(29 days)
No
The device description details a purely mechanical pen injector with a simple memory function for the last dose and time elapsed, based on sensor rotation and storage. There is no mention of algorithms, learning, or data processing beyond simple storage and display.
Yes.
The device facilitates the self-injection of insulin, which is a therapeutic agent used to manage diabetes.
No
The device is an insulin pen injector used for administering a dose of insulin, not for diagnosing a medical condition. While it has a memory function for tracking the last dose and time, this is for tracking administration, not diagnosis.
No
The device is a mechanical pen injector with a memory function and LCD display. It is a physical hardware device for insulin delivery, not solely software.
Based on the provided information, the NovoPen Echo® 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 therapeutic action, delivering a substance into the body.
- Device Description: The device is a mechanical pen injector that delivers insulin. While it has a memory function, its primary function is the physical delivery of medication.
- Lack of In Vitro Testing: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The NovoPen Echo® does not perform any such testing.
- Performance Studies: The performance studies described focus on verifying the mechanical function and compliance with standards related to injection systems, not on the accuracy or reliability of diagnostic testing.
In summary, the NovoPen Echo® is a drug delivery device, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NovoPen Echo® is a re-usable pen injector designed for single-patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [Insulin aspart Injection (rDNA origin)] 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 0.5 unit increments.
Product codes
FMF
Device Description
The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in 0.5 unit increments, from a NovoLog 3 mL PenFill® cartridge. The memory function enables the user of the device to see the quantity of last given dose and hours that have passed since last dose. The operation of the pen-injection of insulin is entirely independent of the operation of the memory function. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected.
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
single-patient use by diabetics for the self-injection of a desired dose of insulin.
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)
Device Verification Tests were run to verify all product requirements are still met and all changes work properly and comply with the requirements specified in ISO11608-1 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems. No clinical testing was provided or required. The results of the testing demonstrate that NovoPen Echo® performs as well as the predicate devices. The results of the testing to standards provide additional evidence that NovoPen Echo® is substantially equivalent to the predicate devices, K150874, NovoPen Echo® and K123766, NovoPen Echo®.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K150874 NovoPen Echo®, K123766 NovoPen Echo®
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2016
Novo Nordisk Inc. Elizabeth D'amato Director, Regulatory Affairs P.O. Box 846 Plainsboro, New Jersey 08536
Re: K162602
Trade/Device Name: Novopen Echo® Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 16, 2016 Received: September 19, 2016
Dear Elizabeth D'amato:
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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21 CFR 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,
Tina
Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162602
Device Name NovoPen Echo®
Indications for Use (Describe)
Indications for Use: The NovoPen Echo® is a re-useable pen injector designed for single patient use by diabetics for the seff-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart (rDNA origin) injection] 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 0.5 unit increments.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------- |
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K162602 SPECIAL 510(K) SUMMARY
| Manufacturer's Name: | Novo Nordisk Inc.
PO Box 846
Plainsboro, NJ 08536 |
|----------------------------------------------------------|--------------------------------------------------------------------------------|
| Corresponding Official: | Elizabeth D'Amato
Director, Regulatory Affairs |
| Telephone Number:
E-mail: | 609-919-7789
lizd@novonordisk.com |
| Preparation Date: | September 23, 2016 |
| Trade Name: | NovoPen Echo® |
| Common or Usual Name: | Dial-A-Dose Insulin Delivery Device (Pen Injector) |
| Classification Name and Number: | Syringe/Piston
Regulation: 21 CFR880.5860
Class: II
Product Code: FMF |
| Primary Predicate Device:
Secondary Predicate Device: | K150874 NovoPen Echo®
K123766 NovoPen Echo® |
Device Description
The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in 0.5 unit increments, from a NovoLog 3 mL PenFill® cartridge. The memory function enables the user of the device to see the quantity of last given dose and hours that have passed since last dose. The operation of the pen-injection of insulin is entirely independent of the operation of the memory function. The intended dose is mechanically set by rotating a dose button. The insulin is injected by depressing the dose button which via mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The device has a memory function and liquid crystal display that allows the user to review the units of the last dose and the number of hours that have elapsed since the last dose was taken. Rotation of the dose button during dose setting causes a sensor to rotate within a coded cylinder. The movement detected by this sensor is stored for later display on the liquid crystal display in the dosage selector module as the number of units injected.
4
Intended Use
The Novo Pen Echo® is a re-usable pen injector designed for single-patient use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [Insulin aspart Injection (rDNA origin)] 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 0.5 unit increments.
Substantial Equivalence Discussion
The injection technique used to administer insulin is the same as the predicate devices. NovoPen Echo . All devices require a needle to penetrate the subcutaneous layer of tissue, an insulin source and a plunger to push the insulin from the source, through the needle and into the subcutaneous laver of tissue. All devices are capable of multiple injections from a single insulin source (cartridge).
NovoPen Echo® has the same 0.5 increment dosing capability as predicate devices and complies with requirements specified in ISO11608-1 Needle-based injection systems for medical use -Requirements and test methods - Part 1: Needle-based injection systems.
The biocompatibility, shelf life and performance testing of the cartridge holder change was evaluated in K123766 and found to meet the product specifications. There have been no changes in the product specification.
Discussion of Differences
The cartridge holder for NovoPen Echo® is being changed to the same cartridge holder that was used in the predicate K123766, NovoPen Echo®.
There have been no changes in the intended use, principle of operation, materials, energy source and performance compared with the predicate devices.
Performance Testing
Device Verification Tests were run to verify all product requirements are still met and all changes work properly and comply with the requirements specified in ISO11608-1 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems.
Shelf Life
The NovoPen Echo® has an in-use lifetime of 5 years provided that the pen is taken into use within two years of the production date. The NovoPen Echo® informs the user via the memory display when the pen has reached its end of life.
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Clinical Tests
No clinical testing was provided or required.
Conclusions
In conclusion, the results of the testing demonstrate that NovoPen Echo® performs as well as the predicate devices.
The results of the testing to standards provide additional evidence that NovoPen Echo® is substantially equivalent to the predicate devices, K150874, NovoPen Echo® and K123766, NovoPen Echo®. The differences between NovoPen Echo® and the predicate devices do not raise any new issues of safety or effectiveness. The differences between NovoPen Echo® and the predicate device do not change the intended use of the product.