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 seff-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 Pro 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 Pro Safety System consist of three components, syringe holder, sleeve and spring. The proposed device will be assembled along with the pre filled syringe by the pharmaceutical company. Upon completion of the injection, 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 document describes the NovaGuard SA Pro Safety System, an accessory for pre-filled syringes designed to prevent needlestick injuries. The submission is a 510(k) premarket notification, which means the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All testing met the required acceptance criteria," but it does not explicitly list the numerical acceptance criteria for each test. It only identifies the types of performance tests conducted and confirms they were measured against "internal performance standards."

Acceptance Criteria (Not explicitly stated, assumed to be met)	Reported Device Performance (Implied)
Syringe assembly force: (Assumed internal standard)	Passed (met internal performance standards)
Pre-activation disassembly force (force applied to RNS): (Assumed internal standard)	Passed (met internal performance standards)
Pre-Activation Disassembly Force Test (force applied to cannula): (Assumed internal standard)	Passed (met internal performance standards)
Clip impact test (Integrated clip feature test): (Assumed internal standard)	Passed (met internal performance standards)
Drop Test - Post-activation with PFS: (Assumed internal standard)	Passed (met internal performance standards)
Drop Test - Pre-activation with PFS: (Assumed internal standard)	Passed (met internal performance standards)
Activation Security: (Assumed internal standard)	Passed (met internal performance standards)
RNS replacement: (Assumed internal standard)	Passed (met internal performance standards)

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

The document does not specify the sample size for any of the performance tests.
The data provenance is not explicitly stated, but based on the context of a 510(k) submission from West Pharmaceutical Services, Inc., an American company, the testing would likely have been conducted in the United States (or by a contracted lab) and would be prospective (i.e., conducted specifically for this submission).

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

This type of study does not involve experts establishing ground truth in the traditional sense (e.g., diagnosing medical conditions). The ground truth for performance testing of a mechanical device like this is determined by engineering specifications and objective measurements against predefined internal standards for force, impact resistance, and functionality. Therefore, this information is not applicable.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective mechanical/performance evaluations, not subjective assessments requiring adjudication.

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 relevant for AI or diagnostic imaging devices where human interpretation is a factor. The NovaGuard SA Pro Safety System is a mechanical safety device. The document explicitly states: "The proposed device, NovaGuard SA Pro Safety System, modifications did not affect the device design impacting activation of the safety prevention feature therefore based upon their risk analysis a simulated use study was deemed not necessary." This indicates that even a human factors or simulated use study was considered unnecessary due to the nature of the modifications.

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

Not Applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on engineering specifications and internal performance standards for mechanical integrity and functionality, rather than expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or therapeutic medical devices.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this mechanical device. This concept applies to machine learning algorithms.

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

Not Applicable. As there is no training set, there is no ground truth for it.

In summary:

The document describes performance testing for a mechanical safety device, the NovaGuard SA Pro Safety System, which focuses on demonstrating its functional safety and mechanical integrity. The relevant "acceptance criteria" are the internal performance standards against which the device was tested, and the "study" is a series of bench tests. The submission argues for substantial equivalence based on these tests and the minor nature of the design modifications compared to the predicate device. Notably, no clinical or simulated use studies were deemed necessary for this 510(k) clearance due to the nature of the device and its modifications.

Summary

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

February 2, 2017

West Pharmaceutical Services, Inc. Ms. Ana Ladino Director of Regulatory Affairs 530 Herman O. West Drive Exton, Pennsylvania 19341-1147

Re: K163511

Trade/Device Name: NovaGuard SA Pro Safety System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 14, 2016 Received: December 15, 2016

Dear Ms. Ladino:

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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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 devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Tina
Kiang-S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163511

Device Name NovaGuard SA Pro 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)

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FOR FDA USE ONLY

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

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510(K) SUMMARY : K163511

NovaGuard SA Pro Safety System Device:

Company Name:

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

Contact Person:

Ana Ladino Director of Regulatory Affairs West Pharmaceutical Services, Inc. Phone: 610-594-3165 Fax: 610-717-0668 E-mail: ana.ladino@westpharma.com

US Agent:

Kevin Lentz Senior Director of Regulatory Affairs 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: January 31, 2017

Classification:

Classification Name: Piston Syringe 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

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Predicate Device:

NovaGuard SA Safety System 510(k) K141464.

Device Description:

Indications for use:

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.

Substantial equivalence:

Based on the indications for use, technology, materials of construction and principle of operation the proposed device, NovaGuard SA Pro Safety System, is substantially equivalent to the predicate device, NovaGuard SA Safety System 510(k) K141464.

