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The Symphony System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood.

The Symphony Pump is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

The Symphony Meter Remote is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood, and as a wireless (RF) remote control to deliver insulin from the Symphony Pump. The Symphony Meter Remote is intended for use for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The Symphony Meter Remote is specifically indicated for use on the finger, forearm or palm. It should not be used for the diagnosis of diabetes or testing of newborns.

The Symphony System combines the use of an insulin pump and a blood glucose meter for the treatment of insulin requiring diabetes. The insulin pump, Symphony Pump, operates as a stand alone device to deliver insulin through an infusion set placed subcutaneously. The blood glucose meter, Symphony Meter Remote, operates as a stand alone device to measure blood glucose concentrations. When paired through radio frequency (RF) communication the Symphony Meter Remote can be used to control bolus insulin delivery, review the status of the Symphony Pump and view and confirm selected pump alerts and warnings.

The provided 510(k) summary for the Symphony Glucose Management System states that "Performance evaluations, both bench and clinical, of the Symphony System were completed and did not raise any new issues of safety and efficacy." However, it does not include specific acceptance criteria or detailed results of these performance evaluations. Therefore, I cannot extract the information requested for a table of acceptance criteria and reported device performance directly from this document.

Similarly, since the detailed study results are not present, I cannot provide details on sample sizes, ground truth establishment for test and training sets, expert qualifications, adjudication methods, or MRMC study results.

This document focuses on establishing substantial equivalence to predicate devices based on device description, intended use, and a general statement about concluded performance evaluations, rather than providing the detailed technical and clinical study report.

In summary, the requested information regarding acceptance criteria and detailed study results is not present in the provided 510(k) summary.

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The Animas ezManager® MAX Diabetes Management Software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. The software supports diabetes management by the patient and/or healthcare professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.

The Animas ezManager MAX Diabetes Management Software, installed onto a patient's or healthcare professional's personal computer, allows downloading of information to and from Animas insulin pumps and specified commercially available blood glucose meters. The software displays downloaded historical data stored in the pump and blood glucose meter such as basal/bolus deliveries and blood glucose measurements. The data can be displayed in reports and logs to facilitate trending and diabetes management.

The provided text describes the Animas ezManager® MAX Diabetes Management Software, its intended use, and substantial equivalence to a predicate device. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, the study design, sample sizes, expert qualifications, or ground truth establishment.

Here's a breakdown of what is and is not available in the provided text, in relation to your request:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document states the device "met software verification and validation test parameters, and label comprehension study requirements" but does not specify what those parameters or requirements were, nor the numerical performance results against them.
• Sample size used for the test set and the data provenance: No details are provided about the size of the test set for verification/validation, nor the origin of any data used.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or ground truth establishment for testing.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "software verification and validation test parameters" would likely involve standalone testing, but no details are provided.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
• The sample size for the training set: As this is software that processes existing data, there isn't a "training set" in the machine learning sense. The software processes data from insulin pumps and blood glucose meters.
• How the ground truth for the training set was established: Not applicable in the machine learning sense for this device. The "ground truth" for this device is the accurate representation and calculation of the data it receives from the connected medical devices.

Information that is available (or can be inferred from) the provided text:

• 1. Acceptance Criteria (Indirectly discussed via testing):

  • Acceptance Criteria (Implied): The Animas ezManager MAX must meet "software verification and validation test parameters" and "label comprehension study requirements."
  • Reported Device Performance: "Results of all testing provide reasonable assurance of safety and effectiveness for its intended use." (No specific metrics or quantitative results are provided).

• 6. If a standalone was done: Yes, non-clinical testing including "software verification and validation test parameters" was performed, which implies standalone performance evaluation of the software itself. The letter states, "The Animas ezManager MAX met software verification and validation test parameters, and label comprehension study requirements to assure the device performs as intended."

• 7. The type of ground truth used: For a device like this, which processes and displays data from other medical devices, the "ground truth" implicitly refers to the accuracy and integrity of the data received from the Animas insulin pumps and specified commercially available blood glucose meters, and the correctness of the software's processing, analysis, and display of that data. The software's function is to accurately reflect external data.

Summary based on the provided text:

The document states that the Animas ezManager MAX Diabetes Management Software underwent "software verification and validation test parameters, and label comprehension study requirements" and that "Results of all testing provide reasonable assurance of safety and effectiveness for its intended use." However, it does not provide detailed acceptance criteria, specific performance metrics, sample sizes, or specifics on how ground truth was established beyond the general statement of validation. It is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results in the way one might expect for a novel therapeutic or diagnostic device requiring extensive efficacy studies.

