(118 days)
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.
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.
The provided document describes a premarket notification (510(k)) for a medical device, the Portex® Needle-Pro® EDGE™ Safety Device with Syringe. This submission focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance data for a new, complex device requiring such rigorous testing.
Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details is not applicable or available within this 510(k) submission.
Here's an breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ISO 594-1:1986(E) (Conical fittings with a 6% taper for syringes, needles and certain other medical equipment-Part 1: General requirements) | Declared conformance to this standard. |
| Conformance to ISO 594-2:1998(E) (Conical fittings with a 6% taper for syringes, needles and certain other medical equipment-Part 2: Lock Fittings) | Declared conformance to this standard. |
| Conformance to ISO 7864:1993(E) (Sterile hypodermic needles for single use) | Declared conformance to this standard. |
| Conformance to ISO 7886-1:1993 (Sterile hypodermic syringes for single use) | Declared conformance to this standard. |
| Substantial Equivalence to Predicate Devices (K041399: Hypodermic Needle-Pro® EDGE™ Needle Protection Device; K030683: Nipro Disposable Syringes) | The FDA determined the devices are substantially equivalent to legally marketed predicate devices. |
Explanation: The "acceptance criteria" here are primarily based on conformance to established international standards for syringes and needles, and the demonstration of substantial equivalence to already approved predicate devices. The "reported device performance" is the declaration of conformance to these standards and the FDA's agreement on substantial equivalence. No specific quantitative performance metrics beyond these were required or provided in this type of submission.
2. Sample size used for the test set and the data provenance:
- Not Applicable/Not Provided. This 510(k) submission did not involve a clinical study with a "test set" in the context of AI or diagnostic device performance evaluation. The review was based on device description, materials, and conformance to standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. No external experts were used to establish ground truth for a test set in this context. The "ground truth" for this submission was based on existing standards and predicate devices.
4. Adjudication method for the test set:
- Not Applicable/Not Provided. No adjudication method for a test set was necessary as per the nature of this 510(k) submission.
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, this was not done. This device is a manual medical syringe with a safety mechanism, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this was not done. This device does not involve an algorithm.
7. The type of ground truth used:
- The "ground truth" in this context is the established performance and safety of the predicate devices and conformance to recognized international standards for medical syringes and needles. The submission posits that because the new device is substantially similar in materials, design, and intended use, and meets the same relevant standards as already-approved devices, it is safe and effective.
8. The sample size for the training set:
- Not Applicable/Not Provided. There was no "training set" in the context of an AI/machine learning algorithm for this device.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided. No training set was used.
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AUG 2 4 2006
ហ
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
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ode F)
ORTE
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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
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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.
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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 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
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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
§ 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).