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This device is an intravascular administration set with a non-coring Huber needle used for drug administration and blood sampling through implanted vascular port systems.

The needle tip is equipped with an anti-needle stick protector to reduce the possibility of accidental needle sticks. This device is also applicable to high-pressure injection with power injectors, when used with a port system indicated for high-pressure injection.

The K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing (here in after K-SHIELD Advantage HP-PAIS) is an intravascular administration set with a non-coring Huber needle used for drug administration and blood sampling through implanted vascular port systems.

The needle tip is equipped with an anti-needle stick protector to reduce the possibility of accidental needle sticks. This device is also applicable to high-pressure injection with power injectors, when used with a port system indicated for high-pressure injection.

This device has a Huber needle for insertion into the septum of an implanted port, for infusion and blood sampling through the port. This needle is equipped with wings of a specific shape and rigidity to ensure that the user can securely hold the device during needle insertion and withdrawal. Additionally, the alignment of the gripping position and the puncture point along a straight line supports accurate puncture placement. The device features a safety mechanism that activates upon needle withdrawal, with a safety shield covering the needle tip.

The activation of the safety mechanism is audibly confirmed by a click sound. Moreover, the device is equipped with high-pressure resistant tubing and clamp, enabling the supply of medications such as contrast media using an automatic injector.

Specification

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The Pen Injector Needle 32.5 is indicated for use with a pen injector device for patients who require the subcutaneous injection of drugs including insulin and human growth hormone as a therapy.

The Pen Injector Needle 32.5 consists of a cannula, needle hub, inner needle cap, outer needle case and seal film. The outer needle case and seal film function as the primary packaging and maintain the sterility when unopened.

The Pen Injector Needle 32.5 is a manually operated, disposable device intended for single use only. The device is individually packaged and sterilized by electron beam. The primary package consists of an outer needle case and sealing film.

The cannula is made of stainless steel and it is Thin Walled. The cannula remains 32.5G throughout the needle length, as a straight hypodermic needle. The cannula is pointed at both the patient interface end, for injection into the patient's body tissue, and the cartridge interface end, to puncture the cartridge for drug delivery.

The Pen Injector Needle 32.5 is available in different needle lengths. The length of the needle patient side (from the glue mount on the hub to the tip of the patient interface end) ranges from 4 mm (5/32") to 8 mm (5/16"). The patient interface end (needle tip) features a 3-bevel, asymmetrical needle edge.

The cartridge interface end is attached to a plastic hub (needle hub) which screws onto a compatible pen injector (not supplied with this device). The length of the needle cartridge side is 6.5 mm (1/4"). The patient interface end (needle tip) is covered by a white plastic needle protector cap (inner needle cap) which is then covered by a clear plastic outer case (outer needle case).

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The Profoject™ Disposable Needle is intended to be used with a Luer lock or Luer slip syringe and injection devices for general purpose fluid injection/aspiration.

The proposed device, Profoject™ Disposable Needle, consists of a needle tube, a needle hub, and a needle cap. The needle tube is made of stainless steel (SUS 304). The needle hub is made of polypropylene, and its color complies with ISO 6009. The needle cap is also made of polypropylene and does not come into contact with the patient. The conical socket of the needle hub is a Luer connector, compatible with other medical devices featuring Luer connectors. The proposed device is available in a variety of configurations, including different needle gauges, lengths, and wall thicknesses. The proposed device is intended for single use only. It is supplied sterile, sterilized by ethylene oxide (EO) with a sterilization assurance level (SAL) of 10-6.

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The PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal(800011 800012, 800013) are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for the safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles. The target population is trained healthcare professionals.

The PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) is injection-molded with high-density polyethylene (HDPE) plastic. Designed for single use, the container is puncture resistant, leak resistant on the sides and bottom, closable, and stable. The container is labeled with a fill line and instructions for snapping the container lid closed. "Do Not Overfill" to prevent overfill. The label is white with black text and a black biohazard symbol printed on an orange-red background.

The container is made of three parts (Base, Lid, and Label) that form a single unit. The red-colored base is conically shaped, and the lid features a clamshell design that snaps in place for a tight seal when the container is full.

The device is a non-sterile, single-use, disposable sharps infectious waste container designed to contain and hold sharps, such as angiocaths, blood needles, lancets, cap needles, and various-sized syringes. The shape of the container is conical and allows for one-hand disposal of sharps and a clamshell lid for means of closure.

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The Community Container (Flap and Daisy) are intended to be used for the collection, transportation and disposal of 1 ml and 2 ml hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml and 2 ml hypodermic needles and syringes.

The Community Containers (Flap and Daisy) are portable molded polypropylene syringe collectors that provide an alternate to re-sheathing a needle with its original protective cover and are designed to safely hold small low volume sharps such as blood needles, lancets, and small syringes.

