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The DANA 3cc Syringe Insulin Reservoir is an accessory to the DANA Diabecare® Insulin Pumps. The DANA 3cc Syringe Insulin Reservoir is intended for the delivery of insulin from the DANA Diabecare® Insulin Pumps using specified insulin administration sets.

The DANA 3cc Syringe Insulin Reservoir is intended exclusively for use with the DANA Diabecare® Insulin Pumps. The DANA Diabecare® Insulin Pumps are external programmable syringe infusion pumps used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pumps are not intended for use with blood or blood products.

The DANA 3cc Syringe Insulin Reservoir is a sterile, single-use, non-pyrogenic, syringe that is designed for use with all versions of the DANA Diabcare® Insulin pump that have been cleared for marketing in the U.S. (K001604, K022317, and K063126). The syringe reservoir is a 3 ml polypropylene syringe with a 300 unit insulin capacity that is supplied with a 22 gauge, 12.7 mm straight needle. The reservoir is filled similarly to filling an insulin syringe. Once filled and inspected for entrapped air, the needle is removed and the syringe reservoir is inserted into the distal end for attachment to the linking screw that connects the syringe reservoir to the DANA Diabecare® Insulin pump. The syringe has groves cut into the distal end for attachment to the linking screw that connects the syringe reservoir to the DANA Diabecare® Insulin Pump.

The proposed DANA 3cc Syringe Insulin Reservoir is a modification of the insulin reservoir accessory described in K001604, the original 510(k) premarket notification for the DANA Diabecare® Insulin Pump. The modification was limited to a change in the gasket configuration and material. The proposed DANA 3cc Syringe Insulin Reservoir has a ring shape gasket that is manufactured from silicone.

The provided text describes a 510(k) submission for the DANA 3cc Syringe Insulin Reservoir, focusing on its substantial equivalence to predicate devices and performance testing. However, it does not explicitly detail specific, quantified acceptance criteria or a comprehensive study report with detailed methodologies and results as one might expect from a formal performance study section.

Based on the provided information, here's a breakdown of the requested elements:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantified acceptance criteria with pass/fail thresholds for specific performance metrics. Instead, it broadly states that "Design verification activities... included evaluation of physical and functional characteristics, and shelf-life testing. The results confirm that the DANA 3cc Syringe Insulin Reservoir showing to may insulin reservoir for all legally marketed versions of the DANA Diabecare® Insulin Pumps and support the claimed shelf life."

This indicates that the device met internal performance standards, but those specific standards and their numerical results are not provided in this summary. The "Comparison Chart for Determination of Substantial Equivalence" focuses on shared design features rather than performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific details on the sample sizes used for the design verification tests (physical, functional, shelf-life). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). The tests were conducted internally by Sooil Development Co., Ltd. as part of their "Design verification activities."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable and not provided in the context of this device. The "ground truth" for an insulin reservoir's performance would typically be established through engineering tests measuring physical and functional attributes against predefined specifications, rather than expert consensus on subjective assessments.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessment where discrepancies need resolution, such as in image analysis or clinical trials. Performance testing for a medical device like an insulin reservoir involves objective measurements, not human adjudication of subjective data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not relevant for this type of device. MRMC studies are used to evaluate the diagnostic performance of human readers (e.g., radiologists) in interpreting medical images, often comparing performance with and without AI assistance. This device is an insulin reservoir, not a diagnostic imaging AI.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a "standalone" performance evaluation was conducted in the sense that the device's physical and functional characteristics were tested independently. The "Design verification activities" were focused on the device itself. While the device is an accessory intended for human use with an insulin pump, the performance reported here is of the reservoir itself, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance testing would be established by predefined engineering specifications, design requirements, and recognized industry standards for insulin delivery devices and sterile medical components. For example, a "ground truth" for capacity would be 300 units as measured by calibrated equipment, or for sterility, it would be the absence of microbial growth as per validated sterilization methods.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device (an insulin reservoir), not an AI algorithm or a diagnostic tool that requires a "training set" of data in the machine learning sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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The DANA Diabecare® IIS is an external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump is not intended for use with blood or blood products.
The DANA Diabecare® IIS insulin pump is an external digitally controlled syringe pump that is intended for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. It is not intended for use with blood or blood products.

