NovoTwist® needle is designed for single use in conjunction with Novo Nordisk injection delivery devices built with bayonet coupling. 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 pressed onto the injection delivery device with a bayonet coupling and twisted a quarter of a revolution until tightness and a confirmatory click is heard. Then the outer and inner caps of the needle are removed. Injection is performed 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. Function checks for the delivery device can be performed with the NovoTwist® needles by using the needle cap. The NovoTwist® needle is used in exactly the same manner as the NovoFine® and the BD Pen needle except it is built with an improved attachment mechanism. NovoTwist® needle is attached to the delivery device via a bayonet thread. This allows the user to press down and twist the needle a quarter of a revolution instead of tightening through several revolutions as with the NovoFine® needle, BD pen needle, and many other commercially marketed hypodermic needles that operate on the same principles. This improved mechanism is intended to reduce the attachment time. In addition, users can hear a confirmatory click when the NovoTwist® needle is attached correctly to the device. This user friendly feature is designed to ensure the needle is attached to the device correctly before beginning the injection.

AI/ML Overview

NovoTwist® Needle Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) summary for the NovoTwist® needle, claiming substantial equivalence to existing predicate devices. It references compliance with several ISO standards and outlines specific non-clinical tests. However, it does not explicitly state specific pass/fail acceptance criteria (e.g., "bubble leak rate must be less than X%") nor does it present quantitative results for how the device performed against these criteria. Instead, it generally states that the tests support the device meeting "specified requirements" and being "safely used."

Therefore, the table below reflects what is implied as acceptance for specific tests and the general statement of performance:

Acceptance Criterion (Implied)	Reported Device Performance
Compliance with ISO 11608-2:2000 (Pen-injectors for medical use - Part 2: Needles - Requirements and test methods)	"NovoTwist® 30G and 32G Tip needles have been subjected to many non-clinical tests throughout the development by Novo Nordisk R&D, and these tests comply with ISO 11608-2:2000..."
Performance and functionality evaluation (prototype tests)	"several prototype tests with NovoTwist® needles were conducted to evaluate the performance and functionality of the needles." (Implied successful evaluation)
Bubble leak test for sterility (per ISO 11607-1:2006)	Conducted as part of final design verification test. "...bubble leak test to ensure sterility..." (Implied successful compliance with standard)
Freedom from defects (per ISO 7864:1993)	Conducted as part of final design verification test for: defect needle point, patient needle point, silicone on patient-end needle, bond between hub and needle tube, visual control of quality of sealing. "...Freedom from defects in accordance with ISO 7864:1993..." (Implied successful compliance with standard)
Biocompatibility (per ISO 10993-1)	Reference made to prior successful biocompatibility tests for NovoFine needles (predicate device), as the cannula and silicone oil (components in contact with human tissue) are identical. "...we reference the biocompatibility tests to those previously conducted for the NovoFine needles in accordance with ISO 10993-1... which have been cleared by the Agency." (Implied successful compliance through substantial equivalence of materials)
Shelf life	"shelf life test has been performed on final released NovoTwist® 30G and 32G Tip needles in accordance with ISO 11607-1:2006..." (Implied successful determination of shelf life according to standard)
Handling test and Usability test	"handling test and usability test are performed..." (Implied successful performance indicating safe and effective use; specifics not detailed.)
Overall Design Verification	"The final design verification test consists of 34 mechanical and visual tests... In summary, the final design verification test supports that Novo Twist needles meet the specified requirements and that the needles can be safely used in various real-life situations of handling and use according to Instructions for Use." (Implied all 34 tests met their respective acceptance criteria.)