The Community Containers (Flap and Daisy) are single use, non-sterile disposable, transportable sharps collectors intended to be used for the collection, transportation and disposal of 1 ml and 2 ml hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml and 2 ml hypodermic needles and syringes.

The Community Containers (Flap and Daisy) are rectangular, with a conical taper and a temporary closure capability, which can be reopened for the storage of additional sharps prior to terminal disposal.

The Community Containers (Flap and Daisy) are approximately 8.7cm (L) x 4.3cm (W) x 15.1cm (H). The cap is opaque plastic with a hinged cap, which can be snapped closed to contain the biohazardous sharps. Each Community Container is individually embossed with a biohazard symbol.

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Intraosseous Infusion Needles are sterile, disposable devices used primarily during pediatric emergencies as an alternative to unsuccessful intravenous access to allow for effective infusion of resuscitative drugs or fluids.

The Intraosseous Infusion Needles are intended for use as an alternative to intravenous access during pediatric emergencies, permitting infusion of drugs and fluids. Intraosseous Infusion Needles consist of two basic components - the needle (composed of a knob, a stylet luer-lock, and a beveled stylet) and the cannula (comprised of a hub, a base plate, and a cannula shaft). The cannula attaches to the needle by the stylet luer-lock and is supplied attached and ready to use. The Intraosseous Infusion Needles are available in the following configurations:

Intraosseous Infusion Needle (with Dieckmann Modification – Standard Hub Design)

Cannula Gauge: 14, 16, 18
Cannula/Stylet Length (cm): 14 Gauge: 3.0; 16 Gauge: 2.5, 3.0, 4.0; 18 Gauge: 2.5, 3.0
Stylet Length (cm): 14 Gauge: 4.6; 16 Gauge: 4.2 (for 2.5cm cannula), 4.65 (for 3.0cm cannula), 5.65 (for 4.0cm cannula); 18 Gauge: 4.2 (for 2.5cm cannula), 4.65 (for 3.0cm cannula)
Stylet Bevel Style: Trocar
Hub Material: Clear Polycarbonate (for 14 and 16 Gauge), Pink Polycarbonate (for 18 Gauge)

The provided FDA 510(k) clearance letter and summary for the Intraosseous Infusion Needles does not contain the detailed information necessary to answer most of the questions you've posed regarding acceptance criteria and study particulars.

This document focuses on justifying "substantial equivalence" to a predicate device, primarily by demonstrating that changes to the sterilization process do not negatively impact safety or effectiveness. It explicitly states that "No additional performance testing was conducted because the design of the subject device is identical to the predicate, K160887."

Therefore, I can only provide limited information based on the text.

Here's what can be inferred and what cannot:

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

The document does not explicitly state acceptance criteria or performance metrics for the device's primary function (intraosseous infusion). The "performance testing" described is related only to the sterilization process.

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

• Test Set Sample Size: Not specified for any performance testing related to the device's functional use or even for the sterilization validation beyond general statements of "performance testing was conducted."
• Data Provenance: Not specified.

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)

Not applicable. The document does not describe studies requiring expert ground truth for device performance related to patient outcomes or imaging. The testing focuses on sterilization process validation.

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

Not applicable. The document does not describe studies requiring adjudication.

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

Not applicable. This device is a physical medical needle, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical needle, not an algorithm.

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

For the sterilization validation, the "ground truth" would be objective laboratory measurements and adherence to international standards (e.g., ANSI/AAMI/ISO 11135 and ISO 10993-7) for sterility and residuals. It's not related to clinical "ground truth" like pathology or outcomes.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

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The TSK SELECT™ Needle is indicated for subcutaneous injections of pharmaceutical products, or for withdrawal of fluids.

The TSK SELECT™ Needle is designed to provide a means of fluid injection and aspiration to and from the body. It is a single lumen needle intended for use with a luer-tip syringe. The TSK SELECT™ Needle consisting of a stainless-steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene, or polycarbonate, depending on the hub type, designed to be connected with a male luer fitting of a syringe. The TSK SELECT™ Needle is intended for manual use by health care professionals for administration of fluids. The TSK SELECT™ Needle is provided sterile, is single use only, non-toxic, non-pyrogenic, and sterilized by gamma irradiation.

There is no indication that the TSK SELECT™ Needle incorporates artificial intelligence (AI) or machine learning (ML). The provided 510(k) clearance letter and summary describe a physical medical device (hypodermic needle) and its non-clinical performance and biocompatibility testing.

Therefore, the specific information requested about AI/ML device acceptance criteria and study details (such as sample size for test/training sets, data provenance, expert ground truthing, adjudication methods, MRMC studies, standalone performance, and effect size with AI assistance) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Indications for Use Comparison: Showing the new device has the same intended use as the predicate.
• Technological Comparison: Highlighting similarities and differences in materials, design, and features, and providing justification (e.g., "does not raise new or different questions of safety and effectiveness") for any differences.
• Non-Clinical Testing: Demonstrating compliance with recognized standards for physical performance, sterilization, and biocompatibility.

