(130 days)
The HumaPen Luxura HD is a reusable pen injector designed for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.
HumaPen Luxura HD 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 3.0 mL insulin cartridges and single-use, detachable and disposable pen needles (supplied separately).
The provided document is a 510(k) summary for the HumaPen Luxura HD, a pen-injector for insulin. It describes the device's characteristics and its equivalence to a predicate device but does not contain the detailed information requested regarding the study design, sample sizes, expert involvement, or specific performance metrics in table format, as typically found in clinical trial reports or detailed scientific studies.
However, I can extract the available information and highlight what is missing based on your request.
Acceptance Criteria and Device Performance (Based on available information)
| Metric | Acceptance Criteria (Standard Reference) | Reported Device Performance (HumaPen Luxura HD) |
|---|---|---|
| Dose Accuracy | ISO 11608-1.2000 requirements | Met ISO 11608-1.2000 requirements |
| Tighter tolerance for 0.5 unit dialing | Met tighter dose accuracy tolerance | |
| Functionality | Not explicitly defined, but implied | Met functionality standards |
| Biocompatibility | ISO 10993-1 | Materials shown to be safe for patient contact |
| Pen Operation and Function | Unchanged from predicate device | Unchanged from currently cleared HumaPen Luxura HD |
Study Information Pertaining to Device Performance
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Sample size used for the test set and the data provenance:
- Not provided. The document states "HumaPen Luxura HD was tested per ISO 11608-1 for dose accuracy and functionality" and "HumaPen Luxura HD components were evaluated for biocompatibility per ISO 10993-1." However, it does not specify the number of devices or components tested, the number of dose deliveries, or the origin of any data used.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. For a mechanical device like an insulin pen, "ground truth" and expert consensus as typically seen in image analysis or diagnostic AI studies are not relevant in the same way. Performance is measured against engineering standards (like ISO 11608-1) and physical properties (like dose delivery).
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Adjudication method for the test set:
- Not applicable/Not provided. Adjudication is not typically used for testing mechanical device performance against engineering standards. The device's output (e.g., delivered dose) is directly measured.
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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 pen-injector, a mechanical medical device, not an AI-assisted diagnostic tool or an imaging system that involves human readers interpreting results. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical pen-injector. The concept of an "algorithm only" or "human-in-the-loop" performance does not apply to this type of device. Its performance is measured based on its mechanical function of drug delivery.
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The type of ground truth used:
- For dose accuracy: Instrumental measurements against an established international standard (ISO 11608-1.2000). The "ground truth" is the physically measured dose delivered by the device compared to the dialed dose, assessed according to the specified tolerances in the standard.
- For biocompatibility: Laboratory testing against established international standard (ISO 10993-1). The "ground truth" here is determined by the results of biocompatibility tests on the device materials.
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The sample size for the training set:
- Not applicable/Not provided. This is a mechanical device, not an AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As this is not an AI/ML device, there is no training set or corresponding ground truth establishment process in that context.
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510(k) Summary
AUG 1 7 2010
09988
1. Submitter's Name
Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285 (317) 276-2000
Contact Person
Steve Johnson, M.B.A, P.E. Associate Regulatory Consultant Phone: (317) 433-4685 Fax:
Date Prepared: April 2, 2010
2. Device Name
| Proprietary Name: | HumaPen Luxura HD |
|---|---|
| Common Name: | Pen-Injector |
| Classification Name: | Piston Syringe |
| Regulation: | 21 CFR 880.5860 |
| Product Code: | FMF |
| Class: | II |
3. Predicate Device
| Manufacturer: | Eli Lilly and Company |
|---|---|
| Proprietary Name: | HumaPen Luxura HD® |
| Submission: | K063151 |
4. Device Description
HumaPen Luxura HD 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 3.0 mL insulin cartridges and single-use, detachable and disposable pen needles (supplied separately).
LY888889 HumaPen Luxura 0.5 Response to Questions US (Quality)
August 2010 CONFIDENTIAL - Eli Lilly and Company
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5. Intended Use
The HumaPen Luxura HD is a reusable pen injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.
6. Technological Characteristics
| Pen Feature | New Device | Predicate Device |
|---|---|---|
| Similarities | ||
| Syringe Type | Piston Syringe | Piston Syringe |
| Intended Use | Delivery of Lilly insulins in3 mL cartridges | Delivery of Lilly insulins in3 mL cartridges |
| Reusable Device | Yes | Yes |
| Delivery Accuracy | Meets ISO 11608-1.2000requirements | Meets ISO 11608-1.2000requirements |
| Cartridge Volume | 3 ml (300 units) | 3 ml (300 units) |
| Maximum Delivered Dose | 30 Units | 30 Units |
| Audible Clicks withEach Increment | Yes | Yes |
| Two-Way Dose Dialing | Yes | Yes |
| Differences | ||
| Unit Increments | Half-Unit increments after0.5 Unit | Half-Unit increments after1 Unit |
7. Performance data
HumaPen Luxura HD was tested per ISO 11608-1 for dose accuracy and functionality. HumaPen Luxura. HumaPen Luxura HD components were evaluated for biocompatibility per ISO 10993-1.
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8. Conclusion
HumaPen Luxura HD has met the standards for dose accuracy and functionality. HumaPen Luxura HD has also met tighter dose accuracy tolerance based on the dialing resolution of 0.5 units. Biocompatibility investigation of materials has shown that the materials used in the HumaPen Luxura HD are safe for patient contact. Pen operation and pen function are unchanged from the currently cleared HumaPen Luxura HD. The HumaPen Luxura HD is substantially equivalent to the currently cleared HumaPen Luxura HD.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Steven T. Johnson PE, MBA Associate Regulatory Consultant Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285
AUG | 7 2010
Re: K100988
Trade/Device Name: HumanPen Luxura HD Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 26, 2010 Received: July 27, 2010
Dear Mr. Johnson:
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 vour 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. Johnson
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/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 Small Manufacturers, International and Consumer Assistance 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,
Wh 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
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Indications for Use
510(k) Number (if known):
Device Name: HumaPen Luxura HD
Indications for Use:
The HumaPen Luxura HD is a reusable pen injector designed for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/OR
Over -The -Counter Use (21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Adel C. Chapman
(Division Sign-Off)
(Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anestheciolors of Devices
Infection Control, Dental Devices
510(k) Number: K100988
§ 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).