(270 days)
HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).
The HumaPen Luxura is a reusable mechanical pen-injector designed for use for the selfinjection 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.
Here's an analysis of the provided text regarding the HumaPen Luxura device, focusing on acceptance criteria and supporting studies:
This document is a 510(k) Premarket Notification from the FDA for the HumaPen Luxura, a reusable insulin pen. It primarily demonstrates substantial equivalence to a predicate device (HumaPen Luxura HD) rather than presenting a comprehensive study of a novel AI-powered device. Therefore, many of the requested categories for AI-specific studies and performance metrics are not applicable or cannot be extracted from this type of document.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (HumaPen Luxura) |
|---|---|
| Dose Accuracy | Meets ISO 11608-1:2012 requirements |
| - Standard Atmosphere | Passed |
| - Cool Atmosphere | Passed |
| - Warm Atmosphere | Passed |
| - Last-dose Accuracy | Passed |
| - Dry Heat | Passed |
| - Cold Storage | Passed |
| - Free Fall | Passed |
| - Vibration | Passed |
| - Damp Heat | Passed |
| - Temperature cycling | Passed |
| - Life-cycle test (9 years operation) | Passed dose accuracy testing after preconditioning |
| Biocompatibility | Meets ISO 10993-1:2009 (exterior materials) |
| Human Factors | Substantially equivalent to predicate device |
| Sterility | Not a sterile device (acceptance: not required to be sterile) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the specific number of devices or test cycles used for each non-clinical performance test. It mentions "sample devices" for the life-cycle test without giving a number.
- Data Provenance: The data is generated from non-clinical performance testing conducted by the device manufacturer, Eli Lilly and Company. This is prospective testing related to device design and manufacturing, not clinical data from patients. The country of origin of the data is implied to be within the company's testing facilities, likely in the US (Indianapolis, IN, is the submitter's location).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The referenced standards (ISO 11608-1:2012, ISO 10993-1:2009) define objective, quantifiable performance metrics, not expert-derived ground truth. Human Factors testing would involve users, but the document does not specify experts for "ground truth" establishment in the sense of AI evaluation.
4. Adjudication method for the test set:
Not applicable. The tests involve objective measurements against predefined criteria in international standards. There is no mention of an adjudication process for subjective assessments.
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:
Not applicable. This device is a mechanical insulin pen and not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the non-clinical performance tests is the defined limits and methodologies within the referenced international standards (ISO 11608-1:2012 for dose accuracy and functionality, ISO 10993-1:2009 for biocompatibility). These are objective, empirically verifiable standards.
8. The sample size for the training set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this mechanical device.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
Eli Lilly and Company c/o Ms. LeeAnn Chambers, M.S., RAC Global Regulatory Affairs, Devices Lilly Corporate Center Indianapolis, Indiana 46285
Re: K142518
Trade/Device Name: HumaPen Luxura Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product code: FMF Dated: April 10, 2015 Received: April 13, 2015
Dear Ms. Chambers:
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 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 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" (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 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
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Indications for Use
510(k) Number (if known) K142518
Device Name HumaPen Luxura
Indications for Use (Describe)
HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (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)
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510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92.
807.92(a)(1)
Submitter Information
Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285
Contact Person: LeeAnn Chambers, M.S., RAC 317-277-1813 chambers_leeann@lilly.com
Date: September 5, 2014
807.92(a)(2)
Device
| Trade Name: | HumaPen Luxura |
|---|---|
| Common Name: | Pen-Injector |
| Classification Name: | Piston Syringe |
| Regulation: | 21 CFR 880.5860 |
| Product Code: | FMF |
| Class: | II |
807.92(a)(3)
Predicate Device
| 510(k) Number | Device Name | Submitter Name |
|---|---|---|
| K100988 | HumaPen Luxura HD | Eli Lilly and Company |
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Device Description 807.92(a)(4)
The HumaPen Luxura is a reusable mechanical pen-injector designed for use for the selfinjection 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.
Intended Use(s) 807.92(a)(5)
HumaPen Luxura is a reusable insulin Pen intended for the self-injection of HUMALOG® (insulin lispro for injection) available in 3 mL Cartridges using disposable Pen Needles (sold separately).
Technological Characteristics 807.92(a)(6)
The HumaPen Luxura is a modification of the predicate device cleared under K100988. Both devices have the same materials of construction but different colors (burgundy and champagne for the new device versus green for the predicate) and different dose increments on the dial (1 unit on the new device dial vs 0.5 unit on the predicate device dial).
| Pen Feature | New Device:HumaPen Luxura | Predicate Device:HumaPen Luxura HDK100988 |
|---|---|---|
| Similarities | ||
| Intended Use | Delivery of Humalog (insulin lisprofor injection) in 3 mL cartridges | Delivery of Humalog (insulin lisprofor injection) 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 11608-1:2012requirements | Meets ISO 11608-1:2000requirements |
| Sterility | Not a sterile device | Not a sterile device |
| Differences | ||
| Dial Increments | 0.01 mL per increment providingone unit (1U) dose increments | 0.005 mL per increment providingone half unit (0.5 U) doseincrements |
| Maximum Delivered Dose | 60 Units | 30 Units |
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Non-Clinical Performance Data 807.92(b)(1)
The HumaPen Luxura device meets the requirements specified in ISO 11608-1:2012 Needlebased 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 sample devices were operated the ● number of actuations expected for 9 years of operation prior to performing dose accuracy testing.
The HumaPen Luxura 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 were evaluated in accordance with this standard and meet the biocompatibility standard.
The results of Human Factors testing have demonstrated that the HumaPen Luxura is substantially equivalent to the predicate device.
Clinical Performance Data 807.92(b)(2)
No clinical tests were performed.
807.92(b)(3)
Conclusions
HumaPen Luxura 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. Pen operation and pen function are unchanged from the currently cleared HumaPen Luxura HD. All the testing performed demonstrates that the new device is as safe and effective as the predicate device.
§ 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).