(76 days)
Not Found
No
The document describes a standard insulin pump and configuration software without mentioning any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as an insulin infusion pump for the management of diabetes mellitus, which is a therapeutic purpose.
No
The device is an insulin infusion pump designed for the continuous delivery of insulin to manage diabetes. It facilitates monitoring and programming of pump settings but does not diagnose diabetes or other conditions.
No
The primary device described is the ACCU-CHEK Spirit Insulin Infusion Pump, which is a physical, battery-operated hardware device for delivering insulin. While the summary mentions "ACCU-CHEK Insulin Pump Configuration Software," this software is described as facilitating the monitoring and programming of the pump settings, indicating it is a component or accessory to the hardware device, not a standalone software-only medical device.
Based on the provided information, the ACCU-CHEK Spirit Insulin Infusion Pump is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous continuous delivery of insulin for the management of diabetes. This is a therapeutic action, delivering a substance into the body.
- Device Description: The description focuses on the mechanical and electronic aspects of delivering insulin.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, etc.) to diagnose, monitor, or screen for a disease or condition. IVDs are used in vitro (outside the body) to analyze samples.
The device is an insulin infusion pump, which is a medical device used for drug delivery.
N/A
Intended Use / Indications for 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.
Product codes
LZG
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 pump and a personal computer. The ACCU-CHEK Insulin Pump Configuration Software facilitates the monitoring and programming of the pump settings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Diagnostics | |
| 9115 Hague Road | ||
| P.O. Box 50457 | ||
| Indianapolis, IN 46250-0457 | ||
| USA | ||
| Contact: | ||
| Phone: | ||
| Fax: | Scott Thiel | |
| Regulatory Affairs Project Principal | ||
| (800) 428-5074 X13362 | ||
| (317) 521-2324 | ||
| E Mail: | scott.thiel@roche.com | |
| Submission Sponsor: | Disetronic Medical Systems AG | |
| Kirchbergstrasse 190 | ||
| CH-3401 Burgdorf | ||
| Switzerland | ||
| 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 | LZG | |
| Class 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
1
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.
2
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The words are arranged on a single line, with 'Public' and 'Health' being slightly larger than 'Service'.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight.
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.
3
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
4
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
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