(279 days)
No
The device description explicitly states it is a "manual, user filled, positive displacement, bolus dosing pump" and there is no mention of AI or ML in the document.
Yes
The device is described as an "Insulin Delivery System" indicated for the "subcutaneous, bolus delivery of physician prescribed insulins" for the "management of diabetes mellitus," which directly addresses a medical condition (diabetes) by delivering medication.
No
Explanation: The device is described as an "Insulin Delivery System" for the bolus delivery of insulin, indicating its function is therapeutic (delivering medication) rather than diagnostic (identifying or monitoring a medical condition).
No
The device description explicitly lists multiple hardware components: an Insulin Delivery Device (IDD), a Fill Syringe, a reusable Inserter, and a Dose Count Card. It also mentions materials like plastics, elastomers, and stainless steel, and describes mechanical aspects like positive displacement and cannula implantation.
Based on the provided text, the Finesse Insulin Delivery System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the subcutaneous, bolus delivery of physician prescribed insulins. This is a therapeutic function, delivering medication directly into the body.
- Device Description: The description details a system for delivering liquid medication (insulin) into the subcutaneous tissue. It includes components like a pump, inserter, syringe, and dose count card, all related to the physical delivery of the drug.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Finesse system does not perform any such analysis of bodily specimens.
Therefore, the Finesse Insulin Delivery System is a medical device for drug delivery, not an IVD.
N/A
Intended Use / Indications for Use
The Finesse Insulin Delivery System is indicated for the subcutaneous, bolus delivery of clinicianprescribed medications, and is adhered to the skin for up to 72 hours with a biocompatible adhesive.
The Finesse Insulin Delivery System is indicated for the subcutaneous, bolus delivery of physician prescribed insulins, in adult persons requiring such medications for the management of diabetes mellitus.
The Finesse Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
Product codes
OPP, LZG
Device Description
The Finesse Insulin Delivery System (IDS) is comprised of a sterile. nonpyrogenic, single-use, external, disposable, ambulatory, liquid medication, bolus dosing device (IDD); a single use, non-pyrogenic, sterile. syringe and needle (Fill Syringe); a reusable Inserter; and a Dose Count Card. The device is intended for subcutaneous delivery of clinicianprescribed medications, and is adhered to the skin for up to 72 hours with a biocompatible adhesive.
The Insulin Delivery Device (IDD) is a manual, user filled, positive displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissues. The syringe and needle are for patient filling of the IDD with liquid medication prior to deployment on the body, and have a maximum capacity of 2ml. The Dose Count Card is utilized by the patient during the dosing session and provides for a written record of date, time and amount of Insulin delivery.
The Finesse IDS materials are biocompatible plastics, elastomers, and stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissues
Indicated Patient Age Range
Adult persons
Intended User / Care Setting
health care professional, a patient, or a patient care-giver
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)
Compatibility and stability studies have been completed that demonstrate the chemical, physical, microbiological stability and biocompatibility of insulin in the Finesse Insulin Delivery device for the period of time specified in the labeling. Design verification studies have been completed that demonstrate the wear and mechanical reliability of the device for the intended period of time. Design verification studies have been completed that demonstrate the usability and reliability of the Inserter accessory. Human factors and clinical evaluation studies have been completed that demonstrate device performance and usability. No clinical performance data is required to validate the intended uses and user needs of the system. Design validation is completed by human factors simulated use and clinical evaluation testing.
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
510(k) Summary of Safety and Effectiveness
APR 1 0 2012
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807,92(c),
Owner's Name, Address, Telephone Number, Contact 1. Person
Name, Address. Telephone Number
Calibra Medical. Inc. 220 Saginaw Drive Redwood City, CA 94063-4725
Contact Person
Richard J. Meader Vice President Regulatory and Quality Affairs Calibra Medical, Inc. 220 Saginaw Drive Redwood City, CA 94063-4725 Direct: 1.650.298.4740 Fax: 1.650.587.8994 rmeader@calibra.com
Date Prepared
- . July 5, 2011
2. Trade Name
Finesse Personal Insulin Delivery Patch
3. Common Name
Disposable Insulin Infusion Pump
4. Classification Name
Pump, infusion, insulin bolus
1
5. Classification
| Code of Federal Regulations Number | 880.5725 |
|---|---|
| Classification Panel | General Hospital |
| Product Code | OPP (primary) |
| LZG (secondary) | |
| Regulatory Class | Class II |
| Review Category | Tier 2 |
6. Identification of the Predicate or Legally Marketed Device
Calibra Medical, Inc. believes that the System described in this Submission is substantially equivalent to the Calibra Medical Finesse Insulin Delivery System cleared under 510(k)s K093065 and K100947.
