HumaPen Savvio

K160668 · Eli Lilly and Company, Inc. · FMF · Jun 3, 2016 · General Hospital

Device Facts

• Record ID: K160668
• Device Name: HumaPen Savvio
• Applicant: Eli Lilly and Company, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jun 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HumaPen Savvio is a reusable insulin pen intended for the self-injection of HUMALOG® (insulin lispro for injection, U-100) available in 3 mL cartridges using disposable pen needles (sold separately).

Device Story

Reusable mechanical pen-injector for insulin self-injection; uses 3 mL insulin cartridges and disposable pen needles. User dials dose (1-60 units) via manual dial. Features Insufficient Remaining Dose (IRD) mechanism preventing dialing beyond remaining cartridge volume. Bayonet-fit cartridge holder attachment. Used by patients in home or clinical settings. Healthcare providers instruct patients on use; output is the physical delivery of insulin. Benefits include accurate, repeatable dosing for diabetes management.

Clinical Evidence

No clinical data. Bench testing performed per ISO 11608-1:2014 for dose accuracy, life-cycle, and environmental stress. Biocompatibility testing (cytotoxicity, skin irritation) performed per ISO 10993-1:2009. Human factors validation testing confirmed usability of the bayonet attachment and IRD feature.

Technological Characteristics

Mechanical pen-injector; reusable. Materials: Anodized aluminum, plated plastics/metals. Dose range: 1-60 units; 1-unit increments. Connectivity: None. Sterilization: Not a sterile device. Standards: ISO 11608-1:2014 (dose accuracy), ISO 10993-1:2009 (biocompatibility).

Indications for Use

Indicated for self-injection of Humalog (insulin lispro, U-100) in 3 mL cartridges for patients requiring insulin therapy.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• HumaPen Luxura (K142518)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3, 2016

Eli Lilly and Company, Inc. Ms. Kevin Bardonner Research Scientist, Global Regulatory Affairs, CMC-Devices Lilly Corporate Center Indianapolis, Indiana 46285

Re: K160668

Trade/Device Name: HumaPen Savvio Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 8, 2016 Received: March 9, 2016

Dear Mr. Bardonner:

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|-----------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | |
| K160668 | |

Device Name HumaPen Savvio

Indications for Use (Describe)

HumaPen Savvio is a reusable insulin pen intended for the self-injection of HUMALOG® (U-100, insulin lispro for injection) available in 3 mL cartridges using disposable pen needles (sold separately).

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <div style="display:inline-block;"> <div style="display:inline-block;vertical-align:middle;width:16px;height:16px;border:1px solid black;">X</div> </div> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <div style="display:inline-block;"> <div style="display:inline-block;vertical-align:middle;width:16px;height:16px;border:1px solid black;"></div> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# K160668 – 510(k) Summary

The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92.

### 807.92(a)(1)

## Submitter Information

Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285

| Contact Person: | Kevin Bardonner, P.E. |
|-----------------|------------------------------------------------------------|
| | Research Scientist, Global Regulatory Affairs, CMC-Devices |
| | Mobile: [phone] |
| | [e-mail] |

Date: 31 May 2016

| 807.92(a)(2) | Proposed Device |
|----------------------|--------------------------|
| Trade Name: | HumaPen Savvio |
| Common Name: | Pen-Injector |
| Classification Name: | Piston Syringe |
| Regulation: | 21 CFR 880.5860 |
| Product Code: | FMF |
| Class: | II |
| 807.92(a)(3) | Predicate Device |
| Trade Name: | HumaPen Luxura (K142518) |
| Common Name: | Pen-Injector |
| Classification Name: | Piston Syringe |
| Regulation: | 21 CFR 880.5860 |
| Product Code: | FMF |
| Class: | II |

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#### Device Description 807.92(a)(4)

The HumaPen Savvio is a reusable mechanical pen-injector designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable, and disposable pen needles (supplied separately). The pen-injector allows the user to dial the desired dose from 1 to 60 units, one unit at a time.

#### 807.92(a)(5) Intended Use(s)

Sterility

HumaPen Savvio is a reusable insulin pen intended for the self-injection of HUMALOG® (insulin lispro for injection, U-100) available in 3 mL cartridges using disposable pen needles (sold separately).

#### Technological Characteristics 807.92(a)(6)

Not a sterile device

| Pen Feature | New Device:<br>HumaPen Savvio<br>(under review in this submission) | Predicate Device:<br>HumaPen Luxura<br>(K142518) |
|------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Delivery of Humalog (insulin lispro<br>for injection, U-100) in 3 mL<br>cartridges | Delivery of Humalog (insulin lispro<br>for injection, U-100) in 3 mL<br>cartridges |
| Cartridge Volume | 3 mL (300 units of U-100 insulin) | 3 mL (300 units of U-100 insulin) |
| Mechanism | Mechanical pen-injector /<br>needle-based injection system | Mechanical pen-injector /<br>needle-based injection system |
| Reusable device | Yes | Yes |
| Two-way dose dialing | Yes | Yes |
| Delivery Accuracy | Meets ISO 11608-1:2014a<br>requirements | Meets ISO 11608-1:2014b<br>requirements |
| Dial Increments | 0.01 mL per increment providing one<br>unit (1U) dose increments | 0.01 mL per increment providing one un<br>(1U) dose increments |
| Maximum Delivered Dose | 60 Units | 60 Units |
| Use life | 6 years | 6 years |

