(268 days)
The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein under the action of gravity.
The device is a Disposable infusion set with needle. Its configuration includes a Protective Cap of Closure-piercing Device, Closure-piercing Device, Clamp, Fluid channel (tubing), Drip chamber upper cover (including the dropper), Drip chamber, Drip chamber base (including Fluid Filter membrane), Flow regulator, Regulator wheel, Luer Lock Connector, Infusion needle hub, Needle tube, Plastic needle handle, Infusion needle protector, Integral air-inlet with air filter and closure, Tubing, Lubricant, and Adhesives. It has a Tubing Diameter of 4 mm and Filter Characteristics of 15µm. It is available in various Needle Gauges and Lengths.
The provided document is a 510(k) summary for a "Disposable infusion set with needle," which is a Class II medical device. This type of device is a physical medical device, not an AI/software device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/software performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test set sample sizes for AI, etc.) is not applicable to this document.
The document discusses physical, mechanical, chemical, and biocompatibility testing according to various ISO and ASTM standards to demonstrate substantial equivalence to a predicate device.
However, to address the spirit of the request regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for a physical medical device as described in this document, I can extract the relevant performance criteria and testing methods from the provided text.
Here's an interpretation based on the provided content for a physical medical device:
Acceptance Criteria and Device Performance for a Disposable Infusion Set with Needle
This document describes the regulatory submission for a Disposable Infusion Set with Needle (K232475) to demonstrate substantial equivalence to a predicate device (K163160). The "acceptance criteria" here refer to the performance requirements established by recognized standards, and the "study" refers to non-clinical performance testing conducted to prove the device meets these criteria.
1. Table of Acceptance Criteria and the Reported Device Performance
The document presents a comparison between the predicate device and the subject device, outlining various performance parameters. The "acceptance criteria" for the subject device are generally implied to be meeting the same performance standards as the predicate, or demonstrating that any differences do not adversely affect safety or performance, as evaluated against relevant ISO and ASRM standards.
"Reported Device Performance" is indicated by the statement that the subject device "met all design specifications as Substantially Equivalent (SE) to the predicate device" and that "The requirements of the standards are met." Specific quantitative results are generally not provided in this summary, but rather a confirmation of compliance.
| Parameter | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| Infusion Set Performance | Compliance Confirmed | |
| Particulate contamination | Contamination index limit is less than 90 | Contamination index limit is less than 90 (Met) |
| Leakage | No leakage | No leakage (Met) |
| Tensile strength | Withstand a static tensile force of not less than 15N for 15s | Can withstand a static tensile force of 15 N for 15s (Met) |
| Closure piercing device | Comply the dimension of ISO 8536-4 | Comply the dimension of ISO 8536-4 (Met) |
| Air-inlet device | Flow of fluid reduced less than 20% of that from a freely ventilated container | Flow of fluid reduced less than 20% of that from a freely ventilated container (Met) |
| Fluid filter | Retention of latex particles is not less than 80% | Retention of latex particles is not less than 80% (Met) |
| Drip chamber and drip tube | 20 drops of distilled water equivalent to (1±0.1) ml/g | 20 drops of distilled water equivalent to (1±0.1) ml/g (Met) |
| Flow rate | Deliver not less than 1000ml | Deliver not less than 1000ml (Met) |
| Construction (Clamps) | Resist flow of fluid/air at 50 kPa when closed | Resist flow of fluid and air at an applied pressure of 50 kPa when closed (Met) |
| Needle Performance | Compliance Confirmed | |
| Cleanliness | Free from particles and extraneous matter | Free from particles and extraneous matter (Met) |
| Needle length | Meet ISO 7864:2016 Clause 4.10 | Met ISO 7864:2016 Clause 4.10 for respective gauges (e.g., 20.72mm for 23G) (Met) |
