Hypodermic Needle-Pro® EDGE" Safety Device: This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.

Hypodermic Needle-Pro® EDGE" Safety Device with Syringe: This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

Device Description

This device is intended for injection or aspiration of fluids into the body. The needle protection device covers the needle after use to help prevent needle sticks. The device features a "onepiece" design of needle hub and protective sheath with a living hinge. The needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position". After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the lugs on the needle hub snap into the clips of the protective sheath resulting in a "bottom snap" and the needle is contained within the sheath. In addition to the "bottom snap", the needle protection sheath for needles equal to or less than !" has one needle retaining hook (except 30g) and the sheath for needles longer than 1" has two hooks. The device is then discarded into a sharps container.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Smiths Medical ASD, Inc. Hypodermic Needle-Pro® EDGE™ Safety Device.

Acceptance Criteria and Device Performance (Implicit)

The document doesn't explicitly list quantifiable "acceptance criteria" in the way one might see for an AI algorithm's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating conformance to established industry standards and through a simulated clinical use study. For medical devices like this, regulatory acceptance often hinges on:

Safety: The device effectively prevents needle sticks after use.
Effectiveness: The device performs its intended function (injection/aspiration, covering the needle).
Substantial Equivalence: The device is as safe and effective as legally marketed predicate devices.
Compliance with Standards: Meeting recognized national and international standards applicable to hypodermic needles and syringes.

Acceptance Criterion (Implicit)	Reported Device Performance
Prevent Needle Sticks (Primary Safety Function)	The device features a "one-piece" design where the needle is pressed into the sheath using a one-handed technique. Lugs on the needle hub snap into clips ("bottom snap"), and additional needle retaining hooks secure the needle within the sheath. The simulated clinical use studies confirmed that the device could be used effectively, with the needle shielded inside the protection device after use. This directly addresses the aim of preventing needle sticks.
Effective Injection/Aspiration	The device is intended for injection or aspiration of fluids. While not explicitly detailed, the design (Luer lock/slip syringe compatibility, permanent needle fixation) and conformance to ISO standards (ISO 594/1, ISO 594-2, ISO 7864, ISO 7886-1) imply its functional effectiveness for these tasks.
Conformance to Industry Standards	Met: Conformance was declared for: - ISO 594/1:1986(E): Conical fittings with 6% (Luer) taper - General requirements. - ISO 594-2:1998(E): Conical fittings with 6% (Luer) taper - Lock Fittings. - ISO 7864:1993(E): Sterile hypodermic needles for single use. - ISO 7886-1:1993: Sterile hypodermic syringes for single use.
Substantial Equivalence to Predicate Devices	The FDA's 510(k) clearance explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." The technological characteristics are noted as "the same hinged style protective sheath that is manually activated after use" as the predicate devices.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: The document states "Simulated clinical use studies were conducted," but it does not specify the sample size (e.g., number of devices tested, number of simulated uses).
- Data Provenance: The study was conducted by Smiths Medical ASD, Inc., and is presumably internal to the company. The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a "simulated clinical use study," it would inherently be prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For a simulated use study of a physical device like this, "ground truth" would likely involve objective observation of device function (e.g., successful activation of safety mechanism, no needle exposure). It's possible the "experts" were the study designers or trained observers, but their number and qualifications are not disclosed.
Adjudication method for the test set:
- This information is not provided. Given the nature of observing a mechanical safety mechanism, formal adjudication (like 2+1 reads) might not have been deemed necessary, or the method was not explicitly documented in the summary.
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-based diagnostic tools where human "readers" (e.g., radiologists) interpret images. This device is a physical medical device (safety hypodermic needle).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in the sense that the device's mechanical function was tested on its own. The "Simulated clinical use studies" would primarily assess the device's ability to shield the needle after use, which is its standalone function without direct human "performance" being the primary variable, beyond successful activation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth would have been objective observation of the device's mechanical function in the simulated clinical use. For example, did the needle successfully retract/shield? Was it securely contained? Was there any accidental needle exposure after activation? This is a direct observation of the device's intended safety outcome.
The sample size for the training set:
- Not applicable / Not provided. For a physical medical device, there isn't typically a "training set" in the computational sense. Device design and engineering are based on principles and iterative testing, not machine learning training data.
How the ground truth for the training set was established:
- Not applicable. As above, there's no "training set" with ground truth in the context of this device. Design validation and verification for a mechanical device involve engineering specifications and tests, rather than labeled training data.

Summary

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smiths

SECTION 5, 510(k) Summary

Company Information:

Smiths Medical ASD, Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812, prompt 4, ext 2493 Contact: Brian D. Farias Regulatory Affairs Manager

Smiths Medical ASD, Inc.

Anesthesia and Safety Devices Division

10 Bowman Drive Keene NH 03431 USA Tel: +1 603 352 3812 Fax: +1 603 352 3703 www.smiths-medical.com

AUG - 2 2007

Summary Prepared: June 29, 2007

Product Name:

Trade Namc: Hypodermic Needle-Pro® EDGE" Safety Device Hypodermic Needle-Pro® EDGE" Safety Device with Syringe

Common Name: Hypodernic Needle with attached needle protection and Syringe with attached needle and needle protection

Classification Name: Hypodermic Single Lumen Needles (21 CFR 880.5570, Product Code FMI) and Piston Syringe (21 CFR 880.5860, Product Code FMF)

Predicate Device(s):

K041399 and K063450 (Smiths Medical ASD, Inc.) Hypodermic Needlc-Pro® EDGE" Needle Protection Device

K061194 (Smiths Medical ASD, Inc.) Portex® Needle-Pro® EDGE™ Safety Device with Syringe

K031453 (Terumo Medical Corporation) SurGuard2™ Safety Hypodermic Needle

Device Description:

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Indications for Use:

Technological Characteristics:

The proposed and predicate devices all employ the same hinged style protective sheath that is manually activated after use.

Non-Clinical Data:

This abbreviated 510(k) submission declares conformance to the following standards:

ISO 594/1:1986(E), International Standard, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment-Part 1: General requirements

ISO 594-2:1998(E), International Standard, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment-Part 2: Lock Fittings

ISO 7864:1993(E), International Standard, Sterile hypodermic needles for single use

ISO 7886-1:1993, International Standard, Sterile hypodermic syringes for single use

Clinical Data:

Simulated clinical use studies were conducted which confirmed that the device could be used effectively, with the needle shielded inside the protection device after use.

Conclusion:

The standards compliance and simulated clinical use studies demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices,

Very truly yours,

SMITHS MEDICAL ASD, INC.

rian D. Farias Regulatory Affairs Manager

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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian D. Farias Regulatory Affairs Manager Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431

AUG - 2 2007

Re: K071785

Trade/Device Name: Hypodermic Needle-Pro® EDGE™ Safety Device Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: June 29, 2007 Received: July 3, 2007

Dear Mr. Farias:

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. Farias

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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). please contact the Office 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 Division of 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/industry/support/index.html.

Sincerely yours,

Shinn-Linn, Ph.D.

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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SECTION 4, Indications for Use Statement

Indications for Use

510(k) Number (if known):

Device Name: Hypodermic Needle-Pro® EDGE™ Safety Device

Indications for Use:

This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

( Javision Sign-Off) Division of Anesthesiology, General Hospital, Intection Control, Dental 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).