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. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure.

Device Description

This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" 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 1" has one needle retaining hook (except 30g) and the sheath for needles longer than 1" has two hooks. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure. An example is removal of the EDGE™ safety device from a blood sampling syringe. The EDGE™ safety device is then discarded into a sharps container.

AI/ML Overview

The provided text describes a 510(k) submission for the Hypodermic Needle-Pro® EDGE™ Safety Device. However, the document does not contain explicit acceptance criteria and corresponding reported device performance in a table format. The study conducted is a "Simulated clinical use studies" for the device, and the document states that these studies "confirmed that the EDGE™ safety device could be used by phlebotomists with no substantial change to their technique and could be safely removed from the syringe after activation."

Based on the information provided in the document, here's a breakdown of the requested details:

Table of acceptance criteria and the reported device performance:

Acceptance Criterion	Reported Device Performance
Device can be used by phlebotomists with no substantial change to their technique.	Confirmed.
Device can be safely removed from the syringe after activation.	Confirmed.

Sample size used for the test set and the data provenance:
The document does not specify the sample size for the "Simulated clinical use studies." It also does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Simulated clinical use studies."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide this information. It only states that the study involved "phlebotomists."
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method.
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 MRMC study was described. This device is a physical medical device (hypodermic needle with safety feature), not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This question is not applicable as the device is a physical medical device, not an algorithm, and its use inherently involves human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth was established through observation and evaluation of the device's functionality during "simulated clinical use studies" by phlebotomists. This would imply an observational assessment of ease of use and safety during a simulated procedure.
The sample size for the training set:
The document does not mention a "training set" as this is not a machine learning model. The clinical studies described are for validation of the device's performance.
How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this type of medical device submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Smiths Medical. The logo is in two parts, with "Smiths" in a bold, sans-serif font and "medical" in a smaller, lighter font. Above the logo is the text "K073/88" in a handwritten style.

bringing technology to life

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. Critical Care Division 10 Bowman Drive Keene, NH 03431 0724, USA T: +1 603 352 3812 F: +1 603 355 8157 www.smiths-medical.com

Summary Prepared: November 9, 2007

Product Name:

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

Common Name: Hypodermic Needle with attached needle protection. Accessory to Blood Sampling Syringes.

Classification Name: Hypodermic Single Lumen Needles (21 CFR 880.5570, Product Code FMI). Accessory to Tubes, Vials, Systems, Serum Separators, Blood Collection (21 CFR 862.1675. Product Code JKA).

Predicate Device(s):

K071785 (Smiths Medical ASD, Inc.) Hypodermic Needle-Pro® EDGE™ Safety Device and EDGE™ Safety Device with Syringe

K911037 (Smiths Medical ASD, Inc.- formerly Concord/Portex) Safety Needle Sheath (modification)

Device Description:

This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" 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 EDGE™ safety device may be removed from the syringe when required by a specific medical procedure. An example is removal of the EDGE™ safety device from a blood sampling syringe. The EDGE™ safety device is then discarded into a sharps container.

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K073188

Indications for Use:

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. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure.

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

Clinical Data:

Simulated clinical use studies were conducted which confirmed that the EDGE™ safety device could be used by phlebotomists with no substantial change to their technique and could be safely removed from the syringe after activation.

Conclusion:

The bench testing 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.

Brian 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 features a stylized depiction of an abstract symbol, resembling a person embracing another, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB -8 2008

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

Re: K073188

Trade/Device Name: Hypodermic Needle-Pro EDGE" Safety Device Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 9, 2007 Received: November 13, 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clues

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): _ K 0 73/88 Device Name: Hypodermic Needle-Pro® EDGE™ Safety Device

Indications for Use:

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Chr. v.

Page 1 of 1

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

K473188 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).