The DANA Diabecare® IIS insulin pump is a modification of the device described in K022317, the DANA Diabecare® II Insulin Pump.
The DANA Diabecare® IIS insulin pump is a digitally controlled syringe pump that provides precise insulin delivery and monitoring of device functions. The DANA Diabecare® IIS insulin pump has two insulin delivery modes, the basal infusion rate and meal bolus injections. The user can program up to 24 basal infusion dosages in one-hour increments and three bolus injections daily. The basal infusion rate can be temporarily increased or reduced to accommodate changes in activity levels.
The DANA Diabecare® IIS insulin pump is battery powered, water resistant, compact, and lightweight. The pump is equipped with safety systems, acoustic signals, and an LCD display that reads "SE" for a system error. The data that can be stored and retrieved from the DANA Diabecare® IIS insulin pump software includes the following: 100 alarms, 500 bolus doses, 500 daily insulin dosages, and 500 prime histories. The pump also has an error log.
DANA Diabecare® IIS is intended to be used with a proprietary insulin reservoir and the infusion set. The insulin reservoir is a 3mL plastic syringe with a 300-unit insulin capacity. Accessories for the device include the SUPERLINE, SUPERLINE-Easy Release, Soft-Release-R and Soft-Release-ST, which are identical to those included with the DANA Diabecare® II Insulin Pump, and consist of a 55cm/(70cm)/110cm length of tubing with a luer-lock connector on the proximal end for attachment to the insulin syringe and a 27G needle on the distal end. Additional accessories necessary for operation and maintenance of the pump, syringe, and infusion set are provided with the DANA Diabecare® IIS pump.

The provided document is a 510(k) summary for the DANA Diabecare® IIS Insulin Pump. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, or accuracy that are typically found in studies for diagnostic or AI-driven medical devices.

Instead, the "Performance Testing" section states: "Module and system verification and validation testing was performed on the modified software for the DANA Diabecare® IIS insulin pump. The verification and validation testing confirmed that all new and modified subroutines performed as designed and conformed to the software requirement specifications. The modified software is safe and effective for controlling and monitoring the operation of the DANA Diabecare® IIS insulin pump. A risk analysis was also performed in accordance with the requirements of Medical Device Directive 93/42/EEC and ISO 14971 which confirmed that the modified DANA Diabecare® IIS insulin pump is safe and effective for its intended use for the subcutaneous delivery of insulin for the treatment of diabetes mellitus."

This indicates that the "acceptance criteria" were related to software requirements and safety standards, not statistical performance metrics against a medical ground truth in the way a diagnostic AI would be evaluated. The "study" mentioned is the internal verification and validation testing and risk analysis, which confirmed compliance with these engineering and regulatory standards.

Therefore, many of the requested elements for a deep learning/AI device evaluation cannot be extracted from this document because it describes an insulin pump, not an AI or diagnostic tool.

Here's a breakdown of the information that can be extracted and an explanation for why other requested information is not present:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided: This device is an insulin pump, not a diagnostic AI system that uses patient data for a "test set" in the common AI sense. The "verification and validation testing" would have involved internal software testing and hardware testing, not a clinical study on a patient test set in the same way.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable / Not Provided: Ground truth in the context of an insulin pump's software validation would relate to whether the code executed correctly and met specifications, not to clinical diagnoses requiring expert medical review.

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

• Not Applicable / Not Provided: As above, this concept does not apply to the software verification and validation of an insulin pump.

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

• No: This is not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.

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

• Not Applicable / Not Provided: The device is an insulin pump; its function is to deliver insulin, not to provide an algorithm-only diagnostic output. Its performance is inherent in its operation, which is always with a human user in the loop providing inputs and monitoring. The "algorithm" here refers to the pump's control software, not a diagnostic AI.

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

• Software Requirements Specifications / Engineering Standards: The "ground truth" for the performance testing of the pump's software would have been the predefined requirements and specifications outlined during its development, as well as relevant safety and performance standards (e.g., ISO 14971, Medical Device Directive 93/42/EEC).

8. The sample size for the training set

• Not Applicable / Not Provided: This device is not an AI system that undergoes "training" on a data set. Its software is programmed and validated.

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

• Not Applicable / Not Provided: As above, the concept of a training set and its ground truth does not apply to this type of device.

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The DANA Diabecare® II external programmable syringe infusion pump and the SUPERLINE-EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets are indicated for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump and administration sets are not intended for use with blood or blood products.