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The Animas ezManager Plus diabetes management software is indicated for use as an accessory to Animas insulin pumps and specified commercially available blood glucose meters. The software supports diabetes management by the patient and/or health care professional by allowing for the review, analysis and evaluation of insulin delivery and blood glucose history information.

The Animas ezManager Plus will also allow download of information from Animas pumps and commercially available blood glucose meters to a hand-held electronic device for display of the information.

The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on health care professional prescribed settings and user entered data.

The Animas ezManager Plus diabetes management system is software that is loaded onto a patient's or health care professional's personal computer to allow for downloading information from Animas insulin pumps and specified commercially available blood glucose meters. The system allows for users to view data stored in the pump and meter history such as basal deliveries, bolus deliveries and blood glucose measurements. The data can be displayed in numerous formats and configurations to facilitate trending and better diabetes management.

The Animas ezManager Plus diabetes management system also allows for Animas pump users to upload personal setting information to their pump. Personal setting information includes basal programs and rates, insulin to carbohydrate ratios, insulin sensitivity factors, target blood glucose ranges, and when available pump food database information (food, serving size and carbohydrate information). This feature allows users the convenience of programming and saving all of this information on their personal computers. Once the information is uploaded to the pump, the user is prompted to verify the active basal program before initiating therapy.

For Animas pumps the download and upload is completed using an IR dongle and the IR window on the back of the pump. For the specified meters, the download is accomplished by using the manufacturer specified connection cables.

The provided text is related to a 510(k) submission for the "Animas ezManager Plus Diabetes Management Software". It describes the device, its intended use, and the FDA's decision regarding its substantial equivalence to predicate devices. However, the document does not contain specific details about acceptance criteria, the study design, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices rather than providing detailed performance study results against predefined acceptance criteria for a new, groundbreaking technology. This type of submission often relies on a comparison of features, intended use, and historical safety/efficacy of predicate devices.

Therefore, I cannot populate the requested table and answer many of the questions from the provided text.

Here's what I can extract and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document does not define specific performance metrics (e.g., accuracy of insulin dose calculation, data transfer integrity rates) or corresponding acceptance thresholds for these metrics. It is a 510(k) summary, which generally focuses on demonstrating substantial equivalence.

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. (The document does not describe a clinical or lab study that would generate this data).

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

• Number of Experts: Not applicable, as no ground truth establishment for a test set is described.
• Qualifications of Experts: Not applicable.

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

• Not applicable, as no test set requiring adjudication is described.

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:

• MRMC Study: Not applicable. The device is a diabetes management software, not an AI-assisted diagnostic imaging tool that would typically involve human readers interpreting cases.
• Effect Size: Not applicable.

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

• Standalone Performance Study: Not described. The software's function is to manage data and calculate doses based on user-entered data and professional settings; it's inherently a human-in-the-loop system where the user interacts with the generated information.

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

• Not applicable, as no ground truth for a performance study is described. The "ground truth" in the context of this device would likely refer to the accuracy of data transfer from pumps/meters and the correctness of insulin/carbohydrate dose calculations based on specified algorithms and user inputs. However, no study demonstrating this is provided.

8. The sample size for the training set:

• Not applicable, as the document does not describe a machine learning model that would require a training set. This is a software system for data management and calculation, not an AI/ML diagnostic or predictive model.

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

• Not applicable.

Summary of what is available from the document:
The document primarily provides descriptive information about the device, its intended use, and the regulatory pathway. It identifies the device as an insulin infusion pump accessory (software) that allows for:

• Downloading data from Animas insulin pumps and blood glucose meters.
• Viewing data in various formats.
• Uploading personal settings (basal programs, ratios, etc.) to Animas pumps.
• Calculating insulin or carbohydrate doses based on prescribed settings and user input.

The document states that the predicate devices were:

• Animas ezManager Plus, K022394
• Deltec, CoZmanager, K062323

The FDA determined the device to be substantially equivalent to these predicate devices for its stated indications for use. This regulatory conclusion is the primary outcome of the 510(k) submission described.

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The Animas Model IR1250 Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients.

