NovoFine® Autocover™ 30G x 8 mm needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products. Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.

Device Description

The NovoFine® Autocover™ 30G x 8mm needle is designed for single use in conjunction with insulin injection delivery devices. Prior to giving an injection, the protective tab is removed from the plastic needle cap of the single-use disposable needle. With the disposable needle remaining in the needle cap, it is then carefully screwed onto the delivery injection device until tight and then the needle cap is removed. Prepare for injection by following the procedure described in the instruction leaflet provided with the pen injection device and instructions from your health care professional. While pushing the needle into the skin, the shield and lock will be pushed into the house enabling the needle to penetrate the skin barrier and into the subcutaneous tissue.

After the injection, the needle is removed from the skin. The NovoFine® Autocover™ needle stick safety mechanism will activate automatically when the needle is withdrawn from the skin. Once NovoFine® Autocover™ is in the locked position, it can no longer be used. The needle is not exposed protecting against an unintentional needlestick. The red indicator windows tells the user that the safety lock has been activated. The needle is detached from the injection device and disposed of in accordance with local regulations. For each subsequent injection, another disposable needle must be used. Delivery device function checks can be performed with the NovoFine Autocover by using the needle cap as described in the instruction leaflet

AI/ML Overview

This retrieved document is a 510(k) Premarket Notification for the NovoFine® Autocover™ 30G Disposable Safety Needle. It details the device's description, intended use, and claims substantial equivalence to predicate devices. It does not contain a quantitative study that establishes acceptance criteria and then proves the device meets those criteria with specific performance metrics and statistical analyses.

Instead, the document highlights:

Substantial Equivalence: The primary assertion is that the NovoFine® Autocover™ 30G needle is substantially equivalent to existing predicate devices (NovoFine® 31G x 6 mm needle (K002403) and BD SafetyGlide™ 25G x 16mm needle (K951254)) in terms of intended use, technology/principle of operation, materials, and performance. This is the basis for FDA clearance in this document.
Non-Clinical Tests: States that "Biocompatibility and performance tests have been performed and the results are in compliance with existing domestic and international standards." However, it does not provide the specific acceptance criteria, test methodologies, or results of these tests.
Clinical Tests (Handling Tests): States that "Handling tests were conducted to investigate the efficacy and safety of the NovoFine® Autocover™ 30G disposable safety needles by diabetes nurse educators, diabetes patients and staff nurses." Again, it does not provide specific acceptance criteria, detailed methodology, sample sizes, or quantitative results from these tests. It only concludes that "Differences between the devices tested do not raise any significant issues of safety and effectiveness."

Therefore, based solely on the provided text, I cannot complete the requested tables and information blocks with specific quantitative data on acceptance criteria and device performance from a formal study.

However, I can extract the information that is present and explain what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with existing domestic and international standards for biocompatibility and performance.	Results "in compliance" with standards. (Specific standards, criteria, and performance results not provided)
Efficacy and safety as determined by handling tests.	"Differences between the devices tested do not raise any significant issues of safety and effectiveness." (Specific endpoints, criteria, and results not provided)
Substantial equivalence to predicate devices (NovoFine® 31G x 6 mm and BD SafetyGlide™ 25G x 16mm) in intended use, technology/principle of operation, materials, and performance.	Document asserts substantial equivalence. (No quantitative comparison metrics provided)

2. Sample Size and Data Provenance for Test Set

Sample Size for Test Set: Not specified. The document mentions "handling tests" conducted by "diabetes nurse educators, diabetes patients and staff nurses" but does not quantify the number of participants or the number of tests performed.
Data Provenance: Not explicitly stated, but the submission is from Novo Nordisk Inc. in Princeton, New Jersey, USA. The "handling tests" imply a prospective clinical use environment, likely within the US given the submission context.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not explicitly stated. The "handling tests" involved "diabetes nurse educators, diabetes patients and staff nurses." Their specific qualifications (e.g., years of experience) are not provided.
Qualifications of Experts: "Diabetes nurse educators, diabetes patients and staff nurses."

4. Adjudication Method

Adjudication Method: Not mentioned. The handling tests appear to be a qualitative assessment of ease of use and safety, not a formal adjudication process for establishing a "ground truth" in the typical sense of measuring diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, this document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is a safety needle, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: No, this document does not describe a standalone algorithm performance study. The device is a physical medical device (safety needle).

7. Type of Ground Truth Used

Type of Ground Truth: The concept of "ground truth" in the context of diagnostic accuracy (e.g., pathology, outcomes data) is not applicable here. The "handling tests" evaluated user experience, efficacy of the safety mechanism, and overall safety. The "ground truth" for compliance with standards would be established by the results of those standard tests (e.g., tensile strength, biological reactivity), which are stated as being in compliance but not detailed.

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. The device is a physical medical device, not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable.

Summary of what the document implies about meeting acceptance criteria:

The document asserts that the device meets acceptance criteria primarily through:

Substantial Equivalence: By demonstrating that the device is fundamentally similar in design, materials, and intended use to previously cleared predicate devices.
Compliance with Standards: By stating that non-clinical performance and biocompatibility tests were conducted and found to be in compliance with existing domestic and international standards.
Positive User Feedback/Handling Test Results: Indicating that handling tests by target users (nurse educators, patients, staff nurses) showed no significant issues regarding efficacy and safety.

