how to deal with potential interoperable devices. This include how the companies work together, who is responsible for what (testing, complaints, reporting, data exchange ... . . )

The content considered the Guidance document "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices" (September 6, 2017)

Testing: In addition to the performance testing described above, mechanical testing, simulated use testing, and other device verification testing was conducted to demonstrate that the system meets its intended use and is safe, reliable, and all safety and reliability critical requirements have been adequately verified.

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Testing to Support System Reliability

Electrical Specification Testing
· Wire Drive Testing
RF Throughput Test Report
Design Visual Inspection

Testing to Support System Safety

Environmental Safety Testing to 60601-1-11
· Safety and Essential Performance Testing to 60601-1
· Pump Activation and Deactivation Testing
· Pump/Controller Connectivity Testing
Insulin Delivery Verification Testing

Clinical tests of the insertion process

The aim of the clinical study was to prove that the insertion process for the Accu-Chek Solo Cannula is safe, robust, and virtually pain-free when the cannula is inserted into the subcutaneous fat tissue by the intended user.

Conclusions

The results of bench performance and clinical performance testing demonstrate that the candidate device is substantially equivalent to the predicate device, Omnipod DASH Insulin Management System With Interoperable Technology (K191679).

The results of nonclinical and clinical performance testing demonstrate that the candidate device has a substantially equivalent safety and effectiveness profile to the predicate device and should perform as intended in the specified use conditions as well as the predicate device per required standards.

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.