(170 days)
The Disposable Syringe with permanently attached needle 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.
The Safety Syringe with permanently attached needle 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. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse.
The proposed Syringes include Disposable Syringe with permanently attached needle and Safety Syringe with permanently attached needle. The Disposable Syringe with permanently attached needle have one kind of product configuration (TKSPN01) and the Safety Syringe with permanently attached needle has two kinds of product configurations (TKSSPN01 and TKSSPN02).
The proposed syringes are available in different combination of syringe volumes and/or needle sizes. The syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10f . The proposed device has a shelf life of three years.
The provided text is a 510(k) Premarket Notification for medical devices, specifically Disposable Syringes with permanently attached needles and Safety Syringes with permanently attached needles. This document focuses on demonstrating substantial equivalence to predicate devices, not on proving overall safety and effectiveness through clinical trials or the type of performance studies typically associated with AI/ML-driven devices.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., ground truth
establishment, adjudication methods, MRMC studies, effect sizes of human reader improvement with AI) are not applicable to this submission.
This document describes the safety and performance testing for a physical medical device (syringes) based on established international and national standards and biocompatibility testing. The "acceptance criteria" here are compliance with these recognized standards and demonstrated equivalence to existing predicate devices.
Here's an attempt to extract the relevant information based on the provided document, addressing the requested points where applicable and noting when information is not present or not relevant to this type of submission:
Device: Disposable Syringe with permanently attached needle; Safety Syringe with permanently attached needle
Regulatory Pathway: 510(k) Premarket Notification (demonstrates substantial equivalence to predicate devices)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for traditional medical devices like syringes are generally defined by compliance with recognized consensus standards and successful completion of specific performance and safety tests. The document doesn't present a "performance table" in the typical sense of AI/ML device metrics (e.g., sensitivity, specificity). Instead, it lists the standards the devices adhere to and states that testing was performed and found acceptable.
| Acceptance Criteria (Standards/Tests) | Reported Device Performance (Compliance/Results) |
|---|---|
| **Biocompatibility Testing (ISO 10993-1:2018 for "Blood path indirect, Limited contact () | Performed |
| Sterilization and Shelf Life Testing | |
| - EO/ECH residue (ISO 10993-7:2008) | Testing performed, validation to ISO 11135, routine control parameters determined. |
| - Bacterial Endotoxin (USP42-NF37 ) | Testing performed, limit adhered to. |
| - Shelf life (3 years) based on aging test (ASTM F1980-16) | Determined based on stability studies, all packaging deemed acceptable for protection and sterility maintenance after environmental conditioning and simulated transportation. |
| - Package integrity (ASTM F88/F88M-15, ASTM F 1929-2015, ASTM F 1886/ F 1886M-16) | Testing performed, all packaging deemed acceptable. |
| Performance Testing (Adherence to relevant ISO standards) | |
| - ISO 7886-1: 2017 (Syringes for manual use) | Testing performed according to the standard. |
| - ISO 7864: 2016 (Stainless Steel Needle Tubing) | Testing performed according to the standard. |
| - ISO 9626:2016 (Stainless Steel Needle Tubing) | Testing performed according to the standard. |
| - ISO 6009:2016 (Hypodermic needles - Colour coding) | Testing performed according to the standard. |
| - ISO 23908:2011 (Sharps injury protection) | Testing performed according to the standard. |
| Substantial Equivalence | Demonstrated through comparison to predicate devices, addressing differences, and showing continued safety and effectiveness through non-clinical testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each specific test. For medical devices like syringes, testing often involves a defined number of units per batch or per test series to meet statistical requirements of the standards (e.g., 30 samples for a particular mechanical test). The document confirms that various tests were "performed" according to the relevant standards, which implies the use of appropriate sample sizes as defined by those standards.
- Data Provenance: The tests are non-clinical (laboratory/bench testing, material analysis, sterility validation). The manufacturer is Anhui Tiankang Medical Technology Co., Ltd. in Tianchang City, Anhui, China. The data would originate from their internal testing or qualified third-party labs, but the specific country of origin for each test data set is not detailed beyond the manufacturer's location. The studies are by nature prospective in the sense that they are conducted specifically to support this regulatory submission, but they are not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus and adjudication is typically relevant to AI/ML devices where the "truth" for image interpretation or diagnosis needs to be established by human experts. For syringes, the "truth" is determined by objective measurements, chemical analyses, and adherence to physical performance specifications outlined in the referenced ISO/ASTM standards. The "experts" involved would be qualified laboratory technicians, engineers, and quality assurance personnel performing the tests according to the standard operating procedures.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3. This concept is for AI/ML device performance evaluation methods, not for physical medical device testing.
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
- Not Applicable. This device is a manual syringe, not an AI-assisted diagnostic tool. No human reader involvement or AI assistance is mentioned or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by objective measurements against defined specifications in international and national consensus standards (e.g., ISO, ASTM, USP). This includes:
- Physical and Mechanical Performance: e.g., plunger force, needle pull-out force, fluid leakage, needle sharpness, volume accuracy based on ISO 7886-1, ISO 7864, ISO 9626.
- Material Properties and Biocompatibility: Chemical analysis, in vitro and in vivo biological tests (Cytotoxicity, Hemolysis, Skin Sensitization, etc.) as per ISO 10993 series for specific material components.
- Sterility Assurance: Sterility testing, bacterial endotoxin testing, and ethylene oxide residue testing according to ISO 11135 and USP standards.
- Shelf-Life Stability: Accelerated aging and real-time stability studies confirming physical properties, sterility, and package integrity over time per ASTM standards.
8. The sample size for the training set
- Not Applicable. This is a traditional medical device, not an AI/ML model that requires training data.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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).