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The device is intended for use to inject fluids or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

Subject Device: The Hypodermic Needle-Pro® EDGE™ Safety Device with Syringe is intended for injection or aspiration of fluids using a Luer slip syringe. The Needle-Protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of polypropylene needle hub and protective sheath with a living hinge. The stainless-steel needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position." After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the lugs on the needle hub snap into the clips of the protective sheath resulting in a "bottom snap" and the needle is contained within the sheath. In addition to the "bottom snap," the Needle-Protection sheath has 2 retaining hooks. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure.i.e., the EDGE™ safety device may be removed from a blood sampling syringe to process the blood sample. The EDGE™ safety device is then discarded into a sharps container. The Subject device is comprised of a 1mL Luer lock syringe with a 23G x 1.5in needle/cannula. This configuration is not currently offered within the Smiths Medical portfolio of Hypodermic Needle-Pro® EDGE™ with syringe devices.

The provided document is a 510(k) summary for the Hypodermic Needle-Pro® EDGE™ Safety Device. It details the device's characteristics, its comparison to a predicate device, and the performance data supporting its substantial equivalence.

Here's an analysis based on your requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for each test in a numerical or pass/fail format. Instead, it indicates that testing was performed in accordance with relevant ISO standards and that "There were no failures identified" for shelf-life, and "Results of the testing conducted, demonstrate the Subject device will perform as intended." This implies that meeting the requirements of these standards constitutes the acceptance criteria.

• Compatibility (Luers): Compliance to ISO 594-2 for Luers on Needle Hub/Safety Sheath and Hypodermic Syringe. |

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

The document does not specify sample sizes for any of the performance tests (biocompatibility, sterilization, shelf-life, or non-clinical bench testing). It also does not mention the country of origin of the data or whether it was retrospective or prospective, beyond stating that it was generated for the 510(k) submission.

3. 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)

This information is not applicable. The device is a hypodermic needle product, not an AI or diagnostic imaging device that would require expert-established ground truth for performance evaluation in the described tests. The "ground truth" for these tests would be defined by the physical and chemical properties measured against the standards, not expert interpretations.

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

This information is not applicable for the type of device and tests described. Adjudication methods are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in ground truth establishment, which is not relevant here.

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

No such study was performed or mentioned. This device is a physical medical device (hypodermic needle), not an AI or diagnostic tool that would involve human readers or AI assistance.

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

This information is not applicable. The device is a physical medical product, not an algorithm.

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

The concept of "ground truth" as typically used for AI or diagnostic devices (e.g., expert consensus, pathology, outcomes data) does not apply here. For the performance tests conducted:

• Biocompatibility: Likely based on standard chemical and biological assays and expert interpretation of material safety.
• Sterilization: Determined by microbial inactivation assays and compliance with sterilization standards.
• Shelf-Life: Determined by stability testing (physical and functional properties) over time.
• Non-Clinical Bench Testing: Determined by objective measurements against quantitative physical and dimensional requirements specified in the relevant ISO standards (e.g., fluid leakage, force required for activation, dimensions).

8. The sample size for the training set

This information is not applicable. No "training set" is mentioned as this is not an AI/machine learning device. The document mentions "predicate device" which is used for comparison, but not as a "training set" in the computational sense.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" for this physical device.

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This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure.

This device is intended for injection or aspiration of fluids. The needle protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of needle hub and protective sheath with a living hinge. The needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position". After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the lugs on the needle hub snap into the clips of the protective sheath resulting in a "bottom snap" and the needle is contained within the sheath. In addition to the "bottom snap", the needle protection sheath for needles equal to or less than 1" has one needle retaining hook (except 30g) and the sheath for needles longer than 1" has two hooks. The EDGE™ safety device may be removed from the syringe when required by a specific medical procedure. An example is removal of the EDGE™ safety device from a blood sampling syringe. The EDGE™ safety device is then discarded into a sharps container.

The provided text describes a 510(k) submission for the Hypodermic Needle-Pro® EDGE™ Safety Device. However, the document does not contain explicit acceptance criteria and corresponding reported device performance in a table format. The study conducted is a "Simulated clinical use studies" for the device, and the document states that these studies "confirmed that the EDGE™ safety device could be used by phlebotomists with no substantial change to their technique and could be safely removed from the syringe after activation."

Based on the information provided in the document, here's a breakdown of the requested details:

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criterion	Reported Device Performance
   Device can be used by phlebotomists with no substantial change to their technique.	Confirmed.
   Device can be safely removed from the syringe after activation.	Confirmed.

2. Sample size used for the test set and the data provenance:
   The document does not specify the sample size for the "Simulated clinical use studies." It also does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "Simulated clinical use studies."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not provide this information. It only states that the study involved "phlebotomists."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   The document does not describe any adjudication method.

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:
   No MRMC study was described. This device is a physical medical device (hypodermic needle with safety feature), not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This question is not applicable as the device is a physical medical device, not an algorithm, and its use inherently involves human interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth was established through observation and evaluation of the device's functionality during "simulated clinical use studies" by phlebotomists. This would imply an observational assessment of ease of use and safety during a simulated procedure.

8. The sample size for the training set:
   The document does not mention a "training set" as this is not a machine learning model. The clinical studies described are for validation of the device's performance.

9. How the ground truth for the training set was established:
   Not applicable, as there is no "training set" for this type of medical device submission.

