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Disposable High Pressure Injector Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.

The product has two types: one type is composed of one or several syringes and one or several accessories. The accessories include connecting tube and medicine aspirator (punctured medicine aspirator and tubular medicine aspirator); the other type is composed of individual accessory; the syringe is composed of barrel, plunger, piston or plunger cap. The connecting tube has one-way and multi-way. One-way connecting tube is composed of locking connector, tubing, female conical fitting, nozzle cap, protective cap or one-way valve; multi-way connecting tube is composed of multi-way connector, locking connector, tubing, female conical fitting, nozzle cap, protective cap, one-way valve or puncture.

Maximum rated pressure for the Disposable High Pressure Injector Syringe is either 300psi (2.07MPa) or 1200psi (8.3MPa). The rated pressure for each models are listed in the following Models and Combinations Table.

The aspirator has tubular medicine aspirator and punctured medicine aspirator. Punctured medicine aspirator has plastic pin.

Product packaging: Primary package is heat-sealed by Tyvek paper and PS blister.

The following configurations of various syringes and accessories are available than are in compatible with market available injectors from Medrad, Liebel-Flarsheim, Acist or Nemoto.

The provided document is a 510(k) summary for the Disposable High Pressure Injector Syringe, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed AI device performance study. Therefore, much of the requested information regarding AI device acceptance criteria, studies, and ground truth establishment is not present in this document.

However, I can extract the acceptance criteria and performance related to the non-clinical and clinical testing performed on the device itself.

Acceptance Criteria and Reported Device Performance (Non-AI device)

Since this document is a 510(k) summary for a physical medical device (Disposable High Pressure Injector Syringe) and not an AI/ML software device, the following points address what is available in the document and explicitly state where information relevant to AI/ML software performance studies is not applicable or provided.

2. Sample size used for the test set and the data provenance:
For Non-Clinical Testing: The document states "Performance testing" for various physical and biological characteristics. However, specific sample sizes for each test (e.g., number of syringes tested for pressure, number of samples for biocompatibility) are not provided. The data provenance is implied to be from the manufacturer (Wuxi Yushou Medical Appliances Co., Ltd) and "external laboratory testing," likely conducted in China given the manufacturer's location. The testing is for the physical device itself, not an AI algorithm.

For Clinical Testing: The document mentions "The clinical testing is used to evaluate the performance of the high pressure syringe and injectors" and lists evaluation points like Appearance, Sliding Performance, Sealing, and Fitting. However, no sample size, patient count, or study design details for this "clinical testing" are provided. It's unclear if this refers to actual human clinical trials or observational use. Given the context of a 510(k) for a basic device, it's highly likely to be limited usability testing rather than a full-scale clinical trial with patient data.

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. This is for a physical medical device, not an AI algorithm requiring expert-established ground truth from medical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for a physical medical device.

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 is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the physical device's performance, the "ground truth" is established through engineering and biological standards (e.g., pressure ratings, ISO 10993 for biocompatibility, ASTM D4169 for transportation). For the "clinical testing" aspects (Appearance, Sliding, Sealing, Fitting), the ground truth would be based on functional performance and visual inspection criteria, implicitly determined by the manufacturer's quality control and comparison to predicate devices, rather than medical ground truth.

8. The sample size for the training set:
Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI device that requires a training set or its associated ground truth establishment.

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The Safety Hypodermic Needle With/Without Syringe device is intended for use in the aspiration of fluids for medical purposes. The Safety Hypodernic Needle With/Without Syringe is compatible for use with standard her lock syringes. Additionally, after withdraval of the needle from the body, the attached can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.

The Safety Hypodermic Needle With/Without Syringe consists of a hypodermic needle with a hinged safety sheath attached to the connector hub with or without an attached hypodermic syringe. This device features a hinged safety sheath attached to the needle hub. The safety sheath which are simultaneously activated when manually pressed over the needle immediately after use and just prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath either by finger or thumb, or by surface activation. The locking mechanisms are positioned within the center and proximal end of the Sheath. The hinge feature allows the medical practitioner to flexibly adjust the sheath to its desired position for use.

The provided text is a 510(k) summary for "Safety Hypodermic Needles With/Without Syringe" and primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It does not describe a study that uses acceptance criteria to prove the device's performance.

Instead, the submission states:

• "Performances: Conforms to ISO7864" for the Safety Hypodermic Needle (compared to predicate K113422).
• "Performances: Conforms to ISO7886-1" for the Safety Hypodermic Needle With Syringe (compared to predicate K110771).
• "Biocompatibility: Conforms to ISO10993" for both.
• "Labeling: Meet the requirements of 21 CFR Part 801" for both.

These statements indicate that the device was evaluated against existing international standards (ISO) and FDA labeling regulations, but the document does not provide details of specific acceptance criteria or the study data that demonstrates conformance to these standards. It rather asserts conformance.

