(88 days)
FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin and somatropin
FlexPen® needle is designed for single use in conjunction with Novo Nordisk injection delivery devices. Prior to giving an injection, the protective tab is removed from the outer needle can of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Prepare for injection by following the procedure described in the user manual provided with the pen injection device and instructions from your health care professional.
After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the FlexPen® needle by using the needle cap as described in the user manuals provided with the Novo Nordisk pen injection devices.
FlexPen® needle is used in exactly the same manner as the NovoFine® needles. The instructions for use are described in the user manuals for Novo Nordisk delivery devices for injection and are the same for all NovoFine® needles and FlexPen® needle.
This device is a hypodermic needle (FlexPen® needle) and the submission is a 510(k), which means it's seeking clearance based on substantial equivalence to predicate devices, rather than proving novel safety and effectiveness through clinical trials. Therefore, the information you've requested regarding acceptance criteria and studies to "prove the device meets acceptance criteria" is largely centered around non-clinical testing for equivalence and manufacturing standards, rather than clinical performance metrics.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Compliance |
|---|---|---|
| Manufacturing Standards | Current Good Manufacturing Practices (cGMP) for Medical Devices | "The FlexPen® needle will be manufactured in accordance with current Good Manufacturing Practices for Medical Devices." |
| Biocompatibility | Compliance with existing domestic and international standards. | "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards." |
| Performance (Functional) | Demonstrated functional equivalence to predicate devices (NovoFine® 32G Tip x 6 mm, NovoFine® Autocover® 30G x 8 mm, and Becton Dickinson BD Pen Needle (29G, 30G, 31G)). This implies meeting mechanical, fluid flow, and usability characteristics implicitly required for a hypodermic needle. Specifically, "Differences between the devices do not raise any significant issues of safety and effectiveness." | "Performance tests have been performed and the results are in compliance with existing domestic and international standards." "Based on the design equivalency and the functional testing, Novo Nordisk had determined that the FlexPen® needle is substantially equivalent to a device currently marketed in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness." |
| Intended Use | To be used with pen injector devices for the subcutaneous injection of insulin and somatropin. | The device's stated indications for use are "FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin and somatropin." This is identical to the predicate devices. |
| Technological Characteristics | Substantial equivalence in technology/principle of operation and materials compared to predicate devices. | "The FlexPen® needle is considered substantially equivalent to the NovoFine® 32G Tip x 6 mm, NovoFine® Autocover® 30G x 8 mm, and to the Becton Dickinson BD Pen Needle (29G, 30G, 31G) in intended use... technology/principle of operation, materials and performance. Differences between the devices do not raise any significant issues of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the "performance tests" or "biocompatibility tests." It only states that these tests were performed. Given the nature of a 510(k) for a hypodermic needle, these tests would likely involve various standard engineering and materials testing methods (e.g., tensile strength, flow rate, corrosion resistance, sterility, cytotoxicity), which often use statistically valid but not necessarily large "sample sizes" in the clinical trial sense.
Data provenance is not explicitly stated (e.g., country of origin), but the tests are implied to be conducted by the manufacturer (Novo Nordisk). These are retrospective in the sense that they are routine tests performed for product development and regulatory submission, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study that involves human interpretation or "ground truth" established by experts in the context of diagnostic performance. The "ground truth" for a hypodermic needle's performance is objective physical and chemical properties and functional characteristics, verified through standardized laboratory testing.
4. Adjudication Method for the Test Set
Not applicable for the reasons stated above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where different human readers interpret cases. The FlexPen® needle is a therapeutic medical device (for drug delivery), not a diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This concept is applicable to AI/ML software devices. The FlexPen® needle is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for the FlexPen® needle's performance is established by:
- Compliance with international and domestic standards for biocompatibility and performance (e.g., ISO standards for hypodermic needles).
- Demonstration of functional equivalence to legally marketed predicate devices through engineering and simulated use testing.
- Adherence to Current Good Manufacturing Practices (cGMP).
8. Sample Size for the Training Set
Not applicable. There is no AI/ML algorithm involved, so no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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K062500 page 1 of 3
FlexPen® needle Disposable Needle Novo Nordisk Inc.
510(k) Premarket Notification
Date Version Status Page
18 August 2006 Novo Nordisk 0.1 Final l of 3
807.87(h) 510(k) Summary
As required by Section 807.92(a)
(1) DATE OF PREPARATION: August 18, 2006
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. FlexPen® needle meets all applicable product and quality standards for hypodermic single lumen needle products.