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Hypodermic Needle-Pro® EDGE" Safety Device: This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.

Hypodermic Needle-Pro® EDGE" Safety Device with Syringe: This device is intended for use to inject fluids into or withdraw fluids from the body. The needle protection device covers the needle after use to help prevent needle sticks.

This device is intended for injection or aspiration of fluids into the body. The needle protection device covers the needle after use to help prevent needle sticks. The device features a "onepiece" design of needle hub and protective sheath with a living hinge. The needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position". After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the lugs on the needle hub snap into the clips of the protective sheath resulting in a "bottom snap" and the needle is contained within the sheath. In addition to the "bottom snap", the needle protection sheath for needles equal to or less than !" has one needle retaining hook (except 30g) and the sheath for needles longer than 1" has two hooks. The device is then discarded into a sharps container.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Smiths Medical ASD, Inc. Hypodermic Needle-Pro® EDGE™ Safety Device.

Acceptance Criteria and Device Performance (Implicit)

The document doesn't explicitly list quantifiable "acceptance criteria" in the way one might see for an AI algorithm's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating conformance to established industry standards and through a simulated clinical use study. For medical devices like this, regulatory acceptance often hinges on:

• Safety: The device effectively prevents needle sticks after use.
• Effectiveness: The device performs its intended function (injection/aspiration, covering the needle).
• Substantial Equivalence: The device is as safe and effective as legally marketed predicate devices.
• Compliance with Standards: Meeting recognized national and international standards applicable to hypodermic needles and syringes.

• ISO 594/1:1986(E): Conical fittings with 6% (Luer) taper - General requirements.
• ISO 594-2:1998(E): Conical fittings with 6% (Luer) taper - Lock Fittings.
• ISO 7864:1993(E): Sterile hypodermic needles for single use.
• ISO 7886-1:1993: Sterile hypodermic syringes for single use. |
  | Substantial Equivalence to Predicate Devices | The FDA's 510(k) clearance explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." The technological characteristics are noted as "the same hinged style protective sheath that is manually activated after use" as the predicate devices. |

Study Details:

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document states "Simulated clinical use studies were conducted," but it does not specify the sample size (e.g., number of devices tested, number of simulated uses).
   • Data Provenance: The study was conducted by Smiths Medical ASD, Inc., and is presumably internal to the company. The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a "simulated clinical use study," it would inherently be prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. For a simulated use study of a physical device like this, "ground truth" would likely involve objective observation of device function (e.g., successful activation of safety mechanism, no needle exposure). It's possible the "experts" were the study designers or trained observers, but their number and qualifications are not disclosed.

3. Adjudication method for the test set:

   • This information is not provided. Given the nature of observing a mechanical safety mechanism, formal adjudication (like 2+1 reads) might not have been deemed necessary, or the method was not explicitly documented in the summary.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-based diagnostic tools where human "readers" (e.g., radiologists) interpret images. This device is a physical medical device (safety hypodermic needle).

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

   • Yes, in the sense that the device's mechanical function was tested on its own. The "Simulated clinical use studies" would primarily assess the device's ability to shield the needle after use, which is its standalone function without direct human "performance" being the primary variable, beyond successful activation.

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

   • The ground truth would have been objective observation of the device's mechanical function in the simulated clinical use. For example, did the needle successfully retract/shield? Was it securely contained? Was there any accidental needle exposure after activation? This is a direct observation of the device's intended safety outcome.

7. The sample size for the training set:

   • Not applicable / Not provided. For a physical medical device, there isn't typically a "training set" in the computational sense. Device design and engineering are based on principles and iterative testing, not machine learning training data.

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

   • Not applicable. As above, there's no "training set" with ground truth in the context of this device. Design validation and verification for a mechanical device involve engineering specifications and tests, rather than labeled training data.

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This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.

This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The device features a "one-piece" design of needle hub and protective sheath with a living hinge. The needle cannula is permanently affixed into the hub. The sheath has an "arrow" indicating the bevel orientation, i.e. when the sheath is oriented to the right, the bevel is in the "up position". After the procedure is completed, the needle is pressed into the sheath using a onehanded technique. As the needle enters the protective sheath, the needle is engaged under the hook and contained within the sheath. The device is then discarded into a sharps container.

The provided document is a 510(k) summary for a hypodermic needle with an attached safety device, seeking substantial equivalence to predicate devices. It focuses on the safety mechanism to prevent needle sticks after use.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "A simulated clinical use study was conducted." However, it does not provide a specific sample size for this study or details regarding the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not specify the number of experts used or their qualifications to establish ground truth for the simulated clinical use study.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for the test set.

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

No, an MRMC comparative effectiveness study was not conducted or reported. The study described is a "simulated clinical use study" focused on the device's functionality rather than comparing human reader performance with and without AI assistance.

6. If a Standalone Study (Algorithm only without human-in-the-loop performance) Was Done

This device is a physical medical device (hypodermic needle with a safety mechanism), not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply. The "simulated clinical use study" refers to the device's physical function.

7. The Type of Ground Truth Used

The "simulated clinical use study" implies that the ground truth was based on direct observation of the device's physical function (i.e., whether the needle was effectively shielded after use) rather than expert consensus on images, pathology, or outcomes data. It's a performance-based assessment.

8. The Sample Size for the Training Set

The document does not mention any training set as this is a physical device, not a machine learning model.

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

As there is no mention of a training set, the method for establishing its ground truth is not applicable.

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