Crucially, the document is a summary and does not include the detailed reports of these tests, which would contain the specific acceptance criteria and the raw or summarized performance data against those criteria. Its purpose is to demonstrate substantial equivalence for regulatory clearance, not to publish a detailed scientific study.

Summary

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K050106

Page 1 of 3

MAR 3 0 2005

NovoFine Autocover™ 30G Disposable Safety Needle

510(k) Premarket Notification

Date Version:

Status:

17 Jan 2005 Novo Nordist

Final

Novo Nordisk Inc

10 807.87(h) 510(k) Summary

As required by Section 807.92(a)

(1) DATE OF PREPARATION: January 15, 2005

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. NovoFine® Autocover™ 30 G x 8 mm needles meet all applicable product and quality standards for hypodermic single lumen needle products.

SUBMITTER'S NAME AND ADDRESS:

Novo Nordisk Inc.	Contact Person: John Signorini
100 College Road West	Tel: 609-987-5967
Princeton, New Jersey 08540	Fax: 609-987-3916

(2) NAME OF DEVICE:

Proprietary Name:	NovoFine® Autocover™TM 30G x 8 mm needles
Common or usual name:	Sterile disposable hypodermic needle
Classification:	Hypodermic single lumen needle
Class:	Class II

(3) SUBSTANTIAL EQUIVALENCE:

The NovoFine® Autocover™ 30G x 8 mm needle is substantially equivalent to the Novo Nordisk NovoFine® 31G x 6 mm needle (K002403) which was cleared by FDA in December 2000 and the Becton Dickenson BD SafetyGlide™ 25G x 16mm needle (K951254) which was cleared by FDA in October 1995.

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

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NovoFine* Autocover™ 30GDisposable Safety NeedleNovo Nordisk Inc	510(k) Premarket Notification	Date:Version:Status	17 Jan 20051Final	Novo Nordisk
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807.87(h) 510(k) Summary (continued)

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.

(4) DEVICE DESCRIPTION:

(5) INTENDED USE:

The intended use for the modified device remains the same as the predicate devices (NovoFine® 31G x 6 mm and BD Safety Glide 25G x 16 mm):

For use in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products.

Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.

{2}------------------------------------------------

NovoFine Autocover™ 30GDisposable Safety Needle	510(k) Premarket Notification	Date:	17 Jan. 2005	Novo Nordisk
		Version:	1
		Status:	Final

Novo Nordisk Inc.

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

(6) TECHNOLOGICAL CHARACTERISTICS:

The NovoFine® Autocover™ 30G needle is substantially equivalent to the NovoFine® 31G and BD SafetyGlide 25G needle in intended use, technology/principle of operation, materials and performance. Differences between the devices do not raise any significant issues of safety and effectiveness.

Section 807.92(b)

(1) NON-CLINICAL TESTS PERFORMED:

The NovoFine® Autocover™ 30G needles 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:

Handling tests were conducted to investigate the efficacy and safety of the NovoFine® Autocover™ 30G disposable safety needles by diabetes nurse educators, diabetes patients and staff nurses. Differences between the devices tested do not raise any significant issues of safety and effectiveness.

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

Based on the design equivalency and the functional and safety testing, Novo Nordisk had determined that the NovoFine® Autocover™ 30G x 8 mm needles are substantially equivalent to the devices currently marketed in the United States. Differences between the devices do not raise any significant issues of safety and effectiveness.

M.U. McElroy, Ph.D., R.E.t.

Barry Reit, PhD Vice President, Regulatory Affairs & Quality Assurance Novo Nordisk Inc.

1/17/05

Date

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 0 2005

Mr. John Signorin Manager, Regulatory Affairs Novo Nordisk. Incorporated 100 College Road West Princeton, New Jersey 08540

Re: K050106

Trade/Device Name: NovoFine® Autocover™ 30G x 8 mm Disposable Safety Needle Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: January 17, 2005 Received: January 18, 2005

Dear Mr. Signorin:

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. Signorin

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 (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.

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 yours.

Sylitte Michau Oms.

Chiu Lin, Ph.D. 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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NovoFine® Autocover™ 30GDisposable Safety NeedleNovo Nordisk Inc.	510(k) Premarket Notification	Date:Version:Status:	17 Jan 20051Final	Novo Nordisk
-------------------------------------------------------------------------------	-------------------------------	------------------------------	---------------------------	--------------

Indication for Use Statement 2

510(k) Number (if known)	Not available K050106
Device Name:	NovoFine® Autocover™ 30G x 8 mm Disposable Safety Needle
Indications For Use:	NovoFine® Autocover™ 30G x 8 mm needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products. Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.
Prescription Use (Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use ✓ (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)

C. Alan Brock

rsion Sim-Off) Chision of Anes hestology, General Hospital, Intection Control Dental Devices

Number. K050106

ノ

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).