(306 days)
Vein set is intended for vein puncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy
Safety vein set is intended for vein puncture to collect blood specimens. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.
Blood collection needle (vein set type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.
Blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.
Safety blood collection needle (vein set type) is intended for use in the blood collection or short-term influsion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk injury.
Safety blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce stick injury
The proposed device is a blood collection device that forms a passage between the patient's vein and a vacuum blood collection tube for collecting blood. The proposed device can also be used for short-term infusion. The proposed devices are divided into several types, some have safety devices and some do not have safety devices, and the safety mechanism helps to reduce the risk of needle stick injuries. The proposed devices are provided sterile, single use. The propose device can be used for vein collect blood/infusion as well as peripheral vein collect blood/infusion, but not central vein collect blood/infusion.
The provided text details the 510(k) submission for several blood collection and intravenous administration devices. It focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a new, innovative device with a complex algorithm. Therefore, many of the questions about acceptance criteria, specific performance metrics, expert qualifications, and study designs for algorithmic performance (like MRMC studies) are not directly applicable or available in this document.
However, I can extract information related to the device's performance as demonstrated by the non-clinical tests conducted to support its substantial equivalence. The "acceptance criteria" here are largely defined by the requirements of the referenced ISO standards and general safety/effectiveness considerations for medical devices of this type.
Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for certain aspects:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" as singular numerical targets for a new algorithm. Instead, it refers to conformity with established international standards for medical devices and safety features. The "reported device performance" is essentially the outcome of these tests, demonstrating compliance.
| Acceptance Criteria (Implicit from Standards) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| In Vitro Cytotoxicity: No cytotoxicity | No Cytotoxicity (Comply with ISO 10993 requirements) |
| Skin Sensitization: No sensitization | No Sensitization (Comply with ISO 10993 requirements) |
| Intracutaneous Reactivity: No intracutaneous reactivity | No Intracutaneous Reactivity (Comply with ISO 10993 requirements) |
| Acute Systemic Toxicity: No systemic toxicity | No Systemic Toxicity (Comply with ISO 10993 requirements) |
| Hemolytic Properties: No hemolytic properties | No Hemolytic (Comply with ISO 10993 requirements) |
| Pyrogenicity: No pyrogenicity | No Pyrogen (Comply with ISO 10993 requirements) |
| In Vivo Thromboresistance: (Implicitly, desired outcome is no) | No (Comply with ISO 10993 requirements) |
| Complement Activation: (Implicitly, desired outcome is no) | No (Comply with ISO 10993 requirements) |
| Sterilization | |
| Sterilization Method: EO Sterilized | EO sterilized (Same as predicate) |
| Sterility Assurance Level (SAL): 10^-6 | 10^-6 (Same as predicate) |
| Endotoxin Limit: 20EU per device | 20EU per device (Same as predicate) |
| Physical/Performance | |
| Conical fittings (Luer taper) per ISO 594-1 & 594-2 | Complies with ISO 594-1:1986 and ISO 594-2:1998 |
| Infusion sets for single use per ISO 8536-4 | Complies with ISO 8536-4:2010 |
| Sterile hypodermic needles per ISO 7864 | Complies with ISO 7864:2016 |
| Stainless steel needle tubing per ISO 9626 | Complies with ISO 9626:2016 |
| Particulate Matter testing per USP | Complies with USP Particulate Matter testing (Method 1) |
| Seal Strength per ASTM F88/F88M-15 | Complies with ASTM F88/F88M-15 |
| Detecting Seal Leaks per ASTM F1929-15 | Complies with ASTM F1929-15 |
| Safety Mechanism (for safety models) | Device safety mechanism performance |
| Simulated Clinical Study | Meet pre-established criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document generally refers to "non clinical tests" and "simulated clinical study" without specifying the exact sample sizes (e.g., number of devices tested) for each specific test mentioned (e.g., cytotoxicity, seal strength). The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated, but the submission is from Jiangsu Kangbao Medical Equipment Co., Ltd. in China, implying testing was likely conducted in China or by labs contracted by them. The studies described are non-clinical and simulated clinical, not human clinical trials.
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 to the provided document. The device is a physical medical instrument (vein set, blood collection needle), not an AI/algorithmic device that requires expert review to establish "ground truth" for interpretations of data like images or clinical signals. The "truth" here is determined by objective physical and biological measurements against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or performance evaluations where human experts are making subjective assessments and a consensus is needed. For physical medical devices tested against standards, the "ground truth" is determined by the test methodology itself (e.g., a tensile strength test yields a numerical result, a cytotoxicity test yields a "yes/no" result based on cellular response).
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 question is not applicable. MRMC studies are used to evaluate the performance of diagnostic imaging aids or similar AI-powered tools that assist human readers. The submitted device is a physical sterile device for blood collection and IV administration, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device described does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" is based on:
- Compliance with international standards: ISO standards (e.g., ISO 10993 for biocompatibility, ISO 594 for Luer fittings, ISO 7864 for needles) and US Pharmacopeia (USP ) for particulate matter.
- Physical and chemical tests: Measuring attributes like seal strength, leak detection, mechanical properties, and material composition.
- Biological tests: Assays for cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemolysis, etc.
- Safety mechanism evaluation: Verification that the safety feature (for applicable models) functions as intended to prevent needle stick injuries, as evaluated in a "simulated clinical study" and "safety feature test".
8. The sample size for the training set
This question is not applicable, as there is no mention of an algorithm or training set for this physical medical device.
9. How the ground truth for the training set was established
This question is not applicable, as there is no mention of an algorithm or training set for this physical medical device.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.