(121 days)
Not Found
No
The device description details a mechanical pen injector with a memory function for tracking dose and time since last dose. The mechanism for dose setting and injection is described as entirely mechanical, and the memory function relies on a sensor detecting rotation, not AI/ML algorithms. There is no mention of AI, ML, or related concepts in the document.
No.
A therapeutic device is one that treats a disease or condition. This device is an insulin pen, which is used to administer insulin, but the device itself does not contain the therapeutic agent (insulin), nor does it treat the condition; it is an administration device.
No
The device description indicates it is a pen injector for insulin, with a memory function for dose history, but it does not analyze patient data or provide medical diagnoses.
No
The device description clearly details a mechanical pen injector with a memory function and liquid crystal display, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, the NovoPen Echo® is not an IVD (In Vitro Diagnostic) device.
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 derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a mechanical pen-injector for delivering insulin. While it has a memory function for tracking doses, this function is related to the delivery of the therapeutic agent, not the analysis of biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The NovoPen Echo® is a drug delivery device.
N/A
Intended Use / Indications for Use
The NovoPen Echo® is a re-useable 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) finsulin 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.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The NovoPen Echo® (STJ) 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 PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [Insulin aspart Injection (rDNA origin)] . 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-injector for the 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. The pen-injector is intended for use with 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 by Novo Nordisk ).
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 / 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)
Device Verification Tests were run to verify all product requirements are still met and all changes work properly and complies with the requirements specified in ISO11608-1:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems.
Software verification and validation regression testing all static, unit, integration and system, tests as well as additional tests for the changes and related risk control measures was conducted and all tests passed.
Results: The results of the testing demonstrate that NovoPen Echo® (STJ) is as safe and effective and performs as well as the predicate device. The results of the testing to standards provide additional evidence that NovoPen Echo® (STJ) is substantially equivalent to the predicate device, NovoPen Echo® (DMD). The differences between NovoPen Echo® (STJ) and the predicate device, NovoPen Echo® (DMD), do not raise any new issues of safety or effectiveness.
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
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 features three human profiles facing right, connected by a flowing ribbon-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2015
Novo Nordisk Inc. Ms. Poonam Tuliani Associate Director, Regulatory Affairs P.O. Box 846 Plainsboro, New Jersey 08536
Re: K150874
Trade/Device Name: NovoPen Echo® Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 30, 2015 Received: July 1, 2015
Dear Ms. Tuliani:
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 (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 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 yours,
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for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150874
Device Name NovoPen Echo®
Indications for Use (Describe)
The NovoPen Echo® is a re-useable 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) finsulin 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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3
Date: Version: Status: Page:
510(k) Summary K150874
21 CFR 807.87(h)
As required by 21 CFR 807.92(a)
Date Prepared: July 29, 2015
This 510(k) Summary is being submitted in accordance with 21 CFR 807.92.
1. Submitter's Name:
Novo Nordisk Inc. P.O. Box 846 Plainsboro, NJ 08536
Contact Person:
Poonam Tuliani Associate Director, Regulatory Affairs Tel: 609-786-5210 Fax: 609-987-3916
2. Device Name:
Proprietary Name: NovoPen Echo® Common Name: Dial-A-Dose Insulin Delivery Device (Pen Injector) Classification Name: Syringe/Piston (FMF) Regulation: 21 CFR 880.5860 Class: Class II
3. Substantial Equivalence:
The manufacturing site for NovoPen Echo® is to be transferred from Site Device Manufacturing Development (DMD), Denmark to Site Tianjin, China (STJ). Hereinafter, the original cleared device is referred to as NovoPen Echo® (DMD) and the modified device is referred to as NovoPen Echo® (STJ).
4
CONFIDENTIAL
Date: Version: Status: Page:
In order to improve manufacturability, production automation, and to align manufacturing with other devices within the NovoPen® family, the following changes have been implemented to NovoPen Echo®.
- Update of software to support manufacturing automation as well as including other minor changes
- . Update of selected components and component material changes for a small number of components
- Labelling changes
The above changes do not affect intended use, indications for use, technological characteristics, functionality of components, principle of operation, shelf life, biocompatibility and device user interface. Therefore, NovoPen Echo® (manufactured in Novo Nordisk (NN), Site Tianjin, China) is substantially equivalent to Novo Nordisk's NovoPen Echo® (manufactured in NN, Site DMD, Denmark), cleared under 510(k) K123766 in August, 2013.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and as supplied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statement related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent laws or their application by the court.
4. Device Description:
The NovoPen Echo® (STJ) 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 PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [Insulin aspart Injection (rDNA origin)] . 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-injector for the 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
5
| NovoPen Echo
Section 5. Special 510(k) Summary
| novoDOCs id:002057078 | CONFIDENTIAL | Date: | 31 July 2015 | Novo Nordisk |
|---|---|---|---|---|
| Version: | 4.0 | |||
| Status: | Final | |||
| Page: | 4 of 5 |
number of units injected. The pen-injector is intended for use with 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 by Novo Nordisk ). NovoPen Echo® (STJ) is substantial equivalent to the primary predicate device NovoPen Echo® (DMD)
- Intended Use including Indication for Use:The Intended Use including Indication for Use for the modified device are as follows:
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.
6. Technological Characteristics:
The NovoPen Echo® (STJ) is considered substantially equivalent to the predicate device in intended use, principle of operation, materials, energy source and performance.
The injection technique used to administer insulin is the same as predicate device, NovoPen Echo® (DMD). Both 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 layer of tissue. Both devices are capable of multiple injections from a single insulin source (cartridge).
Both devices have the same 0.5 increment dosing capability and comply with requirements specified in ISO11608-1:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems.
As required by 21 CFR 807.92(b)
Testing
Performance Data:
Device Verification Tests were run to verify all product requirements are still met and all changes work properly and complies with the requirements specified in ISO11608-1:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems.
6
| NovoPen Echo |
|---|
| Section 5. Special 510(k) Summary |
| novoDOCs id:002057078 |
CONFIDENTIAL
Software verification and validation regression testing all static, unit, integration and system, tests as well as additional tests for the changes and related risk control measures was conducted and all tests passed.
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.
Conclusions:
In conclusion, the results of the testing demonstrate that NovoPen Echo® (STJ) is as safe and effective and performs as well as the predicate device.
The results of the testing to standards provide additional evidence that NovoPen Echo® (STJ) is substantially equivalent to the predicate device, NovoPen Echo® (DMD).
The differences between NovoPen Echo® (STJ) and the predicate device, NovoPen Echo® (DMD), do not raise any new issues of safety or effectiveness.