(112 days)
The Ecomed® Scalp Vein Set is a winged blood collection needle with a tubing used for the collection of venous blood.
The Ecomed® Scalp Vein Set is a sterile winged needle bonded to a flexible tubing with a female luer adapter. The female luer is provided with a protective cap on the end.
The provided text describes a 510(k) premarket notification for the Ecomed® Scalp Vein Set, focusing on its substantial equivalence to an existing device. However, it does not contain detailed information about specific acceptance criteria, comprehensive device performance data, or a study design as typically associated with proving a device meets acceptance criteria in a technical sense.
The document primarily focuses on:
- Intended Use: Withdrawal of venous blood.
- Material Equivalence: The Ecomed® needle is stainless steel, the same as the predicate device (Becton Dickinson's VACUTAINER® Brand Blood Collection Set). The needle protector sleeves and shields are also made from comparable materials (rubber and extruded plastic, respectively).
- Biocompatibility Testing: Non-cytotoxicity was demonstrated in testing performed in accordance with ISO 10993, along with endotoxin testing. This is the closest mention of performance testing, but specific acceptance criteria or detailed results are not provided beyond "demonstrated."
Therefore, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Functionality as a winged blood collection needle for venous blood withdrawal. | Stated to have the "same intended use" as the predicate device (Becton Dickinson's VACUTAINER® Brand Blood Collection Set). |
| Material Composition | Needle material equivalent to predicate; protector sleeves and shields made of comparable materials. | Ecomed® needle is stainless steel, same as BD needle. Both protector sleeves are rubber. Both shields are extruded plastic. |
| Biocompatibility | Non-cytotoxic; acceptable endotoxin levels. | Non-cytotoxicity demonstrated per ISO 10993. Endotoxin testing also performed. |
| Sterility | Device is sterile. | Stated as a "sterile winged needle." |
Note: The document provides very high-level assertions. Specific quantitative acceptance limits (e.g., maximum allowable cytotoxicity, specific endotoxin limits) and detailed performance results are not included in this summary.
2. Sample Size for Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document only mentions that testing was performed (e.g., for non-cytotoxicity, endotoxin).
- Data Provenance: Not specified. It does not mention country of origin or whether the data was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable/Not mentioned. This type of information is typically relevant for studies involving human interpretation or subjective assessments (e.g., image-based diagnostics), which is not the primary focus of the information provided for this simple medical device. The "ground truth" for material equivalence or biocompatibility comes from standardized tests and material specifications.
4. Adjudication Method for Test Set
- Not applicable/Not mentioned. Adjudication is typically used when multiple human experts provide opinions that need to be reconciled for a ground truth, which is not the case here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed or mentioned. This type of study is relevant for AI algorithms aiding human readers, which is not the nature of the Ecomed® Scalp Vein Set.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone performance study in the context of an "algorithm only" device was not performed or mentioned. The Ecomed® Scalp Vein Set is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used
- The ground truth for the claims made (material equivalence, biocompatibility) would be based on:
- Manufacturer Specifications & Material Certificates: For material composition.
- Standardized Assay Results: For biocompatibility (e.g., ISO 10993 cytotoxicity assay results, endotoxin assay results).
8. Sample Size for the Training Set
- Not applicable/Not mentioned. The Ecomed® Scalp Vein Set is a physical device, not a machine learning model, so there is no "training set."
9. How Ground Truth for the Training Set Was Established
- Not applicable/Not mentioned (as there is no training set).
§ 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.