(83 days)
Not Found
No
The description focuses on mechanical and material aspects of insulin delivery and does not mention any computational or algorithmic decision-making processes.
Yes
The device is intended for the bolus delivery of insulin for the management of diabetes mellitus, which is a therapeutic purpose.
No
The device is described as an insulin delivery system for administering medication, not for diagnosing a condition. Its function is to deliver insulin, a treatment for diabetes, rather than to detect or characterize the disease itself.
No
The device description explicitly details physical components such as a drug delivery device, infusion cannula, inserter, and filler, made of plastics, elastomers, and stainless steel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin." This describes a device used to administer a substance into the body for therapeutic purposes.
- Device Description: The description details a system for delivering medication subcutaneously, including a cannula, inserter, and filler. This is consistent with a drug delivery device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are used in vitro (outside the body) to analyze biological samples.
Therefore, the Finesse Insulin Delivery System is a drug delivery device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Finesse Insulin Delivery System is indicated for the subcutaneous, bolus delivery of insulin, for the management of diabetes mellitus in persons requiring insulin.
Product codes (comma separated list FDA assigned to the subject device)
OPP, LZG
Device Description
The Finesse Insulin Delivery System is a sterile, nonpyrogenic, single-use, external, disposable, ambulatory, insulin, bolus dosing system through which clinician-prescribed medications are delivered subcutaneously. The Finesse Insulin Delivery System is composed of a positive volume displacement drug delivery device with infusion cannula and integrated Inserter, and a drug delivery device filler. The device is adhered to the skin with a biocompatible adhesive.
The Finesse Insulin Delivery System has an integrated cannula and Inserter. The infusion cannula Inserter is used to place the cannula in the subcutaneous tissues. It contains an insertion needle located in the lumen of the infusion catheter cannula. A safety mechanism prevents premature actuation of the insertion needle mechanism to prevent injuries. Following cannula placement, the needle is retracted within the body of the Inserter to prevent sharps exposure. Once the needle is retracted, the Inserter automatically releases the Inserter from the drug delivery component.
The Finesse Insulin Delivery System 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
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)
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 device labeling. Design verification studies have been completed that demonstrate the wear and mechanical reliability of the device for the period of time specified in the device labeling. User studies have completed that demonstrate the readability and user comprehension of the labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 100947
510(k) Summary of Safety and Effectiveness
510(k) Summary of Safety and Effectiveness
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
April 28, 2010
2. Trade Name
Finesse Personal Insulin Delivery Patch
3. Common Name
Disposable Insulin Infusion Pump
4. Classification Name
Pump, infusion, insulin bolus
1
Classification 5.
| 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 (K093065).
7. Device Description
The Finesse Insulin Delivery System is a sterile, nonpyrogenic, single-use, external, disposable, ambulatory, insulin, bolus dosing system through which clinician-prescribed medications are delivered subcutaneously. The Finesse Insulin Delivery System is composed of a positive volume displacement drug delivery device with infusion cannula and integrated Inserter, and a drug delivery device filler. The device is adhered to the skin with a biocompatible adhesive.
The Finesse Insulin Delivery System has an integrated cannula and Inserter. The infusion cannula Inserter is used to place the cannula in the subcutaneous tissues. It contains an insertion needle located in the lumen of the infusion catheter cannula. A safety mechanism prevents premature actuation of the insertion needle mechanism to prevent injuries. Following cannula placement, the needle is retracted within the body of the Inserter to prevent sharps exposure. Once the needle is retracted, the Inserter automatically releases the Inserter from the drug delivery component.
The Finesse Insulin Delivery System materials are biocompatible plastics, elastomers, and stainless steel.
2
Intended Use 8.
The Finesse Insulin Delivery System is indicated for the subcutaneous, bolus delivery of insulin, for the management of diabetes mellitus in persons requiring insulin.
Performance Data 9.
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 device labeling. Design verification studies have been completed that demonstrate the wear and mechanical reliability of the device for the period of time specified in the device labeling. User studies have completed that demonstrate the readability and user comprehension of the labeling.
Technological Comparison 10.
The modified Finesse Insulin Delivery System is technologically identical to the predicate device. The subject device has modified labeling that allows the device to be used with insulin for up to 48 - 72 hours. Duration of usage of insulin in the device is to be consistent with labeling provided by the insulin drug manufacturer.
END OF SUMMARY
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
JUN 2 8 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Richard J. Meader Vice President, Regulatory and Quality Affairs Calibra Medical, Incorporated 220 Saginaw Drive Redwood City, California 94063
Re: K100947
Trade/Device Name: Finesse Personal Insulin Delivery Patch, Model FG 2000 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: OPP Dated: June 16, 2010 Received: June 17, 2010
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.
4
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/Resourcesfor You/Industry/default.htm.
Sincerely yours
Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Finesse Insulin Delivery System
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 the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in 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)
Ali Chay
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: K100947
Attachment 3 Indications for Use
Page 99 of 219