(86 days)
Not Found
No
The device description and performance studies indicate a purely mechanical pen-injector with no mention of AI or ML capabilities.
Yes
The device is described as an "insulin pen intended for the self-injection of HUMALOG® (U-100, insulin lispro for injection)". Insulin is a medication used to treat diabetes, and the pen facilitates its delivery, thus serving a therapeutic purpose.
No
The HumaPen Savvio is described as a "reusable insulin pen intended for the self-injection of HUMALOG®" and a "reusable mechanical pen-injector designed for use for the self-injection of insulin." Its function is to allow users to "dial the desired dose from 1 to 60 units" and inject it. It does not mention any capabilities for diagnosing a condition, analyzing patient data for diagnostic purposes, or otherwise providing medical insights for diagnosis.
No
The device description explicitly states it is a "reusable mechanical pen-injector" and describes physical components and testing related to mechanical performance and materials, indicating it is a hardware device.
Based on the provided information, the HumaPen Savvio is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the self-injection of insulin. This is a therapeutic delivery method, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "reusable mechanical pen-injector." This aligns with a drug delivery device, not a device used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The HumaPen Savvio is a medical device, specifically a drug delivery system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-injection
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)
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:
- 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.
Clinical Performance Data
No clinical tests were performed.
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.
HumaPen Luxura (K142518)
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
§ 880.5860 Piston syringe.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle.
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.
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
| 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
3
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: (317) 209-5585 | |
| bardonner_kevin_s@lilly.com |
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 |
4
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:
HumaPen Savvio
(under review in this submission) | Predicate Device:
HumaPen Luxura
(K142518) |
|------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Delivery of Humalog (insulin lispro
for injection, U-100) in 3 mL
cartridges | Delivery of Humalog (insulin lispro
for injection, U-100) in 3 mL
cartridges |
| Cartridge Volume | 3 mL (300 units of U-100 insulin) | 3 mL (300 units of U-100 insulin) |
| Mechanism | Mechanical pen-injector /
needle-based injection system | Mechanical pen-injector /
needle-based injection system |
| Reusable device | Yes | Yes |
| Two-way dose dialing | Yes | Yes |
| Delivery Accuracy | Meets ISO 11608-1:2014a
requirements | Meets ISO 11608-1:2014b
requirements |
| Dial Increments | 0.01 mL per increment providing one
unit (1U) dose increments | 0.01 mL per increment providing one un
(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
5
| Pen Feature | New Device:
HumaPen Savvio
(under review in this submission) | Predicate Device:
HumaPen Luxura
K142518 |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | | |
| Cartridge Holder attachment
to the pen body | 1/4 turn bayonet fit | Screw threads that take 2 $\frac{1}{2}$ turns to
attach |
| Insufficient Remaining
Dose (IRD) featurec | Patient cannot dial more than the
deliverable amount of insulin
remaining in the cartridge, prior to
injection. | The pen-injector will allow a user to dial
a dose that is greater than what is
remaining in the insulin cartridge. Once
the pen-injector has completed the
delivery of the insulin available within the
cartridge (i.e., empties the insulin
cartridge), the portion of the dose that was
not injected will be displayed on the dose
dial; that is, the dose dial will not return
to "0" as it would if the entire dose was
delivered. |
| Exterior materials | Anodized aluminum and plated
plastics and metals | Powder-coated and plated plastics and
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:
6
- 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.