Since the request is specifically about AI/ML device criteria and studies, and this device is not an AI/ML device, I cannot provide the requested information based on the input. The document does not contain any data relevant to AI/ML performance metrics.

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Intended Purpose: The K-Pack Embrace™ Active Safety Needle, being a hypodermic needle with safety shield, is intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The safety shield shall be manually locked (activated), after use, to cover the needle to minimize the risk of accidental needle stick.

Indications: The K-Pack Embrace™ Active Safety Needle is for general application – for treatment (injection of fluids) or diagnosis (withdrawal of fluids).

The K-Pack Embrace™ Active Safety Needle is a hypodermic single lumen needle, for single use consisting of stainless steel cannula that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polycarbonate designed to be connected with a male luer connector (nozzle) of a hypodermic syringe. The K-Pack Embrace™ Active Safety Needle is compatible for use with standard luer slip and luer lock syringes. The K-Pack Embrace™ Active Safety Needle is packed in a hard plastic container (cap and case) made of polypropylene and sealed with a label.

This device features a hinged safety shield, made of polycarbonate, attached to the needle hub. The safety feature is activated when the safety shield is manually pressed over the needle immediately after use and prior to disposal to minimize the risk of accidental needle stick injuries. The safety shield is activated with a one-handed operation, using the finger, thumb, or surface activation.

The K-Pack Embrace™ Active Safety Needle is sterilized by ethylene oxide.

I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the K-Pack Embrace™ Active Safety Needle does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria in the way you've requested (e.g., details about AI studies, sample sizes for training/test sets, expert adjudication, MRMC studies, and nuanced ground truth establishment).

The document is a standard 510(k) clearance letter for a medical device (a hypodermic needle with a safety shield) that demonstrates substantial equivalence to a predicate device. The "Non Clinical Test" section focuses on:

• Performance testing: Verification of the device's design against recognized international standards (ISO 7864, ISO 9626, ISO 80369-7, ISO 6009, ISO 23908, ISO 11607-1, USP <788>, and FDA guidance on sharps injury prevention). These standards define various physical and functional requirements for hypodermic needles and their safety features.
• Biocompatibility testing: Evaluation of the materials in contact with the body according to ISO 10993.
• Sterilization and shelf-life testing: Validation of the sterilization method (Ethylene Oxide) according to ISO 11135 and shelf-life studies according to ASTM F1980.

The document does not describe an AI/ML-based device or a study involving human readers, AI assistance, ground truth established by experts, or any of the elements typically associated with the kind of acceptance criteria you've detailed in your prompt (e.g., sensitivity, specificity, AUC for an AI model).

Therefore, I cannot populate the table or answer the specific questions related to AI/ML study design and expert review methodology based on the provided text. The device described is a physical medical device, not a diagnostic AI system.

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The purpose of this Guideline is to provide clarity and guidance regarding the use of a digital pathology system which utilizes artificial intelligence (AI)-based image analysis algorithms. It describes the intended use of the system and covers relevant considerations related to its functionality, setup, and use in a pathology laboratory environment. This includes the following:

• Clear indications for use, including the patient population, sample type, purpose of the analysis, and interpretation of the results.
• Description of the AI algorithms used, including their validation and performance characteristics.
• Guidelines for system setup and configuration, including hardware and software requirements, calibration procedures, and quality control measures.
• Recommendations for training and competency assessment of users.
• Instructions for data management and archiving.
• Considerations for potential limitations and risks associated with the use of the system.
• Reporting of results, including integration with laboratory information systems.
• Post-market surveillance and system updates.
• Adherence to relevant regulatory requirements and standards.

By following this Guideline, pathology laboratories can ensure the safe and effective use of AI-based image analysis in digital pathology, contributing to improved diagnostic accuracy and patient care.

A compact USB-C hub designed to expand connectivity options, featuring multiple ports including USB-A, HDMI, SD card reader, and a passthrough charging port, ideal for laptops with limited ports.

The provided FDA clearance letter for Terumo's Hypodermic Needle (K243309) does not describe a study involving acceptance criteria for device performance in the context of an AI/ML or diagnostic imaging device. Instead, this document is a 510(k) submission for a medical device (a hypodermic needle) that demonstrates substantial equivalence to a predicate device.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to performance verification tests for a physical medical device (hypodermic needle), rather than the kind of AI/ML or diagnostic performance evaluation described in the prompt's request.

Therefore, the requested information (table of acceptance criteria and device performance for AI/ML, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is not applicable to this document.

