(76 days)
The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.
The ACCU-CHEK Spirit Insulin Infusion Pump is an ambulatory, battery operated insulin pump designed for continuous delivery of insulin. The design allows for delivery of 0.0 to 25.0 units of U100 insulin per hour in basal rates and up to 25.0 units of U100 insulin per meal or meal bolus. The pump is made of impact resistant plastic. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors. The ACCU-CHEK Spirit Insulin Infusion Pump is equipped with an IR-Interface in order to enable data transmission between the pump and a personal computer. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.
This 510(k) submission (K060876) for the ACCU-CHEK® Spirit Insulin Infusion Pump is a Special 510(k) for a modification to an already cleared device (K042887). The modification primarily concerns the addition of the "ACCU-CHEK Insulin Pump Configuration Software" which facilitates monitoring and programming of pump settings.
The document states that the software has been verified and validated and that no new issues were raised regarding safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table format. However, the core acceptance criterion for this Special 510(k) is substantial equivalence to the predicate device (K042887).
| Acceptance Criteria (Implicit for Special 510(k)) | Reported Device Performance |
|---|---|
| Maintain the same intended use. | Same intended use. |
| Maintain the same technological characteristics (or demonstrate safety/effectiveness if different). | Same features, with the addition of software for monitoring/programming. |
| Not raise new questions of safety or effectiveness. | Software has been verified and validated; no new issues identified regarding safety and effectiveness. |
| Software performs as intended. | Software facilitates monitoring and programming of pump settings. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "software testing performed" and that the software "has been verified and validated." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number of experts used to establish ground truth or their qualifications. The testing approach appears to be focused on software verification and validation rather than clinical performance adjudicated by medical experts.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method as it primarily concerns software verification and validation, not a clinical study involving human judgment on cases.
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 MRMC comparative effectiveness study was mentioned. The device is an insulin pump and software, not an AI-assisted diagnostic or interpretive tool that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
The "ACCU-CHEK Insulin Pump Configuration Software" itself would be considered a standalone component, as it performs its functions independent of direct human intervention in the data processing, although it facilitates monitoring and programming by a human. The verification and validation of this software would essentially be demonstrating its standalone performance against its specifications. However, the document does not explicitly describe this as a "standalone study" in the context of typical AI/CAD device evaluation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc):
For the "software testing," the ground truth would likely be defined by the software requirements and design specifications. This would involve verifying that the software functions correctly, calculates values accurately, and displays information as intended, rather than clinical ground truth like pathology or expert consensus on a medical diagnosis.
8. The Sample Size for the Training Set:
The document does not mention a training set sample size. This is expected as the software likely follows traditional software development and testing methodologies (verification and validation) rather than machine learning or AI paradigms that require distinct training sets.
9. How the Ground Truth for the Training Set was Established:
As no training set is mentioned or implied, this information is not applicable/provided.
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Disetronic Medical Systems AG Special 510(k) Premarket Notification Submission ACCU-CHEK Spirit Insulin Infusion Pump
| SECTION 3 - 510(k) SUMMARY | K060876 | JUN 15 2006 |
|---|---|---|
| Submission Correspondent:Address: | Roche Diagnostics9115 Hague RoadP.O. Box 50457Indianapolis, IN 46250-0457USA | |
| Contact:Phone:Fax: | Scott ThielRegulatory Affairs Project Principal(800) 428-5074 X13362(317) 521-2324 | |
| E Mail: | scott.thiel@roche.com | |
| Submission Sponsor: | Disetronic Medical Systems AGKirchbergstrasse 190CH-3401 BurgdorfSwitzerland | |
| Date Prepared: | March 30, 2006 | |
| Trade Name: | ACCU-CHEK® Spirit Insulin Infusion Pump | |
| Common Name: | Insulin infusion pump and accessories | |
| Classification: | Pump, infusion, insulin | |
| Regulation # | 21 CFR 880.5725 | |
| Product Code | LZGClass II device |
Description: The ACCU-CHEK Spirit Insulin Infusion Pump is an ambulatory, battery operated insulin pump designed for continuous delivery of insulin. The design allows for delivery of 0.0 to 25.0 units of U100 insulin per hour in basal rates and up to 25.0 units of U100 insulin per meal or meal bolus. The pump is made of impact resistant plastic. The pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors.
The ACCU-CHEK Spirit Insulin Infusion Pump is equipped with an IR-Interface in order to enable data transmission between the
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Disetronic Medical Systems AG Special 510(k) Premarket Notification Submission ACCU-CHEK Spirit Insulin Infusion Pump
pump and a personal computer. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.
- Intended Use: The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.
- Predicate Devices: The ACCU-CHEK Spirit Insulin Infusion Pump in this submission is a modification to the predicate device of the same name with 510(k):
510(k) #: K042887 ACCU-CHEK Spirit Insulin Infusion Pump Disetronic Medical Systems AG Cleared on March 18, 2005
Safety and Effectiveness:
The ACCU-CHEK Spirit Insulin Infusion Pump has the same indications for use, and features as the previously cleared device. The addition of the ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings. The software has been verified and validated and no new issues were raised regarding safety and effectiveness.
Summary and Conclusion Regarding Substantial Equivalence:
By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.
The ACCU-CHEK Spirit Insulin Infusion Pump has the same indications for use, and features as the previously cleared device, with the addition of the Insulin Pump Configuration Software for use in programming the ACCU-CHEK Spirit Insulin Infusion Pump and monitoring data collected on the ACCU-CHEK Spirit Insulin Infusion Purmp. Based on the design equivalency and the software testing performed, we have determined that the implementation of the ACCU-CHEK Insulin Pump Configuration Software for the ACCU-CHEK Spirit Insulin Infusion Pump to be substantially equivalent to the predicate device currently cleared via K042887.
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JUN 1 5 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Disetronic Medical Systems AG C/O Mr. Scott Thiel Regulatory Affairs Project Principal Roche Diagnostics 9115 Hague Road Indianapolis, Indiana 46250-0457
Re: K060876
Trade/Device Name: ACCU-CHEK® Spirit Insulin Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: March 30, 2006 Received: March 31, 2006
Dear Mr. Thiel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 -- Mr. Thiel
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: ACCU-CHEK® Spirit Insulin Infusion Pump
The ACCU-CHEK Spirit Insulin Infusion Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.
Prescription Use _X (Per 21 CFR 801.109) OR
Over the Use
Counter
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Centa V.m
1977 - 1171)
Anesthesiology, General Hospital,
Control. Dental Devices
tor K4648JL
Page 1 of 1
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).