| Bond of hub and needle tube | Not broken by the minimum force | Not broken by the minimum force (Met) |
| Stiffness | Deflection is less than 0.50mm | Deflection is less than 0.50mm (Met) |
| Dimensions of needle tubing | Meet ISO 9626:2016 Clause 5.6 | Met ISO 9626:2016 Clause 5.6 for respective gauges (e.g., 0.627mm for 23G) (Met) |
| Resistance to breakage | The tubing is not break | No breakage (Met) |
| Resistance to corrosion | No evidence of corrosion | No corrosion (Met) |
| Biocompatibility | Compliance Confirmed | |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity (Met) |
| Intracutaneous Reactivity | No Intracutaneous Reactivity | No Intracutaneous Reactivity (Met) |
| Skin Sensitization | No Skin Sensitization | No Skin Sensitization (Met) |
| Acute Systemic Toxicity | No Acute Systemic Toxicity | No Acute Systemic Toxicity (Met) |
| Hemolysis | No Hemolysis | No Hemolysis (Met) |
| Pyrogen | No pyrogen | No pyrogen (Met) |
| Other tests | Compliance Confirmed | |
| Seal strength | (Standards apply, e.g., ASTM F88/F88M-15) | Met (Tests performed per ASTM F88/F88M-15) |
| Internal pressure | (Standards apply, e.g., ASTM F1140/F1140M-13) | Met (Tests performed per ASTM F1140/F1140M-13) |
| Dye Penetration | (Standards apply, e.g., ASTM F1929-15) | Met (Tests performed per ASTM F1929-15) |
| EO residue | (Standards apply, e.g., ISO 10993-7:2008) | Met (Tests performed per ISO 10993-7:2008) |
| ECH residue | (Standards apply, e.g., ISO 10993-7:2008) | Met (Tests performed per ISO 10993-7:2008) |
| Bacterial Endotoxin Limit | (Standards apply, e.g., USP NF ) | Met (Tests performed per USP NF ) |
| Shelf-Life Evaluation | Maintain performance after accelerated aging | Met (Physical, Mechanical, Chemical, Package & Sterility Tests on aged samples) |
| Transportation Testing | Maintain package integrity | Met (Tests performed to verify package integrity) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of infusion sets tested for leakage, tensile strength, etc.). It generally refers to compliance with recognized standards (e.g., ISO 8536-4, ISO 7864), which themselves specify required sample sizes for testing.
- Data Provenance: The tests are non-clinical (laboratory/bench testing) performed by the manufacturer, Shandong Zhushi Pharmaceutical Group Co., Ltd. in China. The data would be derived from these internal tests. The term "retrospective or prospective" is not applicable to this type of device performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable. For a physical medical device like an infusion set, "ground truth" is established by direct physical, chemical, and biological testing against engineering and safety standards, not by expert consensus or interpretation of images. The tests evaluate measurable properties (e.g., tensile strength, flow rate, particulate count, presence of toxins) directly.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in studies involving human interpretation (e.g., radiologists reviewing images) where there might be inter-reader variability. For physical device performance testing, results are typically objective measurements or observations against predefined pass/fail criteria from a standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This question is not applicable. MRMC studies are used to assess the performance of diagnostic devices or AI systems, particularly how human readers perform with and without AI assistance on cases. This device is an infusion set, not a diagnostic or AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This device is a physical medical device, not an algorithm or AI.
7. The type of ground truth used
For this physical medical device, the "ground truth" is defined by:
- Established Industry Standards: Such as ISO 8536-4, ISO 7864, ISO 9626, USP NF , USP NF , ISO 10993 series, ASTM F1929, ASTM F88, etc. These standards specify acceptable ranges, limits, or characteristics for device performance and material safety.
- Direct Measurement and Observation: Performance is determined by physical tests (e.g., measuring tensile strength, observing leakage), chemical analyses (e.g., residual EO, particulate count), and biological assays (e.g., cytotoxicity, pyrogen testing).
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of a physical medical device. This term refers to data used to train an AI algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as #8.
§ 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.