(7 days)
The Terumo Venoject Luer Adapter is a sterile, non-invasive device that permits blood specimen collection from hypodermic needles, blood vessel catheters, or blood collection systems/devices with luer fittings. When blood samples are to be obtained with a single venipuncture, the luer adapter is a conduit between the collection needle and the collection container.
The Terumo Venoject Lucr Adapter is a sterile, single use device consisting of a cannula joined to a screw connector which is connected to a male luer taper. The cannula is covered with a synthetic isoprene rubber tip for stopping blood flow. When blood is collected using an evacuated blood collecting system, the collection container is placed over the cannula, pushing the rubber tip back, allowing blood flow. When the collection container is removed, the rubber tip extends back over the cannula, stopping blood flow. The luer adapter has no direct patient contact.
The provided text describes a 510(k) submission for the Terumo Venoject Luer Adapter, demonstrating its substantial equivalence to a predicate device. However, it does not contain the level of detail typically found in a clinical study report or a performance study outlining acceptance criteria and detailed device performance results.
The document focuses on:
- Intended Use and Description: What the device is and what it does.
- Substantial Equivalence: Comparing the proposed device to an already cleared predicate device (K983490) based on intended use, description/specifications, technology/principles of operation, materials, and performance.
- Safety Information: Sterility, biocompatibility screening, and expiration dating.
- Regulatory Conclusion: FDA's substantial equivalence determination.
Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment are not available in the provided text, as this type of information is usually presented in specific performance testing reports, not a summary of a 510(k) submission for a non-invasive, substantially equivalent device.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not present:
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A table of acceptance criteria and the reported device performance
The document states: "The performance of the Venoject Luer Adapter has been evaluated and the device performs according to the specification. There are no significant differences in specifications and performance between proposed device and predicate."
It specifies material composition and operational principles as being identical to the predicate. The performance evaluation is generic and does not provide specific quantitative acceptance criteria or detailed performance metrics.
Acceptance Criteria (Implied) Reported Device Performance Sterility Assurance Level 10⁻⁶ SAL (Validated per EN 550, ISO 11135) Biocompatibility No indication for additional testing from screening tests Expiration Dating Established at 30 months Functionality (General) Performs according to specification Equivalence to Predicate No significant differences in specifications and performance to K983490 (Implies it meets predicate's performance) -
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The document refers to "evaluation" of performance but does not provide details on specific test sample sizes.
- Data provenance: Not specified. The manufacturer is Terumo Europe N.V. (Belgium), but the source of specific performance data is not detailed. Given the nature of a 510(k) for a basic medical device, much of this "evaluation" would likely involve internal engineering tests, material testing, and potentially some simulated use or bench testing rather than clinical trials.
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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)
Not applicable or not specified. This device is a blood collection accessory. Performance evaluation for such a device typically involves engineering and laboratory testing for physical properties, sterility, and functionality (e.g., flow rates, leak testing, ease of use with other components), rather than expert assessment of patient outcomes or image interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable or not specified. As mentioned above, the performance evaluation is not described in terms of a clinical study requiring expert adjudication.
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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 device is a mechanical blood collection adapter, not an AI-powered diagnostic or imaging device, and therefore, MRMC studies are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a mechanical blood collection adapter, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not specified explicitly. For device performance, the "ground truth" would likely be engineering specifications, material standards, and functional requirements (e.g., no leaks, proper sealing, specified sterility level) rather than clinical "ground truth" like pathology or outcomes data. The document states its performance was "evaluated" against "the specification."
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The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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.