(107 days)
Not Found
No
The description focuses on the mechanical and electronic display aspects of a reusable pen injector for insulin, with no mention of AI or ML capabilities.
Yes
The device is described as a pen injector for the self-injection of insulin by diabetics, which is a therapeutic intervention for managing diabetes.
No
Explanation: The device is described as a pen injector for self-injection of insulin, used for delivering a drug (insulin). It does not appear to collect any data or provide any analysis of a patient's condition for diagnostic purposes.
No
The device is a reusable mechanical pen-injector with an electronic display, indicating it is a hardware device with some electronic components, not solely software.
Based on the provided information, the HumaPen Memoir is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the self-injection of insulin by diabetics. This is a therapeutic delivery device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description confirms it's a mechanical pen-injector for delivering medication.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information.
Therefore, the HumaPen Memoir falls under the category of a drug delivery device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HumaPen Memoir 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 insulin (Humalog® and Humulin®) and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose in one-unit increments up to 60 units.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
HumaPen Memoir is a reusable mechanical pen-injector with electronic display designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company Humalog and Humulin 3.0 mL 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
diabetics for the 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)
Not Found
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.
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
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7 2006 APR 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:
2. Device Name
| Proprietary Name: | HumaPen Memoir |
|---|---|
| Common Name: | Pen-Injector |
| Classification Name: | Piston Syringe |
3. Predicate Device
| Manufacturer: | Novo Nordisk Pharmaceuticals |
|---|---|
| Proprietary Name: | Innovo® |
| Submission: | K010359 |
4. Device Description
HumaPen Memoir is a reusable mechanical pen-injector with electronic display designed for use for the self-injection of insulin. The pen-injector is intended for use with Eli Lilly and Company Humalog and Humulin 3.0 mL cartridges and single-use, detachable and disposable pen needles (supplied separately).
5. Intended Use
HumaPen Memoir has been developed for the injection of Humalog and Humulin from Eli Lilly and Company 3.0 mL cartridges.
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6. Technological Characteristics
| Pen Feature | New Device | Predicate Device |
|---|---|---|
| Similarities: | ||
| Syringe Type | Piston Syringe | Piston Syringe |
| Intended Use | Delivery of Humalog and | |
| Humulin in Lilly 3 mL cartridges. | Delivery of Novolin in Novo | |
| Nordisk PenFill 3 mL | ||
| cartridges. | ||
| Specific drug use | Insulin | Insulin |
| Reusable device | Yes | Yes |
| Delivery accuracy | Meets ISO 11608-1.2000 | |
| requirements | Meets ISO 11608-1 (Part 1) | |
| requirements | ||
| Cartridge Volume | 3ml (300 units) | 3ml (300 units) |
| Unit increments | One Unit increments | One Unit increments |
| Audible clicks with each increment | Yes | Yes |
| Dose Display | Electronic LCD | Electronic LCD |
| Display check when powered on | Yes | Yes |
| Last Dose Indication | Yes | Yes |
| Two-way dose dialing | Yes | Yes |
| Non-replaceable battery | Yes | Yes |
| Differences: | ||
| Body Material | Metal | Plastic |
| Maximum dose units | 60 | 70 |
| Dose Memory | Last 16 doses | Last dose |
| Time and date of last dose | Yes | No |
| Pen life (battery) | 3 yrs | 5 yrs |
| Low battery display | ||
| indication | Yes | Yes |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and wings. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 7 2006
Ms. LeeAnn Chambers Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285
Re: K053563
Trade/Device Name: HumaPen Memoir Regulation Number: 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: March 23, 2006 Received: March 27, 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 (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 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
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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sndtte Y. Micker
MD
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
Indications For Use
510(k) Number (if known): K053563
Device Name: HumaPen Memoir
Indications For Use:
The HumaPen Memoir 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 insulin (Humalog® and Humulin®) and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose in one-unit increments up to 60 units.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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