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 Description

The twiist system described herein contains a modification of the labeling of the previously cleared DEKA ACE Pump System (K233952) to add the ConvaTec contact™ detach 23" subcutaneous infusion set and the ConvaTec inset™ 23" and 32" subcutaneous infusions sets as compatible for use with the twiist system.

The twiist system is a wearable alternate controller enabled (ACE) insulin infusion pump intended to subcutaneously deliver 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 to receive, confirm, and execute commands. The pump is intended for single patient, ambulatory use and requires a prescription. The twiist system is intended for the management of diabetes mellitus in persons six years of age and greater.

The twiist system, consistent with the predicate K233952, consists of the following durable and disposable components:

Pump: A durable pump that incorporates fluid delivery algorithms and interfaces to a cassette, external wireless user interface, and iCGM. The pump is powered by a rechargeable lithium ion battery.
Cassette: A single-use pumping cassette that combines microfluidic valves, a pump chamber, insulin reservoir, and Acoustic Volume Sensing (AVS) measurement chamber. The cassette interfaces to a pump and off-the-shelf infusion sets.
Sequel twiist App: An iOS mobile application that serves as the primary user interface for the system. The twiist app can be downloaded onto the user's personal iPhone.

AI/ML Overview

The provided FDA Clearance Letter, specifically the 510(k) Summary, details the technical characteristics and testing for the "twiist system" and its substantial equivalence to the "DEKA ACE Pump System" (K233952).

This submission (K250930) is a Special 510(k), meaning it focuses on a modification rather than a completely new device. The primary modification here is the addition of compatibility with new infusion sets (ConvaTec contact™ detach 23" and ConvaTec inset™ 23" and 32") to an already cleared device. This type of submission relies heavily on demonstrating that the performance with the new components is equivalent to the established performance of the predicate device under the original clearance.

Therefore, the study described here is primarily focused on bench testing to demonstrate compatibility and similar performance with the new infusion sets, using established methodologies and acceptance criteria from the previous clearance (K233952).

Here's the breakdown of the acceptance criteria and the study as described in the provided document:

Acceptance Criteria and Device Performance for the twiist system (K250930)

This 510(k) submission for the twiist system (K250930) is a Special 510(k), specifically addressing the addition of new compatible infusion sets. As such, the acceptance criteria and reported performance for key functional aspects of the pump itself (e.g., basal and bolus accuracy, occlusion detection) are identical to those established and validated for the predicate device, DEKA ACE Pump System (K233952). The study conducted for K250930 primarily focused on demonstrating that these established performance characteristics are maintained when using the newly added infusion sets.

1. Table of Acceptance Criteria and Reported Device Performance

Since the core pump performance characteristics are "Unchanged from K233952" and "Same" as the predicate device, the acceptance criteria and reported performance values listed in the "Technological Characteristic Comparison" table reflect the established performance of the twiist system (and its predicate) for various parameters. The specific study for K250930 demonstrated that the device continues to meet these previously set criteria with the new infusion sets.

Characteristic	Acceptance Criteria (from K233952)	Reported Device Performance (with new infusion sets, as per K250930)
Insulin Basal Rate Delivery Range	0 units/hour - 30 units/hour	0 units/hour - 30 units/hour (Same as predicate)
Insulin Bolus Delivery Range	Programmable from 0.05 - 25.00 Units in 0.01 Unit increments.	Programmable from 0.05 - 25.00 Units in 0.01 Unit increments (Same as predicate)
Basal Accuracy	Unchanged from K233952 (Specific criteria not detailed in this summary, but implied met)	Unchanged from K233952 (Specific performance not detailed, but implied met through testing with new sets)
Bolus Accuracy	Unchanged from K233952 (Specific criteria not detailed in this summary, but implied met)	Unchanged from K233952 (Specific performance not detailed, but implied met through testing with new sets)
Bolus Volume after Occlusion Release	No more than 0.74 units.	No more than 0.74 units. (Same as predicate)
Time to occlusion alarm	10 min (Bolus); 3 hours (Basal, 1 U/h); 6 hours (Basal, 0.1 U/hr)	10 min (Bolus); 3 hours (Basal, 1 U/h); 6 hours (Basal, 0.1 U/hr) (Same as predicate)

The supporting language states: "Performance testing with the added ConvaTec infusion sets demonstrates that subject device performance is equivalent to the predicate device. The methods and acceptance criteria used in this testing are well established in the previous clearance (K233952)."