The Animas Model IR1250 Insulin Infusion Pump is an external syringe pump and delivery system that provides subcutaneous delivery of insulin for patients with diabetes mellitus who would benefit from a continuous insulin infusion process. The Model IR1250 is used with any insulin infusion set which incorporates a luer style connection. The pump incorporates serial communications via an infrared (IR) interface with accessories which include the Animas IR to RS-232 serial interface adaptor (the "dongle"), the Animas IR1200 cradle to hold the pump and the Animas ezManager Plus software for the user's personal computer. As with the IR1200, this connection allows the user and/or the physician to transfer (download) data stored in the pump to the personal computer where it may be displayed, printed and saved. With the IR1250 this same connection will allow the user to program the pump, via the PC with ezManager Plus software, with selected user pump settings (basal program, bolus limits, etc.) and non-operational, personalized information including user selection of names for basal settings and musical tunes for initial alert/reminder warnings prior to the present pump alert/warning sounds. Also available to the user is the option to use a PC with ezManager Plus software, to upload and/or modify selected food items and related carbohydrate information, for storage in, and reference/use directly from, pump memory. The pump is intended for multiple years of use. To hold the insulin for subcutaneous delivery, Animas provides sterile, single use, disposable insulin cartridges for use specifically with the IR1200 series pumps. As with the IR1200, the IR1250 will deliver a prescribed dosage of insulin as a single programmable bolus or at multiple programmable basal rates. The system will also provide set up information, dosage history, alarms, error and warning messages, device status, and self test capabilities.

This document is a 510(k) summary for the Animas Model IR1250 Insulin Infusion Pump and does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document focuses on:

• Device Description: The Animas Model IR1250 is an external syringe pump for subcutaneous insulin delivery.
• Predicate Device: Animas Model IR1200 Insulin Infusion Pump.
• Modifications: Increased storage capability and minor software modifications allowing PC programming and storage of food/carbohydrate information.
• Intended Use: Same as the predicate device – programmable basal and bolus insulin delivery for diabetes management.
• Comparison of Technological Features: The modified device and predicate are identical in design, materials, and construction. The changes are minor and do not affect safety or effectiveness.
• FDA Determination: Substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving their fulfillment as it is not present in the provided text. The document is primarily a regulatory submission establishing substantial equivalence to a predicate device, rather than a performance study report.

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The Animas Model IR 1200 Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients. This device is intended for home use and is a prescription device.

The Animas Model IR 1200 Insulin Infusion Pump is an external syringe pump and delivery system that provides subcutaneous delivery of insulin for patients with diabetes mellitus who would benefit from a continuous insulin infusion process. The Model IR 1200 is used with an infusion set, e.g., the Animas ezSet™ The pump incorporates serial communications via an infrared (IR) interface. The user may download records from the pump for Daily Totals, Alarm History, Bolus History, as well as Basal Rate programs and Pump Settings. The pump is intended for multiple years of use and the insulin syringe is a sterile, single use disposable manufactured for Animas. The system will deliver a prescribed dosage of insulin as a single programmable bolus or at multiple programmable basal rates. The system will also provide set up information, dosage history, alarms, error and warning messages, device status, and self test capabilities.

The provided text is a 510(k) summary for the Animas Model IR 1200 Insulin Infusion Pump. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training set was established.

The document primarily focuses on establishing substantial equivalence based on design, materials, and construction, rather than detailed performance study results against specific criteria. The statement in Section 1 "The differences between the new device and the predicate device do not affect the safety or effectiveness of the device" is a high-level assertion but not supported by detailed study data in this document.

Therefore, I cannot fulfill your request for this specific information based on the provided input. The document does not contain the necessary details to construct the requested table and answer the study-related questions.

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The Animas ezManager Plus is indicated for use as an accessory to the Animas IR1000 insulin pump and a number of commercially available blood glucose meters to download data from these devices to a patient's or a physician's personal computer where it may be displayed, printed, and saved. The Animas ezManager Plus is also indicated for the management of diabetes by calculating an insulin or carbohydrate dose based on physician prescribed settings and user entered data.

The Animas ezManager Plus diabetes management software is intended for a Microsoft Windows based personal computer or a Palm handheld organizer. The ezManager Plus allows the user to download, view, print, and save data from a number of commercially available glucose meters and the Animas IR1000 Insulin Infusion Pump. It also calculates an insulin or carbohydrate dosage based physician prescribed settings and data entered by the user. This software was developed using a Borland Delphi integrated development environment using an MS Access database structure and ActiveX Data Objects database connections. The synchronization dynamic library is totally compliant with the Palm Operating System (OS) Conduit requirement and was developed using Microsoft Visual C++ and the Palm OS Software Development Kit.

