(235 days)
The EasyPoint® Blood Collection Plus is intended for use with evacuated blood collection tubes for venous blood collection, while aiding in the prevention of needlestick injuries and contaminated needle exposure.
The EasyPoint® Blood Collection Plus is a blood collection tube holder with an attached needle, and is intended to facilitate blood collection from patients. The device contains a sharps injury prevention feature (needlestick prevention feature - chamber, utilizing automated retraction technology) which covers the entire needle when activated. The EasyPoint® Blood Collection Plus aids in the prevention of needlestick injuries during normal handling and disposal, and prevents re-use of a contaminated needle. The EasyPoint® Blood Collection Plus allows for multiple sample draws from a single venipuncture. After blood collection is complete, the retraction mechanism is activated and the device disassembles itself by retracting the contaminated needle into the safety chamber. The safety mechanism allows the user to activate the needle retraction while the needle is still in the patient, preventing exposure to the contaminated needle. The safety mechanism can be activated using one step and allows the user's hands to remain behind the sharp during activation.
This document is a 510(k) summary for the EasyPoint® Blood Collection Plus device, which is a blood collection tube holder with an attached needle and aims to prevent needlestick injuries. The document describes the device, its intended use, comparison to a predicate device (Vacutainer® Eclipse™ Blood Collection Needle), and performance data to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a direct table of "acceptance criteria" with a corresponding "reported device performance" per se. Instead, it describes various types of performance testing conducted and states that the device "meets requirements for its intended use" based on the results.
Here's an attempt to infer and organize the information into a table format based on the "VII. PERFORMANCE DATA" section:
| Performance Test Category | Acceptance Criteria (Inferred from Test Type) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1, ISO 14971, and FDA Guidance for Industry and FDA Staff "Use of International Standard ISO 10993-1" (i.e., non-cytotoxic, non-sensitizer, non-irritant, non-pyrogenic, non-hemolytic, no acute systemic toxicity). | "It was found to be non-cytotoxic, a non-sensitizer, a non-irritant, nonpyrogenic, non-hemolytic, and to not produce acute systemic toxicity." |
| Mechanical Testing | Compliance with applicable design requirements of ISO 7864 and ISO 9626. Performance tests for functionality (retraction) force, needle pullout force, rubber sleeve pullout force, needle cap separation force, puncture/penetration force, and no leak under pressure. | "Engineering and performance testing on the EasyPoint® Blood Collection Plus was performed according to applicable design requirements of ISO 7864 and ISO 9626. Performance tests were developed by Retractable Technologies, Inc. to measure the functionality (retraction) force, needle pullout force, rubber sleeve pullout force, needle cap separation force, puncture/penetration force, and to verify that the device does not leak under pressure." (The document states these tests were performed, implying successful meeting of criteria for each, but doesn't provide specific numerical results or thresholds). |
| Simulated Use Study | Device performs safely and effectively when used by a variety of healthcare workers in a simulated use scenario; comparable to currently legally marketed blood collection tube holders with regards to safety, ease of use, effective use, needlestick prevention, and device functionality. | "The study showed that the EasyPoint® Blood Collection Plus is comparable to currently legally marketed blood collection tube holders with regards to safety, ease of use. effective use, needlestick prevention, and device functionality." |
| Sterilization Validation | Compliance with ISO 11135 and achievement of a Sterility Assurance Level (SAL) of 10-6. | "Sterilization validation was performed according to ISO 11135...demonstrated that the sterilization process continues to be effective and to meet the sterility assurance level (SAL) of 10-6." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document mentions "Simulated Use Study" and "Mechanical Testing," but it does not explicitly state the numerical sample size for any of these tests. It refers to "Additional details and reports can be found in the body of this submission," implying these numbers would be in the full submission.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. The "Simulated Use Study" sounds like a prospective human factors validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: For the "Simulated Use Study," the document mentions "a variety of healthcare workers." It does not specify the number of experts or readers.
- Qualifications of Experts: It refers to "healthcare workers," but does not detail their specific qualifications (e.g., years of experience, specific roles).
4. Adjudication method for the test set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set, especially in the context of user studies or performance evaluations requiring subjective assessments. Since these are performance tests for a physical device, and not an AI model, expert consensus or adjudication in the traditional sense might not apply in the same way.
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 document is for a physical medical device (blood collection tube holder with needlestick prevention), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- As stated above, this is a physical device, not an algorithm. Therefore, a standalone performance evaluation of an algorithm does not apply and was not done. The mechanical and sterilization tests would be closest to "standalone" in that they test the device's inherent properties.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a physical device, "ground truth" is established differently than for diagnostic algorithms.
- Biocompatibility: Ground truth is established by adherence to recognized ISO standards and FDA guidance, and the results of laboratory tests.
- Mechanical Testing: Ground truth is established by engineering specifications, ISO standards (ISO 7864, ISO 9626), and internal performance test criteria validated by the manufacturer (e.g., force measurements, leak tests).
- Simulated Use Study: Ground truth is established by observed performance of the device by healthcare workers against predefined safety, ease of use, and functionality metrics, with comparability to legally marketed predicate devices. This involves observed user actions and outcomes.
- Sterilization Validation: Ground truth is established by adherence to ISO standards (ISO 11135) and achieving the specified sterility assurance level (SAL).
8. The sample size for the training set
- This document is for a physical device, not an AI model. Therefore, there is no "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable as there is no "training set" for this physical device.
§ 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.