(85 days)
K983874, NDA 20-986/S-004
K983874, NDA 20-986/S-004
No
The description focuses on the mechanical aspects of a reusable pen injector for insulin, with no mention of AI or ML capabilities.
No.
The device is a pen injector for self-administering insulin, which is a drug delivery device, not a therapeutic device itself. Its function is to deliver medication, not to provide therapy.
No
The device is described as a reusable pen injector for self-injection of insulin, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "reusable mechanical pen-injector," indicating it is a physical hardware device.
Based on the provided information, the HumaPen Luxura HD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the self-injection of insulin by diabetics. This is a drug delivery device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description confirms it's a mechanical pen-injector for insulin delivery.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, etc.)
- Providing diagnostic information
- Using reagents or assays
The HumaPen Luxura HD is a medical device, specifically a drug delivery device, but it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
NSC
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).
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K983874, NDA 20-986/S-004
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
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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 |
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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)
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