The primary function of the NOVAguard™ Safety Needle is for the injection of fluids into or withdrawal of fluids from parts of the body below the surface of the skin. The needle stick prevention feature helps prevent accidental needle sticks by shielding the needle after use.

Device Description

NOV Aguard™ is a sharps injury protection device with a passively activated safety shield. The NOV Aguard™ product has a female luer connector, compatible with a luer-lock syringe, on one side and a stainless steel cannula on the other. A shield is mounted around the cannula. This product is packaged in a rigid container sealed by a Tyvek lid to facilitate sterilization. The product is removed from the package and connected to a luer-lock syringe simultaneously; this is accomplished when attaching the syringe, turning it in a clockwise direction. During this process, the shield is automatically moved to a position where the cannula tip is exposed so that the user can easily see it. An injection is given using the standard common technique. Inserting the cannula into the patient displaces the shield causing the shield legs to move apart and act like a spring. Upon removal, the spring force of the shield legs forces the shield over the tip of the cannula into a locked position.

The NOV Aguard™ Safety Needle is an assembly of three components. A cannula, a hub and a safety shield.

AI/ML Overview

The provided text describes a 510(k) submission for the NOVAguard™ Safety Needle, asserting its substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria. Therefore, the information requested in the prompt based on "acceptance criteria" and a "study that proves the device meets the acceptance criteria" is largely not present in the provided document.

Here's an analysis based on the information available and what is not present:

Missing Information:
The document does not provide:

A table of specific acceptance criteria (e.g., minimum performance thresholds for parameters like activation force, shield engagement time, etc.).
Reported device performance against such specific criteria.
Details of a standalone study specifically designed to prove acceptance criteria (e.g., a performance study with a test set, ground truth, expert readers, etc.). This document focuses on demonstrating substantial equivalence to already approved predicate devices.
Sample sizes for a test or training set in the context of performance evaluation.
Data provenance for such tests.
Citations of experts, their qualifications, or adjudication methods for establishing ground truth for performance.
Information about a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
Information on how ground truth for training or test sets was established.

Information that can be inferred or is partially present:

The document asserts the device's safety and effectiveness implicitly through its comparison to predicate devices, and through general quality control measures.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Biocompatibility: Blood contacting materials suitability *	Biocompatible as per FDA General Program Memorandum #G95-1 (5/1/95) and ISO-10993.
Sterility: Device is sterile during packaging *	Packaged sterile.
Functional Equivalence: Similar mechanism to prevent needle sticks with predicate devices.	Passively activated safety shield upon needle withdrawal, providing needle stick prevention.
Luer-lock Compatibility: Compatible with standard luer-lock syringes.	Compatible for use with standard luer-lock syringes.
Single Use: Designed for single use.	Single use device, to be discarded after use.
Ergonomics: Designed ergonomically.	Designed ergonomically.
Manufacturing Quality: Meets release specifications.	Finished products tested and meet all required release specifications prior to distribution.

Note: The "acceptance criteria" here are inferred from the claims of the 510(k) submission regarding its similarity to predicate devices and general regulatory compliance rather than explicit metrics from a performance study.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any performance testing. The submission relies on demonstrating substantial equivalence, not novel performance data from a specific test set.
Data Provenance: Not applicable in the context of a performance study test set. The biocompatibility testing likely involved laboratory tests following international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The document does not describe a performance study involving expert assessment or ground truth establishment for a test set.

4. Adjudication method for the test set:

Not applicable. No test set adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical medical device (safety needle), not an AI-powered diagnostic tool. MRMC studies are irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For biocompatibility: Ground truth was established by adherence to FDA General Program Memorandum #G95-1 and ISO-10993 testing results.
For manufacturing quality: Finished products are tested against "required release specifications." The specific criteria for these specifications are not detailed in the summary but would constitute the "ground truth" for manufacturing quality.
For functional aspects (e.g., safety shield activation, luer-lock compatibility): Implied to be verified through engineering and functional testing, comparing favorably to predicate devices, though specific "ground truth" methodologies are not described.

8. The sample size for the training set:

Not applicable. No "training set" in the context of a machine learning algorithm is mentioned.

9. How the ground truth for the training set was established:

Not applicable.

Summary

{0}------------------------------------------------

APR 2 4 2009

Image /page/0/Picture/2 description: The image shows the logo for West, a company that delivers innovative solutions. The word "West" is written in a bold, sans-serif font, with the "t" extending into a diamond shape filled with horizontal lines. Below the word "West" is the tagline "Delivering Innovative Solutions" in a smaller, sans-serif font.

