Single use devices that are indicated for use as an accessory with prefilled ISO Standard plastic 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 needle sticks. The intended patient population is unrestricted and may include children and adults, for parenteral methods of administration.

Device Description

This submission is provided for modifications to the predicate device, which includes design changes and addition of an optional loose extended finger flange. Details are provided in Table 1 hereafter.

The Safe'n'Sound® Staked Passive Delivery System - Plajex® Version is a non-sterile single use anti-needle stick accessory for use with Plajex® sterile prefilled ISO Standard plastic syringes. It fits with Plajex® 1 mL-long staked syringes with a maximum needle length of ½". It consists of a subassembly with a loose plunger rod and an optional loose extended finger flange. The proposed device will be assembled along with the prefilled syringe by the pharmaceutical company. Upon completion of the injection, the needle is then covered by the body protecting the user from potential sharps needle stick injury.

The device is made of molded plastic and have a stainless steel spring.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Safe'n'Sound® Staked Passive Delivery System - Plajex® version, which is an anti-needle stick accessory for prefilled syringes. This document primarily focuses on demonstrating substantial equivalence to a predicate device through design changes, bench testing, biocompatibility testing, and simulated clinical use studies.

However, the document does not contain detailed acceptance criteria or a study proving the device meets those criteria in the typical format of a diagnostic AI/ML device study. Instead, the performance testing focuses on showing the device functions as intended and is substantially equivalent to a predicate device, primarily addressing mechanical and safety aspects of a medical device, not diagnostic accuracy.

Therefore, for your specific requests, much of the information, particularly points 2-5, 7-9 which pertain to AI/ML device studies, is not present in the provided text. I will answer what is available and indicate when information is not provided.

1. A table of acceptance criteria and the reported device performance

The document states that performance testing was conducted according to ISO standards, but it does not specify quantitative acceptance criteria or detailed reported device performance in a table format.

Acceptance Criteria and Reported Device Performance (as inferred from the document):

Acceptance Criteria (Inferred from Standards)	Reported Device Performance (Summary from Document)
For Performance Testing (ISO 23908:2011, ISO 7886-4, ISO 8537):	- "It confirmed the product functions as intended and is substantially equivalent to the predicate device."
- Device functions as intended
- Substantial equivalence to predicate device (K141664)
For Biocompatibility Testing (ISO 10993-5, ISO 10993-10):	- "Biocompatibility testing performed demonstrates that the product meets ISO 10993-5 and ISO 10993-10 requirements."
- Compliance with ISO 10993-5 (Cytotoxicity)	- "Biocompatibility tests conducted (cytotoxicity, irritation and sensitization) demonstrate that Safe'n'Sound® Plajex® version including EFF is biocompatible..."
- Compliance with ISO 10993-10 (Irritation and Skin Sensitization)
For Simulated Clinical Use Testing (Guidance for Industry and FDA Staff for Medical Devices with Sharps Injury Prevention Features dated August 9, 2005, and ISO 23908:2011):	- "It confirmed that the Safe'n'Sound® Staked Passive Delivery System - Plajex® version could be used to shield needles inside the protection device after use."
- Ability to shield needles inside the protection device after use to prevent accidental needle sticks	- "It demonstrates that the device is as safe, as effective, and performs as well as the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes (number of devices tested) for the performance, biocompatibility, or simulated clinical use studies. It also does not provide information on the data provenance such as country of origin or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of device and studies described. The "ground truth" here would relate to the physical and functional performance of the medical device, not diagnostic interpretations by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to the type of device and studies described. Adjudication methods are typically used in clinical studies involving human interpretation or assessments, which is not the focus of these engineering and performance tests.

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 such study was conducted or described. This type of study is relevant for AI/ML diagnostic devices, not for a physical sharps injury prevention device. The comparison here is between the new device and a predicate device in terms of safety and effectiveness, not human reader performance.

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

This concept is not applicable to this physical medical device. This device is an accessory to a syringe and its performance is inherently tied to its mechanical function and human interaction during use.

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

The "ground truth" for this device's performance would be derived from:

Reference standards in the ISO norms (e.g., specific force required, shielding effectiveness).
Visual inspection or mechanical measurement of device functionality (e.g., successful needle shielding).
Biocompatibility assessments based on established biological response criteria.
The established safety and effectiveness profile of the predicate device for demonstrating substantial equivalence.

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm that requires a training set.

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

This is not applicable as there is no AI/ML algorithm that requires a training set.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible.

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

June 2, 2015

Nemera Ms. Beatrice Grand Demars Regulatory Compliance Manager 20 Avenue de La Gare La Verilliere, 38292 FRANCE

Re: K150562

Trade/Device Name: Safe'n'Sound® Staked Passive Delivery System - Plajex® Version Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: February 27, 2015 Received: March 6, 2015

Dear Ms. Grand Demars:

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}------------------------------------------------

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 (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 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 vours.

