K Number
K043419
Device Name
P&P SAFETY SYRINGE
Date Cleared
2005-04-15

(123 days)

Product Code
Regulation Number
880.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
Device Description
The p&p Safety Syringe consists of a calibrated hollow barrel (which can contain the medication) and the distal end of the barrel has Luer Lock Tip. The needle can be changed depending on the required gauge, since the syringe is compatible with general needles. The Safety Cap can be moved back and forth as safety feature. The safety cap has a printing mark "LOCK LINE". The adaptor is colored with medical grade blue pigment . The plunger and gasket are the same shape as the conventional syringes. When user gives the intramuscular/subcutaneous injection, he/she pushes the knob of the plunger to the end. After completing the intramuscular/ subcutaneous injection, the user turns the safety cap to the left side, and then pushes it forward until the marking ("LOCK LINE") on the safety cap touches the bottom line of the blue adaptor in order to lock the safety cap and the adaptor. The blue color of the adaptor allows the user to distinguish the locking position clearly and easily. Then the safety cap can no longer be moved back and forth, thus preventing needlestick injury. Then the syringe can be disposed in the appropriate sharps container. This is a simple and elegant design which is highly reliable.
More Information

Not Found

No
The device description details a mechanical safety mechanism for a syringe and does not mention any computational or learning-based components.

No
The device is a safety hypodermic syringe for injection of medication, serving as a delivery mechanism rather than providing a therapeutic effect itself. Its primary function is to prevent needlestick injuries, which is a safety feature, not a therapeutic one.

No

The device description indicates it is a "safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients" and "aids in prevention of needlestick injuries," which are therapeutic and safety functions, not diagnostic.

No

The device description clearly outlines physical components like a barrel, Luer Lock Tip, needle, safety cap, plunger, and gasket, indicating it is a hardware device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "intramuscular and subcutaneous injection of medication to patients" and "aids in prevention of needlestick injuries." This describes a device used on a patient for administering medication, not a device used with a sample taken from a patient to diagnose a condition.
  • Device Description: The description details a syringe with features for safe injection and disposal. It does not mention any components or processes related to analyzing biological samples.
  • Anatomical Site: The anatomical sites mentioned are "Intramuscular and subcutaneous," which are locations on the body for injection, not locations where samples are collected for in vitro testing.
  • Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or diagnostic purposes.

An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This syringe does not fit that description.

N/A

Intended Use / Indications for Use

    1. Indications for Use (intended use) . This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.

Product codes

MEG

Device Description

The p&p Safety Syringe consists of a calibrated hollow barrel (which can contain the medication) and the distal end of the barrel has Luer Lock Tip. The needle can be changed depending on the required gauge, since the syringe is compatible with general needles. The Safety Cap can be moved back and forth as safety feature. The safety cap has a printing mark "LOCK LINE". The adaptor is colored with medical grade blue pigment . The plunger and gasket are the same shape as the conventional syringes. When user gives the intramuscular/subcutaneous injection, he/she pushes the knob of the plunger to the end. After completing the intramuscular/ subcutaneous injection, the user turns the safety cap to the left side, and then pushes it forward until the marking ("LOCK LINE") on the safety cap touches the bottom line of the blue adaptor in order to lock the safety cap and the adaptor. The blue color of the adaptor allows the user to distinguish the locking position clearly and easily. Then the safety cap can no longer be moved back and forth, thus preventing needlestick injury. Then the syringe can be disposed in the appropriate sharps container. This is a simple and elegant design which is highly reliable.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

A clinical investigation was performed, and test for the comparison between p&p Safety Syringe and the legally marketed predicate device was performed in accordance with "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA". The results of the investigation showed that the p&p Safety Syringe is clinically acceptable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K031163

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

K043419(f.1x^2)

APR 1 5 2005

510(K) Summary Medexel Medical Manufacturing Co., Ltd. 536-65 Kumkwang-Ri KumKwang-Myun, Ansung-Si, Kyunggi-Do, 456 - 862 Korea Tel : 82-31-677-8004~6 Fax : 82-31-677-8007 Contact: J. M. Shim, Managing Director March 1, 2005

