(95 days)
Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Safety Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Safety Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by trained healthcare professionals in accordance with the instructions. The safety shield to aid in the protection agamst accidental needle stick injury.
Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only.
The Blood Collection Set with Holder, Blood Collection Set, and Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector. The devices are individually wrapped and sterile with a luer port. The luer port can connect FDAcleared accessories like luer adapter, holder, etc.
The Safety Blood Collection Set with Holder, Safety Blood Collection Set, and Safety Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation and ensures the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without needle holder) is individually wrapped sterile with a luer port. The luer port can connect FDA-cleared accessories like luer adapter, holder, etc.
The safety feature is operated by releasing a latch mechanism whereby the user slides a winged cover over the needle as it is removed from the patient. Once the needle is covered, the safety cover locks in place. There is no ability to clean and reuse these because the safety feature cannot be deactivated without bending the needle and rendering it unusable.
The devices are used for venous blood collection and/or the short-term infusion of intravenous fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions. It can be used with an intravascular administration set, syringe, or other device to administer fluids.
The provided document is a 510(k) Premarket Notification from the U.S. FDA, which concerns the substantial equivalency of a medical device to legally marketed predicate devices. This type of submission focuses on demonstrating that a new device is "as safe and effective" as a predicate device and often relies on comparisons to known standards and existing devices rather than extensive clinical studies.
Therefore, the document does not describe a study that aims to prove that the device meets acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, F1-score for an AI algorithm, or human reader improvement with AI assistance).
Instead, the acceptance criteria and performance data provided in this document relate to the physical and functional performance, biocompatibility, sterilization, and packaging of a medical device (Winged Infusion Sets, Blood Collection Sets, and Needle Holders).
Here's an analysis of the provided information within the context of a medical device 510(k) submission, specifically addressing the points in your request where applicable, and noting where the information is not provided due to the nature of this type of submission (i.e., it's not an AI/ML device).
Analysis of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:
This document describes the non-clinical performance testing conducted to support the substantial equivalence claim for physical medical devices (Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder). It does not pertain to an AI/ML device, and therefore, many of your specific questions related to AI/ML performance metrics, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable and are not found in this document.
The "acceptance criteria" here are compliance with recognized international and national standards for medical devices of this type. The "study" proving the device meets these criteria refers to the non-clinical performance testing conducted against these standards.
1. A table of acceptance criteria and the reported device performance
The document lists the standards that the device was tested against. The "reported device performance" is a blanket statement that "All the pre-determined acceptance criteria were met." There isn't a specific table with numerical performance metrics for each criterion; rather, it indicates compliance with the listed standards.
| Category | Acceptance Criteria (Standards Complied With) | Reported Device Performance |
|---|---|---|
| Performance | - ISO 8536-4-2019: Infusion equipment for medical use --Part 4: Infusion sets for single use, gravity feed |
- ISO 9626 Second edition 2016-08-01: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 7864 Fourth edition 2016-08-01: Sterile hypodermic needles for single use -Requirements and test methods
- ISO 80369-7 First edition 2016-10-15: Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20 First edition 2015-05-15: Small-bore connectors for liquids and gases in healthcare applications part 20: common test methods.
- ISO 23908 First edition 2011-06-11: Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters, and needles used for blood sampling | "All the pre-determined acceptance criteria were met." |
| Biocompatibility | - ISO10993-5: 2009: In Vitro Cytotoxicity - ISO10993-10: 2021: Skin Sensitization
- ISO10993-23: 2021: Intracutaneous Reactivity Test
- ISO10993-11: 2017: Acute Systemic Toxicity
- ISO10993-4:2017: Coagulation test
- ISO10993-4: 2017: Complement activity (SC5b-9) Test
- ISO10993-4: 2017: Hemolytic Properties Test
- ISO10993-3: Ames Test
- ISO10993-3: Mammalian Chromosome Aberration Test | "All the pre-determined acceptance criteria were met." |
| Sterilization | - ISO11135-1: Sterilization of health care products ethylene oxide part 1 - ISO11737-1: Sterilization of medical devices-Microbiological Methods-Part 1
- ISO11737-2: Sterilization of medical devices -- Microbiological methods - Part 2
- ISO10993-7: Biological evaluation of medical devices - Part 7: Test of Ethylene Oxide Residuals.
- ANSI/AAMI ST72: Bacterial endotoxins - Test methods | "All the pre-determined acceptance criteria were met." |
| Packaging &
Shelf Life | - ISO 11607-1:2006/(R) 2010: Packaging for terminally sterilized medical devices - ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM D3078-02 (2021): Standard Test Method for Determination of Leaks in - Flexible Packaging by Bubble Emission.
- ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials | "All the pre-determined acceptance criteria were met." |
Specific tests performed for Packaging and Shelf Life: Accelerated Aging Test, Simulated shipping distribution testing, Visual inspection, Performance Inspection (Chemical performance and Physical performance), Sterile Test, Vacuum Leak Test, Dye penetration test, Tensile Seal Strength Test.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for each test mentioned (e.g., how many devices were tested for tensile strength, biocompatibility, etc.). The data provenance is not explicitly stated in terms of country of origin but is implied to be from the manufacturer's testing (Jiangsu Kangbao Medical Equipment Co., Ltd, China). The testing is non-clinical, likely conducted retrospectively for the purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable. This is not an AI/ML device that requires expert-established ground truth from, for example, medical images. The "ground truth" here is adherence to specified engineering, material, and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device requiring human review/adjudication of outputs.
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 is not an AI/ML device. "Clinical Data: No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is physical and material science standards (e.g., ISO, ASTM standards for materials, performance, sterilization, and packaging). Compliance with these established industry standards constitutes the "ground truth" for device safety and effectiveness in this context.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in the AI sense. The manufacturing processes and designs would be "trained" in an engineering sense over time and through quality control, but this is not data for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no AI/ML training set. The "ground truth" for manufacturing and design would be engineering specifications and quality control parameters.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.