Tina
Kiang -S

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

Enclosure

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

Indications for Use

510(k) Number (if known)

K150562

Device Name

Safe'n'Sound® Staked Passive Delivery System - Plajex® version

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 Drug 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}------------------------------------------------

Section 5: 510(k) Summary

Assigned 510(k) number:	K150562
Company:	Nemera600 Deerfield ParkwayBuffalo Grove, IL 60089Phone: (800) 537-0178Fax: (847) 325-3795
Contact:	Beatrice GRAND DEMARS
Date Prepared:	June 1, 2015
Trade/Proprietary Name:	Safe'n'Sound® Staked Passive Delivery System –Plajex® version
Classification Name:	Piston syringe
Classification/Product Code:	21 CFR 880.5860, Class II, Product Code MEG
Predicate Device:	K141664 Safe'n'Sound® Passive Delivery System– Cone version by Nemera

Device Description:

The device is made of molded plastic and have a stainless steel spring.

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

Abbreviated 510(k) Safe'n'Sound® Staked Passive Delivery System - Plajex® version K150562

Intended Use:

Single use devices that are indicated for use as an accessory with prefilled ISO Standard plastic syringes to aid in the protection of healthcare professionals, patients who selfinject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needle sticks. The intended patient population is unrestricted and may include children and adults, for parenteral methods of administration.

The subject of this premarket notification is an adjustment of device design in order to make it compatible with ISO Standard plastic syringe, while the legally marketed device is currently compatible with ISO Standard glass syringe. This premarket notification also covers the description of an optional loose extended finger flange. These changes imply slight modification of design but do not impact the fundamental technology of the device.

Technological Characteristic Comparison Summary to Predicate Device:

The Safe'n'Sound® Staked Passive Delivery System - Plajex® version is similar to the predicate device in general technological features and principle of operation. Both are molded plastic subassemblies and plunger rod. Both have a spring that activates upon injection completion to fully contain the needle. However, the Cone, Sleeve and Plunger Rod components has been slightly redesigned to fit with Plajex® syringe.

In addition, the Safe'n'Sound® Staked Passive Delivery System - Plajex® version proposes an optional loose Extended Finger Flange (EFF) to increase handle surface. EFF component is made in same material than Plunger Rod with addition of an orange dye.

A side by side comparison is available below in Table 1.

These changes do not raise new questions of safety and effectiveness of the device as proven by design and process validations, bench testing, biocompatibility testing and simulated clinical use studies performed.

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

Abbreviated 510(k)
Safe'n'Sound® Staked Passive Delivery System – Plajex® version
K150562

Side by Side Comparison with the Predicate Devic Table 1

	New deviceSafe'n'Sound® Staked Passive DeliverySystem - Plajex® Version	Predicate deviceSafe'n'Sound® Staked Passive DeliverySystem - Cone version	Discussion
Generaltechnologicalfeatures andprinciple ofoperation	Molded plastic assembly consisting of body, cone, sleeve, plunger rod, EFF (optional) and spring that activates upon injection completion to fully contain the needle	Molded plastic assembly consisting of body, cone, sleeve, plunger rod, and spring that activates upon injection completion to fully contain the needle	Same principle, EFF optional component has been added to the new device to increase finger flange surface.
Material composition
Body	Polycarbonate (transparent, natural with no colorant)		Same material
Cone	Polycarbonate (transparent, natural with no colorant)		Same material
Sleeve	Polycarbonate (transparent, natural with no colorant)		Same material
Spring	Bright stainless steel		Same material
Plunger rod	Polypropylene with colorant (white masterbatch)		Same material
Extended FingerFlange (EFF)	Polypropylene with colorant (orangemasterbatch)	Not applicable	EFF component is made in same material than Plunger Rod with addition of an orange dye**
Mechanical specification
Specifications	Internal specifications		Same specifications unless 2 items (syringe loading and EFF disassembly) adapted due to the change in the design
	* Change has been assessed. Biocompatibility	tests conducted (cytotoxicity, irritation and sensitization) demonstrate that Safe'n'Sound® Plajex® version

ncluding EFF is biocompatible regarding the see Section 15. Design Vestig, bench testig, and testig and simulated dinial use sucer "Pajer" versio

{6}------------------------------------------------

Performance Testing:

Performance has being tested on the Safe'n'Sound® Staked Passive Delivery System -Plajex® version following ISO 23908:2011. Bench testing has been performed following ISO7886-4 and ISO 8537 standards. It confirmed the product functions as intended and is substantially equivalent to the predicate device. Biocompatibility testing performed demonstrates that the product meets ISO 10993-5 and ISO 10993-10 requirements.

Simulated Clinical Testing:

Simulated clinical use testing has been performed. It confirmed that the Safe'n'Sound® Staked Passive Delivery System - Plajex® version could be used to shield needles inside the protection device after use. The study follows Guidance for Industry and FDA Staff for Medical Devices with Sharps Injury Prevention Features dated August 9, 2005 and ISO 23908:2011 standard. It demonstrates that the device is as safe, as effective, and performs as well as the predicate device.

Conclusion:

Based upon the design, technology, performance, functional testing, and intended use, the Safe'n'Sound® Staked Passive Delivery System - Plajex® version is substantially equivalent to predicate device currently marketed under the Federal Food, Drug and Cosmetic Act. Tests performed demonstrates that Safe'n'Sound® Staked Passive Delivery System - Plajex® version is as safe and as effective as the predicate device.

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).