The UltraSafe Passive™, X-Series, Needle Guard is intended for use as a safety mechanism designed to reduce the occurrence of accidental needlesticks to healthcare professionals during disposal of a used syringe and needle assembly. The UltraSafe Passive, X-Series, Needle Guard is snapped onto the barrel of an ISO Standard pre-filled glass syringe, in a retracted position. Upon completing the injection, the UltraSafe Passive, X-Series, Needle Guard passively activates and covers the exposed needle. When the Passive Needle Guard is activated, it provides protection from an accidental needlestick. The healthcare professional disposes the used syringe and needle assembly in a sharps container.

UltraSafe Passive™, X-Series, Needle Guards are single use devices that are indicated for use as an accessory with ISO Standard pre-filled glass syringes to protect healthcare professionals from accidental needle sticks.

Device Description

The UltraSafe Passive™, X-Series, Needle Guard is an accessory for ISO Standard pre-filled glass syringes. ISO Standard pre-filled glass syringes are supplied in multiple sizes. They fit with ISO Standard pre-filled glass syringes ranging from 0.5 mL to 5.0 mL of fill volume.

The guards are designed to meet the requirements specified in ISO 11040-4 Prefilled syringes - Part 4 Glass barrels for injectables (March 1995).

AI/ML Overview

The provided text describes a 510(k) submission for the UltraSafe Passive™, X-Series, Needle Guard. The submission focuses on demonstrating substantial equivalence to a predicate device, the UltraSafe® Injection System Needle Guard - B-Series, rather than establishing de novo acceptance criteria associated with a specific diagnostic performance outcome.

Instead of traditional diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy), the study evaluates the safety, performance, and usability of the new passive device compared to the manually activated predicate device through a controlled simulated clinical use test.

Here's an analysis of the "acceptance criteria" and the study based on the provided text:

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

Acceptance Criteria Category	Device Performance (UltraSafe Passive™, X-Series)
Needle Stick Safety	Rated equal to, or better than, the B-Series.
Overall Performance	Rated equal to, or better than, the B-Series.
Usability	Rated equal to, or better than, the B-Series.
Clarity & Adequacy of Directions for Use	Rated equal to, or better than, the B-Series.
Response to Need for In-Service Training	Rated equal to, or better than, the B-Series.

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

Sample Size: Not explicitly stated beyond "nurses involved in this study" and "study participants." The exact number of nurses is not provided.
Data Provenance: The study was a "controlled simulated clinical use test." It is prospective in nature, as it involved active participation of users with the device. The country of origin is not specified but given the company information (Carlsbad, CA, USA) and the FDA submission, it can be inferred that the study was likely conducted in the USA.

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 in the context of this device. The "ground truth" here is subjective user feedback and comparative assessment by "nurses" on safety, performance, and usability, rather than an objective diagnostic or clinical outcome requiring expert consensus for ground truth establishment.

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

Not applicable. There was no "ground truth" to adjudicate in the traditional sense of diagnostic accuracy. The study involved user ratings and comparisons.

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 mechanical safety accessory, not an AI or imaging device that would involve human "readers" interpreting cases. The study was a comparative user evaluation of a medical device's safety features and usability.

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

Not applicable. This device is a physical accessory where "human-in-the-loop performance" (i.e., use by healthcare professionals) is its primary mode of operation and evaluation.

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

The "ground truth" was established through user evaluation and comparative ratings by nurses during a simulated clinical use test. It's based on subjective feedback and direct comparison of the new device (X-Series) against the predicate device (B-Series) on parameters of safety, performance, and usability. There is no objective medical ground truth (like pathology or clinical outcomes) being assessed for this type of device.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of mechanical device evaluation. The "iterative user evaluations" conducted by Safety Syringes, Inc. prior to the controlled simulated clinical use test might be considered analogous to developmental testing, but not a formal "training set" in the context of AI/machine learning.

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

Not applicable as there was no formal "training set" with ground truth in the traditional sense for this device.

