(71 days)
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.
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 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 onehanded 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 is a 510(k) summary for a hypodermic needle with an attached safety device, seeking substantial equivalence to predicate devices. It focuses on the safety mechanism to prevent needle sticks after use.
Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Efficacy (Needle Stick Prevention) | "A simulated clinical use study was conducted which confirmed that the device could be used effectively with the needle shielded inside the protection device after use." |
| Conformance to ISO 594-1:1986(E) (Conical fittings with a 6% taper for syringes, needles, and 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. |
| Functional Equivalence (Intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe) | This is the stated indication for use and implied to be met. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "A simulated clinical use study was conducted." However, it does not provide a specific sample size for this study or details regarding the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used or their qualifications to establish ground truth for the simulated clinical use study.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted or reported. The study described is a "simulated clinical use study" focused on the device's functionality rather than comparing human reader performance with and without AI assistance.
6. If a Standalone Study (Algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical device (hypodermic needle with a safety mechanism), not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply. The "simulated clinical use study" refers to the device's physical function.
7. The Type of Ground Truth Used
The "simulated clinical use study" implies that the ground truth was based on direct observation of the device's physical function (i.e., whether the needle was effectively shielded after use) rather than expert consensus on images, pathology, or outcomes data. It's a performance-based assessment.
8. The Sample Size for the Training Set
The document does not mention any training set as this is a physical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, the method for establishing its ground truth is not applicable.
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JAN 2 5 2007
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: November 14, 2006
Product Name:
Trade Name: Portex® Hypodermic Needle-Pro® EDGE™ Safety Device
Common Name: Hypodermic Needle with attached needle protection
Classification Name: Hypodermic Single Lumen Needles (21 CFR 880.5570, Product Code FMI)
Predicate Device(s):
K041399 (Smiths Medical ASD, Inc.) Hypodermic Needle-Pro® EDGE™ Needle Protection Device
K031453 (Terumo Medical Corporation) SurGuard2™ Safety Hypodermic Needle
Device Description:
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 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 onehanded 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.
Image /page/0/Picture/16 description: The image shows the word "smiths" in a bold, sans-serif font. The letters are black and stand out against a white background. The font appears to be rounded, giving the word a soft and modern look. The image is simple and clear, focusing solely on the text.
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
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Indications for Use:
This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. This device is intended for informed after use to help prevent needle sticks.
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% taper for syringes, needles 100 001 in 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
Clinical Data:
A simulated clinical use study was 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 study demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate device.
Very truly yours,
SMITHS MEDICAL ASD, INC.
Brian D. Farias Regulatory Affairs Manager
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brian Farias Manager, Regulatory Affairs Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431-0724
JAN 2 5 , GD
Re: K063450
Trade/Device Name: Portex® Hypodermic Needle-Pro® EDGE Safety Device Model 401810 18gx1" Model 401910 19gx1" Model 402010 20gx1" Model 402110 21gx1"
Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: November 14, 2006 Received: November 15, 2006
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 (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.
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): f) CCC 9 '>(
Device Name: Portex® 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)
in D.m.
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Status Capital 11:22:00 11:22 2020
§ 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).