Each UltraSafe® Injection System Needle Guard is attached to an ISO standard glass syringe that is pre-filled and equipped with a shield that covers the needle during disposal intending to reduce the occurrence of accidental needle sticks to users. This device is used for a wide range of patients from children to adults and parenteral methods of administration.

Device Description

The UltraSafe® Needle Guerd is an accessory to the ISO 11040-4 standard glass syringe that is pre-filled. The device is totally disposable. It is a safety guard that can be mated with a pre-filled syringe of the same size. After use of the syringe, the guard is activated covering the needle and thus protecting the caregiver by eliminating the need to recap the needle and minimizing accidental needle stick injuries during disposal of the syringe/needle.

AI/ML Overview

This document is a 510(k) Premarket Notification for the UltraSafe® Injection System Needle Guard, which is a safety accessory for pre-filled syringes. The submission primarily focuses on establishing substantial equivalence to a predicate device.

Acceptance criteria and device performance are not explicitly detailed in a quantitative table with specific metrics and thresholds. Instead, the document provides a qualitative comparison to the predicate device, emphasizing safety features and material equivalence.

Here's an analysis of the provided information regarding acceptance criteria and study details:

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

Specific quantitative acceptance criteria (e.g., "force to activate guard > X N", "puncture resistance > Y psi") are not provided nor is quantitative performance data. The document relies on a descriptive comparison to the predicate device.

Acceptance Criteria (Implicit/Qualitative):
- Needle Guard requires two-handed action to cover the needle.
- Needle Guards possess "considerably greater strength than the predicate device."
- Easy assembly and use with a pre-filled syringe.
- Provides the same usable needle length as an unguarded needle in the "ready-to-use" position.
- Allows typical hypodermic procedures equivalently to standard, unguarded needles.
- Biocompatible materials (same as predicate).
- Provides a shield that covers the needle during disposal to reduce accidental needle sticks.
Reported Device Performance (Qualitative):
- "The Needle Guard requires a two-handed action in order to cover the needle point after use."
- "The Needle Guards have been tested and found to have considerably greater strength than the predicate device."
- "The Guard is easy to assemble and use with a prefilled syringe."
- "With the Needle Guards in the "ready-to-use" position, they provide the same useable needle length as an unguarded needle."
- "The user can perform typical hypodermic procedures equivalently to standard, unguarded needles."
- "The material has passed biocompatibility tests." (Implicitly, the UltraSafe® material has passed, as it is the same as the predicate).

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 for Test Set: Not specified. The document mentions "The Needle Guards have been tested," but does not provide details on the number of units tested or the methodology.
Data Provenance: Not specified. There is no mention of the country of origin or whether testing was 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):

Not applicable. The submission relies on engineering and material testing, not expert interpretation of outputs like in AI/imaging devices.

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

Not applicable. There is no mention of adjudication, as the assessment is based on physical performance and material properties rather than subjective interpretation requiring consensus.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, which is not the nature of this needle guard.

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

Not applicable. This device is a mechanical safety accessory, not an algorithm. Its performance is inherent to its design and material properties, not an AI or software component.

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

The "ground truth" for this device would be established through engineering performance testing (e.g., strength, ease of use, ability to cover the needle) and biocompatibility testing to confirm material safety. This isn't a "ground truth" in the conventional sense of clinical diagnoses.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

Not applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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

K972878

UltraSafe® Injection System 510(k) Premarket Notification Models B50, B100, B100L, B150, B225 and B300 Needle Guard

OCT 3 0 1997

9.0 Summary of Safety and Effectiveness

Safety Syringes Contact Person 9.1

David Mitchell Safety Syringes, Inc. 250 West Colorado Blvd. Suite # 101 Arcadia, CA 91007 (626) 821.1121 Phone (626) 821.1009 Fax

9.2 Device Name

UltraSafe® Injection System Needle Guard

9.3 Predicate Devices

Safety Syringes UltraSafe® Aspirating Syringe - K944425

9.4 Product Description and Function

Safety Syringes, Inc. UltraSafe® B Series Needle Guard 510/k) Submission

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

Comparison to Predicate Devices/Equivalence 9.5

Descriptive Comparison to Legally Marketed Devices The Needle Guard requires a two-handed action in order to cover the needle point after use.

The Needle Guards have been tested and found to have considerably greater strength than the predicate device. The Guard is easy to assemble and use with a prefilled syringe.

With the Needle Guards in the "ready-to-use" position, they provide the same useable needle length as an unguarded needle. The user can perform typical hypodermic procedures equivalently to standard, unguarded needles.

9.6 Comparison of Materials

The UltraSafe® Injection System Needle Guards are made of K-Resin KR03 and KR01, which are the same materials as the Safety Syringes predicate device.

9.7 Safety and Efficacy Information

Biocompatibility:

The UltraSafe® Injection System uses the same material as the Safety Syringes predicate device. The material has passed biocompatibility tests.

Labeled Warning Statements: Hands must remain behind the needle at all times during use and disposal.

Safety Syringes, Inc. UltraSafe B Series Needle Guard 510(k) Submission

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

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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3.0 1997

Mr. Anthony R. Perez CEO & President Safety Syringes, Incorporated 250 W. Colorado Boulevard, Suite 101 Arcadia, California 91007

Re : K972878 Ultrasafe® Injection System Needle Guard, Trade Name: Models B50,B100,B100L,B150,B225 & B300 Regulatory Class: II Product Code: FMF Dated: July 31, 1997 Received: August 4, 1997

Dear Mr. Perez:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does

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

Paqe 2 - Mr. Perez

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

... ..

Enclosure

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

510(k) Number (if known): K972878

Device Name: UltraSafe® Injection System Needle Guard Models B50, B100, B100L, B150, B225 & B300

Indications For Use:

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

Patricie Croate

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972878
Prescription Use ✓
(Per 21 CFR 801.109)
OR

Over-The-Counter Use

(Optional Format 1-2-96)

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).