Summary

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K042712

510(k) Summary

OCT 15 2004

Special 510(k) summary of safety and effectiveness

Device Identification

Trade Name - UltraSafe Passive™, X-Series, Needle Guard - Models X50, X100, X100L, X150, X225, X300, X500 Classification Name - Syringe, Piston (accessory) Classification - Class II Product Code - 80 FMF

Predicate Device

The UltraSafe® Injection System Needle Guard - Models B50, B100L. B150, B225, and B300

Device Description

The guards are designed to meet the requirements specified in ISO 11040-4 Prefilled syringes - Part 4 Glass barrels for injectables (March 1995).

Intended Use

The intended patient population is unrestricted and includes children and adults.

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K042712
292

The intended environment of use is where healthcare professionals are required to administer medication, including vaccines, by means of a syringe.

Indications for Use

This device is used on a wide range of patients, including children and adults, and parenteral methods of administration.

Comparison of the UltraSafe® Injection System Needle Guard - B-Series to the UltraSafe Passive™, X-Series, Needle Guard

The UltraSafe Passive™ X-Series, Needle Guards are modifications of the previously cleared (K002070) UltraSafe Injection System Needle Guard, B-Series. The B-Series are manually activated needle guards. The X-Series are passively (automatically) activated needle guards.

The basic design, function, intended use, and indications for use of the B-Series and X-Series are similar.

Safety Syringes, Inc. conducted iterative user evaluations of the X-Series needle guard. A controlled simulated clinical use test was conducted with the UltraSafe Passive, X-Series, Needle Guard to validate the product in the hands of typical users. The UltraSafe Injection System Needle Guard, B-Series, was used as the control.

In the controlled simulated clinical use test, each of the specified acceptance criteria were either met or exceeded. The nurses involved in this study rated the X-Series to be equal to, or better than, the B-Series on all of the parameters related to safety, performance, and usability.

In addition to evaluating safety, performance, and usability parameters, there were questions of the study participants regarding the clarity and adequacy of the written and illustrated Directions for Use, and the participants' response to the need for in-service training. On each of the parameters, the X-Series rated as equal to, or better, than the B-Series.

K9722878 Thomas L. Hale 10/07/04

03 10

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three horizontal lines curving upwards, resembling a person with outstretched arms.

OCT 1 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas L. Hall Director, Regulatory Affairs and Quality Assurance Safety Syringes, Incorporated 1939 Palomar Oaks Way, Suite A, Carlsbad, California 92009

Re: K042712

Trade/Device Name: Tamper Evident UltraSafe® Passive™ Delivery System Syringe, Piston (Accessory) Regulation Number: 880.5860 Regulation Name: Antistick Syringe, Piston Syringe Regulatory Class: II Product Code: MEG, FMF Dated: September 27, 2004 Received: September 30, 2004

Dear Mr. Hall:

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. Hall

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 nean that 1 Dr mas made statutes and regulations administered by other Federal agencies. or the Act of ally I outstar the Act's requirements, including, but not limited to: registration r ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 er result in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as be former 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) Prinstet notification. The FDA finding of substantial equivalence of your device to a promative noticate 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), rr you decire spiee 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 maj count 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/dsma/dsmamain.html

Sincerely yours,

Susan Runner
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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K0427/2

Indications for Use Statement

510(k) Number: _

Tamper Evident Device Name: UltraSafe® Passive™ Delivery System Syringe, Piston (Accessory)

Indications for Use:

Single Use devices that are indicated for use as an accessory with pre-filled \SO
le from that are indicated for use of he diberary professionals from Single Ose devices that are indication for ass as the althcare professionals from accidental needlesticks.

These devices can be used on a wide range of patients, including children and adults, and parenteral methods of administration.

Anew Navesse for Adw 10/14/04

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K042712

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Concurrence of CDRH, Office of Device Evaluation

Prescription Use × (Per 21 CFR 801.109 OR

Over the Counter______________________________________________________________________________________________________________________________________________________________

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).

510(k) Summary

Special 510(k) summary of safety and effectiveness

Company information

Device Identification

Predicate Device

Device Description

Intended Use

Indications for Use

Comparison of the UltraSafe® Injection System Needle Guard - B-Series to the UltraSafe Passive™, X-Series, Needle Guard

Indications for Use Statement

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

§ 880.5860 Piston syringe.