The following modifications have been made to the predicate device, NovaGuard SA Safety System 510(k) K14146:

. Syringe holder modifications to implement integrated clip features instead of a separate clip component.
. Syringe holder modifications to aid in the molding and assembly process and to smooth the syringe holder fingers profile.

The predicate device. NovaGuard SA Safety System (K141464) includes a separate clip component. The proposed device, NovaGuard SA Pro Safety System includes an integrated clip feature on the syringe holder instead of a separate clip component. This change was implemented to facilitate the pharmaceutical manufacturer assembly process of the proposed device, NovaGuard SA Pro Safety System, with their prefilled syringe. This device modification eliminates the need to assemble a clip component as a separate operation.

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Areas forComparison	Predicate Device:NovaGuard SA SafetySystem (K141464)	Proposed Device:NovaGuard SA ProSafety System	Comparison
Indications forUse	Single use device that isindicated for use as anaccessory with pre-filled ISO Standardglass syringes to aid inthe protection ofhealthcareprofessionals, patientswho self-inject doctorprescribed medicationsand individuals thatassist self-injectingpatients from accidentalneedle sticks. Theintended patientpopulation isunrestricted and mayinclude children andadults and parenteralmethods ofadministration.	Single use device that isindicated for use as anaccessory with pre-filled ISO Standardglass syringes to aid inthe protection ofhealthcareprofessionals, patientswho self-inject doctorprescribed medicationsand individuals thatassist self-injectingpatients from accidentalneedle sticks. Theintended patientpopulation isunrestricted and mayinclude children andadults and parenteralmethods ofadministration.	Identical
Use	Single Use	Single Use	Identical
Prescription Use	Yes	Yes	Identical
Contraindication	None	None	Identical
Components	Syringe holder, sleeve,spring and clip	Syringe holder, sleeveand spring	ModifiedIntegrated clipreplaces the clipcomponent
CompatibleSyringes	Pre-filled ISO Standardglass syringes	Pre-filled ISO Standardglass syringes	Identical
Syringe size	1mL Long	1mL Long	Identical
Needle Length	Max 5/8" length	Max 5/8" length	Identical
Needle shieldrequirement	Rigid	Rigid	Identical
Syringe holdermaterial of	Polycarbonate	Polycarbonate	Identical
Areas forComparison	Predicate Device:NovaGuard SA SafetySystem (K141464)	Proposed Device:NovaGuard SA ProSafety System	Comparison
construction
Sleeve material ofconstruction	Polycarbonate	Polycarbonate	Identical
Spring material ofconstruction	Stainless Steel	Stainless Steel	Identical
Clip material ofconstruction	Polycarbonate	N/A	ModifiedThe NovaGuard SAPro Safety Systemdoes not have aseparate clipcomponent
Biocompatible	YesPer ISO 10993-1	YesPer ISO 10993-1	Identical
Sterilization	Non- sterile	Non- sterile	Identical

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Performance Testing:

Based on the verification and validation activities, along with the risk assessment evaluation, it was determined that the following tests needed to be performed on the proposed device, NovaGuard SA Pro Safety System.

Syringe assembly force
Pre-activation disassembly force (force applied to RNS) ●
. Pre-Activation Disassembly Force Test (force applied to cannula)
Clip impact test (Integrated clip feature test) ●
Drop Test Post-activation with PFS ●
Drop Test - Pre-activation with PFS
Activation Security
. RNS replacement

All testing met the required acceptance criteria.

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Performance Testing Summary
Test Name	Testing Standard
Syringe assembly force	Tested to internal performance standards
Pre-activation disassembly force (force applied to RNS)	Tested to internal performance standards
Pre-Activation Disassembly Force Test (force applied to cannula)	Tested to internal performance standards
Clip impact test (Integrated clip feature test)	Tested to internal performance standards
Drop Test - Post-activation with PFS	Tested to internal performance standards
Drop Test - Pre-activation with PFS	Tested to internal performance standards
Activation Security	Tested to internal performance standards
RNS replacement	Tested to internal performance standards

The bench testing evaluation of the proposed device, NovaGuard SA Pro Safety System, does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device.

Clinical Testing:

The proposed device, NovaGuard SA Pro Safety System, modifications did not affect the device design impacting activation of the safety prevention feature therefore based upon their risk analysis a simulated use study was deemed not necessary.

Conclusion:

Based on the indications for use, technology, materials of construction and principle of operation the proposed device NovaGuard SA Pro Safety System, is substantially equivalent to the predicate device, NovaGuard SA Safety System (K141464).

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).