(112 days)
Not Found
No
The description focuses on mechanical and material aspects of insulin delivery and does not mention any computational or algorithmic components indicative of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes.
The device is intended for the bolus delivery of insulin for the management of diabetes mellitus, which is a therapeutic purpose.
No
This device is described as an insulin delivery system for the management of diabetes mellitus, which is a therapeutic function, not a diagnostic one. It delivers medication rather than diagnosing a condition.
No
The device description explicitly details physical components such as a drug delivery device, infusion cannula, integrated Inserter, and drug delivery device filler, all made of physical materials. This indicates it is a hardware device, not software-only.
Based on the provided information, the Finesse Insulin Delivery System is not an In Vitro Diagnostic (IVD) device.
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 that delivers a therapeutic substance to the body, not a device that tests a sample from the body to provide diagnostic information.
- Device Description: The description details a system for delivering insulin subcutaneously, including a drug delivery device, cannula, and inserter. It focuses on the mechanism of delivery and placement, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, or any other biological sample. There is no mention of providing diagnostic information about a patient's condition based on such analysis.
In summary, the Finesse Insulin Delivery System is a drug delivery device, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Finesse Insulin Delivery System is intended 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 drug delivery device filler. The device is adhered to the skin for up to 48 hours 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
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).
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)
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 testing.
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
510(k) Summary of Safety and Effectiveness
JAN 2 0 7010
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
January 20, 2010
2. Trade Name
Finesse Personal Insulin Delivery Patch
Common Name 3.
Disposable Insulin Infusion Pump
Classification Name 4.
Pump, infusion, insulin bolus
5. Classification
K093065 510(k) Summary
1
| 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 |
Identification of the Predicate or Legally Marketed Device 6.
Calibra Medical, Inc. believes that the System described in this Submission is substantially equivalent to a combination of the Eli Lilly and Company HumaPen Memoir (K053563) and the Biovalve Insulin Delivery System (K050971).
Device Description 7.
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 drug delivery device filler. The device is adhered to the skin for up to 48 hours 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 intended for the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.
Technological Characteristics 9.
The Finesse Insulin Delivery System meets the description of a pump, infusion, insulin as established in product code 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 48 hours and has a flexible cannula placed in the subcutaneous tissues to deliver insulin. This is equivalent to the characteristics of the BioValve device
Non-Clinical Performance Data 10.
Data establishing conformance to the following consensus standards and FDA guidance is maintained in the design history file and establishes the substantial equivalence with the predicate devices. The conclusions drawn from the data support the equivalence, safety, and effectiveness of the system.
| Consensus Standards and FDA Guidance | ||
|---|---|---|
| Number | Title | |
| ANSI/AAMI/ISO 10993-1: | ||
| 2003 | Biological evaluation of medical devices -- Part 1: Evaluation | |
| and testing | ||
| USP30-NF25 | Assays: 85 Bacterial Endotoxins Test, 121 Insulin Assays, 591 | |
| Zinc Determination, 621 Chromatography, 791 pH | ||
| Consensus Standards and FDA Guidance | ||
| Number | Title | |
| ANSI/AAMI HE74: 2001 | Human factors design process for medical devices | |
| IEC 62366 Edition 1.0 2007- | ||
| 10 | Application of usability engineering to medical devices | |
| ASTM D 4169 - 05:2005 | Standard Practice for Performance Testing of Shipping | |
| Containers and Systems | ||
| ASTM F 88 - 07a:2007 | Standard Test Method for Seal Strength of Flexible Barrier | |
| Materials | ||
| ASTM F 1929 - 1998 (2004) | Standard Test Method for Detecting Seal Leaks in Porous | |
| Medical Packaging by Dye Penetration | ||
| ASTM F 1980 - 2007 | Standard Guide for Accelerated Aging of Sterile Medical Device | |
| Packages | ||
| ANSI/IEC 60529: 2004 | Degrees Of Protection Provided By Enclosures | |
| ISO 7864:1993 | Sterile Hypodermic Needles for single use | |
| ISO 8537:1991, A1:2000 | Sterile single-use syringes, with or without needle, for insulin | |
| ISO 9626:1991, A1:2001 | Sterile single-use intravascular catheters -Part 1 General | |
| requirements | ||
| ISO 10555-1-1995, A1-1999, | ||
| A2-2004 | Sterile single-use intravascular catheters -Part 1 General | |
| requirements | ||
| ISO 10555-5-1996, A1-1999, | ||
| TC1: 2002 | Sterile, single-use intravascular catheters -Part 5 Over-needle | |
| peripheral catheters | ||
| ISO 11608-1:2000 | Pen-injectors for medical use - Part 1 Pen-injectors - | |
| Requirements and test methods | ||
| ANSI/AAMI ST67:2003 | Sterilization of health care products-Requirements for | |
| products labeled "STERILE" | ||
| ANSI/AAMI/ISO 11137-1: | ||
| 2006 | Sterilization of health care products- Radiation- Part 1: | |
| Requirements for development, validation, and routine control | ||
| of a sterilization process for medical devices | ||
| ANSI/AAMI/ISO 11137-2:2006 | Sterilization of health care products -Radiation -Part 2: | |
| Establishing the sterilization dose | ||
| ANSI/AAMI/ISO 11607-1: | ||
| 2006 | Packaging for Terminally Sterilized Medical Devices Part 1: | |
| Requirements for Materials, Sterile Barrier Systems and | ||
| Packaging Systems | ||
| Consensus Standards and FDA Guidance | ||
| Number | Title | |
| ANSI/AAMI/ISO 11607-2: | ||
| 2006 | Packaging for Terminally Sterilized Medical Devices Part 2: | |
| Validation Requirements for Forming, Sealing and Assembly | ||
| Process | ||
| ISO 15223: 2000, A1: 2001, | ||
| A2: 2004 | Medical Devices - Symbols to be used with medical device | |
| labels, labeling and information to be supplied | ||
| ANSI/AAMI/IEC TR60878: | ||
| 2003 | Graphical symbols for electrical equipment in medical practice | |
| FDA Guidance April 1993 | Guidance on the Content of Premarket Notification 510(k) | |
| Submissions for Piston Syringes | ||
| FDA Guidance March 1995 | Guidance On Premarket Notification 510(K) Submission For | |
| Short-Term And Long-Term Intravascular Catheters |
3
.
4
11. Clinical Performance Data
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 testing.
5
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Richard J. Meader Vice President of Regulatory and Quality Affairs Calibra Medical, Incorporated 220 Saginaw Drive Redwood City, California 94063-4725
JAN 2 0 2010
Re: K093065
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: December 29, 2009 Received: December 30, 2009
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.
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.
6
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/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 vours.
Th 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
Enclosure
7
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 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)
Carl B. Stokes
Page 1 of 1
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K093065
Section 2 - Indications for Use
Page 30 of 2043