(89 days)
K#000455
Not Found
No
The device description and performance studies focus on the mechanical safety feature of a hypodermic needle and do not mention any computational or data-driven components indicative of AI/ML.
No.
The device is a needle guard designed to prevent needlestick injuries and for medication administration, not for therapeutic treatment itself.
No
The device is a needle guard intended for safe medication withdrawal and injection, and for preventing needlestick injuries. It does not perform any diagnostic functions.
No
The device description clearly outlines physical components made of materials like Stainless Steel, Nylon, Polypropylene, and PETG, 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 to withdraw and inject medications into a patient. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description details a hypodermic needle with a safety feature for preventing needlestick injuries. This aligns with a device used for administering substances to the body, not for testing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on the delivery of medication.
N/A
Intended Use / Indications for Use
The intended use of the Amersham Health Needle Guard is to withdraw medications from a vial or ampule and to inject these medications subcutaneously, intramuscularly, intravenously, or via I.V. access ports. This device may aid in the prevention of needlestick injury.
Product codes
FMI
Device Description
The Amersham Health Needle Guard is a sterile, single use hypodermic needle designed to be used in conjunction with a disposable 3ml synnge. The device consists of six basic constituents, a Stainless Steel needle bonded to a Nylon hub, a Polypropylene cannula cover, a Nylon Luer attachment connected to a Polysulfone Luer hub used to connect to a syringe, and a PETG Protective sleeve. Once the Amersham Health Needle Guard is attached to a syringe, the cannula cover is removed, exposing the needle. In this condition the needle can be inserted into a vial or ampule to withdraw medication into the syringe or to administer the medication through injection. Once the needle is withdrawn from the patient, the sleeve is pushed forward to the locked safety position for disposal. The sharps safety feature is an active safety feature
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
Simulated use testing was conducted to determine the effectiveness of the safety feature mechanism in preventing accidental sharp object injuries. The simulated use testing also determined the usability of the "Instructions for Use".
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Human clinical studies were not conducted on the Amersham Health Needle Guard device because the design and intended use of the devices are not significantly different to warrant these studies. However, simulated use testing was conducted on the Amersham Health Needle Guard safety feature designed to reduce the risk of needlestick accidents.
A risk analysis was assessed during the simulated testing. Based on the testing results and findings we have concluded that there were no unexpected risks in use of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K#000455
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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510(k) SUMMARY
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K033409.
1. Submitter Identification:
Gettig Pharmaceutical Instrument Company A Division of Gettig Technologies, Inc. One Streamside Place West P.O. Box 85 Spring Mills, PA 16875
Date Summary Prepared:
January 12, 2004
2. Name of the Device:
Amersham Health Needle Guard
3 Predicate Device Information:
Gettig Guard, Gettig Pharmaceutical Instrument Company, Spring Mills, PA, K#000455.
4. Device Description:
The Amersham Health Needle Guard is a sterile, single use hypodermic needle designed to be used in conjunction with a disposable 3ml synnge. The device consists of six basic constituents, a Stainless Steel needle bonded to a Nylon hub, a Polypropylene cannula cover, a Nylon Luer attachment connected to a Polysulfone Luer hub used to connect to a syringe, and a PETG Protective sleeve. Once the Amersham Health Needle Guard is attached to a syringe, the cannula cover is removed, exposing the needle. In this condition the needle can be inserted into a vial or ampule to withdraw medication into the syringe or to administer the medication through injection. Once the needle is withdrawn from the patient, the sleeve is pushed forward to the locked safety position for disposal. The sharps safety feature is an active safety feature
5. Intended Use:
The intended use of the Amersham Health Needle Guard is to withdraw medications from a via| or ampule and to iniect these medications subcutaneously, intramuscularlay. intravenously, or via I.V. access ports. This device may aid in the prevention of needlestick injury.
Image /page/0/Picture/17 description: The image shows a logo with the word "GETTIG" on top of a square shape. The square is divided into sections, with the left side featuring a semi-circle shape. The right side of the square has a smaller square shape in the bottom right corner.
