twiist system

K250930 · Deka Research & Development Corp. · QFG · Apr 2, 2025 · Clinical Chemistry

Device Facts

• Record ID: K250930
• Device Name: twiist system
• Applicant: Deka Research & Development Corp.
• Product Code: QFG · Clinical Chemistry
• Decision Date: Apr 2, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The twiist system is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages 6 and above. 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 twiist system is intended for single patient, home use and requires a prescription. The bolus calculator is indicated for use for aiding the user in determining the bolus insulin dosage for management of diabetes mellitus based on consumed carbohydrates, operator entered blood glucose, insulin sensitivity, insulin to carbohydrate ratio, target glucose values, and current insulin on board.

Device Story

twiist system; alternate controller enabled infusion pump (ACE pump); delivers insulin continuously at set/variable rates for diabetes management. Modification involves updating device labeling to include additional compatible infusion sets. Fundamental scientific technology remains unchanged from predicate. Device operates via infusion pump mechanism; compatible with cleared infusion sets. Used by patients for diabetes management; prescription required.

Clinical Evidence

No clinical data; bench testing and design control activities provided to support modification.

Technological Characteristics

Microprocessor-controlled micro-dosing pump with AVS feedback. Powered by rechargeable Li-ion battery. IP28 ingress protection. Biocompatible per ISO 10993. Sterilized via Gamma radiation (ISO 11137-1). Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 60601-1-10, 60601-1-11, 60601-2-24, ISO 14971. Connectivity: Wireless communication with external devices/apps.

Indications for Use

Indicated for subcutaneous insulin delivery for diabetes mellitus management in patients ages 6 and older. Includes bolus calculator for dosage determination based on carbohydrates, blood glucose, insulin sensitivity, insulin-to-carbohydrate ratio, target glucose, and insulin-on-board.

Regulatory Classification

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.

Special Controls

Alternate controller enabled infusion pumps must comply with the following special controls:

*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 <25 percent, 25 percent to <75 percent, 75 percent to <95 percent, 95 percent to <105 percent, 105 percent to <125 percent, 125 percent to <175 percent, 175 to 250 percent, and >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.

Predicate Devices

• Deka ACE Pump System (K233952)

Submission Summary (Full Text)

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FDA

U.S. FOOD &amp; DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K250930

B Applicant

DEKA Research &amp; Development Corp.

C Proprietary and Established Names

twiist system

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QFG | Class II | 21 CFR 880.5730 - Alternate Controller Enabled Infusion Pump | CH – Clinical Chemistry |
| NDC | Class II | 21 CFR 868.1890 - Predictive pulmonary-function value calculator | CH – Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. Deka ACE Pump System, K233952.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available,

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device **has not changed**. This change was for a modification to a previously cleared device to update the device labeling to add additional infusion sets to the list of compatible infusion sets. All compatible infusion sets have been separately cleared.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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