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The REVOLUTION Holder is used in blood drawing procedures. It is used with PUNCTUR-GUARD® Blood Collection Needles only, and is compatible with standard blood sample tubes as well as pediatric inserts.

The REVOLUTION Holder should be used by health care workers experienced in phlebotomy.

At the end of a blood draw, the holder dial is rotated clockwise 90°. This rotation activates the safety mechanism of the PUNCTUR-GUARD® needle, which reduces the probability of an accidental needle stick.

The needle can be eliminated quickly by a push on the release button. The holder is re-usable for up to 100 draws, including 20 cleanings.

The REVOLUTION Holder is designed to hold PUNCTUR-GUARD® Blood Collection Needles during blood drawing procedures, and to allow blunting of PUNCTUR-GUARD® needles prior to removal from the patient. Blunting reduces the probability of accidental needle sticks which are a major risk for infection with HIV or hepatitis. Blunting is performed by turning the dial at the holder's end.

The REVOLUTION Holder is non-sterile and can be used for up to 100 blood draws, including 20 cleanings. Contaminated needles can be released quickly in a one-handed operation by a manual push on the release button.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PUNCTUR-GUARD REVOLUTION™ Blood Collection Needle Holder:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): The document states, "Sample sizes reflected the significance of the particular functions, expressed in appropriate AQL levels." It does not provide specific numerical sample sizes for each test.
• Data Provenance: The tests were conducted internally by Bio-Plexus technical staff and externally by "outside health care workers." The country of origin is not explicitly stated, but Bio-Plexus, Inc. is located in Vernon, CT, USA, suggesting the testing was likely conducted in the US. The testing appears to be prospective as it's part of the development and validation of the new device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The document mentions "outside health care workers" participated in "complete functional testing in blood drawing procedures."
• Number of Experts: Not specified.
• Qualifications of Experts: The term "health care workers" is broad. More specific qualifications (e.g., phlebotomists with X years of experience, nurses, physicians) are not provided.

4. Adjudication Method for the Test Set

• The document describes "pass/fail evaluations" and mentions "functional testing." It does not provide details on an adjudication method like 2+1 or 3+1 for resolving discrepancies in evaluations. It implicitly suggests that the tests were designed with clear pass/fail criteria, possibly eliminating the need for complex adjudication for objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was NOT performed. The tests focused on the performance of the device itself and its equivalence to a predicate, not on how human readers (or users) improve their performance with or without AI assistance. The device is a mechanical blood collection holder, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a form of standalone testing was done. The device itself was tested for its mechanical and functional performance (holder integrity, needle insertion torque, safety feature activation, reusability) separate from a human operator, with human users primarily verifying the functionality during simulated use. Since this is a mechanical device and not an algorithm, "standalone" here refers to the device's inherent function rather than an algorithm's performance.

7. The Type of Ground Truth Used

• The ground truth was established through objective measurements (force and torque measurements), pass/fail evaluations against predefined design specifications, and simulated use testing verified by technical staff and healthcare workers. This constitutes a combination of engineering specifications and direct observational evidence of function. It does not involve "expert consensus" in the sense of interpreting medical images or pathology.

8. The Sample Size for the Training Set

• Not Applicable. The device is a mechanical blood collection holder, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable (as there is no training set for a mechanical device).

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The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder which is recommended for use with standard blood collection needles including the PUNCTUR-GUARD® Blood Collection Needle as well as PUNCTUR-GUARD® Winged Sets for Blood Collection. It also mates with the Bio-Plexus Needle Disposal Container for easy needle disposal. This is a non-sterile reusable device recommended for a maximum of 100 uses.

The Bio-Plexus DROP-IT® Needle Holder is a venipuncture needle holder comprised of an assembly of 5 plastic injection molded parts. The device rigidly holds a blood collection needle during the venipuncture procedure and also allows the needle to be released by use of a pushbutton rather than by unwinding. This device is for use with standard blood collection needles including Punctur-Guard® blood collection needles and winged sets. Standard blood collection needles include the Becton Dickinson Vacutainer® Needle, the Sherwood Monoject® Needle and the Terumo Venoject® Needle. The DROP-IT® Needle Holder performs the same functions as other legally marketed needle holders, for example, the Vacutainer® Brand Needle Holder #4893 and the Sage Products AutoDrop® Needle Holder #1510.

This 510(k) summary for the Bio-Plexus DROP-IT® Needle Holder does not contain explicit acceptance criteria or a detailed study to prove the device meets such criteria. It primarily focuses on demonstrating substantial equivalence to predicate devices already on the market.

However, based on the information provided, we can infer some aspects and highlight what is missing:

Inferred Acceptance Criteria and Reported Device Performance (based on Section 0):

Missing Information Regarding the Study:

The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a new clinical or performance study with acceptance criteria. As such, most of the requested information about a specific study is not present in this document.

Here's why and what is missing:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not explicitly stated. The document asserts that the device "performs the same functions as other legally marketed needle holders." This typically implies comparison to existing devices, but details of any specific performance testing dataset (size, origin, retrospective/prospective nature) are absent. This 510(k) focuses on mechanical function and equivalence, which might rely on bench testing rather than human subject data.