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6. Comparison to Predicate Device:
Similarities and Differences:
The Amersham Health Needle Guard incorporates attributes from several currently marketed devices. In reference to the Gettig Guard, the action and function of the mancedo devices: 'n rolar in both use and application. Both allow for the needle to be protective sibere to birninge with medicament, and permanent covering of the needle exposed for ming the oyeence is that the Gettig Guard allows for the protective sleeve to cover the needle prior to injection, for handling and transport, while the Amersham cover the needle Guard allows for a cannula cover to cover the needle during handling and transport.
Substantial Equivalence:
Our testing results discussed in a later section, have shown that the Amersham Health Needle Guard meets our specifications for hypodermic needles. Based on this analysis we conclude the device to be safe and effective for its intended use. The Amersham we conclude Guard is similar in feel, function and intended use to currently marketed r Child Noodie Gallery, Therefore, we believe the device to be substantially equivalent to currently marketed devices.
7 Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
- a) ANSI/AAMI/ISO Sterilization Standards 11137-194 Section B 3.4.1, Method 1: Dose Setting Using Bioburden Information. Bioburden and Sterilization per ISO 11737-1 and ISO 11737-2.
- b) ISO 7864, "Sterile Hypodermic Needles for Single Use". Third Edition, 1993.
- c) ISO 594-2, "Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings, First Edition.
- d) ASTM A751 for Stainless Steel 304 Series
8. Discussion of Clinical Tests Performed:
Human clinical studies were not conducted on the Amersham Health Needle Guard device because the design and intended use of the devices are not significantly different to warrant these studies. However, simulated use testing was conducted on the Amersham Health Needle Guard safety feature designed to reduce the risk of needlestick accidents.
Simulated use testing was conducted to determine the effectiveness of the safety feature mechanism in preventing accidental sharp object injuries. The simulated use testing also determined the usability of the "Instructions for Use".
Attached as Exhibit #4 is the evaluation form that was utilized to record simulated use testing data, along with the results and conclusions of the study findings.
A risk analysis was assessed during the simulated testing. Based on the testing results and findings we have concluded that there were no unexpected risks in use of this device.
Image /page/1/Picture/16 description: The image shows a logo with the word "GETTIG" on top of a stylized graphic. The graphic appears to be a combination of geometric shapes, possibly representing a shield or emblem. The overall design is simple and clean, with a focus on the text and the geometric shapes.
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9. Conclusions:
The Amersham Health Needle Guard has the same intended use and similar technological characteristics as the predicate device. Moreover, the bench testing and simulated use testing demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Amersham Health Needle Guard is substantially equivalent to the predicate device.
Image /page/2/Picture/3 description: The image shows a logo with the word "GETTIG" on top. Below the word is a design that includes a partial circle on the left and a square shape on the right. The square shape has some internal lines or patterns within it. The overall design appears to be a stylized emblem or symbol.
Gellig Pharmaceutica Instrumen
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three wavy lines extending from its body, representing the department's mission to promote health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2004
Mr. James A. Benz Gettig Pharmaceutical Instrument Company 1 Stream Side Place West P.O. Box 85 Spring Mills, Pennsylvania 16875-0085
Re: K033409
Trade/Device Name: Amersham Health Needle Guard Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: October 20, 2003 Received: October 27, 2003
Dear Mr. Benz:
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 4 mendments, 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. Benz
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 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
5
Exhibit B
Page of 1 ー
510(k) Number (if known): K033409
Device Name Amersham Health Needle Guard
Indications For Use:
The intended use of the Amersham Health Needle Guard is to withdraw medications from a vial or ampule and to inject these medications subcutaneously, intramuscularly, intravenously, or via I.V. access ports. This device may aid in the prevention of needlestick injury.
Prescription Use V (Per 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)
Vick Hubbard, Interim Branch Chief
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number KO 3 -