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510(k) Data Aggregation
(30 days)
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile
PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile Syringe is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
PLPT LDV LC Sterile Syringe / PLPT LDV LL Sterile Syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the skin. The device consists of a calibrated barrel (cylinder) with a plunger, and metal tube that is sharpened at one end and at the other end joined to a female connector (hub). This device is intended for various medical applications and is not dedication administration. The distal end of the barrel has a Luer-Cone or Luer-lock connector for the attachment to a hypodermic needle or an administration set. The attached needle is covered by the protective cap which is intended to provide physical protection to the needle tube. The attached needle may have a safety guard that protects the user after use. This product is packed by sterile paper and sterilized by EO gas, and is a single-use device.
This document is a 510(k) summary for the PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe and PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile Syringe. It outlines the performance data and equivalence comparison to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily relies on compliance with established ISO standards and USP requirements rather than defining specific acceptance criteria values with corresponding measured performance values in a single table. Instead, it states that tests were "passed" or "met requirements." This is typical for medical device submissions demonstrating substantial equivalence to a predicate device by adhering to recognized consensus standards.
Here's a summary of the acceptance criteria (standards/test criteria) and reported performance:
| Test Item | Test Method / Test Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | All evaluation acceptance criteria were met. | |
| Cytotoxicity Test | When tested accordingly to ISO 10993-5, tests for in vitro cytotoxicity - Test on extracts method, it should satisfy the requirements. | Pass |
| Hemolysis Test | When tested accordingly to ISO 10993-4, Selection of tests for interactions with blood - evaluation of hemolytic properties of medical devices and medical device materials, it should satisfy the requirements. | Pass |
| Intracutaneous Reactivity Test | When tested accordingly to ISO 10993-10, Tests for irritation and skin sensitization - Animal intracutaneous (Intradermal) reactivity test, it should satisfy the requirements. | Pass |
| Skin Sensitization Test | When tested accordingly to ISO 10993-10, Tests for irritation and skin sensitization - Guinea pig maximization test (GPMT), it should satisfy the requirements. | Pass |
| Acute Systemic Toxicity Test | When tested accordingly to ISO 10993-11, Tests for systemic toxicity - Acute systemic toxicity, it should satisfy the requirements. | Pass |
| Pyrogen Test | When tested accordingly to ISO 10993-11, Tests for systemic toxicity - Information on material-mediated pyrogens, it should satisfy the requirements. | Pass |
| LAL Test | USP39 , Bacterial Endotoxins Test | Pass |
| Particulate Matter Injection | USP , Particulate Matter for Injections (Method 1 Light Obscuration Particle Count Test). Test result should satisfy the requirements described in the USP . | Pass |
| Sterility and LAL Test | ||
| LAL test | USP39 , Bacterial Endotoxins Test (Unit : EU/Device) | Pass |
| E.O sterilization validation | According to ISO 11135:2014 E.O 30%, CO2 70% Temperature: 50 ± 7°C Exposure time: 5 hours | Pass |
| Sterility test | According to ISO 11737-2 | Pass |
| E.O Residual test | Under the conditions of ISO 10993-7:2008, Ethylene oxide sterilization residuals, the test articles should meet the test requirements. | Pass |
| Needle Injury Test | ||
| Needle penetration force | ISO 23908: 2011 Sharps injury protection | Pass |
| Pull-out force | ISO 23908: 2011 Sharps injury protection | Pass |
| Needle cap removal force | ISO 23908: 2011 Sharps injury protection | Pass |
| Activation (locking) force | ISO 23908: 2011 Sharps injury protection | Pass |
| Unlocking force | ISO 23908: 2011 Sharps injury protection | Pass |
| Mechanical Performance | Complies with ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use. | Complies |
| Needle Performance Requirements | ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods. | |
| ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods. | Complies | |
| Safety Feature Performance Specs | ISO 23908:2011 Sharps Injury Protection - Requirements And Test Methods - Sharps Protection Features For Single-Use Hypodermic Needles, Introducers For Catheters And Needles Used For Blood Sampling. | Complies |
| Dead Space Specification (Syringe) | ≤ 0.023mL with 95% confidence/95% reliability | ≤ 0.023mL |
| Dead Space Specification (Needle) | ≤ 0.0054ml (No specific confidence/reliability mentioned for needle, but implied to meet this target) | ≤ 0.0054ml |
| Shelf Life | ISO 11607-1:2006 and ISO 11607-2:2006 compliance for 5 years. | Validated for 5 years |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Bench tests for the device's performance were conducted." and "Performance testing was conducted for this change". However, it does not specify the sample sizes used for the test sets for any of the performance or biocompatibility evaluations.