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: The document states that the final design verification test involved "34 mechanical and visual tests" but does not specify the exact number of NovoTwist® needles tested for each of these tests. It only mentions that "The needle samples tested are manufactured, sterilized, packaged and labelled on validated equipment and QA-released in accordance with cGMP..."
Data Provenance: The document implies the tests were conducted by "Novo Nordisk R&D" and that "The needle samples tested are manufactured...in accordance with cGMP for Medical Devices (ISO 13485:2003 Medical devices - Quality management systems Requirements for regulatory purposes)." This suggests the data is prospective and likely originated from internal company testing, presumably in facilities compliant with quality management systems. The country of origin for the data is not explicitly stated, but Novo Nordisk is a Danish multinational company.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as the described tests are non-clinical (mechanical, visual, sterility, biocompatibility, shelf-life, handling, and usability) and do not involve human assessment of medical images or patient outcomes that would require expert ground truth establishment in the traditional sense (e.g., by radiologists). The "ground truth" for these tests would be defined by the technical specifications and standards (e.g., ISO 11608-2) the device is being tested against.

4. Adjudication Method for the Test Set

This information is not applicable. The tests described are objective, physical, or chemical measurements/inspections against predefined specifications or standards. They do not involve subjective assessments requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests are required." The submission relies on non-clinical testing and substantial equivalence to predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device, NovoTwist® needle, is a physical medical device (hypodermic needle), not a software algorithm or AI-powered system where a "standalone" algorithm-only performance would be relevant.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established international standards and internal specifications. For example:

ISO 11608-2:2000 (Pen-injectors for medical use - Part 2: Needles - Requirements and test methods)
ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems)
ISO 7864:1993 (Sterile hypodermic needles for single use)
ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system)
Internal design specifications for mechanical, visual, and functional performance.

8. The Sample Size for the Training Set

This information is not applicable. As a physical medical device (hypodermic needle), there is no "training set" in the context of machine learning or artificial intelligence. The development process involves prototype testing and design verification, not algorithm training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

Summary

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Koa 3109

NovoTwist needle Disposable Needle Novo Nordisk Inc.

CONFIDENTIAL

Date: Version Status: Page:

June 2010 Novo Nordisk 1

Final Page 2 of 8

JUN 1 8 2010

807.87(h) 510(k) Summary

As required by Section 807.92 (a)

(1) DATE OF PREPARATION: 2010-6-9

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. NovoTwist® needle meets all applicable product and quality standards for hypodermic single lumen needle products.

SUBMITTER'S NAME AND ADDRESS:

Novo Nordisk Inc. Contact Person: 100 College Road West Cindy Cao, Ph. D. Princeton, New Jersey 08540 Tel: 609-987-3914 Fax: 609-987-3916

(2) NAME OF DEVICE:

Proprietary Name:	NovoTwist® needle
	30G x 8 mm
	32G Tip x 5mm
Common or usual name:	Sterile disposable hypodermic needle
Classification:	Hypodermic single lumen needle (21 CFR 880.5570)
Class:	Class II

(3) SUBSTANTIAL EQUIVALENCE:

Novo Twist® 30G and 32G Tip needles are disposable needles which are substantially equivalent to the Novo Nordisk's NovoFine® 32G Tip (0.23/ 0.25 mm) x 6 mm disposable needle, cleared under 510(k) K062500 and K090111, to the NovoFine® Autocover® 30G x 8 mm disposable needle, cleared under 510(k) K050106, and to the BD Pen needle, 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 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 applications by the court.

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NovoTwist needle Disposable Needle Novo Nordisk Inc.

CONFIDENTIAL

Date: Version: Status: Page:

June 2010 Novo Nordisk 1 Final Page 3 of 8

807.87(h) 510(k) Summary (continued)

(4) DEVICE DESCRIPTION:

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. Function checks for the delivery device can be performed with the NovoTwist® needles by using the needle cap.

The NovoTwist® needle is used in exactly the same manner as the NovoFine® and the BD Pen needle except it is built with an improved attachment mechanism. NovoTwist® needle is attached to the delivery device via a bayonet thread. This allows the user to press down and twist the needle a quarter of a revolution instead of tightening through several revolutions as with the NovoFine® needle, BD pen needle, and many other commercially marketed hypodermic needles that operate on the same principles. This improved mechanism is intended to reduce the attachment time. In addition, users can hear a confirmatory click when the NovoTwist® needle is attached correctly to the device. This user friendly feature is designed to ensure the needle is attached to the device correctly before beginning the injection.

