(89 days)
Not Found
No
The document describes a programmable insulin pump with a remote control, focusing on delivering insulin at set and variable rates. There is no mention of AI, ML, or any learning capabilities. The performance studies are usability and sharps injury prevention studies, not related to algorithmic performance.
Yes
The device is described as an "Insulin Delivery System" intended for the "continuous delivery of insulin" for the "management of diabetes mellitus," which directly indicates its role in treating a medical condition.
No
The device is described as an insulin delivery system for the management of diabetes, which involves continuous delivery of insulin rather than diagnosing the condition.
No
The device description explicitly states that the Solo™ MicroPump Insulin Delivery System is comprised of two connected parts: a disposable reservoir and a reusable pump, which includes the pumping mechanism and electronic components. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "continuous delivery of insulin... for the management of diabetes mellitus." This describes a therapeutic device that delivers a substance to the body, not a device that performs tests on samples taken from the body.
- Device Description: The description details a "miniature, portable programmable insulin pump" that "adheres to the patient's skin" and "delivers basal and bolus insulin doses." This aligns with the function of an insulin delivery system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is to administer a treatment (insulin) directly to the patient.
N/A
Intended Use / Indications for Use
The Solo™ MicroPump Insulin Delivery System is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Product codes
LZG
Device Description
The Solo™ MicroPump Insulin Delivery System (Solo™) is a miniature, portable programmable insulin pump, which adheres to the patient's skin. The MicroPump is comprised of two connected parts: a disposable reservoir, in which the insulin is stored and a reusable pump, which includes the pumping mechanism and electronic components. The MicroPump is controlled via a remote control unit.
The Solo™ is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician, and includes the features available in the predicate devices.
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
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Summary of Performance Studies
Two simulated clinical use studies were conducted to support the current 510(k) submission:
- Operation of the Solo™ MicroPump Insulin Delivery System by Non-Adults- A Summative Usability Study.
- Simulated Clinical Use of the Solo™ MicroPump Sharps Injury Prevention Features.
These studies, with the non-adult user population, were designed and executed according to FDA guidance and international standards (HE74-2001 and IEC 60601-1-6), as presented in Section 20 of the 510(k) packet. Study results clearly demonstrated that Solo™ is safe for use by non-adults and their caregivers.
Key Metrics
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
510(K) Summary
JAN 2 5 2010
Solo™ MicroPump Insulin Delivery System
510(k) Number Kog 3364
Applicant's Name:
Medingo Ltd. Yoqneam Industrial Park Building 7 - 3rd Floor P.O. Box 261 Yoqneam, Israel, 20692 Phone: (+972) 73-713-1313 (+972) 73-713-1314 Fax:
Contact Person:
Name: Arava HaCohen VP Quality and Regulatory Affairs Title: (+972) 73-713-1303 Tel: (+972) 73-713-1314 Fax: Email: arava@medingo.com
Trade Name:
Solo™ MicroPump Insulin Delivery System
Classification Name:
Insulin infusion pump
Classification:
FDA has classified insulin infusion pumps as class II devices (product code LZG) and they are reviewed by the General Hospital panel.
Solo™ MicroPump Insulin Delivery System - Page 5-2
1
Predicate Devices:
- Medingo Solo™ Insulin Patch Pump, insulin infusion pump, product code A LZG, cleared for marketing under K090245 ("Solo™")
-
iXL Diabetes Management System (Insulet Corp.), product code LZG, cleared for marketing under K031373, K042792
Intended Use:
The Solo™ MicroPump Insulin Delivery System is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Device Description:
The Solo™ MicroPump Insulin Delivery System (Solo™) is a miniature, portable programmable insulin pump, which adheres to the patient's skin. The MicroPump is comprised of two connected parts: a disposable reservoir, in which the insulin is stored and a reusable pump, which includes the pumping mechanism and electronic components. The MicroPump is controlled via a remote control unit.
The Solo™ is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician, and includes the features available in the predicate devices.
Technological Characteristics:
The Solo™ MicroPump Insulin Delivery System is identical to the predicate Solo™ approved under K090245 except for some minor modifications, none of which individually, or in aggregate, require the submission of a new 510(k).
Solo™ MicroPump Insulin Delivery System - Page 5-3
2
Performance Testing:
Two simulated clinical use studies were conducted to support the current 510(k) submission :
-
- Operation of the Solo™ MicroPump Insulin Delivery System by Non-Adults- A Summative Usability Study.
-
- Simulated Clinical Use of the Solo™ MicroPump Sharps Injury Prevention Features.
These studies, with the non-adult user population, were designed and executed according to FDA guidance and international standards (HE74-2001 and IEC 60601-1-6), as presented in Section 20 of the 510(k) packet. Study results clearly demonstrated that Solo™ is safe for use by non-adults and their caregivers.
Conclusion:
The Solo™ MicroPump Insulin Delivery System presented in this 510(k) submission is the same as the predicate cleared Solo™, except for the deletion of the contraindication for use by persons under the age of 18.
By deleting the age contraindication, the Solo™ MicroPump Insulin Delivery System is substantially equivalent to the predicate iXL Diabetes Management System. Based on the information provided in this submission, Medingo believes that Solo™ is substantially equivalent to its predicate devices without raising any new safety or effectiveness issues.
Solo™ MicroPump Insulin Delivery System - Page 5-4
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Ms. Arava Hacohen Vice President Quality and Regulatory Affairs Medingo Limited Yoqneam Industrial Park Building 7 -- 3rd Floor P.O. Box 261 Yoqneam 20692 ISRAEL
JAN 9 5 2010
Re: K093364
Trade/Device Name: Solo™ MicroPump Insulin Delivery System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: October 21, 2009 Received: October 28, 2009
Dear Ms. Hacohen:
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 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.
4
Page 2 - Ms. Hacohen
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Rh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K042264
Device Name:
Solo™ MicroPump Insulin Delivery System
Indications for Use:
The Solo™ MicroPump Insulin Delivery System is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The Solo™ Insulin Patch Pump is for prescription use only.
Prescription Use _ X (Per 21 CFR 801.109)
Over the Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093364
Solo™ MicroPump Insulin Delivery System - Page 4-2