2. 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/Not stated. Given the nature of a needle holder, "ground truth" as it's typically understood for diagnostic devices (e.g., in image analysis) isn't directly relevant. Functional performance would likely be assessed through engineering tests or direct comparison to predicate devices, not expert adjudication of a "truth."

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not stated. Adjudication methods are relevant for subjective assessments, often in diagnostic studies. For a mechanical device like a needle holder, performance would be measured objectively (e.g., successful needle retention, force required for release, number of cycles before failure).

4. 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:

   • No. Not applicable. This is a diagnostic study design typically used for AI-powered interpretation of medical images. The Bio-Plexus DROP-IT® Needle Holder is a mechanical venipuncture device, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This refers to the performance of an algorithm without human input, relevant for AI. The device is a human-operated mechanical tool.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly stated for a "test set." For a mechanical device, the "ground truth" of its performance would be its actual measurable function (e.g., securely holding a needle for X force, successfully releasing a needle upon button press, enduring 100 uses without failure). This would be established through engineering specifications and bench testing, not expert consensus in the diagnostic sense.

7. The sample size for the training set:

   • Not applicable/Not stated. "Training set" is a term from machine learning/AI. For a mechanical device, there isn't a training set in this context. Design and testing are based on engineering principles and regulatory requirements.

8. How the ground truth for the training set was established:

   • Not applicable/Not stated. As above, this concept doesn't apply to a mechanical non-AI device.

In summary: The provided 510(k) summary focuses on establishing substantial equivalence by stating that the Bio-Plexus DROP-IT® Needle Holder performs the same functions as several legally marketed predicate devices and listing its features and intended use. It does not include a detailed study report with explicit acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader studies as would be found for more complex diagnostic or AI-driven medical devices. The "proof" for this type of device typically comes from engineering testing, comparison to established standards, and demonstration that it meets design specifications analogous to the predicate devices.

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The BIO-PLEXUS™ Needle Disposal Container is to be used by healthcare workers in healthcare facilities and in the home healthcare setting for the disposal of contaminated PUNCTUR-GUARD® needles and accessories.

The BIO-PLEXUS™ Needle Disposal Container is a single use, one quart, puncture resistant container comprised of a bucket like base and an affixed cover. The bucket and the cover are plastic injection molded from polypropelene. The cover has three openings and two hinged lids.

I am sorry, but the provided text describes a medical device, specifically a "Needle Disposal Container," and its intended use. It does not contain any information about clinical studies, performance metrics, acceptance criteria, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as none of that information is present in the input text.

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provides sterile vascular access for the collection of blood utilizing a vacuum tube system or syringe. allows vascular access with a low entry angle and firm needle tip control. permits collection of blood via a flexible tubing, effectively dissociating the puncture site from the proximal end of the device.

The PUNCTUR-GUARD® Winged Set is comprised of a sharp, lubricated stainless steel front needle which is attached to a flexible winged body. A blunt inner cannula is contained inside the front needle and provides the fluid path. A third wing is provided to actuate the blunting cannula forward of the needle point. The third wing is connected to flexible tubing at the end of which is a female luer connector. The device will be available in two configurations, with a male luer cap covering the female luer connector or with a Multi-Sample Lure Adapter (MSLA) attached to the female luer connector. The MSLA is comprised of a valved needle, hub with female luer connector and threaded section for the attachment of a holder. BIO-PLEXUS manufactures a one piece Needle Holder.

This 510(k) summary (K961251) describes a PUNCTUR-GUARD® Winged Set, a single-lumen hypodermic needle for blood collection. This document is a pre-market notification for a medical device and therefore does not contain the acceptance criteria and study information typically associated with AI/ML-driven device performance evaluations.

The provided text focuses on demonstrating the substantial equivalence of the PUNCTUR-GUARD® Winged Set to already marketed devices, rather than establishing acceptance criteria and proving performance through rigorous studies in the way an AI/ML device would.

Here's why the requested information cannot be extracted from this document:

• Device Type: This is a physical medical device (a needle) with a specific mechanical function, not an AI/ML diagnostic or prognostic tool. Therefore, concepts like sensitivity, specificity, AUC, human reader improvement with AI, standalone performance, training sets, and ground truth for AI algorithms are not applicable.
• Regulatory Pathway: A 510(k) summary primarily aims to demonstrate "substantial equivalence" to a predicate device already on the market. This often involves showing similar intended use, technological characteristics, and safety/performance through bench testing and simulated use, rather than extensive clinical efficacy trials against defined performance metrics like an AI/ML device.
• Content of the Document: The document explicitly states its purpose is to show substantial equivalence to existing winged blood collection sets and focuses on descriptive comparison and basic performance testing (bench tests and simulated use) to confirm similarities.

Therefore, it is not possible to fill out the requested table and answer the study-related questions for this specific input because the document does not contain information relevant to AI/ML device evaluation.

If this were an AI/ML device 510(k) summary, the information would typically be found in sections detailing clinical studies, performance data, algorithm validation, and comparison to a gold standard.

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