K Number
K061194
Device Name
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
Date Cleared
2006-08-24

(118 days)

Product Code
Regulation Number
880.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 consists of the two predicate devices preattached, packaged and sterilized. 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. 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 needle is engaged under the hook and contained within the sheath. The device is then discarded into a sharps container.
More Information

Not Found

No
The device description and intended use focus on mechanical features for needle protection and fluid injection/withdrawal. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.

No.
The device description indicates its use for injecting or withdrawing fluids, with a primary focus on needle protection after use. It does not perform a therapeutic function but rather facilitates medical procedures.

No

The device is described as being used to inject or withdraw fluids, and for needle protection. There is no mention of diagnostic purposes like analyzing data, detecting conditions, or monitoring physiological parameters.

No

The device description clearly details physical components like a needle, hub, protective sheath, and living hinge, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is clearly stated as "to inject fluids into or withdraw fluids from the body." This describes a device used for direct interaction with the patient's body, not for testing samples in vitro (outside the body).
  • Device Description: The description details a syringe with a needle and a needle protection device. This is consistent with a device used for administering or collecting substances from a living organism.
  • Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on testing biological specimens.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical for fluid transfer and needle safety.

N/A

Intended Use / Indications for Use

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.

Product codes

MEG

Device Description

This device consists of the two predicate devices preattached, packaged and sterilized. 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. 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 needle is engaged under the hook and contained within the sheath. The device is then discarded into a sharps container.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not required

Key Metrics

Not Found

Predicate Device(s)

K041399, K030683

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

K061194

AUG 2 4 2006

Anesthesia and Safety Devices Division

Smiths Medical ASD, Inc.

Keene NH 03431-0724 USA

10 Bowman Drive

Tel: +1 603 352 3812

Fax: +1 603 352 3703 www.smitns-medical.com

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

Summary Prepared: April 27, 2006

Product Name:

Trade Name: Portex® Needle-Pro® EDGE Safety Device with Syringe

Common Name: Syringe with attached needle and needle protection.

Classification Name: Syringe, Piston (21 CFR 880.5860, Product Code B

Predicate Device(s):

K041399 (Smiths Medical ASD, Inc.) Hypodermic Needle-Pro® EDGE™ Needle Protection Device

K030683 (Nipro Corporation) Nipro Disposable Syringes

Device Description:

This device consists of the two predicate devices preattached, packaged and sterilized. 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. 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 needle is engaged under the hook and contained within the sheath. The device is then discarded into a sharps container.

8

&G
ode F)

ORTE

1

Indications for Use:

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,

Technological Characteristics:

The proposed and predicate devices are made of the EXACT same materials and 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% 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% 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:

Not required

Conclusion:

The standards compliance demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SMITHS MEDICAL ASD, INC.

R
R
Brian D. Farias

Brian D. Farias Regulatory Affairs Manager

2

Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2006

Mr. Brian D. Farias, Regulatory Affairs Manager Smiths Medical ASD, Incorporated Anesthesia and Safety Devices Division 10 Bowman Drive Keene, New Hampshire 03431-0724

Re: K061194

Trade/Device Name: Portex Needle-Pro Edge Safety Device with syringe

22 g 1 inch needle with 3 ml syringe

23 g 1inch needle with 3 ml syringe

25 g 1 inch needle with 3 ml syringe

25 g 5/8 inch needle with 3 ml syringe

Regulation Number: 880.5860

Regulation Name: Syringe, Antistick Regulatory Class: II

Product Code: MEG

Dated: August 18, 2006

Received: August 21, 2006

Dear Mr. Farias:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are 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 vour devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.

3

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 devices comply 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 (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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,

signature

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

4

SECTION 4, Indications for Use Statement

Indications for Use

510(k) Number (if known): + 0601194 Device Name: Portex® Needle-Pro® EDGE" Safety Device with Syringe

Indications for Use:

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.

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

Anthony Vent

ാന Gigh Olgh Sthesiology, General Hospital, ്cion Control, Dental Devices

Number. Kq61194