Study Details for K250930

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

The document states: "Bench performance testing was conducted to qualify the additional infusion sets for use with the subject device, and to establish substantial equivalence to the predicate device in terms of safety and effectiveness."

Test Set Sample Size: The exact sample size (number of devices, number of tests run per device/infusion set combination) for the bench testing is not specified in this 510(k) summary. However, it's implied that sufficient testing was performed to "demonstrate" performance equivalence.
Data Provenance: The data is from bench testing, which typically occurs in a controlled laboratory environment. The country of origin of the data is not explicitly stated, but given DEKA Research & Development Corp. is based in Manchester, New Hampshire, USA, it's highly probable the testing was conducted in the USA. The data is prospective in the sense that it was generated specifically for this 510(k) submission to qualify the new infusion sets.

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

This question is not applicable to this type of device and study. The ground truth for infusion pumps involves precise physical measurements of fluid delivery, rather than subjective expert interpretations (like in radiology). The "ground truth" for the test set is established by calibrated laboratory equipment and measurement techniques compliant with relevant standards (e.g., ISO 13485:2016).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where subjective human interpretation (e.g., image reading) requires consensus building. For bench testing of an infusion pump, the measurements are objective.

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

This question is not applicable. MRMC studies are specific to diagnostic devices (often AI-powered) that assist human interpretation of medical images or data. The twiist system is an insulin infusion pump, a therapeutic device, not a diagnostic one.

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

Yes, in a sense. The "pump" itself (the microprocessor-controlled mechanism with AVS feedback) delivers insulin "standalone" based on its algorithms. The bench testing performed to verify its accuracy and safety with the new infusion sets is a form of standalone performance evaluation in a controlled environment, demonstrating the device's inherent functional capabilities without human intervention during the actual delivery process.

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

The ground truth used for this device's performance testing (and for the predicate) is objective physical measurement based on highly accurate and calibrated laboratory equipment designed for fluid delivery assessment. This would involve measuring the actual volume of insulin delivered, flow rates, pressure changes, and time to alarm, compared to the programmed parameters.

8. The sample size for the training set

This question is not applicable. Infusion pumps like the twiist system are engineered medical devices that operate based on deterministic algorithms and physical principles, not machine learning or AI models that require "training sets" in the typical sense.

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

This question is not applicable for the same reason as #8. The device's "behavior" is designed and verified rather than "learned" from a training set.

Summary

U.S. Food & Drug Administration FDA Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov

April 2, 2025

DEKA Research & Development Corp.
William Calhoun
Regulatory Affairs Project Manager
340 Commercial Street
Manchester, New Hampshire 03101

Re: K250930
Trade/Device Name: twiist system
Regulation Number: 21 CFR 880.5730
Regulation Name: Alternate Controller Enabled Infusion Pump
Regulatory Class: Class II
Product Code: QFG, NDC
Dated: March 27, 2025
Received: March 28, 2025

Dear William Calhoun:

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"

Page 2

K250930 - William Calhoun Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

Page 3

K250930 - William Calhoun Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,

Paula V. Caposino -S

Paula Caposino, Ph.D.
Deputy Division Director
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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K250930

Device Name: twiist system

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

510(k) Summary for K250930

twiist system Page 1 of 6

This 510(k) Summary of Safety and Effectiveness information is prepared in accordance with the requirements of 21 CFR Part 807.92.

Submitter Information

510(k) Sponsor: DEKA Research & Development
340 Commercial Street
Manchester, NH 03101

Contact Person(s): Paul Smolenski (primary), William Calhoun (alternate)
Regulatory Affairs
Phone: (603) 669-5139
Fax: (603) 624-0573
psmolenski@dekaresearch.com, wcalhoun@dekaresearch.com

Date Prepared: April 1, 2025

Proposed Device(s)

Trade/Proprietary Name: twiist system
Classification Name: Alternate Controller Enabled Insulin Infusion Pump
Device Classification: 880.5730
Product Code: QFG
Class: II
Device Panel: Clinical Chemistry

Predicate Device

The predicate device is the DEKA ACE Pump System, cleared under premarket notification K233952 on March 13, 2024.