(5) INTENDED USE:

Novo Twist needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide and somatropin.

(6) TECHNOLOGICAL CHARACTERISTICS:

The NovoTwist® needle is considered substantially equivalent to the NovoFine® 32G Tip needles, the NovoFine Autocover 30G needles, and the BD pen needles in intended use, technology, principle of operation, materials and performance. For a detailed side by side comparison to

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NovoTwist needleDisposable NeedleNovo Nordisk Inc.	CONFIDENTIAL		Date:Version:Status:Page:	June 20101FinalPage 4 of 8	Novo Nordisk
------------------------------------------------------------	--------------	--	---------------------------------------	----------------------------------------	--------------

807.87(h) 510(k) Summary (continued)

Novo Nordisk's NovoFine needles and the BD needles cleared by the Agency, please see Table 1: Comparison to a legally marketed device. N/A is used where the documentation is considered to be proprietary information of BD.

Materials in NovoTwist® 30G are identical to those in the NovoTwist® 32G Tip needles. NovoTwist® needles consist of almost the same components and materials as NovoFine® Autocover® 30G and NovoFine® 32G Tip needles. A detailed side by side comparison of the materials in NovoTwist® 30G and 32G Tip needles with those in the NovoFine® needles is presented in Table 2: Material description of NovoTwist®.

In conclusion, the difference between the NovoTwist® and the NovoFine® and BD Pen needles is the attachment mechanism, and it does not raise any significant issues of safety and effectiveness.

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NovoTwist® needle
Disposable Needle
Novo Nordisk Inc.

Novo Nordisk

Parameters	Intended use	Product typeMaterialsDurability	Biocompatibility	ReuseLabeling	Specifications	NovoTwist® 32G Tip	NovoTwist® 30G	NovoFine® 32G TipK062500, K090111	NovoFine® Autocover® 30GK050106	BD Pen Needle 29G, 30G, 31GK051899
						TBD	TBD
	Subcutaneous injection ofinsulin, liraglutide andsomatropin	Hypodermic pen needleSee Table 2	2 years from production date	DS/EN ISO 10993-1, seeAppendix E	N/A - single useSee Section 5	Subcutaneous injection ofinsulin, liraglutide andsomatropin	Subcutaneous injection ofinsulin, liraglutide andsomatropin	Subcutaneous injection ofinsulin, liraglutide andsomatropin	Subcutaneous injection ofinsulin	Subcutaneous injection ofdrugs, including insulinand exenatide
						Hypodermic pen needleSee Table 2	Hypodermic pen needleSee Table 2	Hypodermic pen needleSee Table 2	-Hypodermic pen needleSee Table 2	Hypodermic pen needle
						2 years from production date	2 years from production date	5 years from productiondate	3 years from productiondate	N/A
						DS/EN ISO 10993-1, seeAppendix E	DS/EN ISO 10993-1, seeAppendix E	DS/EN ISO 10993-1, seeAppendix E	DS/EN ISO 10993-1,Appendix E	N/A
						N/A - single useSee Section 5	N/A-single useSee Section 5	N/A - single useSee Section 5	N/A - single useSee Section 5	N/A - single use
Outer Diameter,Tip						0.22-0.25 mm	0.30-0.32 mm	0.22-0.25 mm	0.30-0.32 mm	N/A
Outer Diameter,cylindrical part						0.25-0.27 mm	0.165-0.185 mm	0.25-0.27 mm	0.165-0.185mm	5, 8, 12.7 mm31, 30, 29
Inner Diameter						0.145-0.16 mm0.03-0.053 mm	N/A	0.145-0.16 mm0.03-0.053 mm	N/A	N/A
Wall Thickness,Tip						0.045-0.063 mm	0.058-0.078 mm	0.045-0.063 mm	0.058-0.078 mm	N/A
Wall Thickness,Cylindrical part						14.82-15.88 mm	17.85-18.85 mm	15.82-16.88 mm	33.87-34.93 mm	N/A
Total Length						5 mm	8 mm	6 mm	8 mm	N/A
Length from Hub							30		30	N/A
Gauge						31/32 Tip		31/32 Tip		N/A
Tip Configuration						1.st and 2.nd grinding andglass blasting	1.st and 2.nd grinding and glassblasting	1.st and 2.nd grinding andglass blasting	1.st and 2.nd grinding andglass blasting	N/A
Cover Color						Light Blue (RAL 5012)	Yellow (RAL 1021)	Light Blue (RAL 5012)	Yellow (Pantone 116U)	N/A
Cover Strength						Pmin = 56mBarFmin = 22 N	Pmin = 56mBarFmin = 22 N	Pmin = 70mBarFmin = 22 N	Pmin = 70mBarFmin = 22 N	N/A
Hub/Sneedlezbond strength						N/A	N/A	N/A	N/A	N/A
Needle Stick PreventionFeatures						N/A	N/A	N/A	Passive/Automatic	N/A
Activation Process						N/A	N/A	N/A	Visual	N/A
Safety Indicator						N/A	N/A	N/A	No	N/A
Safety Override						N/A	N/A	N/A	N/A	N/A