7. Device Description
The Finesse Insulin Delivery System (IDS) is comprised of a sterile. nonpyrogenic, single-use, external, disposable, ambulatory, liquid medication, bolus dosing device (IDD); a single use, non-pyrogenic, sterile. syringe and needle (Fill Syringe); a reusable Inserter; and a Dose Count Card. The device is intended for subcutaneous delivery of clinicianprescribed medications, and is adhered to the skin for up to 72 hours with a biocompatible adhesive.
The Insulin Delivery Device (IDD) is a manual, user filled, positive displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissues. The syringe and needle are for patient filling of the IDD with liquid medication prior to deployment on the body, and have a maximum capacity of 2ml. The Dose Count Card is utilized by the patient during the dosing session and provides for a written record of date, time and amount of Insulin delivery.
The Finesse IDS materials are biocompatible plastics, elastomers, and stainless steel.
2
8. Intended Use
The Finesse Insulin Delivery System is indicated for the subcutaneous, bolus delivery of physician prescribed insulins, in adult persons requiring such medications for the management of diabetes mellitus.
9. Technological Characteristics
The Finesse Insulin Delivery System meets the description of a pump, infusion, insulin bolus as established in product code 80-OPP. The system is identical to other insulin delivery devices in that it uses a positive volume displacement type of manual piston to precisely deliver discrete doses of medication from the internal reservoir. The Finesse has no power source. It is non-electrically powered. The Finesse piston is actuated by the mechanical action of the user's fingers pressing on the buttons. The Finesse has a reservoir to hold the medicinal product (insulin). The Finesse has a single lumen catheter/cannula that delivers the drug to the subcutaneous tissues. The Finesse is used by a health care professional, a patient, or a patient care-giver to deliver the drug (i.e., drug delivery requires competent human interaction).
The Finesse is worn for up to 72 hours and has a flexible cannula placed in the subcutaneous tissues to deliver insulin. This is equivalent to the characteristics of the Calibra Medical Finesse Insulin Delivery System (product code 80-OPP) cleared under 510(k) K093065 and K100947.
Non-Clinical Performance Data 10.
Compatibility and stability studies have been completed that demonstrate the chemical, physical, microbiological stability and biocompatibility of insulin in the Finesse Insulin Delivery device for the period of time specified in the labeling. Design verification studies have been completed that demonstrate the wear and mechanical reliability of the device for the intended period of time. Design verification studies have been completed that demonstrate the usability and reliability of the Inserter accessory. Human factors and clinical evaluation studies have been completed that demonstrate device performance and usability.
Clinical Performance Data 11.
3
No clinical performance data is required to validate the intended uses and user needs of the system. Design validation is completed by human factors simulated use and clinical evaluation testing.
12. Conclusions
The Finesse Insulin Delivery System is substantially equivalent in its intended use, performance, safety, effectiveness, underlying scientific and operating principles used and performs as well as or better than the predicate Finesse Insulin Delivery System (K093065 and K100947).
END OF SUMMARY
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 0 2012
Mr. Richard J. Meader Vice President Regulatory and Quality Affairs Calibra Medical, Inc 220 Saginaw Drive Redwood City, California 94063
Re: K111924
Trade/Device Name: Finesse Personal Insulin Delivery Patch Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: OPP, LZG Dated: April 5, 2012 Received: April 6, 2012
Dear Mr. Meader:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
5
Page 2 - Mr. Meader
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony V. Adutan
(Inthony 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
Enclosure
6
510(k) Page 0030 of 3660
Indications for Use
510(k) Number (if known): Not known.
Device Name: Finesse Personal Insulin Delivery Patch
The Finesse Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
Prescription Use
AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Gil. for RZC Apr 11, 2012
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: _ K 111924
Section 2 - Indications for Use
510(k) Page 0030 of 3660