NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)

K182387 · Novo Nordisk, Inc. · FMF · Dec 17, 2018 · General Hospital

Device Facts

• Record ID: K182387
• Device Name: NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
• Applicant: Novo Nordisk, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Dec 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 injection], Fiasp® 100 units/mL (U-100) [insulin aspart 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.

Device Story

Reusable mechanical pen injector for insulin delivery; patient self-use. Input: manual rotation of dose button (0.5 to 30 units). Operation: mechanical coupling drives piston to expel insulin; independent memory function tracks last dose and elapsed time. Sensor in coded cylinder detects rotation; data stored and displayed on LCD. Benefit: accurate insulin dosing and memory tracking for diabetes management.

Clinical Evidence

No clinical data provided. Bench testing performed to verify dose accuracy with Fiasp 3 mL PenFill cartridges per ISO 11608-1:2014 requirements.

Technological Characteristics

Reusable mechanical pen injector; 0.5-30 unit dose range; 0.5 unit increments. Uses 3 mL PenFill cartridges. Includes LCD memory display. Complies with ISO 11608-1. Battery-powered for memory function.

Indications for Use

Indicated for single patient use by diabetics for self-injection of insulin using 3 mL PenFill cartridges (NovoLog or Fiasp).

Regulatory Classification

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.

Predicate Devices

• NovoPen Echo (K162602)

Submission Summary (Full Text)

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December 17, 2018

Novo Nordisk Inc. Elizabeth D'amato Director, Regulatory Affairs 800 Scudders Mill Rd Plainsboro, New Jersey 08536

Re: K182387

Trade/Device Name: NovoPen Echo Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 26, 2018 Received: November 27, 2018

#### 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Alan M.
Stevens -S

Tina Kiang, Ph.D. for 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) K182387

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 injection], Fiasp® 100 units/mL (U-100) [insulin aspart 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) | |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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## TRADITIONAL 510(K) SUMMARY

| Manufacturer's Name: | Novo Nordisk Inc.<br>PO Box 846<br>Plainsboro, NJ 08536 |
|---------------------------------|---------------------------------------------------------------------------------|
| Corresponding Official: | Elizabeth D'Amato<br>Director, Regulatory Affairs |
| Telephone Number:<br>E-mail: | 609-919-7789<br>[e-mail] |
| Preparation Date: | December 14, 2018 |
| Trade Name: | NovoPen Echo® |
| Common or Usual Name: | Dial-A-Dose Insulin Delivery Device (Pen Injector) |
| Classification Name and Number: | Piston Syringe<br>Regulation: 21 CFR 880.5860<br>Class: II<br>Product Code: FMF |
| Primary Predicate Device: | K162602 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

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crystal display in the dosage selector module as the number of units injected. The NovoPen Echo® is substantially equivalent to NovoPen Echo® cleared under K162602.

## Intended Use

The Intended Use including Indication for Use for the proposed device is as follows: 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) [insulin aspart injection], Fiasp® 100 units/mL (U-100) [insulin aspart 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.

## Substantial Equivalence Discussion

The NovoPen Echo® is substantially equivalent to NovoPen Echo® cleared under K162602 on October 18, 2016.

There are no changes made to the NovoPen Echo® device from the previously cleared NovoPen Echo® (K162602). Intended use, user, and user environment of the NovoPen Echo® are the same for NovoLog® and Fiasp® 3 mL PenFill. Therefore, based on the dose accuracy data with Fiasp® the addition of Fiasp® 3 mL PenFill is not expected to impact the safe and effective use of the NovoPen Echo®. The proposed NovoPen Echo® is substantially equivalent to NovoPen Echo® cleared under K162602.

# Discussion of Differences

The purpose for submitting this Traditional 510(k) is to obtain marketing clearance for NovoPen Echo expand the currently approved intended use to include Fiasp® (insulin aspart injection) 3mL PenFill® cartridges.

There have been no changes in the principle of operation, materials, energy source and performance compared with the predicate devices.

# Performance Testing

Device Verification Tests confirm that the NovoPen Echo meets the requirements of ISO11608-1 Needle-based injection systems for medical use - Requirement and test methods - Part 1: Needle based injection systems.

Novo Nordisk proposes to expand the currently approved intended use for NovoPen Echo to include the use of Fiasp® (insulin aspart injection) 3mL PenFill® cartridges. Therefore, the dose accuracy performance test of the Fiasp® (insulin aspart injection) 3 mL PenFill® cartridges with NovoPen Echo® was performed which meets the requirements of ISO11608-1:2014.

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## 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.

## 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 device.

The results of the testing to standards provide additional evidence that NovoPen Echo® is substantially equivalent to the predicate device, NovoPen Echo®. The differences between NovoPen Echo® and the predicate device do not raise any new performance issues. The differences between NovoPen Echo® and the predicate device do not change the intended use of the product.