The document primarily focuses on:

• Substantial Equivalence: Demonstrating that the new needle is as safe and effective as a previously cleared predicate device, despite a minor change (increased inner diameter/thin wall vs. regular wall).
• Non-Clinical Testing: Citing compliance with various ISO standards for hypodermic needles, biocompatibility, sterilization, and shelf-life, which are the "acceptance criteria" for this type of device.
• No Clinical Testing: Explicitly stating that clinical test data was not included because the changes were supported by non-clinical performance verification.

If this were an AI/ML or diagnostic device, the document would contain sections detailing sensitivity, specificity, AUC, human reader studies, etc., none of which are present here.

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The needle is used to access surgically implanted vascular ports.

Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.

In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle.

The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days.

This submission is new design primarily involve changes to addition of new needle lengths and specifications.

The provided FDA 510(k) clearance letter and summary for the Promisemed Safety Huber Needles details a medical device that is a physical product (a needle), not a software-based AI/ML medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) does not apply to this specific device.

The 510(k) submission for the Promisemed Safety Huber Needles focuses on demonstrating substantial equivalence to a predicate device (K243332) primarily through non-clinical performance testing for physical and mechanical properties, and a comparison of technological characteristics.

Here's a breakdown of the relevant information provided in the document:

Device Description and Purpose:

The Promisemed Safety Huber Needle is a non-coring intravascular infusion set with a right-angle needle and a manually activated needle-stick prevention safety mechanism. It is used to access surgically implanted vascular ports and, for the high-pressure resistant model, can be used for high-pressure injection of contrast media for CT imaging. It is for adult use only.

Nature of This Submission:

This 510(k) submission is for a device modification that primarily involves:

1. Addition of new needle lengths (16mm, 17mm, 20mm) for Type D and Type E needles.
2. Addition of a new specification: "without lubrication" for the needle tip.

The manufacturer asserts that these changes "do not introduce new risks as the fundamental technology and operation remain the same" and that the device remains "substantially equivalent" to its predicate device.

Acceptance Criteria and Study for This Device:

Since this is a physical medical device and not an AI/ML system, the "acceptance criteria" are based on meeting established performance specifications and international standards for hypodermic needles and infusion sets. The "study" that proves the device meets these criteria is the suite of non-clinical (bench) tests performed.

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

The document lists the types of tests performed and the standards they adhere to, implying that the acceptance criteria are successful completion according to these standards. It does not provide specific quantitative acceptance thresholds (e.g., "puncture force must be X-Y Newtons") nor the raw performance data, but rather states that "All verification and validation tests passed without deviations."

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

• Sample Size: Not explicitly stated in the 510(k) summary. For physical device performance testing, sample sizes are typically determined by statistical methods based on specified confidence levels or are prescribed by the testing standards themselves (e.g., a certain number of units per lot).
• Data Provenance: The tests were conducted by Promisemed Hangzhou Meditech Co., Ltd. in China ("Promisemed Hangzhou Meditech Co., Ltd. completed the following non-clinical tests"). This is a retrospective collection of data for the purpose of the 510(k) submission.

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

• N/A. This concept applies to AI/ML device ground truth establishment, often involving clinical image interpretation. For a physical device like a needle, "ground truth" is established by adherence to engineering specifications and international standards, tested by qualified engineers and technicians using calibrated equipment.

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

• N/A. This concept relates to human expert consensus in clinical data annotation for AI/ML validation. Physical device testing relies on objective measurements against defined criteria.

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:

• N/A. An MRMC study is for evaluating the impact of AI assistance on human diagnostic performance. This device is a physical medical instrument, not an AI software.

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

• N/A. This pertains to AI algorithm performance. The device here is a standalone physical needle.

7. The type of ground truth used:

• Engineering Specifications and International Standards: For a physical device, "ground truth" is adherence to predefined engineering specifications (e.g., dimensions, material properties, force resistance) and compliance with internationally recognized standards (like ISO 7864, ISO 9626, ASTM F3212). The testing confirms that the device's physical properties and functionality meet these established objective benchmarks.

8. The sample size for the training set:

• N/A. This concept is relevant for AI/ML model development. This device does not involve a "training set" in the computational sense.

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

• N/A. As above, this applies to AI/ML.

Summary of Key Takeaways from the Document:

The 510(k) submission successfully demonstrated substantial equivalence by confirming through non-clinical testing that the modified Promisemed Safety Huber Needles:

• Maintain the same intended use, technological characteristics, and principle of operation as the predicate device.
• The added needle lengths and the "without lubrication" option do not introduce new safety or effectiveness risks.
• All required performance tests (appearance, dimensions, needle point, fragment, sheath/cap, puncture force) passed without deviations, confirming adherence to relevant ISO and ASTM standards.
• No clinical testing was deemed necessary for this type of modification, reinforcing that the changes were not considered to impact fundamental safety or effectiveness parameters requiring human clinical data.

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