This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The Needle-Pro® device is not designed for use with a luer lock syringe.

Device Description

This device is intended for injection or aspiration of fluids utilizing a luer slip syringe. The needle protection device is an integral component of the device as it comes pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the needle bevel by swiveling the orange arm to the desired position. After the procedure is completed, the needle is pressed into the sheath using a onehanded technique. As the needle enters the protective sheath, the needle protection device engages and the needle is contained within the sheath. The device should be immediately be disposed into a sharps container. This device is not designed for use with a luer lock syringe. The device is supplied with 25G, 26G, 27G needles both with and without a syringe.

AI/ML Overview

The provided text, a 510(k) summary for the "Hypodermic Needle-Pro® Needle with Needle Protection Device" and "Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device," does not include specific acceptance criteria or an analytical study detailing device performance against such criteria.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (K923127 Needle-Pro™ Cartridge) through non-clinical bench testing.

Here's an analysis of the information available in the document:

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

The document does not explicitly state numerical acceptance criteria for specific performance metrics. It makes a general claim:

Acceptance Criteria	Reported Device Performance
Not explicitly defined, but implied to be "equal or greater ability to resist static and dynamic forces, as compared to the predicate devices, while testing for needle disengagement."	"The bench test data submitted demonstrates that the proposed device has an equal or greater ability to resist static and dynamic forces, as compared to the predicate devices, while testing for needle disengagement."

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

Sample size: Not specified.
Data provenance: Bench test (non-clinical) data. The country of origin is not specified, but the applicant company, SIMS Portex Inc., is based in Keene, NH, USA. The data is prospective in the sense that it was generated for the purpose of this submission, but it's not clinical data.

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

This is not applicable as the study was non-clinical bench testing comparing the device to a predicate, not assessing a diagnostic or predictive performance against a "ground truth" established by experts.

4. Adjudication method for the test set:

This is not applicable as the study was non-clinical bench testing, not involving human interpretation or 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:

This is not applicable. The device is a medical product (hypodermic needle and syringe), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This is not applicable. The device is a physical medical product, not an algorithm.

7. The type of ground truth used:

This is not applicable in the traditional sense of diagnostic accuracy. The "ground truth" for the non-clinical testing would be the established performance characteristics of the predicate device regarding its resistance to forces and needle disengagement. The goal was to prove the new device performed at least as well.

8. The sample size for the training set:

This is not applicable. There is no "training set" in the context of this 510(k) submission as it concerns a physical medical device, not a machine learning algorithm.

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

This is not applicable for the reasons stated above.

Summary

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K011925

Image /page/0/Picture/1 description: The image shows the logo for Smiths Industries Medical Systems. The logo consists of two parts: a stylized graphic on the left and the text "SMITHS INDUSTRIES Medical Systems" on the right. The text is arranged in two lines, with "SMITHS INDUSTRIES" in a bold, sans-serif font and "Medical Systems" in a smaller, italicized font.

JUL 1 2 2001

SIMS Portex Inc.

10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: 603-352-3812 Fax: 603-352-3703

K: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

510(K) SUMMARY:

COMPANY INFORMATION:

SIMS Portex Inc 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Brian D. Farias Regulatory Affairs Specialist

PREPARATION DATE OF SUMMARY:

June 19, 2001

TRADE NAME:

Hypodermic Needle-Pro® Needle with Needle Protection Device Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device

COMMON NAME:

Hypodermic Needle and Syringe with attached needle protection

PRODUCT CLASS/CLASSIFICATION:

Class II, 80 FMI, 21 CFR 880.5570 (Hypodermic Single Lumen Needles) This filing is under FMI as the needle protection device is attached to the needle.

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PREDICATE DEVICE(S):

K923127 Needle-Pro™ Cartridge

DESCRIPTION:

INDICATIONS FOR USE:

TECHNICAL CHARACTERISTICS:

The proposed device is composed of the same components and materials as the predicate devices. The device is sold sterile.

NON-CLINICAL DATA:

The bench test data submitted demonstrates that the proposed device has an equal or greater ability to resist static and dynamic forces, as compared to the predicate devices, while testing for needle disengagement.

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CLINICAL DATA:

Not applicable

CONCLUSION:

The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SIMS PORTEX INC.

Brian D. Farias Regulatory Affairs Specialist

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 overlapping, abstract shapes that resemble birds in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2001

Mr. Brain D. Farias Regulatory Affairs Specialist Sims Portex, Incorporated 10 Bowman Drive Keene, New Hampshire 03431

K011925 Re:

Hypodermic Needles-Pro® Needle with Trade/Device Name: Needle Protection Device and Hypodermic Needle-Pro® Syringe and Needle Potection Device Needles Regulation Number: 880.5570 Regulatory Class: II Product Code: FMI Dated: June 19, 2001 Received: June 20, 2001

Dear Mr Farias:

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 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). 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 reqistration, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਬ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2- Mr. Farias

In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does 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 asboragof 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) 594-4692. 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" (21CFR 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Susan Tunnes

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

Enclosure

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B: INTENDED USE OF DEVICE

PROPOSED INDICATIONS FOR USE:

Page 1 of 1

510(k) Number (if known): Unknown

Device Name:

Hypodermic Needle-Pro® Needle with Needle Protection Device Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use_ Prescription Use

Patricia Cuscenite

(Division Sign-Off) (Division Sign-Chi)
Division of Dental, Infection Control, Division oral Hospital Devices 510(k) Number ---

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).