The predicate device has not been subject to a design-related recall.

Device Description

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twiist system Page 2 of 6
510(k) Summary

The twiist system was previously cleared and indicated for use with other FDA-cleared subcutaneous infusion sets. This Special 510(k) utilizes the same test methodology and acceptance criteria used in its previous clearance to demonstrate compatibility with the additional infusion sets described in this submission. No changes to the hardware or software of the system from that of the predicate are necessary to add the ConvaTec contact detach and ConvaTec inset infusion set compatibility claims.

The twiist system, consistent with the predicate K233952, consists of the following durable and disposable components:

Pump: A durable pump that incorporates fluid delivery algorithms and interfaces to a cassette, external wireless user interface, and iCGM. The pump is powered by a rechargeable lithium ion battery.
Cassette: A single-use pumping cassette that combines microfluidic valves, a pump chamber, insulin reservoir, and Acoustic Volume Sensing (AVS) measurement chamber. The cassette interfaces to a pump and off-the-shelf infusion sets.
Sequel twiist App: An iOS mobile application that serves as the primary user interface for the system. The twiist app can be downloaded onto the user's personal iPhone.

Indications for Use

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twiist system Page 3 of 6
510(k) Summary

Substantial Equivalence Discussion

Intended Use Comparison

The tables below includes a matrix of the intended use between the subject device and the predicate device.

Characteristic	Predicate Device (K233952)	Subject Device	Substantial Equivalence
Device Classification Regulation and Product Code	Class II Alternate controller enabled insulin infusion pump 21 CFR 880.5730 Product Code: QFG	Class II Alternate controller enabled insulin infusion pump 21 CFR 880.5730 Product Code: QFG	No change
Indications for Use	The DEKA ACE Pump 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 pump 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.	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 name updated. No other changes to indications for use.
Prescription Use	Yes	Yes	No Change
Intended Population	Persons with Diabetes Mellitus ages 6 and above	Persons with Diabetes Mellitus ages 6 and above	No Change
Environment of Use	In professional healthcare facilities and home healthcare environments	In professional healthcare facilities and home healthcare environments	No Change

The intended use and indications for use remain unchanged in the subject device with respect to the predicate device (K233952).

Technological Characteristic Comparison

The table below compares the technological characteristics of the subject device with those of the predicate device.

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twiist system Page 4 of 6
510(k) Summary

Characteristic	Predicate Device (K233952)	Subject Device	Equivalence
Delivery Method	Microprocessor controlled Micro- dosing pump mechanism supplemented with acoustic volume sensor (AVS) feedback for monitoring delivery accuracy.	Microprocessor controlled Micro- dosing pump mechanism supplemented with acoustic volume sensor (AVS) feedback for monitoring delivery accuracy.	Same
Insulin Basal Rate Delivery Range	0 units/hour - 30 units/hour	0 units/hour - 30 units/hour	Same
Insulin Bolus Delivery Range	Programmable from 0.05 - 25.00 Units in 0.01 Unit increments.	Programmable from 0.05 - 25.00 Units in 0.01 Unit increments.	Same
Basal Accuracy	Unchanged from K233952	Unchanged from K233952	Same
Bolus Accuracy	Unchanged from K233952	Unchanged from K233952	Same
Bolus Volume after Occlusion Release	No more than 0.74 units.	No more than 0.74 units.	Same
Time to occlusion alarm	10 min (Bolus); 3 hours (Basal, 1 U/h); 6 hours (Basal, 0.1 U/hr)	10 min (Bolus); 3 hours (Basal, 1 U/h); 6 hours (Basal, 0.1 U/hr)	Same
Material Biocompatibility	Compliant with ISO-10993	Compliant with ISO-10993	Same
Cartridge/Cassette Shelf Life	1 year	1 year	Same
Ingress Protection	IP28, indicating protection from continuous immersion in water. The pump can tolerate immersion to depths of up to 12 feet (3.7 m) for 1 hour.	IP28, indicating protection from continuous immersion in water. The pump can tolerate immersion to depths of up to 12 feet (3.7 m) for 1 hour.	Same
Applicable Safety Standards	• IEC 60601-1• IEC 60601-1-2• IEC 60601-1-6• IEC 60601-1-8• IEC 60601-1-10• IEC 60601-1-11• IEC 60601-2-24• ISO 11137-1 (Sterilized via Gamma Radiation)• ISO 14971	• IEC 60601-1• IEC 60601-1-2• IEC 60601-1-6• IEC 60601-1-8• IEC 60601-1-10• IEC 60601-1-11• IEC 60601-2-24• ISO 11137-1 (Sterilized via Gamma Radiation)• ISO 14971	Same
Power Source	Rechargeable Lithium Ion Battery	Rechargeable Lithium Ion Battery	Same
Pump Storage Conditions	Temperatures of -25 °C (-13 °F) to 70 °C (158 °F) Non-condensing humidity 15% to 90%	Temperatures of -25 °C (-13 °F) to 70 °C (158 °F) Non-condensing humidity 15% to 90%	Same
Operating Conditions	Temperatures of 5 °C (41 °F) to 40 °C (104 °F) Non-condensing humidity of 15% to 90%	Temperatures of 5 °C (41 °F) to 40 °C (104 °F) Non-condensing humidity of 15% to 90%	Same
System User Feedback	Visual, audible, and vibratory	Visual, audio, and vibratory	Same