Not a sterile device

The HumaPen Savyio pen-injector is a modification of the predicate device cleared under K14251

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| Pen Feature | New Device:<br>HumaPen Savvio<br>(under review in this submission) | Predicate Device:<br>HumaPen Luxura<br>K142518 |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | | |
| Cartridge Holder attachment<br>to the pen body | 1/4 turn bayonet fit | Screw threads that take 2 $\frac{1}{2}$ turns to<br>attach |
| Insufficient Remaining<br>Dose (IRD) featurec | Patient cannot dial more than the<br>deliverable amount of insulin<br>remaining in the cartridge, prior to<br>injection. | The pen-injector will allow a user to dial<br>a dose that is greater than what is<br>remaining in the insulin cartridge. Once<br>the pen-injector has completed the<br>delivery of the insulin available within the<br>cartridge (i.e., empties the insulin<br>cartridge), the portion of the dose that was<br>not injected will be displayed on the dose<br>dial; that is, the dose dial will not return<br>to "0" as it would if the entire dose was<br>delivered. |
| Exterior materials | Anodized aluminum and plated<br>plastics and metals | Powder-coated and plated plastics and<br>metals |
| Colors available | Red | Burgundy. Champagne |

4 ISO 11608-1:2014 testing was conducted using Becton-Dickinson needles, as recommended in the HumaPen Savvio instructions for use

b Performance testing of the HumaPen Luxura pen-injector was performed in accordance with ISO 11608-1:2012. A newer version of the standard has been published that provides editorial changes and corrections that have no impact on test methods or requirements. Testing performed in accordance with the 2012 version also meets the requirements of the 2014 version.

S ISO 11608-1:2014, Section 5.5 (General design requirements) lists four options for IRD features in paragraph i. HumaPen Savvio uses method (1), while HumaPen Luxura uses method (4).

The user interface of the HumaPen Savvio differs from the predicate in two minor aspects: cartridge holder attachment to pen body and the IRD feature (see above table). A risk analysis was conducted along with human factors testing to assess the user's ability to attach the HumaPen Savvio cartridge holder to the pen body and to properly use the IRD feature. The human factors validation testing showed that users were successfully able to attach the cartridge holder to the HumaPen Savvio device (using the bayonet fit). It also showed that users were able to successfully dial and dose using the HumaPen Savvio IRD feature. During life-cycle testing that exposed these two features to 9 years of simulated use (1.5 x the number of doses anticipated over 6 years), there were no issues with dose accuracy or pen functionality (i.e. no broken components, no over-dialing beyond what remained in the cartridge, and no cartridge holder attachment/detachment issues). The new exterior material of construction for this device was tested and passed the international biocompatibility standard. Therefore, these minor differences of the user interface from the predicate do not raise new questions of safety or effectiveness or add risk.

#### 807.92(b)(1) Nonclinical Performance Data

The HumaPen Savvio pen-injector meets the requirements specified in ISO 11608-1:2014 Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems. The device design has passed the dose accuracy requirements after preconditioning in the following conditions defined in the ISO 11608-1 standard:

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- Standard Atmosphere
- Cool Atmosphere
- Warm Atmosphere ●
- Last-dose Accuracy
- Dry Heat
- Cold Storage ●
- Free Fall
- Vibration
- Damp Heat
- Temperature cycling (Cyclical)
- Life-cycle test ●
- To support a 6 year in-use life, the devices were operated the number of actuations (i.e. O exhausting the full volume of 3 mL cartridges by expelling typical doses up to and including the IRD) expected for 9 years of operation prior to performing dose accuracy testing; this included the installation of a new needle to the cartridge holder for each injection as well as removal and installation of a new cartridge when the previous cartridge was exhausted.

The HumaPen Savvio is a surface contacting device that contacts intact skin only according to the definitions in ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The exterior materials of the device (including the cartridge holder) were evaluated for in vitro cytotoxicity, skin irritation in accordance with this standard and meet the biocompatibility standard.

The results of Human Factors testing have demonstrated that the two modifications related to the user interface of the HumaPen Savvio pen-injector did not adversely impact performance or usability of the device, demonstrating that the HumaPen Savvio is substantially equivalent to the predicate device.

#### 807.92(b)(2) Clinical Performance Data

No clinical tests were performed.

#### 807.92(b)(3) Conclusions

HumaPen Savvio has met the standards for dose accuracy and functionality identified in the international standard for needle-based injection systems. The device materials meet the biocompatibility standard. The results of human factors studies demonstrated that the mitigations have reduced risks as far as possible given the limits of conventional "dial-and-dose" technology used in the HumaPen Savvio pen-injector. Evaluation of the HumaPen Savvio indicates that the differences between the HumaPen Savvio and the predicate device, HumaPen Luxura, do not raise any new issues of safety or effectiveness. HumaPen Savvio is substantially equivalent to the predicate device.