(121 days)
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.
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 ).
The provided document is a 510(k) summary for the NovoPen Echo® device, specifically for a change in manufacturing location and minor updates to the device. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a de novo study with novel acceptance criteria and reported device performance from a new efficacy trial.
Therefore, the document does not contain the detailed information necessary to fully address all points concerning acceptance criteria and study design as typically expected for a new device's efficacy study.
However, based on the available information, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document states that the device was evaluated against the requirements specified in ISO 11608-1:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems. This standard would define the acceptance criteria for performance aspects such as dosing accuracy, dose button force, and other functional parameters relevant to pen injectors.
While specific numerical acceptance criteria and reported performance values are not provided in this summary, the document states:
- "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"
- "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."
- "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)."
Therefore, the implied acceptance criteria are compliance with ISO 11608-1:2012 and the reported device performance is that it met all product requirements and passed all tests, demonstrating substantial equivalence to the predicate device.
Without the full test reports, a detailed table with specific numerical criteria and results cannot be generated from this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the summary.
- Data Provenance: The tests were conducted to support the transfer of manufacturing from Denmark (DMD) to Tianjin, China (STJ), implying the testing was performed on devices produced at the new manufacturing site. The study is prospective in the sense that newly manufactured devices were tested to confirm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to the type of device (pen injector) and the nature of this submission (manufacturing change). Ground truth for a pen injector's functional performance would typically be established through engineering measurements and adherence to international standards, not through expert consensus on diagnostic images or similar expert review processes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and submission. Adjudication methods are typically used in studies involving subjective interpretation (e.g., medical imaging) to resolve disagreements among human readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The NovoPen Echo® is a mechanical pen injector designed for patient self-injection, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is typically relevant for AI/software devices. The NovoPen Echo® is a mechanical device with a memory function and liquid crystal display; its "memory function" is described as a sensor detecting movement for display, not a complex algorithm performing diagnosis or analysis. The performance verified was related to the mechanical and display functionalities, meaning a form of "standalone" evaluation of the device's technical specifications was performed according to ISO standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is objective measurement against the specifications and requirements outlined in ISO 11608-1:2012 and potentially internal product requirements for dose accuracy, delivery force, functionality of the display, etc. This is based on engineering and physical measurement standards, not expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This device is not an AI-driven learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable (as per point 8).
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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.
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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
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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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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).
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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
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| NovoPen EchoSection 5. Special 510(k) SummarynovoDOCs 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.
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| 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.
§ 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).