SUBMITTER'S NAME AND ADDRESS:
Novo Nordisk Inc. 100 College Road West Princeton, New Jersey 08540
Contact Person: Rick Spring Tel: 609-987-5046 Fax: 609-987-3916
(2) NAME OF DEVICE:
| Proprietary Name: | FlexPen® needle |
|---|---|
| Common or usual name: | Sterile disposable hypodermic needle |
| Classification: | Hypodermic single lumen needle (21 CFR 880.5570) |
| Class: | Class II |
(3) SUBSTANTIAL EQUIVALENCE:
FlexPen® needle is a disposable needle which is substantially equivalent to Novo Nordisk's NovoFine® 32G Tip (0.23/ 0.25 mm) x 6 mm disposable needle, cleared under 510(k) K053470, NovoFine® Autocover® 30G x 8 mm, cleared under 510(k) K050106, and to the Becton Dickinson BD Pen Needle (29G, 30G, 31G) x (5 mm, 8 mm, 12.7 mm), cleared under 510(k) K051899.
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.
NOV 2 1 2006
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FlexPen® needle Disposable Needle Novo Nordisk Inc.
510(k) Premarket Notification
Datc: Version: Status: Pagc:
18 August 2006 Novo Nordisk (). I Final 2 of 3
807.87(h) 510(k) Summary (Continued)
(4) DEVICE DESCRIPTION:
FlexPen® needle is designed for single use in conjunction with Novo Nordisk injection delivery devices. Prior to giving an injection, the protective tab is removed from the outer needle can of the single-use disposable needle. With the disposable needle remaining in the outer needle cap, it is then carefully screwed onto the injection delivery device until tight and then the needle outer and inner caps are removed. Prepare for injection by following the procedure described in the user manual provided with the pen injection device and instructions from your health care professional.
After the injection, the needle is removed from the skin. The needle is detached from the injection device and disposed of in accordance with national/local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the FlexPen® needle by using the needle cap as described in the user manuals provided with the Novo Nordisk pen injection devices.
FlexPen® needle is used in exactly the same manner as the NovoFine® needles. The instructions for use are described in the user manuals for Novo Nordisk delivery devices for injection and are the same for all NovoFine® needles and FlexPen® needle.
(5) INTENDED USE:
FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin and somatropin.
(6) TECHNOLOGICAL CHARACTERISTICS:
The FlexPen® needle is considered substantially equivalent to the NovoFine® 32G Tip x 6 mm, NovoFine® Autocover® 30G x 8 mm, and to the Becton Dickinson BD Pen Needle (29G, 30G, 31G) in intended use (intended for use with pen injector devices for the subcutaneous injection of insulin and somatropin), technology/principle of operation, materials and performance. Differences between the devices do not raise any significant issues of safety and effectiveness. See Table 1 for comparison to a legally marketed device.
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KUC2500 Page 3 of 3
FlexPen® needic Disposable Needle Novo Nordisk Inc.
510(k) Premarket Notification
Date: Version: Status: Page:
18 August 2006 Novo Nordisk 0.1 Final 3 of 3
807.87(h) 510(k) Summary (Continued)
As required by Section 807.92(b)
(1) NON-CLINICAL TESTS PERFORMED:
The FlexPen® needle will be manufactured in accordance with current Good Manufacturing Practices for Medical Devices. Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards.
(2) CLINICAL TESTS SUBMITTED:
No clinical tests are required.
(3) CONCLUSIONS DRAWN FROM THE NON-CLINICAL AND CLINICAL TESTS:
Based on the design equivalency and the functional testing, Novo Nordisk had determined that the FlexPen® needle is substantially equivalent to a device currently marketed in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness.
Mary Ann McElligott, Ph.D. Associate Vice President, Regulatory Affairs Novo Nordisk Inc.
Date
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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the department's name, which is written in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rick Spring Manager, Regulatory Affairs Novo Nordisk. Incorporated 100 College Road West Princeton, New Jersey 08540-7810
NOV 2 1 2006
Re: K062500
Trade/Device Name: FlexPen® Needle 32G Tip x 6mm (1/4") Disposable Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 24, 2006 Received: August 25, 2006
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Aury Sarlion for
Chiu Lin, Ph. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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FlexPen® necdlc Disposable Needle Novo Nordisk Inc.
510(k) Premarket Notification
Date: Version: Status: Page:
August 2006 Novo Nordisk 1.0 Final l of l
Indications for Use Statement
510(k) Number (if known)
Device Name:
Indications For Use:
FlexPen® needle 32G Tip x 6mm (1/4") Disposable Needle
FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin and somatropin
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).