The DANA Diabecare® II insulin pump, SUPERLINE-EasyRelease (EasyRelease) Infusion Set, and Soft-Release Infusion Sets are modifications of the DANA Diabecare® insulin pump and SUPERLINE infusion set that were described in K001604, the 510(k) premarket notification for the DANA Diabecare® insulin infusion pump. The modifications made to the parent DANA Diabecare® insulin pump to produce the modified DANA Diabecare® II Insulin Pump were limited to software modifications including changes to the basal and bolus insulin delivery modes. features accessed via the password-protected (lock-out) mode, and the addition of alarms, a fail-safe function, and the ability to store and retrieve information (alarm, bolus dose, daily insulin dose). The overall design of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets is identical to the design of the parent SUPERLINE Infusion Set. The design modifications are limited to the following: - Addition of a site for disconnecting the insulin pump from the infusion set . without removing the needle from the abdomen - Replacement of the infusion needle with an indwelling soft cannula (Soft-. Release-R and Soft-Release-ST only) The two versions of the Soft-Release Infusion Sets differ in the design of the detachment site and cannula assembly. The Soft-Release-R Infusion Set has a sliding lock detachment site and a "rectangular" cannula oriented perpendicular to the infusion tubing axis. The Soft-Release-ST has a turning screw lock detachment site that uses a conical fitting and a straight cannula oriented parallel to the infusion tubing axis. There are minor differences in the materials used for the construction of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets as compared to the parent SUPERLINE.

Here's an analysis of the provided text regarding the DANA Diabecare® II Insulin Pump and SUPERLINE Infusion Sets, focusing on acceptance criteria and supporting studies:

It's important to note that the provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full, detailed study report with extensive acceptance criteria and performance statistics like a PMA. Therefore, some of the requested information (especially quantitative data, training set details, or complex study designs like MRMC) is not explicitly present or as detailed as one might expect in a scientific publication.

Acceptance Criteria and Reported Device Performance

The document describes several performance tests and their outcomes, which serve as the acceptance criteria for ensuring the modifications made to the device still meet safety and effectiveness standards.

Additional Information on the Study (if available)

1. Sample size used for the test set and the data provenance:

   • The document does not explicitly state the sample sizes for the burst, bioburden, insulin potency, or shelf-life testing. These would typically be determined by statistical methods or regulatory guidance for such tests.
   • The data provenance (e.g., country of origin, retrospective/prospective) is not specified. Given the manufacturer is from Korea, it's likely the testing was performed there or by a contract lab; however, this is not confirmed in the text. This is a design verification activity, not a clinical trial.

2. 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 the described performance testing. The "ground truth" for burst, bioburden, and insulin stability tests is typically established through objective measurements against defined chemical, physical, and microbiological standards, not relying on expert interpretation in the same way as, for example, image interpretation in a diagnostic device.

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

   • This question is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, where there might be disagreement. These are objective engineering and laboratory tests.

4. 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 is not applicable as this device is an insulin pump and infusion set, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or would be relevant.

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

   • Not applicable as this is a medical device (pump and infusion sets), not a standalone algorithm or AI. While the pump has software with algorithms, the "standalone" performance here relates to the device's functional integrity (e.g., accurate insulin delivery, absence of leaks), not an AI's interpretative power.

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

   • For the described tests:
     • Biocompatibility: Ground truth is established by adherence to ISO 10993-1 standards and validated laboratory test results (e.g., cytotoxicity assays, sensitization tests).
     • Burst Testing: Ground truth is the physical presence or absence of leakage under specified pressure.
     • Bioburden Testing: Ground truth is the microbiological count meeting sterility assurance levels.
     • Insulin Potency Assay: Ground truth is the measured concentration/activity of insulin remaining relative to a control or baseline, determined by validated chemical assays.
     • Shelf-Life Testing: Ground truth is the maintenance of all specified performance criteria (e.g., sterility, dimensional stability, material integrity, functional operation) over the stated period.
   • These are all objective, laboratory-based measurements against established scientific and regulatory standards.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning model, so there is no "training set." The development of the device involves engineering design, material selection, and verification testing.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

In summary: The provided 510(k) summary focuses on demonstrating the safety and effectiveness of the physical device modifications through performance testing against established engineering and regulatory standards (e.g., biocompatibility, physical integrity, stability). It does not involve AI or diagnostic interpretations, thus many of the questions related to AI/algorithmic performance, human readers, and ground truth in that context are not relevant to this submission.

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