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NovoTwist needle		Date:	June 2010
Disposable Needle	CONFIDENTIAL	Version:	1
Novo Nordisk Inc.		Status:	Final
		Page:	Page 6 of 8

Material description of NovoTwist® needles: Table 2

Component	NovoTwist® 30G and 32G Tip1Manufacturing site NMS	NovoFine® Autocover® 30G2Manufacturing site NMS	NovoFine® 32G TipManufacturing site Nipro, Japan
1. The hub	Polypropylene (PP)Color: White	Polypropylene (PP)Color: Moplen HP548ROr Moplen HP548R WhiteOr RF365MO Neutral	Polypropylene (PP)
2. Glue	Eccobond, 927-10-EFOne component epoxy adhesiveColor: Light yellow	Eccobond, 927-10-EFOne component epoxy adhesiveColor: Light yellow	Eccobond 927-10-EOne component epoxy adhesiveColor: Light yellow
3. The inner cap	Polyethylene (PE)Color: Transparent	N/A	Polyethylene (PE)
4. The outer cap	Polypropylene (PP)Color: Transparent Blue	Polypropylene (PP)Color: Moplen HP548ROr Moplen HP548R WhiteOr RF365MO Neutral	Polypropylene (PP)
5. The cannula	Stainless steelAISI 304/JISG 4305DIN-kurzname: X 5 CrNi 18 9	Stainless steelAISI 304/JISG 4305DIN-kurzname: X5 CrNi 18 9	Stainless steelAISI 304/JISG 4305DIN-kurzname: X 5 CrNi 18 9
Ad 5. Lubricating oilfor the patient needle	MDX4-4159Medical Grade Dispersion(partly hardened silicone)	MDX4-4159Medical Grade Dispersion(partly hardened silicone)	MDX4-4159Medical Grade Dispersion(partly hardened silicone)
Ad 5. Lubricating oilfor the back needle	Medical Fluid Silicone Oil12500 cSt	Medical Fluid Silicone Oil12500 cSt	Medical Fluid Silicone Oil12500 cSt
6. The sealing paper/protective tab	Gas permeable sealing paper60 g/m² for steam sterilization	Gas permeable sealing paper60 g/m² for steam sterilisation	Bactite 60K 43 g/m² coated withPS-118 lacquer 6 g/m² forethylene oxide sterilization

Note 1: See Figure 3 regarding the drawing of individual components.

Note 2: Some of the specific components and materials used for NovoFine® Autocover® 30G is not shown in the table as they are related to the unique shield mechanism of prevention of needle stick injuries.

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Novo Twist needle Disposable Needle Novo Nordisk Inc.

CONFIDENTIAL

Date: Version: Status: Page:

June 2010 1 Final

Novo Nordisk

Page 7 of 8

Final
of 8

807.87(h) 510(k) Summary (continued)

As required by Section 807.92(b) .