The provided text is a 510(k) summary for the Animas ezManager Plus, an insulin pump and glucose meter management software. It describes the device, its intended use, and its comparison to predicate devices, ultimately leading to a finding of substantial equivalence by the FDA. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document focuses on regulatory approval based on substantial equivalence to existing devices, rather than detailed performance study results.

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The Animas ezSerter™ Infusion Set Inserter is intended to aid in the insertion of the Animas ezSet™ infusion sets. This device is intended for home use and is a prescription device.

The Animas ezSerter™ Infusion Set Inserter is a simple device for automatically inserting the cannula of the Animas ezSef™ angled infusion sets subcutaneously. The inserter is composed of several molded plastic pieces and stainless steel springs. An elongated molded plastic housing acts as a handle and a quide for an internally mounted spring-loaded carrier. An opening in the proximal end of the carrier accepts and retains the handle of the introducer needle hub.

This document, K021700, is a 510(k) summary for the Animas ezSerter™ Infusion Set Inserter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert-read ground truth.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert qualifications, and ground truth establishment is not available in this document.

The 510(k) summary describes:

• Device Name: Animas ezSerter™ Infusion Set Inserter
• Intended Use: To aid in the insertion of Animas ezSet™ infusion sets.
• Predicate Device: MiniMed Sil-Serter™ Infusion Set Insertion System
• Comparison of Technical Features: Both are spring-loaded devices where the user loads the infusion set, compresses a spring, and activates the device. The 510(k) states that "The differences between the new device and the predicate devices do not affect the safety or effectiveness of the device." This statement implies that the device's performance is considered to be on par with the predicate, but specific performance data or acceptance criteria are not detailed in this summary.

In summary, this document is a regulatory submission for substantial equivalence and does not contain the kind of detailed performance study results, acceptance criteria, or ground truth methodology typically found in clinical validation reports for AI/diagnostic devices.

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The Animas Model R1000 IR Insulin Infusion Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients. The accessories to the Model R1000 IR, the Animas RS-232 IR serial interface adator (the "dongle"), the Animas R1000 IR cradle to hold the pump and the Animas ezLink™ software are intended to transfer data stored in the pump to the personal computer of a patient or a physician, where it may be displayed, printed, and saved.

This device is intended for home use and is a prescription device.

The Animas Model R1000 IR Insulin Infusion Pump is an external syringe pump and delivery system that provides subcutaneous delivery of insulin for patients with diabetes mellitus who would benefit from a continuous insulin infusion process. The Model R1000 IR is used with an infusion set, e.g., the Animas ezSet™. The pump incorporates serial communications via an infrared (IR) interface. The Animas RS-232 IR serial interface adaptor (the "dongle"), the Animas R1000 IR cradle to hold the pump, and the Animas ezLink™ software for the user's personal computer are the remaining components of the system. The ezLink™ software will allow the user to download records from the pump for Daily Totals, Alarm History, Bolus History, as well as Basal Rate programs and PUMP Settings. A leather case and a belt clip are provided as accessories. The pump is intended for multiple years of use and the insulin syringe is a sterile, single use disposable manufactured for Animas.

The system will deliver a prescribed dosage of insulin as a single programmable bolus or at multiple programmable basal rates. The system will also provide set up information, dosage history, alarms, error and warning messages, device status, and self test capabilities.

This document is a 510(k) premarket notification for the Animas Model R1000 IR Insulin Infusion Pump. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device by describing the device, its intended use, and emphasizing that the only difference from the predicate is the addition of an infrared (IR) communication capability. It explicitly states: "This difference between the modified device and the predicate device does not affect the safety or effectiveness of the device."

Therefore, I cannot provide the requested information as it is not present in the provided text. This type of regulatory submission often relies on the established safety and effectiveness of the predicate device for minor modifications, rather than requiring new, extensive performance studies with specific acceptance criteria.

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The Animas EZ Set Infusion set is intended to provide infusion of medicine, including insulin, from an external infusion pump. This device is intended for home use and is a prescription device.

