(381 days)
Not Found
No
The device description and performance studies focus on the physical design and functional equivalence of a disposable needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The FlexPen® needle is a single-use accessory designed for injecting substances like insulin. It facilitates the delivery of medication but does not inherently treat a condition itself.
No
Explanation: The device is a needle intended for the subcutaneous injection of substances like insulin, not for diagnosing medical conditions. It is used to deliver a treatment, not to identify a disease or condition.
No
The device description clearly describes a physical needle intended for subcutaneous injection, which is a hardware component.
Based on the provided information, the FlexPen® needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous injection of substances (insulin, liraglutide, somatropin) into the body. This is a therapeutic delivery method, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical design and use of the needle for injection, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases, monitor conditions, or determine compatibility. The FlexPen® needle's function is to deliver medication into the body.
N/A
Intended Use / Indications for Use
FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.
Product codes (comma separated list FDA assigned to the subject device)
FMI
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 cap 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.
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
Not Found
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)
NON-CLINICAL TESTS PERFORMED: None
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.
CLINICAL TESTS SUBMITTED: No clinical tests are required.
CONCLUSIONS DRAWN FROM THE NON-CLINICAL AND CLINICAL TESTS: Based on the design equivalency and the functional testing, Novo Nordisk had determined that 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.
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.
K062500, K053470, K050106, K051899
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
§ 880.5570 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).
0
CONFIDENTIAL
Date: Version: Status: Page:
17 September 2009 -Final
P. lot
Steve Nordick
5 of 7
807.87(h) 510(k) Summary
As required by Section 807.92(a)
FEB - 1 2010
(1) DATE OF PREPARATION: September 16, 2009
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.
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: Common or usual name: Classification: Class:
FlexPen® needle Sterile disposable hypodermic needle Hypodermic single lumen needle (21 CFR 880.5570) Class II
(3) SUBSTANTIAL EQUIVALENCE:
FlexPen® needle is a disposable which is substantially equivalent to K062500 cleared on November 21, 2006, 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.
1
FlexPen needle 510(k) - K090111 Novo Nordisk Inc.
CONFIDENTIAL
Date: Version: Status: Page:
LOROIII p.2 of 3
17 September 2009 | Novo Nordisk
Final
6 of 7
(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 cap 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® needle is intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.
(6) TECHNOLOGICAL CHARACTERISTICS:
FlexPen® needle is considered substantially equivalent to K062500, 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, liraglutide and somatropin), technology/principle of operation, materials and performance. Differences between the devices do not raise any significant issues of safety and effectiveness.
2
090111 p. 3 of 3
FlexPen needlc 510(k) - K090111 Novo Nordisk Inc.
'CONFIDENTIAL
Date: Version: Status: Page:
As required by Section 807.92(b)
(1) NON-CLINICAL TESTS PERFORMED: None
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 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.
(1) me Ellingto
Mary Ann McElligott, Ph D. Associate Vice President, Regulatory Affairs Novo Nordisk Inc.
18 Sept 04
Date
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenne Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Rick Spring Senior Manager, Regulatory Affairs Novo Nordisk, Incorporated 100 College Road West Princeton, New Jersey 08540
FEB - 1 2010
Re: K090111
Trade/Device Name: FlexPen Needle 32G Tip x 6mm (1/4") Disposable Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: January 26, 2010 Received: January 27, 2010
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.
4
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 (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 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/dcfault.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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
5
FlexPen needle 510(k) - K090111 Novo Nordisk Inc. Date: Version: Status: l'age:
Novo Nordisk
4 of 7
40
1
Final
4 of 7
1
Final
Indications for Use Statement
510(k) Number (if known)
Device Name:
FlexPen needle 32G Tip x 6mm (1/4") Disposable Needle
Indications For Use:
FlexPen® needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
Charles G. Koch
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090111