101 Gordon Drive · Lionville, PA 19341 TEL 610-594-2900 • FAX 610-594-3000 westpharma com

510(k) summary for the NOVAGUARD™ SAFETY NEEDLE (as required by section 807.92)

510(k) Notification submitted by:

Contact person:

Date Summary Prepared

Trade Name:

Classification name:

Common device name:

Predicate devices:

Manufacturer:

West Pharmaceutical Services Inc. 101 Gordon Drive Lionville, PA 19341 USA Phone: (610) 594-2900 Fax: (610) 594-3016

Mr. Ari Y. Sobel Director, Regulatory Affairs

September 30, 2008

NOVAguard™ Safety Needle

General Hospital Class II, 80FMI Per 21 CFR 880.5570 Hypodermic Single Lumen Needle (with Antistick Feature)

Hypodermic needle with safety sheath or needle with needle protection device

BD Eclipse™ Hypodermic Needle 510(k) No. K043397 Becton, Dickinson & Company

SATETYGLIDE™ NEEDLE 510(k) No. K951254 Becton, Dickinson Vacutainer Systems Preanalytical Solutions

MONOJECTTM SAFETY NEEDLE 510(k) No. K012736 Tyco Healthcare (Covidien)

TERUMO SURGUARD2TM SAFETY NEEDLE 510(k) No. K040531 Terumo Medical Corp

West Pharmaceutical Services Inc. 101 Gordon Drive Lionville, PA 19341 USA

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for "West Delivering Innovative Solutions". The word "West" is in large, bold, black letters, with the tagline "Delivering Innovative Solutions" underneath in a smaller font. To the right of the word "West" is a diamond shape made up of horizontal lines, with a trademark symbol in the upper right corner.

101 Gordon Drive · Lionville, PA 19341 TEL 610-594-2900 · FAX 610-594-3000 westpharma.com

Material:

The NOV Aguard™ Safety Needle is classified as Externally Communicating Device, Blood Path Indirect, Limited Duration of Contact (< 24 hr). The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-I: Evaluation and Testing". Results of the testing demonstrate that the blood contacting materials are biocompatible and were determined suitable for the Indications for Use of this product.

Device Description:

The NOV Aguard™ Safety Needle is an assembly of three components. A cannula, a hub and a safety shield.

Indications for Use:

Technological comparison to Predicate Device:

The NOVAguard The Safety Needle Indications for Use is similar to the Eclipse™, the MONOJECT™ Safety Needle and the SurGuard2TM all are intended for parenteral delivery or the withdrawal of body fluids.

All devices are compatible for use with standard luer lock syringes. Once the needle is withdrawn the safety feature is activated (either manually or automatically) and the needle should be discarded in a sharps bin. The safety needle is a single use device and should be discarded after use.

All devices are packaged sterile and designed ergonomically.

Any differences between the NOVAguard™ Safety Needle solution and the equivalent devices have no significant influence on safety or effectiveness.

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

Image /page/2/Picture/1 description: The image shows the logo for West, a company that delivers innovative solutions. The word "West" is written in a bold, sans-serif font, with the letters slightly overlapping each other. To the right of the word "West" is a diamond shape made up of horizontal lines. Below the word "West" is the tagline "Delivering Innovative Solutions".

101 Gordon Drive · Lionville, PA 19341 TEL 610-594-2900 · FAX 610-594-3000 westpharma.com

Safety and Effectiveness:

Finished products are tested and must meet all required release specifications prior to distribution. The array of testing required for release include but are not limited to; Physical testing and visual examination (in-process and finished product).

Conclusion:

It is our conclusion that the NOVAguard™ Safety Needle and its predicates are substantially equivalent in their Indications for Use, design, material, sterility and packaging.

The NOVAguard™ Safety Needle is to be used in a similar manner to the predicate devices with the exception that the NOVAguard is passive and does not require manual activation and introduces no new issues of safety and effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ari Y. Sobel Director, Regulatory Affairs West Pharmaceutical Services, Incorporated 101 Gordon Drive Lionville, Pennsylvania 19341

APR 2 4 2009

Re: K082908

Trade/Device Name: NOVAguard™ Safety Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 9, 2009 Received: April 10, 2009

Dear Mr. Sobel:

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 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.

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

{4}------------------------------------------------

Page 2- Mr. Sobel

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Chase

Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Submission: NOVAguard™ Safety Needle

Indications for Use

510(k) Number (if known):

Device Name: NOVAguard™:Safety Needle

Indications for Use: The primary function of the NOVAguard™ Safety Needle is for the injection of fluids into or withdrawal of fluids from parts of the body below the surface of the skin. The needle stick prevention feature helps prevent accidental needle sticks by shielding the needle after use.

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 OF NEEDED)

signature

(Division Sign-Off)

(Division of Anesthesiology, General Alggenarence of CDRH, Office of Device Evaluation (ODE) Infection Control, Dental Devices

K082908 510(k) Number: _

Page of

CONFIDENTIAL West Pharmaceutical Services Inc. NOVAguard TM SAFETY NEEDLE: Abb. 510(k) Submission September 30, 2008

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).