FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000

K093065 · Calibra Medical, Inc. · OPP · Jan 20, 2010 · General Hospital

Device Facts

• Record ID: K093065
• Device Name: FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
• Applicant: Calibra Medical, Inc.
• Product Code: OPP · General Hospital
• Decision Date: Jan 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Finesse Personal Insulin Delivery Patch is a sterile, single-use, disposable, ambulatory, bolus insulin delivery system. Device consists of a positive volume displacement drug delivery component, infusion cannula, and integrated Inserter. User adheres device to skin for up to 48 hours. Inserter places cannula into subcutaneous tissue via an insertion needle; needle retracts automatically into Inserter body post-placement to prevent sharps exposure. Device is non-electrically powered; user manually presses buttons to actuate a piston, delivering discrete insulin doses from an internal reservoir through the cannula. Operated by patients, caregivers, or healthcare professionals. Provides a mechanical method for precise bolus insulin administration without electronic components.

Clinical Evidence

No clinical performance data was required. Design validation was completed via human factors simulated use testing. Conformance to consensus standards (ISO, ASTM, IEC) for biocompatibility, sterility, packaging, and mechanical performance was established through bench testing.

Technological Characteristics

Non-electrically powered, manual piston-driven infusion pump. Materials: biocompatible plastics, elastomers, stainless steel. Form factor: wearable patch with integrated cannula/inserter. Connectivity: none. Sterilization: radiation. Standards: ISO 10993-1 (biocompatibility), ISO 7864, ISO 8537, ISO 11608-1, ISO 11137 (sterilization), ASTM D4169, ASTM F88, ASTM F1929, ASTM F1980.

Indications for Use

Indicated for subcutaneous, bolus insulin delivery in patients with diabetes mellitus requiring insulin therapy.

Regulatory Classification

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.

Predicate Devices

• HumaPen Memoir (K053563)
• Biovalve Insulin Delivery System (K050971)

Submission Summary (Full Text)

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# 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: [phone] [e-mail]

# 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

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| Code of Federal Regulations Number | 880.5725 |
|------------------------------------|----------------------------------|
| Classification Panel | General Hospital |
| Product Code | OPP (Primary)<br>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.

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#### 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:<br>2003 | Biological evaluation of medical devices -- Part 1: Evaluation<br>and testing | |
| USP30-NF25 | Assays: 85 Bacterial Endotoxins Test, 121 Insulin Assays, 591<br>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-<br>10 | Application of usability engineering to medical devices | |
| ASTM D 4169 - 05:2005 | Standard Practice for Performance Testing of Shipping<br>Containers and Systems | |
| ASTM F 88 - 07a:2007 | Standard Test Method for Seal Strength of Flexible Barrier<br>Materials | |
| ASTM F 1929 - 1998 (2004) | Standard Test Method for Detecting Seal Leaks in Porous<br>Medical Packaging by Dye Penetration | |
| ASTM F 1980 - 2007 | Standard Guide for Accelerated Aging of Sterile Medical Device<br>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<br>requirements | |
| ISO 10555-1-1995, A1-1999,<br>A2-2004 | Sterile single-use intravascular catheters -Part 1 General<br>requirements | |
| ISO 10555-5-1996, A1-1999,<br>TC1: 2002 | Sterile, single-use intravascular catheters -Part 5 Over-needle<br>peripheral catheters | |
| ISO 11608-1:2000 | Pen-injectors for medical use - Part 1 Pen-injectors -<br>Requirements and test methods | |
| ANSI/AAMI ST67:2003 | Sterilization of health care products-Requirements for<br>products labeled "STERILE" | |
| ANSI/AAMI/ISO 11137-1:<br>2006 | Sterilization of health care products- Radiation- Part 1:<br>Requirements for development, validation, and routine control<br>of a sterilization process for medical devices | |
| ANSI/AAMI/ISO 11137-2:2006 | Sterilization of health care products -Radiation -Part 2:<br>Establishing the sterilization dose | |
| ANSI/AAMI/ISO 11607-1:<br>2006 | Packaging for Terminally Sterilized Medical Devices Part 1:<br>Requirements for Materials, Sterile Barrier Systems and<br>Packaging Systems | |
| Consensus Standards and FDA Guidance | | |
| Number | Title | |
| ANSI/AAMI/ISO 11607-2:<br>2006 | Packaging for Terminally Sterilized Medical Devices Part 2:<br>Validation Requirements for Forming, Sealing and Assembly<br>Process | |
| ISO 15223: 2000, A1: 2001,<br>A2: 2004 | Medical Devices - Symbols to be used with medical device<br>labels, labeling and information to be supplied | |
| ANSI/AAMI/IEC TR60878:<br>2003 | Graphical symbols for electrical equipment in medical practice | |
| FDA Guidance April 1993 | Guidance on the Content of Premarket Notification 510(k)<br>Submissions for Piston Syringes | |
| FDA Guidance March 1995 | Guidance On Premarket Notification 510(K) Submission For<br>Short-Term And Long-Term Intravascular Catheters | |

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#### 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.

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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.

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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/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 [phone] or [phone] 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

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# 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

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