(191 days)
Nanum Syringe is the plastic syringe for Single use, with/without needle is intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:
Device: Nanum Syringe (Piston Syringe)
Summary of Study Type: This documentation describes a bench testing and biocompatibility testing study conducted to demonstrate substantial equivalence of the Nanum Syringe to a legally marketed predicate device (K190002, Shanghai Kohope Medical Devices Co., Ltd. Sterile Hypodermic Syringe for Single use). The study's purpose is to show that the Nanum Syringe performs in a substantially equivalent manner in terms of functionality and biological safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Requirement) | Reported Device Performance (Result) | Details / Standard Referenced |
|---|---|---|---|
| Mechanical/Physical | |||
| Appearance and Structure | MFDA Notification No. 2018-72, The standards for the medical device | Pass | MFDA Notification No. 2018-72 |
| Nozzle | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Pass | ISO 7886-1:2017 (Report: MTK-2019-000829) |
| Scale | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Pass | ISO 7886-1:2017 |
| Piston/Plunger Assembly | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Pass | ISO 7886-1:2017 |
| Tightness | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Pass | ISO 7886-1:2017 |
| Extraction Test : pH | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Pass | ISO 7886-1:2017 |
| Extraction Test : Heavy Metal | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Pass | ISO 7886-1:2017 |
| Extraction Test : Potassium Permanganate-Reducible Substances | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Pass | ISO 7886-1:2017 |
| Extraction Test : Residue on Evaporation | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Pass | ISO 7886-1:2017 |
| Quantity of Silicone Oil | ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | Pass | ISO 7886-1:2017 |
| Shelf Life | ASTM1980-07: 2011 Standard guide for Accelerated Aging of Sterile Barrier System for Medical Device & ISO11607-1:2006 Packaging for terminally sterilized medical devices | Pass | ASTM1980-07: 2011, ISO11607-1:2006 (Reports: NC-SLR-1902, NC-060-F0729, NC-060-F0421) |
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass | ISO 10993-5(2009) |
| Acute Systemic Toxicity Test | ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass | ISO 10993-11(2009) |
| Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass | ISO 10993-11 |
| Sensitization Test | ISO 10993-10 (2010) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass | ISO 10993-10 (2010) |
| Hemolytic Test | ISO 10993-4:2017, ASTM F756-17 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Pass | ISO 10993-4:2017, ASTM F756-17 |
| Intracutaneous Reactivity Test | ISO 10993-10 (2010) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass | ISO 10993-10 (2010) |
| LAL Test (Endotoxin) | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass | ISO 10993-11 (Report: MSK-2020-002259) |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample sizes used for each individual test within the bench and biocompatibility studies. It only states that "Bench test were performed" and lists the tests.
- Sample Size (Test Set): Not explicitly stated for each test.
- Data Provenance: The tests are described as "Bench test were performed." This implies the data were generated in a laboratory setting, likely by Nanum Company Co., Ltd or a testing facility they contracted. The company is located in Daegu, Korea, suggesting the testing was performed there or outsourced. The studies are prospective in nature, as they involve newly manufactured devices being subjected to specific tests to determine their performance against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: This type of testing (bench and biocompatibility) generally relies on standardized protocols and objective measurements, not on human expert consensus to establish "ground truth" in the diagnostic sense. Therefore, the concept of "experts" establishing a ground truth as one would for image review or clinical outcomes is not applicable here.
- Qualifications of Experts: Not applicable. The results are typically interpreted by qualified laboratory personnel following the specified test standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. For bench and biocompatibility testing, results are typically objectively measured and compared against predefined pass/fail criteria outlined in the relevant ISO or ASTM standards. There is no mention of a subjective "adjudication" process akin to what would be used for clinical trial endpoints or image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This is a medical device (syringe), not an AI-powered diagnostic or assistive technology. The evaluation focuses on the physical and biological properties of the syringe.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone performance evaluation (as defined for an algorithm) was not done. This device is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on established international and national standards for medical device performance and biocompatibility.
- For mechanical/physical tests, the ground truth is defined by the objective pass/fail criteria specified in standards like ISO 7886-1:2017 and MFDA Notification No. 2018-72.
- For biocompatibility tests, the ground truth is defined by the objective pass/fail criteria specified in standards like ISO 10993 series and ASTM F756-17, which evaluate the biological response to the device materials.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical product designed and manufactured to meet specific specifications.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device evaluation.
§ 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).