(251 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 Penli ill " 3 mL cartridges of Novo Nordisk insulin 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 one-half (1/2) unit increments.
The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in half unit increments, from a Novo Nordisk 3.0 mL insulin cartridge. 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 Novo Nordisk 3.0 mL insulin cartridges and single-use, detachable and disposable pen needle (supplied separately by Novo Nordisk).
The provided text describes the NovoPen Echo® insulin delivery device and its 510(k) summary. However, it does not contain the detailed acceptance criteria and study information as requested. The document states that the device meets design requirements and complies with ISO 11608-1, and that Human Factor testing documented its safety. It also mentions a shelf life.
Here's a breakdown of what is present and what is missing from your request:
What is present (to a limited extent):
- Acceptance Criteria Mention: The document states that "The results of design verification testing has documented that the NovoPen Echo® meets all its design requirements and complies with the requirements specified in ISO 11608-1 Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods." This implies that the acceptance criteria are based on ISO 11608-1, but the specific numerical criteria or performance targets are not listed. It also mentions that "Human Factor testing has documented that the NovoPen Echo" is safe to use."
- Study Mention: "Design verification testing" and "Human Factor testing" are mentioned as studies performed.
- Device Performance Mention: It states the device "meets all its design requirements and complies with the requirements specified in ISO 11608-1" and "is safe to use." Specific performance metrics are not given.
What is largely missing from the provided text:
- A table of acceptance criteria and the reported device performance: The text mentions meeting ISO 11608-1, but doesn't detail the requirements from that standard or the specific performance results in a table format.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific "test set" or "ground truth" derived from experts for performance metrics is detailed. The human factors testing likely involved users, but specifics are absent.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable as this is a medical device (insulin pen), not an AI diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device.
- The type of ground truth used: Not applicable for device performance in the context of ISO standards. For human factors, "safety" is the ground truth, assessed by user interaction.
- The sample size for the training set: Not applicable for a mechanical device.
- How the ground truth for the training set was established: Not applicable for a mechanical device.
Table of Acceptance Criteria and Reported Device Performance (Based only on the provided text, heavily inferred):
| Acceptance Criteria Category | Specific Criteria (Inferred from Text) | Reported Device Performance (From Text) |
|---|---|---|
| Device Performance | Meets design requirements as per ISO 11608-1 | "The results of design verification testing has documented that the NovoPen Echo® meets all its design requirements and complies with the requirements specified in ISO 11608-1 Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods." |
| Safety and Usability (Human Factors) | Safe for use by intended users in intended environment for intended use | "The results of Human Factor testing has documented that the NovoPen Echo" is safe to use by the intended users in the intended environment for the intended use." |
| Shelf Life | 5 years in-use lifetime (if taken into use within 2 years of production date) | "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." |
In summary, the provided 510(k) summary is a high-level document confirming that testing was done and the device met requirements set by an international standard (ISO 11608-1) and human factors principles. It does not elaborate on the specific details of those tests, such as sample sizes, ground truth establishment methods, or the specific numerical performance results.
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Image /page/0/Picture/1 description: The image shows the logo for Novo Nordisk. The logo features a black and white drawing of a bull with a sun-like object above its head. Below the bull, the words "novo nordisk" are written in a sans-serif font. The registered trademark symbol is to the right of the company name.
510(k) Summary
- Submitter's Name: Novo Nordisk Inc. P.O. Box 846 Plainsboro, NJ 08536
Contact Person
AUG 15 2013
Lois Kotkoskie Ph. D. Senior Director Regulatory Affairs Tel: 609-987-5973 Fax: 609-987-3916 Date Prepared: June 19, 2013
- Device Name:
Proprietary Name: Common Name: Classification Name: Regulation: Class:
NovoPen Echo® Dial-A-Dose Insulin Delivery Device (Pen Injector) Syringe/Piston (FMF) 21 CFR 880.5860 Class II
3. Predicate Device:
510(k) cleared device (Primary Predicate Device)
Manufacturer: Novo Nordisk K010359 Innovo® Proprietary Name:
4. Device Description:
The NovoPen Echo® is a reusable mechanical pen-injector capable of injecting a dose of up to 30 units of insulin, in half unit increments, from a Novo Nordisk 3.0 mL insulin cartridge. 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
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Image /page/1/Picture/0 description: The image shows the logo for Novo Nordisk. The logo features a bull-like animal with a sun-like object above its head. Below the animal is the text "novo nordisk" in a sans-serif font, with a trademark symbol to the right of the text.
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 Novo Nordisk 3.0 mL insulin cartridges and single-use, detachable and disposable pen needle (supplied separately by Novo Nordisk).
5. Intended Use including Indication for 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 3.0 mL cartridges of Novo Nordisk insulin 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 one half (1/2) unit increments.
6. Technological Characteristics:
The NovoPen Echo® is considered substantially equivalent to the predicate device in intended use, principle of operation, memory function, energy source and performance. The memory function of the predicate device has identical functionality as the NovoPen Echo. The injection technique used to administer insulin is the same for each device. Each device requires 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. Each device is capable of multiple injections from a single insulin source (cartridge).
7. Testing
Performance Data:
The results of design verification testing has documented that the NovoPen Echo® meets all its design requirements and complies with the requirements specified in ISO! 1608-1 Pen-injectors for medical use - Part 1: Pen-injectors - Requirements and test methods.
The results of Human Factor testing has documented that the NovoPen Echo" is safe to use by the intended users in the intended environment for the intended use.
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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Image /page/2/Picture/0 description: The image shows the logo for Novo Nordisk. The logo features a drawing of an Apis bull with a sun disk between its horns. Below the drawing is the text "novo nordisk" in a lowercase sans-serif font, with the registered trademark symbol to the right.
8. Conclusions:
In conclusion, the results of the testing demonstrate that NovoPen Echo is as safe and effective and performs as well as the predicate device.
The results of the testing to voluntary standards provide additional evidence that NovoPen Echo is substantially equivalent to the predicate device in terms of safety, efficacy and performance.
The differences between NovoPen Echo® and the predicate device do not raise any new issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2013
Novo Nordisk, Incorporated Mr. Rick Spring Associate Director, Regulatory Affairs P.O. Box 846 PLAINSBORO NJ 08536
Re: K123766
Trade/Device Name: NovoPen Echo® Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 22, 2013 Received: July 23, 2013
Dear Mr. Spring:
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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Page 2 - Mr. Spring
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division 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 Statement
510(k) Number (if known):
Device Name: NovoPen Echo®
くう
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 Penli ill " 3 mL cartridges of Novo Nordisk insulin 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 one-half (1/2) unit increments.
Prescription Use
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Richard C. Chapman | |
|---|---|
| 2013.08.14 12:33:40 | |
| -04'00' |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
ifection Control, Dental Devices
| 510(k) Number: | K123766 |
|---|---|
| ---------------- | --------- |
§ 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).