(1) NON-CLINICAL TESTS:

Novo Twist® 30G and 32G Tip needles have been subjected to many non-clinical tests throughout the development by Novo Nordisk R&D, and these tests comply with ISO 11608-2:2000 Peniniectors for medical use - Part 2: Needles - Requirements and test methods.

First, several prototype tests with NovoTwist® needles were conducted to evaluate the performance and functionality of the needles.

Second, NovoTwist® needles are subjected to a final design verification test. The needle samples tested are manufactured, sterilized, packaged and labelled on validated equipment and QA-released in accordance with cGMP for Medical Devices (ISO 13485:2003 Medical devices - Quality management systems Requirements for regulatory purposes). The final design verification test consists of 34 mechanical and visual tests (Appendix D of original 510(k) submission). Some of the key design verification tests performed include the bubble leak test to ensure sterility in accordance with ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems; Freedom from defects in accordance with ISO 7864:1993 Sterile hypodermic needles for single use, i. e. defect needle point, patient needle point, silicone on patient-end needle, bond between hub and needle tube and visual control of quality of sealing. In summary, the final design verification test supports that Novo Twist needles meet the specified requirements and that the needles can be safely used in various real-life situations of handling and use according to Instructions for Use.

Third, shelf life test has been performed on final released NovoTwist® 30G and 32G Tip needles in accordance with ISO 11607-1:2006 (see Appendix 3 in the submission of June 10, 2010).

Fourth, the cannula and silicone oil are the only components of the needle in contact with human tissue, and the composition of the cannula and silicone oil of NovoTwist® needles are identical to that of NovoFine® needles, the substantially equivalent device (see Table 2). Therefore we reference the biocompatibility tests to those previously conducted for the NovoFine needles in accordance with ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system, which have been cleared by the Agency (see Appendix E in the original 510(k) submission).

Finally, handling test and usability test are performed (see Appendix G in the original submission).

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NovoTwist® needleDisposable NeedleNovo Nordisk Inc.	CONFIDENTIAL	Date:Version:Status:Page:	June 20101FinalPage 8 of 8	Novo Nordi
-------------------------------------------------------------	--------------	---------------------------------------	----------------------------------------	------------

The NovoTwist needles are manufactured in accordance with current Good Manufacturing Practices for Medical Devices.

(2) CLINICAL TESTS:

No clinical tests are required.

(3) CONCLUSIONS DRAWN FROM THE NON-CLINICAL AND CLINICAL TESTS:

Based on the design equivalency and the finctional testing, Novo Nordisk had determined that the Block on the using equivalent of the Novolines " 30 of Tip acede (K062500,
NovoTwist" needle is substantially equivalent to the Novolline" 32G States of Story of which are currently marketed in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness.

Date

Mary Ann McElligott, Ph.D. Associate Vice President, Regulatory Affairs Novo Nordisk Inc.

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Image /page/7/Picture/1 description: The image is a circular seal with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with three thick, curved lines forming its wings and body, giving it a modern and abstract appearance.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 8 2010

Cindy Cao, Ph.D. Senior Manager, Regulatory Affairs Novo Nordisk Incorporated 100 College Road West Princeton, New Jersey 08540-7810

Re: K093109

Trade/Device Name: NovoTwist® Needle, Models 30G x 8mm (1/3") & 32G Tip x 5mm (1/5") Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: June 10, 2010 Received: June 11, 2010

Dear Dr. Cao:

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- Dr. Cao

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Susan Quiroz

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

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NovoTwist® needle 510(k) - K093109 Novo Nordisk Inc.

CONFIDENTIAL

Date: Version: Status: Page:

l Final

Page 12 of 16

Indications for Use Statement

K093109 510(k) Number (if known)

Device Name:

NovoTwist® needle

32G Tip x 5mm Disposable Needle

30G x 8mm Disposable Needle

Indications For Use:

NovoTwist® 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)

Over-The-Counter Use AND/OR (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)

(Division Director)

510(k) Number: K093109

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Regulation Number and Section

§ 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).