(63 days)
This device is intended for injection or aspiration of fluids utilizing 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 utilizing a standard 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 pennanently 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 immediately discarded into a sharps container.
This document describes a 510(k) premarket notification for a medical device called the Hypodermic Needle-Pro® EDGE™ Needle Protection Device. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and a simulated clinical study.
Acceptance Criteria and Device Performance:
The document explicitly states that the bench testing and the simulated clinical study "did not raise any new issues with regards to safety or efficacy" and that the "proposed device was well received." This implies that the device met the acceptance criteria by demonstrating no new safety or efficacy concerns compared to the predicate devices. However, the document does not provide specific quantitative acceptance criteria or detailed reported device performance metrics in a tabular format as commonly seen in medical device studies with defined endpoints. Instead, it relies on a qualitative assessment of "no new issues."
Therefore, a table of acceptance criteria and reported device performance cannot be generated with specific numerical data from the provided text.
Study Details:
The information provided relates to two main types of studies: Non-Clinical Data (Bench Testing) and Clinical Data (Simulated Clinical Study).
Here's a breakdown based on the provided text:
1. Non-Clinical Data (Bench Testing):
- Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "Bench testing was conducted comparing the proposed and predicate devices," implying a comparison with multiple units, but no specific sample size is given. Data provenance is not specified beyond being "bench testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Bench testing typically relies on standardized methods and measurements rather than expert consensus for ground truth.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No. This type of study is not relevant for bench testing of a hypodermic needle.
- Standalone performance: Yes, the bench testing assessed the device's technical characteristics and conformance to standards.
- Type of ground truth used: Conformance to established standards (ISO 594-1:1986(E), ISO 594-2:1998(E), ISO 7864:1993(E)) and guidance documents (Guidance on the Content of Premarket Notification [510(k)] submissions for hypodermic single lumen needles, Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features).
- Sample size for the training set: Not applicable for bench testing.
- How the ground truth for the training set was established: Not applicable.
2. Clinical Data (Simulated Clinical Study):
- Sample size used for the test set and the data provenance: Not explicitly stated. The document mentions "A simulated Clinical was conducted...with Smiths Medical's predicate device as the control." A specific number of participants or uses is not provided. Data provenance is not specified.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. While it's a "simulated clinical," the specific method of evaluation or the involvement of experts for ground truth is not detailed. The phrase "the proposed device was well received" suggests user feedback was likely collected, but the role of 'experts' in establishing ground truth is not elaborated.
- Adjudication method: Not described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No. This type of study is typically for image-based diagnostic devices.
- Standalone performance: Yes, the "simulated clinical" assessed the device's performance, although the "control" implies a comparative aspect. The primary goal was to ensure no new safety or efficacy issues arose with the proposed device itself.
- Type of ground truth used: The "well received" comment suggests a subjective assessment of user satisfaction and absence of immediate issues. It's not a quantitative "ground truth" derived from pathology or specific outcomes data. The study aimed to ensure the device operated as intended and was acceptable in a simulated use environment compared to the predicate.
- Sample size for the training set: Not applicable. This was an evaluation of the device.
- How the ground truth for the training set was established: Not applicable.
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JUL 2 8 2004
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Smiths Medical ASD, Inc.
Anesthesia and Safety Devices Division
10 Bowman Drive Keena NH 03431-0724 USA Tel: +1 603 352 3812 Fax -1 603 352 3703 www.smilhs-medical.com
J: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) SUMMARY:
COMPANY INFORMATION:
Smiths Medical ASD, Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Brian D. Farias Regulatory Affairs Manager
PREPARATION DATE OF SUMMARY :
May 25, 2004 (Revised July 22, 2004)
TRADE NAME:
Hypodermic Needle-Pro® EDGE™ Needle Protection Device.
COMMON NAME:
Hypodermic Needle with integral needle protection
PRODUCT CLASS/CLASSIFICATION:
Class II, 80 FMI, 21 CFR 880.5570 (Hypodermic Single Lumen Needles)
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PREDICATE DEVICE(S):
K923127 Needle-Pro™ Cartridge and K951254 Becton Dickinson SafetyGlide™ Needles
DESCRIPTION:
This device is intended for injection or aspiration of fluids utilizing a standard 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 pennanently 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 immediately discarded into a sharps container.
INDICATIONS FOR USE:
This device is intended for injection of aspiration of fluids utilizing a Luer Lock or Lucr slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.
TECHNICAL CHARACTERISTICS:
The proposed and predicate devices are made of similar materials and employ the same hinged style protective sheath that is manually activated after use.
NON-CLINICAL DATA:
Bench testing was conducted comparing the proposed and predicate devices; none of the data raises any new issues with regards to safety or efficacy.
Bench testing was performed on the basis of the following guidance documents and conformance to the following standards was demonstrated except for any inapplicable requirements or deviations identified for each standard in the submission.
Guidance on the Content of Premarket Notification [510(k)] submissions for hypodermic single lumen needles, April 1993
Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA, December 31, 2002.
ISO 594-1:1986(E), International Standard, Conical fittings with a 6% taper for syringes, needles and certain ather medical equipment-Part 1 : General reguirements
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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 was conducted on the proposed device with Smiths Medical's predicate device as the control. The proposed device was well received and the study did not raise any new issues with regards to safety or efficacy.
CONCLUSION:
The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.
Very truly yours,
SMITHS MEDICAL ASD, INC.
BR
Brian D. Farias Regulatory Affairs Manager
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2004
Mr. Brian D. Farias Regulatory Affairs Manager Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431-0724
Re: K041399
Trade/Device Name: Hypodermic Needle-Pro® EDGE™ Needle Protection Device Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 25, 2004 Received: May 26, 2004
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely vours.
Chris
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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K0411399
B: INDICATIONS FOR USE OF DEVICE Indications for Use
510(k) Number (if known): K041399
Device Name: Hypodermic Needle-Pro® F.DGE™ Needle Protection Device
Indications for Use:
This device is intended for injection or aspiration of fluids utilizing a Luer Lock or Luer I his device is intended for the covers the needle after use to help prevent needle sticks.
Prescription Use (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)
Arene Nareme for ADW 7/27/04
(Division Sign-Off)
Page 1 of 1
Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: K041399
§ 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).