    1. Identification of the Device: Proprietary-Trade Name: p&p Safety Syringe Classification Name: Piston Syringe Common/Usual Name: Safety Syringe
    1. Equivalent legally marketed device: SEZ safety syringe [K031163]
    1. Indications for Use (intended use) . This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
    1. Description of the Device: The p&p Safety Syringe consists of a calibrated hollow barrel (which can contain the medication) and the distal end of the barrel has Luer Lock Tip. The needle can be changed depending on the required gauge, since the syringe is compatible with general needles. The Safety Cap can be moved back and forth as safety feature. The safety cap has a printing mark "LOCK LINE". The adaptor is colored with medical grade blue pigment . The plunger and gasket are the same shape as the conventional syringes. When user gives the intramuscular/subcutaneous injection, he/she pushes the knob of the plunger to the end. After completing the intramuscular/ subcutaneous injection, the user turns the safety cap to the left side, and then pushes it forward until the marking ("LOCK LINE") on the safety cap touches the bottom line of the blue adaptor in order to lock the safety cap and the adaptor. The blue color of the adaptor allows the user to distinguish the locking position clearly and easily. Then the safety cap can no longer be moved back and forth, thus preventing needlestick injury. Then the syringe can be disposed in the appropriate sharps container. This is a simple and elegant design which is highly reliable.

Image /page/0/Picture/7 description: The image shows two syringes. The syringe on the left has an arrow pointing up and to the right, and a curved arrow indicating rotation. The syringe on the right is in a resting position. Both syringes have needles attached.

1

| Device Name | SEZ safety syringe
[K031163] | p&p Safety Syringe |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This device is a Safety hypodermic
syringe for Intramuscular and
Subcutaneous injection.
This device aids in prevention of
needlestick injuries. | Identical |
| Principle operation | Activation of safety feature consists
of two steps :

  1. Disassemble needle assembly
    from the barrel by turning the
    plunger
  2. Retract needle into barrel and
    confine it in the barrel by pushing
    the plunger forward before
    disposal. | Activation of safety feature
    consists of the following steps :
  3. While holding the safety
    sheath.
  4. Turn the flange of the barrel
    to the right. And pull it back
    until "LOCK LINE" touches
    the bottom of the blue adaptor.
    Dispose the syringe into the
    sharps container. |
    | Volume (ml/cc) | 3 | 3 |
    | Nozzle type | Female conical lock fitting with
    rotatable internally threaded neck | Male conical lock fitting (Luer Lock Tip) with rotatable internally threaded neck |
    | Barrel Marking | Scale: conforms to ISO7886-
    1:1993(E) | Identical |
    | Reuse | Non-reusable | Identical |
    | Biocompatibility | Conform to ISO 10993-1 | Identical |
    | Materials | 1) Plastic parts : polypropylene
    (homo type) | Identical |
    | | 2) Gasket : thermoplastic rubber | Identical |
    | | 3) Packing film : Medipeel film | Identical |
    | | 4) Packing paper : Ethypel
    paper | Identical |
    | Sterility | Sterilized by ethylene oxide gas
    SAL = 10-6 | Identical |
    1. Safety and Effectiveness, comparison to predicate device:
    1. Conclusion: In all material respects, the p&p Safety Syringe is substantially equivalent to the predicate device. The conclusion is based on biocompatibility testing, clinical testing, compliance with voluntary standards, and comparison to the predicate device. A clinical investigation was performed, and test for the comparison between p&p Safety Syringe and the legally marketed predicate device was performed in accordance with "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA". The results of the investigation showed that the p&p Safety Syringe is clinically acceptable.

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is positioned within a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

APR 1 5 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medexel Medical Manufacturing Company Limited C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates PO Box 7007 Deerfield, Illinois 60015

Re: K043419

Trade/Device Name: p&p Safety Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: March 4, 2005 Received: March 25, 2005

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becalen between by substantially equivalent (for the referenced above and have determined and to ta legally marketed predicate devices marketed in moreations for use stated in the envioral 1, 1976, the enactment date of the Medical Device interstate commerce pror to reay 20, 1978, and essified in accordance with the provisions of Amendments, of to devices that have been reclassions approval of a prematice the premarket the Federal Food, Drug, and Cosment 1 100 ( 100 may, therefore, subject to the general approval application (1 M7Y). 1 Oa 2 ... The general controls provisions of the Act include controls provisions of the Fet. "The gential of encess, good manufacturing practice, lequirements for anitations against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into crime and regulations affecting. (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In the Colorel your device can be found in the Code of Pederal Regalabors, 2017 device in the Federal Register.

3

Page 2 - Mr. Kamm

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. or mo ret or arry with all the Act's requirements, including, but not limited to: registration r ou intilet comply wart 807); labeling (21 CFR Part 801); good manufacturing practice and instille (21 - 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), r you acutact 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,

Chris L.

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

Indications for Use

510(k) Number (if known): K043419

Device Name: p&p Safety Syringe

Indications For Use:

This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

signature

ivision Sign-Off) Civision of Anesthesiology, General Hospital, Intection Control, Dental Devices

510(k) Number: _ k 44 34 19

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