The Animas EZ Set Infusion Set is an infusion adminstration set with the proximal end connecting to a medicine reservoir syringe within an infusion pump and the distal end inserted in the subcutaneous itssue of a user. The device consists of two components, an infusion site assembly and a tubing connector assembly. The infusion site assembly consists of a cannula housing with a disposable insertion hub assembly. The main body of the cannula housing has a thin self-adhesive pad for attachment to the skin. A soft flexible 22 gauge cannula extends below the flat bottom of the housing to penetrate the skin at a slight angle. A detachable insertion needle assembly is intitially connected to the cannula housing assembly to insert the soft flexible cannula subcutaneously. It is then removed and replaced by the needle hub assembly to deliver medication. An elastomeric septum seals the entrance to the cannula when the needle hub assembly is removed. The tubing connector assembly consists of a length of flexible plastic tubing made from polyvinyl chloride with a co-extruded polyethylene liner. The tubing is attached to a female Luer Lock connector at one end and a short needle mounted in the main body of the needle hub at the opposite end. The main body provides a means to align and attach the needle hub to the cannula housing assembly by means of a quick release connector. When the cannula housing and the needle hub are connected, the needle penetrates the septum allowing medication to flow from the pump through the flexible tubing, the needle, and the cannula into the patient's body. The needle hub assembly may be easily released from the cannula housing by squeezing the resilient side members deflecting the retaining band above a bump on the cannula housing. This allows the needle housing to slide freely off the cannula housing. The quick release connector allows the user to temporarily disconnect the tubing at the insertion site for activities such as dressing or bathing. In addition to complete administration sets, infusion site sets without the tubing i and quick release connector will also be available.

This document is a 510(k) premarket notification for the Animas EZ Set Infusion Set. It details the device's description, intended use, and comparison to predicate devices. However, it does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it provide information on sample sizes, ground truth establishment, or expert involvement for performance evaluation studies.

The provided text is a regulatory submission for market clearance, not a clinical or performance study report. Therefore, most of the requested information regarding acceptance criteria and performance study details is not present in this document.

Here's a breakdown of why the requested information is absent and what can be inferred:

• Acceptance Criteria and Reported Device Performance: This document states the device is "substantially equivalent" to predicate devices. This means the FDA has determined it performs as intended and is as safe and effective as devices already on the market. However, specific quantifiable performance metrics and acceptance criteria tested in a study are not included. The focus is on similarity in design and intended use.
• Sample Size, Ground Truth, Experts, Adjudication, MRMC studies, Standalone Performance: These are elements of a performance study. A 510(k) submission often references such studies or provides summaries if they were conducted for claims of substantial equivalence. This particular document, however, does not detail any such specific performance studies.
  • For a device like an infusion set, performance criteria would typically relate to:
    • Flow rate accuracy and consistency
    • Leakage prevention
    • Insertion force and patient comfort
    • Durability and connection integrity
    • Biocompatibility
    • Sterility
  • These would be evaluated through various engineering tests, bench tests, and potentially limited human use studies if new claims were being made. The document implies these tests were done to support the "substantial equivalence" claim, but the details are not provided.
• Training Set and Ground Truth for Training Set: Since no algorithm or AI component is mentioned, there would be no training set in the context of an AI/ML device.

What can be extracted from the document is limited to regulatory information:

• Device Name: Animas EZ Set Infusion Set
• Predicate Devices: MiniMed Paradigm Silhouette Infusion Set, Maersk Medical Comfort Infusion Set, Disetronic Tender Infusion Set
• Intended Use: For infusion of medicine, including insulin, from an external infusion pump, for home use, and a prescription device.
• Regulatory Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices.

In summary, the provided text does not contain the specific performance study information (acceptance criteria, sample sizes, ground truth, expert details, etc.) you are requesting because it is a regulatory clearance document focused on demonstrating substantial equivalence, not a detailed technical report of a performance study. Such study details would typically be found in accompanying technical reports or clinical trial summaries, which are not part of this 510(k) summary.

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The Animas Corporation R1000 Series Insulin Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of Type 1 and certain instances of Type 2 diabetes mellitus. The pump is indicated for use in diabetics who have good personnal hygiene, who have established control over their blood glucose and who do not have unpredictable or large variations in blood glucose levels.

The Animas Corporation R1000 Series Insulin Pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in insulin dependent patients.

This device is intended for home use and is a prescription device.

Not Found

This 510(k) summary for the Animas Corporation R1000 Series Insulin Pump does not contain the information required to populate the acceptance criteria table or describe a study proving the device meets acceptance criteria.

The provided text focuses on regulatory approval, intended use, and substantial equivalence to predicate devices, rather than presenting detailed performance data or a specific study designed to demonstrate compliance with acceptance criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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