Single use device that is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Device Description

The proposed device, NovaGuard SA Safety System, is a non-sterile, single use anti needlestick accessory for pre-filled ISO standard glass syringes that are 1ml long with a max needle length of 5/8" The NovaGuard SA Safety System consist of two components, a subassembly (syringe holder, sleeve and spring) and a clip. The proposed device will be assembled along with the pre filled syringe by the pharmaceutical company. Upon completion of the needle is then covered by the sleeve protecting the user from potential sharps needle stick injury. There is a visual, tactile and audible recognition that the device safety feature has activated.

AI/ML Overview

The provided text describes the NovaGuard SA Safety System, an accessory for pre-filled syringes designed to prevent needlestick injuries. However, the document is a 510(k) summary for FDA clearance and does not contain detailed information about specific acceptance criteria or a comprehensive study report in the format requested.

Therefore, I cannot populate all the fields in the table or answer all the questions directly from the provided text. The information is primarily focused on demonstrating substantial equivalence to predicate devices and fulfilling FDA guidance requirements.

Here's what can be extracted and inferred, along with limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a detailed quantitative manner as "acceptance criteria X and reported performance Y." Instead, the document mentions compliance with general principles and performance requirements for sharps injury prevention devices.

Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Device functions as intended.	"It was confirmed that the device functioned as intended." (Bench testing)
Biocompatibility requirements met.	"Biocompatibility testing performed demonstrates that the NovaGuard SA Safety System, met the requirements of ISO 10993- 1 Biological evaluation of medical devices- Part 1: Evaluation and testing. Per this standard, The NovaGuard Safety System is categorized as skin contact with a duration of category A- limited (< 24 h)."
No premature activation.	"did not activate prematurely under expected conditions of use" (Simulated use study)
Provides protection against unintended sharps injury until disposal.	"provided protection against unintended sharps injury until disposal." (Simulated use study)
Does not impede or adversely affect the intended clinical performance.	"did not impede or adversely affect the intended clinical performance of the device" (Simulated use study)
Failure rate for activation (implied acceptable low rate).	"528 devices were tested with zero failures for activation for a '97.5% confident that the true failure rate was no higher than 0.7% and 99.5% confidence that it is no higher than 1 %' as per the FDA Guidance."

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

Sample Size for Test Set: 528 devices (for the simulated use study).
Data Provenance: The document does not explicitly state the country of origin or if the study was retrospective or prospective. It describes "simulated use studies," which are typically prospective.

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

This information is not provided in the document. The study described is a performance validation of the mechanical safety feature, not one requiring expert interpretation of results in the traditional sense of diagnostic AI. The "ground truth" here would be objective observations of device function (e.g., did the safety feature activate correctly).

4. Adjudication method for the test set

This information is not provided. Given the nature of a mechanical safety device, it's unlikely a multi-expert adjudication method was used in the same way it would be for image interpretation. The "failures" would likely be objectively observable or measurable during the simulated use.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging devices where human interpretation is a key component. The NovaGuard SA Safety System is a physical medical device designed to prevent sharps injuries.

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

The device is a physical, mechanical system. There is no "algorithm only" or "AI" component to assess in a standalone manner. The performance described is inherent to the device itself.

7. The type of ground truth used

The ground truth used for the simulated use study appears to be objective observation of device activation and function (e.g., "zero failures for activation," "did not activate prematurely," "provided protection"). This is based on mechanical performance rather than clinical outcomes or expert consensus in a diagnostic sense.

8. The sample size for the training set

This information is not applicable as the device does not employ machine learning or AI that would require a "training set."

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

This information is not applicable as the device does not employ machine learning or AI.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human face in profile, repeated three times to create a sense of depth and connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the face.

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

West Pharmaceutical Services C/O Mr. Kevin Lentz Director of Regulatory Affairs/PDS Group 530 Herman O. West Drive Exton, PA 19341

Re: K141464

Trade/Device Name: NovaGuard SA Safety System Regulation Number: 21 CFR 880.5860 Regulation Name: Syringe, Anti Stick Regulatory Class: II Product Code: MEG Dated: August 13, 2014 Received: August 15, 2014

Dear Mr. Lentz:

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.

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

Page 2 - Mr. Lentz

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

Digitally signed by Richard C. Chapman -S Date: 2014.09.10 12:39:17 -04'00'

for

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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

Indications for Use

510(k) Number (if known) K141464

Device Name NovaGuard SA Safety System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(K) SUMMARY 5

NovaGuard SA Safety System Device:

Company Name:

West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, PA 19341-1147 Phone: (610) 594-3105

Contact Person:

Kevin Lentz Director of Regulatory Affairs/PDS group West Pharmaceutical Services, Inc. Phone: 610-594-4353 Fax: 610-717-0668 E-mail: kevin.lentz@westpharma.com

US Agent:

Kevin Lentz Director of Regulatory Affairs/PDS group West Pharmaceutical Services, Inc. 530 Herman O. West Drive Exton, PA 19341-1147 Phone: 610-594-4353 Fax: 610-717-0668 E-mail: kevin.lentz@westpharma.com

Preparation date: 30 May 2014

Classification:

Classification Name: Piston Syringe (Accessory) Trade Name: NovaGuard SA Safety System Common/Usual Name: Anti Stick Syringe Product Code: MEG Regulation No.: 21 CFR 880.5860 Class: II Panel Identification: General Hospital Panel

CONFIDENTIAL

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

Predicate Devices:

UltraSafe Passive PLUS Needle Guard (K123743) Safe'n'Sound Passive Delivery System (K101233)

Device Description:

Indications for use:

Substantial equivalence:

Based on the indications for use, technology, design features and principle of operation the proposed device, NovaGuard SA Safety System, is substantially equivalent to the predicate devices, UltraSafe Passive PLUS Needle Guard (K123743) and Safe'n'Sound Passive Delivery System (K101233).

Performance Testing:

Bench testing was performed on the proposed device, NovaGuard SA Safety System. It was confirmed that the device functioned as intended.

Biocompatibility testing performed demonstrates that the NovaGuard SA Safety System, met the requirements of ISO 10993- 1 Biological evaluation of medical devices- Part 1: Evaluation and testing. Per this standard, The NovaGuard Safety System is categorized as skin contact with a duration of category A- limited (< 24 h).

Clinical Testing:

As per FDA guidance Medical Devices with Sharps Injury Prevention Features, simulated use studies were conducted on the proposed device, NovaGuard SA Safety System. 528 devices were tested with zero failures for activation for a "97.5% confident that the true failure rate was no higher than 0.7% and 99.5% confidence that it is no higher than 1 %" as per the FDA Guidance to ensure that the NovaGuard SA Safety System did not impede or adversely

CONFIDENTIAL

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

affect the intended clinical performance of the device, did not activate prematurely under expected conditions of use and provided protection against unintended sharps injury until disposal.

Conclusion:

Based on the indications for use, technology, design features, and principle of operation the proposed device, NovaGuard SA Safety System, is substantially equivalent to predicate devices UltraSafe Passive PLUS Needle Guard (K123743) and Safe'n'Sound Passive Delivery System (K101233).

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).