Therefore, for the specific questions requested, the information regarding a detailed performance study, sample sizes, ground truth establishment, expert adjudication, or MRMC studies is not available in the provided text. The document focuses on a comparative analysis of characteristics with predicate devices to demonstrate substantial equivalence, rather than a standalone performance study with defined acceptance criteria and results.

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Sterile Piston Hypodermic Syringes (With/Without Needed for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the fennector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from the body.

The hypodermic needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe.

The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip/Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas. And it is a Non-Pyrogenic and single use device. The mainly raw materials are PP, PE and rubber.

The Hypodermic Needle is a single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection. The needle is sterilized by EtO gas. and it is a Non-Pyrogenic and single use device. The mainly raw materials are PP and stainless steel.

The provided text is a 510(k) summary for WUXI YUSHOU MEDICAL APPLICANCES CO., LTD's "Iston Syringe With/Without Needle." This document outlines the substantial equivalence of the new device to existing predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria through clinical or performance data.

The FDA 510(k) pathway is for devices that are "substantially equivalent" to predicate devices already on the market. It does not typically involve the kind of detailed clinical study data, ground truth establishment, or multi-reader multi-case (MRMC) studies that would be necessary to demonstrate performance against acceptance criteria in the way you've described for an AI/CADe device.

Therefore, many of the requested fields cannot be filled from the provided document. The acceptance criteria in this context are implicitly that the device performs equivalently to the predicate devices and meets relevant recognized standards (like ISO).

Here's a breakdown based on the information available:

1. Table of acceptance criteria and the reported device performance

For a traditional medical device like a syringe or needle, "acceptance criteria" are typically defined by recognized standards (e.g., ISO for sterility, performance, biocompatibility) and comparisons to predicate devices. The document states that the device conforms to these standards, implying it meets the criteria.

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

• Sample size: Not explicitly mentioned in terms of a "test set" for clinical performance. The document refers to conformance to standards, which would involve testing multiple units, but the specific sample size for these tests is not provided in this summary.
• Data provenance: Not explicitly mentioned. Testing would likely have been conducted by the manufacturer or a contracted lab in China to demonstrate conformance to ISO standards. The submission is from China.
• Retrospective or prospective: Not applicable in this context; these terms are used for clinical studies with patient data, which is not described here.

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

• Number of experts: Not applicable. Ground truth, in the context of AI/CADe, refers to a definitive diagnosis or finding. For a syringe/needle, "ground truth" relates to its physical performance and material properties. Compliance with standards is typically assessed through engineering tests and material analysis by qualified technicians/engineers, not medical experts establishing a "ground truth" for a diagnostic outcome.
• Qualifications of experts: Not applicable for establishing diagnostic ground truth.

4. Adjudication method for the test set

• Adjudication method: Not applicable. Adjudication is used to resolve discrepancies in expert interpretations in diagnostic studies. For device performance, adherence to standards is demonstrated through validated test methods.

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

• MRMC study: No. This is not applicable to a hypodermic syringe or needle. MRMC studies are for diagnostic devices, especially those involving human interpretation of medical images with or without AI assistance.

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

• Standalone performance: No. This is not applicable to an entirely mechanical medical device like a syringe/needle.

7. The type of ground truth used

• Type of ground truth: The "ground truth" here is the adherence to established international standards (ISO7886-1 for syringes, ISO7864 for needles, ISO10993 for biocompatibility) and regulatory requirements (21 CFR Part 801 for labeling). This is affirmed through technical testing and documentation, rather than clinical outcomes or expert consensus on a diagnostic finding.

8. The sample size for the training set

• Training set sample size: Not applicable. This device is not an AI/ML product and does not have a "training set."

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

• Ground truth establishment for training set: Not applicable.

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The device's primary intended use is general purpose injection of fluids into, or withdrawal of fluids from the body, below the surface of the skin except for phlebotomy. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.

The Safety Syringe per (21 CFR § 880.5860) is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle.

This 510(k) summary (K053519) describes a Safety Syringe. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it describe any AI/algorithm component.

The document is a standard 510(k) submission for a medical device (a syringe with a safety feature to prevent needle stick injuries). The FDA's letter states that they reviewed the premarket notification and determined the devices are substantially equivalent to legally marketed predicate devices. This determination is based on the device's design, materials, and intended use being similar to existing cleared devices, and it implies that the device meets generally accepted performance standards for syringes, but no specific performance study details are provided in this summary.

Therefore, I cannot provide the requested information from the given text.

Here's why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: This information is not present. The summary focuses on the device description, intended use, classification, and predicate device.
2. Sample sized used for the test set and the data provenance: No test set or study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or experts are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there's no mention of a diagnostic study or "ground truth" in this context.
8. The sample size for the training set: Not applicable. This is not an AI/software device and no training sets are mentioned.
9. How the ground truth for the training set was established: Not applicable.

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