(83 days)
The Finesse Insulin Delivery System is intended for the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.
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.
The provided text does not contain information about acceptance criteria or specific studies that prove the device meets these criteria in the typical format of a clinical or performance study. Instead, it describes general design verification and user studies without specific metrics or methodologies.
Here's a breakdown of the available information based on your requested points:
1. A table of acceptance criteria and the reported device performance
The document mentions "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" and "User studies have completed that demonstrate the readability and user comprehension of the labeling."
However, specific acceptance criteria (e.g., "device must deliver X +/- Y% of intended insulin dose") and quantitative performance results are NOT provided in this 510(k) summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is NOT provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is NOT provided in the document. The studies mentioned are general "design verification" and "user studies," which typically don't involve expert establishment of ground truth in the same way a diagnostic device might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is NOT provided in the document.
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
This information is NOT applicable as the device is an insulin delivery system, not an AI-powered diagnostic device that involves human "readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is NOT applicable as the device is an insulin delivery system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is NOT provided in the document. The general nature of the studies ("compatibility and stability," "wear and mechanical reliability," "user comprehension") suggests that ground truth would be established through direct measurements, chemical analysis, mechanical testing, and user feedback, rather than expert consensus on diagnostic interpretations.
8. The sample size for the training set
This information is NOT provided in the document. The device is a mechanical/electronic system, not a machine learning algorithm that typically requires a "training set."
9. How the ground truth for the training set was established
This information is NOT applicable as the device is a medical device, not a machine learning algorithm.
Summary of what is available:
The 510(k) Summary for the Finesse Personal Insulin Delivery Patch (K100947) states that:
- Compatibility and stability studies were performed to demonstrate chemical, physical, microbiological stability, and biocompatibility of insulin in the device for the specified period.
- Design verification studies were completed to demonstrate the wear and mechanical reliability of the device for the specified period.
- User studies were completed to demonstrate the readability and user comprehension of the labeling.
The document indicates that these studies (without providing details like sample sizes, specific metrics, or methodologies) were sufficient for FDA to determine substantial equivalence based on the modified labeling for extended usage duration. The primary change from the predicate device (K093065) was this extended usage period (from an unspecified duration to 48-72 hours, consistent with insulin manufacturer labeling).
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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
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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.
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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
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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.
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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
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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
§ 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).