← Product Code [NSC](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NSC) · K063151 # HUMAPEN LUXURA HD (K063151) _Eli Lilly and Co. · NSC · Jan 9, 2007 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NSC/K063151 ## Device Facts - **Applicant:** Eli Lilly and Co. - **Product Code:** [NSC](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NSC.md) - **Decision Date:** Jan 9, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5860 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for 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 1 to 30 units in one-half (1/2) unit increments. ## Device Story HumaPen Luxura HD is a reusable mechanical pen-injector for insulin self-administration; utilizes 3 mL insulin cartridges and detachable, disposable pen needles. User dials dose (1 to 30 units) in 0.5-unit increments; mechanical mechanism delivers insulin. Intended for diabetic patients; used in home or clinical settings. Device provides precise dosing control for insulin therapy; benefits patient through simplified, accurate self-injection. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Reusable mechanical pen-injector; 3 mL cartridge capacity; 30-unit maximum dose; 0.5-unit dose increments. Compatible with Eli Lilly 3 mL insulin cartridges and standard disposable pen needles. Non-electronic, purely mechanical operation. ## Regulatory 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 - NovoPen® Junior (NDA 20-986/S-004) - Autopen® ([K983874](/device/K983874.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 510(k) Summary #### 1. Submitter's Name Eli Lilly and Company Lilly Corporate Center Indianapolis, IN 46285 (317) 276-2000 ### Contact Person LeeAnn Chambers, M.S., RAC Associate Regulatory Consultant Phone: (317) 277-1813 FAX: (317) 276-1887 Date Prepared: October 11, 2006 #### 2. Device Name | Proprietary Name: | HumaPen Luxura HD | |----------------------|-------------------| | Common Name: | Pen-Injector | | Classification Name: | Piston Syringe | #### 3 Predicate Devices | Manufacturer: | Novo Nordisk Pharmaceuticals, Inc | |-------------------|-----------------------------------| | Proprietary Name: | NovoPen® Junior | | Submission: | NDA 20-986/S-004 | | Manufacturer: | Owen Mumford Inc. | |-------------------|-------------------| | Proprietary Name: | Autopen® | | Submission: | K983874 | ### 4. Device Description HumaPen Luxura HD is a reusable mechanical pen-injector designed 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). #### 5. Intended Use HumaPen Luxura HD has been developed for the injection of insulin from Eli Lilly and Company 3 mL cartridges. JAN - 9 2007 K063151 Page 10 1 of 2 {1}------------------------------------------------ Kau3151 2 of Page 11 ## 6. Technological Characteristics | Pen Feature | New Device
HumaPen Luxura HD | Predicate Device
NovoPen Junior | Predicate Device
Autopen | |------------------------------|---------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------| | Intended Use | Delivery of Lilly insulins
in 3 mL cartridges. | Delivery of Novo Nordisk
insulins from PenFill 3 mL
cartridges. | Delivery of insulin from
replaceable 3 mL
cartridges. | | Compatible
drug products | HumaLog and Humulin | Novolog, Novolin R,
Novolin N, Novolin 70/30 | Eli Lilly 3 mL insulin
cartridges | | Reusable
device | Yes | Yes | Yes | | Cartridge
Volume | 3 mL (300 units) | 3 mL (300 units) | 3 mL (300 units) | | Maximum
Delivered
Dose | 30 Units | 35 Units | 42 Units | | Unit
increments | Half-Unit increments
after 1 Unit | Half-Unit increments after
1 Unit | 2 Unit increments | {2}------------------------------------------------ Public Health Service Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Eli Lilly and Company Ms. LeeAnn Chambers Regulatory Scientist Pharmaceutical Delivery Systems Lilly Corporate Center Indianapolis, Indiana 46285 JAN - 9 2007 Re: K063151 Trade/Device Name: HumaPen Luxura HD Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: NSC Dated: October 11, 2006 Received: October 18, 2006 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {3}------------------------------------------------ Page 2 - Ms. Chambers 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Chules Tin-Lien, Ph.D. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ KOG3151 1841 Page 9 # 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 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 1 to 30 units in one-half (1/2) unit increments. 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) f.e. HBV Division of Anesthesiology, General Hospital, Infection Control, Dental Devices Number: K06315) Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NSC/K063151](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NSC/K063151) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com