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twiist system Page 5 of 6
510(k) Summary

Characteristic	Predicate Device (K233952)	Subject Device	Equivalence
Battery Operating Time	72 hours	72 hours	Same
Compatible Insulins	Humalog U-100Novolog U-100	Humalog U-100Novolog U-100	Same
Infusion Set	• Medtronic MiniMed Quick-set Infusion Set: ○ 43 inch MMT-390 ○ 42 inch MMT-391 ○ 23 inch MMT-392 ○ 23 inch MMT-393• Medtronic MiniMed Silhouette Infusion Set: ○ 23 inch MMT-373• Unomedical Comfort™: ○ 23 inch• Smiths Medical Cleo 90 Infusion Set: ○ 24 inch 21-7220-24 ○ 31 inch 21-7221-24 ○ 42 inch 21-7222-24 ○ 24 inch 21-7230-24 ○ 31 inch 21-7231-24 ○ 42 inch 21-7232-24	• Medtronic MiniMed Quick-set Infusion Set: ○ 43 inch MMT-390 ○ 42 inch MMT-391 ○ 23 inch MMT-392 ○ 23 inch MMT-393• Medtronic MiniMed Silhouette Infusion Set: ○ 23 inch MMT-373• Unomedical Comfort™: ○ 23 inch• Smiths Medical Cleo 90 Infusion Set: ○ 24 inch 21-7220-24 ○ 31 inch 21-7221-24 ○ 42 inch 21-7222-24 ○ 24 inch 21-7230-24 ○ 31 inch 21-7231-24 ○ 42 inch 21-7232-24• ConvaTec contact detach Infusion Set: ○ 23 inch (FG000016-03)• ConvaTec inset Infusion Set: ○ 23 inch (FG000016-01) ○ 32 inch (FG000016-05)	EquivalentThe subject device has additional compatible infusion sets. The ConvaTec contact detach and inset infusion sets have similar physical characteristics to the other infusion sets currently included on the device label. Performance testing with the added ConvaTec infusion sets demonstrates that subject device performance is equivalent to the predicate device. The methods and acceptance criteria used in this testing are well established in the previous clearance (K233952).

Animal, Clinical, and Bench Data

Bench performance testing was conducted to qualify the additional infusion sets for use with the subject device, and to establish substantial equivalence to the predicate device in terms of safety and effectiveness.

No animal or clinical data were obtained in support of this premarket submission.

Design Control

The twiist system was specified and developed by DEKA. DEKA complies with the FDA Quality System Regulation as specified in 21 CFR 820, as well as to ISO 13485:2016.

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twiist system Page 6 of 6
510(k) Summary

Conclusion

The differences between the predicate and the subject device do not raise different questions of safety or effectiveness. The twiist system is substantially equivalent to the predicate DEKA ACE Pump System, cleared under premarket notification K233952.

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.