The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is "Poonglim Pharmatech Inc." located in "Gunsan, 54001, Republic of Korea." The nature of the tests (bench, biocompatibility, sterility) implies prospective testing on manufactured devices, not retrospective data analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable and not provided in the document. The tests performed are objective, laboratory-based physical, chemical, and biological tests governed by international standards (ISO, USP). They do not require interpretation by a panel of human experts in the way clinical diagnostic or AI-based image analysis studies might.
4. Adjudication Method for the Test Set:
This information is not applicable as the tests are objective, laboratory-based evaluations against predetermined criteria. There is no human subjective assessment that requires adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided. This document pertains to the market clearance of a sterile syringe, which is a physical medical device. It does not involve any artificial intelligence (AI) component or human diagnostic interpretation that would warrant an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This device is a physical syringe and does not have an algorithm or AI component.
7. The Type of Ground Truth Used:
The "ground truth" for the performance criteria and biocompatibility assessments is based on established international consensus standards (ISO) and pharmacopeial monographs (USP). For instance, cytotoxicity is evaluated against requirements of ISO 10993-5, sterility against ISO 11737-2, and mechanical properties against ISO 7886-1 and ISO 23908. These standards define the acceptable limits and methodologies, which serve as the "ground truth" for compliance.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This device is a physical syringe and does not involve machine learning or a training set.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable and not provided as there is no training set for this type of device.
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(445 days)
PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile
PLPT LDV (Low Dead Volume) LC(Luer-Cone) Sterile Syringe / PLPT LDV (Low Dead Volume) LL(Luer-Lock) Sterile Syringe is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
PLPT LDV LC Sterile Syringe / PLPT LDV LL Sterile Syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body the surface of the skin. The device consists of a calibrated barrel (cylinder) with plunger, and metal tube that is sharpened at one end and at the other end joined to a female connector (hub). This device is intended for various medical applications and is not dedication administration. At the distal end of the barrel has a Luer-Cone or Luer-lock connector for the attachment to a hypodermic needle or an administration set. Attached needle has covered by the protective cap which is intended to provide physical protection to the needle tube. Attached needle may have safety guard that protect the user after use. This product is packed by sterile paper and sterilized by EO gas, and single-use device.
This document describes the regulatory approval for a medical device, specifically a Low Dead Volume (LDV) Sterile Syringe (PLPT LDV LC/LL Sterile Syringe). The provided text is an FDA 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or clinical superiority through extensive comparative clinical trials.
Therefore, the information about acceptance criteria and study proving the device meets those criteria will be focused on bench testing and biocompatibility assessments demonstrating equivalence to established standards and predicate devices, rather than complex multi-reader, multi-case studies typically seen for AI/ML devices.
Here's the breakdown based on the provided text:
Device: PLPT LDV (Low Dead Volume) LC (Luer-Cone) Sterile Syringe and PLPT LDV (Low Dead Volume) LL (Luer-Lock) Sterile Syringe.
Indications for Use: Intended for use by healthcare professionals for general purpose aspiration of fluid from vials, ampoules, and liquid injection below the surface of the skin.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established international standards for medical devices and comparison to predicate devices. The device's performance is demonstrated through adherence to these standards and the fulfillment of specific regulatory requirements.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard / Test Method / Limit) | Reported Device Performance (Compliance / Result) |
|---|---|---|
| Mechanical Performance | ISO 7886-1:2017 Sterile hypodermic syringes for single use (Syringe performance) | Complies with ISO 7886-1:2017 |
| ISO 7864:2016 Sterile hypodermic needles for single use (Needle performance) | Complies with ISO 7864:2016 | |
| ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices | Complies with ISO 9626:2016 | |
| ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications (Connector performance) | Complies with ISO 80369-7:2021 | |
| Biocompatibility | ISO 10993-1:2018 (Body contact: External communication device – Blood path indirect; Duration: Limited (, Bacterial Endotoxins Test) | Satisfied requirements |
| Particulate Matter Injection (USP ) | Satisfied requirements | |
| Sterility | ISO 11135:2014 Ethylene Oxide (EO) Sterilization Validation (Parameters: EO 30%, CO2 70%; Temp: 50 ±7°C; Exposure: 5 hours) | Validated and deemed acceptable. |
| Sterility Test (ISO 11737-2) | Complied | |
| EO Residual Test (ISO 10993-7:2008) | Met test requirements | |
| Sterility Assurance Level (SAL) | 10⁻⁶ | |
| Endotoxin Limit | 20 EU per device | |
| Low Dead Volume | Syringe Dead Space: ≤ 0.023 mL | ≤ 0.023 mL (Same as predicate) |
| Needle Dead Space: , USP ). |
These standards define the acceptable performance characteristics for syringes and needles.
8. The sample size for the training set:
Not applicable. This device is a physical product and does not involve AI/ML requiring a "training set" in the computational sense.
9. How the ground truth for the training set was established:
Not applicable for the same reason as above.
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