(123 days)
This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
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.
The provided text describes a 510(k) submission for the "p&p Safety Syringe," seeking clearance based on substantial equivalence to a predicate device, the "SEZ safety syringe [K031163]". The document focuses on comparing the new device to the predicate device and does not contain detailed information about specific acceptance criteria or a dedicated study proving device performance against those criteria in a quantitative manner (e.g., sensitivity, specificity, accuracy, etc.) as might be found for a diagnostic algorithm.
Instead, the "clinical investigation" mentioned is likely a human factors study or a performance study designed to demonstrate that the safety mechanism of the p&p Safety Syringe functions as intended and is comparable to or better than the predicate device in terms of preventing needlestick injuries, as per guidance documents like "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA."
Given the information provided, here's a breakdown, with acknowledgements of missing details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative targets (e.g., "must achieve X% reduction in needlestick injuries"). Instead, the primary "acceptance criterion" appears to be substantial equivalence to the predicate device, the SEZ safety syringe [K031163], in terms of:
- Intended Use: Identical clinical application (intramuscular and subcutaneous injections, prevention of needlestick injuries).
- Principle of Operation: While the mechanism of activation differs, the outcome (locking the needle to prevent injury) is equivalent. The provided text details the steps for each device's safety feature activation.
- Performance Characteristics:
- Volume: 3ml/cc (Identical)
- Nozzle type: Male conical lock fitting (Luer Lock Tip) with rotatable internally threaded neck, functionally equivalent to the predicate's female conical lock fitting with rotatable internally threaded neck for needle attachment.
- Barrel Marking: Conforms to ISO7886-1:1993(E) (Identical)
- Reuse: Non-reusable (Identical)
- Biocompatibility: Conforms to ISO 10993-1 (Identical)
- Materials: Identical (Polypropylene, thermoplastic rubber, Medipeel film, Ethypel paper)
- Sterility: Sterilized by ethylene oxide gas, SAL = 10-6 (Identical)
The "reported device performance" is that "The results of the investigation showed that the p&p Safety Syringe is clinically acceptable" and "In all material respects, the p&p Safety Syringe is substantially equivalent to the predicate device." While not precise metrics, this is the reported performance against the overarching regulatory requirement of substantial equivalence.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (p&p Safety Syringe) |
|---|---|
| Intended Use: Safety hypodermic syringe for intramuscular and subcutaneous injection, preventing needlestick injuries. | Identical |
| Volume (ml/cc): 3 | 3 |
| Nozzle type: Compatible with general needles, secure locking mechanism. | Male conical lock fitting (Luer Lock Tip) with rotatable internally threaded neck, allowing for needle changes. |
| Barrel Marking: Conforms to ISO7886-1:1993(E) | Identical |
| Reuse: Non-reusable | Identical |
| Biocompatibility: Conforms to ISO 10993-1 | Identical |
| Materials: Polypropylene, thermoplastic rubber, Medipeel film, Ethypel paper. | Identical |
| Sterility: Sterilized by ethylene oxide gas, SAL = 10-6 | Identical |
| Needlestick Injury Prevention: Effective safety feature comparable to predicate. | "Clinically acceptable" and "Substantially equivalent" to predicate based on a clinical investigation guided by "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "A clinical investigation was performed," but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the full study report, which is not provided here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a medical device focused on safety features, "experts" might refer to healthcare professionals evaluating the ease of use and effectiveness of the safety mechanism.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study in the context of diagnostic AI (e.g., radiologists interpreting images with and without AI assistance) was not done. This submission is for a physical medical device (safety syringe), not a diagnostic algorithm. The "clinical investigation" mentioned would likely involve observational studies or human factors assessments of the syringe's physical safety mechanism.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical safety syringe, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for a safety syringe would primarily be established through:
- Experimental testing: Verifying the mechanical function of the safety lock (e.g., does it consistently lock, can it be easily unlocked unintentionally).
- Human factors evaluation/clinical observation: Assessing whether healthcare professionals can effectively activate the safety mechanism in a clinical setting and if it demonstrably reduces the risk of needlestick injuries.
- Comparison to predicate device performance: Demonstrating that the new device performs at least as well as a legally marketed device in preventing injuries.
The document states, "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'." This guidance would outline the expected methods to establish "ground truth" or evidence of effectiveness for such devices, which primarily relies on performance testing and potentially user studies to confirm the safety feature's efficacy.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical safety syringe and does not involve AI model training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical safety syringe and does not involve AI model training.
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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
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- Identification of the Device: Proprietary-Trade Name: p&p Safety Syringe Classification Name: Piston Syringe Common/Usual Name: Safety Syringe
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- Equivalent legally marketed device: SEZ safety syringe [K031163]
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- 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.
-
- 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.
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| Device Name | SEZ safety syringe[K031163] | p&p Safety Syringe |
|---|---|---|
| Intended Use | This device is a Safety hypodermicsyringe for Intramuscular andSubcutaneous injection.This device aids in prevention ofneedlestick injuries. | Identical |
| Principle operation | Activation of safety feature consistsof two steps :1) Disassemble needle assemblyfrom the barrel by turning theplunger2) Retract needle into barrel andconfine it in the barrel by pushingthe plunger forward beforedisposal. | Activation of safety featureconsists of the following steps :1) While holding the safetysheath.2) Turn the flange of the barrelto the right. And pull it backuntil "LOCK LINE" touchesthe bottom of the blue adaptor.Dispose the syringe into thesharps container. |
| Volume (ml/cc) | 3 | 3 |
| Nozzle type | Female conical lock fitting withrotatable 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 : Ethypelpaper | Identical | |
| Sterility | Sterilized by ethylene oxide gasSAL = 10-6 | Identical |
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- Safety and Effectiveness, comparison to predicate device:
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- 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.
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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.
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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
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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
Page 1 of 1
§ 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).