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The Hantech Pre-filled 0.9% Normal Saline Flush Syringes, are in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the manufacturer for the appropriate device.

The Hantech Pre-filled 0.9% Normal Saline Flush Syringes is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The device will be marketed as 10mL syringe with a 3mL, 5mL or10mL fill volume according to the market needs. It is terminally sterilized by steam sterilization. The product has a shelf life of 1 years.

The provided document (K231363) is a 510(k) summary for Hantech Pre-filled 0.9% Normal Saline Flush Syringes. This type of device is a sterile medical product, not an AI/ML-driven diagnostic or image analysis tool.

Therefore, the concepts of acceptance criteria, test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, and training sets do not apply in the context of this device and the information provided in the 510(k) summary.

The document describes non-clinical bench testing to demonstrate the substantial equivalence of the Hantech Pre-filled 0.9% Normal Saline Flush Syringes to a legally marketed predicate device. The "acceptance criteria" here refer to the predefined standards and limits for the physical, chemical, and biological properties of the syringe and its contents, as well as the sterilization process, which are based on recognized international and national standards (e.g., ISO, USP).

Here's an interpretation of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table summarizing the non-clinical testing performed. The "Acceptance criteria" column lists the standards/criteria the device must meet, and the "Conclusion" column indicates "Pass" for all tests, meaning the device met these criteria.

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

The document explicitly states "Summary of clinical Testing: N/A," meaning no clinical trials were conducted. The testing described is bench testing (laboratory-based, non-human, non-animal testing) of the physical product, its components, and its contents. The sample sizes for each specific test (e.g., how many syringes were tested for dimensions, or how many batches for chemical composition) are not provided in this summary document. Data provenance would be the manufacturer's internal testing facilities in China. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to demonstrate compliance.

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

This question is not applicable. The "ground truth" for a medical device like a syringe is established by validated measurement methods and recognized standards, not by expert consensus on clinical findings. For example, the pH of the saline is measured by a pH meter against a standard, not by an expert's opinion.

4. Adjudication Method for the Test Set:

Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, like image reading, not for objective bench testing of a physical product.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is typically performed for diagnostic devices (e.g., AI in radiology) where the performance of human readers, with and without AI assistance, is compared. This device is a pre-filled saline syringe.

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

No, this concept is entirely irrelevant for a medical device such as a pre-filled saline syringe. This applies to AI/ML algorithms.

7. The Type of Ground Truth Used:

The "ground truth" (or more accurately, the reference standard) for this device's performance is based on:

• Recognized consensus standards: International Organization for Standardization (ISO) standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993 series)
• United States Pharmacopeia (USP) monographs and general chapters: (e.g., USP for pH, USP for identification tests, USP for particulate matter, USP for Bacterial Endotoxins, USP31- for Sterility tests, USP monographs for Sodium Chloride Injection)
• Manufacturer's internal specifications: Which must meet or exceed these recognized standards.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of device.

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The Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. It is sterile and for single use only. It can be used by the patient at home or healthcare professionals at medical/health care centers.

The Disposable Insulin Pen Needle consists of a needle tube, a needle hub, a needle container, a needle shield and a seal. The needle tube is a double-ended needle that can be assembled into the needle hub using UV glue. The needle hub has the means of needle assembly attachment to allow it to be screwed onto the pen-injector device. This allows the Non-Patient (NP) end of the needle to penetrate through the rubber septum of the pen injector cartridge. The Patient and NP ends of the needle are lubricated using silicon oil for ease of injection and rubber septum penetration. The needle shield is assembled over the Patient end of the needle to protect the point from damage and accidental needle sticks. This needle assembly is inserted into a needle container and sealed with a peel-away label to provide a sterile barrier and tamper evidence. The peelaway label is pre-printed with information, which includes the lot number and needle gauge / length. It is supplied with several models. Different models are distinguished by needle gauge and length. The Disposable Insulin Pen Needle is a single-use disposable device and is provided sterile (EO sterilization). It is non-toxic and nonpyrogenic.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the Hantech Medical Device Co., Ltd. Disposable Insulin Pen Needle (K222739).

It's important to note that this document is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, rather than a full study proving a device meets novel acceptance criteria. Therefore, many of the typical AI/ML study components (like expert consensus, adjudication, MRMC studies, training set details) are not applicable here. This submission focuses on demonstrating that the new device performs similarly to an already approved device through established engineering and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are generally derived from recognized international and national standards, and "reported device performance" indicates conformity to these standards.

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

The document does not specify a "test set" in the context of clinical data or AI model evaluation. Instead, testing refers to product compliance with international standards for medical devices. The sample sizes for these specific engineering and biocompatibility tests are not detailed in this summary, but would typically be defined by the relevant ISO standards (e.g., a certain number of units for sterility testing or mechanical strength tests).

• Data Provenance: The tests were conducted by the manufacturer, Hantech Medical Device Co., Ltd., which is located in Ningbo, Zhejiang, China. The testing would be prospective in the sense that physical devices were manufactured and then tested to demonstrate compliance.

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

Not applicable. For this type of medical device 510(k) submission, "ground truth" is not established by human experts interpreting clinical data. Instead, it's established by objective measurements against predefined engineering standards and biocompatibility requirements. The "experts" involved would be qualified laboratory technicians, engineers, and biocompatibility specialists carrying out the specified tests following established protocols.

4. Adjudication Method for the Test Set

Not applicable. There is no qualitative assessment by human readers that would require an adjudication method. Test results are quantitative measurements or assessments against scientific 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

Not applicable. This device is a physical medical product (insulin pen needle), not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. As noted above, this is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this substantially equivalent device is the demonstrated compliance with recognized international and national standards for mechanical performance, sterility, and biocompatibility, as well as comparison to the characteristics of a legally marketed predicate device. This is based on objective laboratory and quality control testing, not clinical outcomes data, pathology, or expert consensus on interpretations.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device, so no training set or its associated ground truth establishment is relevant.

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The product is intended for subcutaneous injection of U-40 insulin in the treatment of diabetes.
The product is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.

The Disposable Insulin Syringe is designed for subcutaneous injection of a desired dose of U-100 and U-40 insulin and has capacity of 0.3mL, 0.5mL, and 1.0mL. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a needle, barrel, needle cap, plunger, piston, and plunger cap(only type A). The needle is a single ended lubricated stainless-steel cannula. The needle is covered by a polypropylene needle cap which is placed on the barrel. The barrel is molded from polypropylene with the exterior permanently marked with the proper scale markings. The piston is attached to the plunger and a Polypropylene plunger cap is placed over the plunger rod(only type A). All products are EO sterilized. The subject device operates on the principle of a piston syringe and has a shelf life of 5 years.

The provided submission is for a medical device (Disposable Insulin Syringe), not an AI/ML powered device. Therefore, a table of acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML is not applicable. The information requested (multi reader multi case study, standalone performance, ground truth establishment, training set sample size, etc.) pertains to AI/ML device evaluations and cannot be extracted from this document, which describes the testing and comparison of a traditional medical device against a predicate device.

The document discusses various performance data, including biocompatibility, sterilization, shelf life, and physical performance testing according to ISO and ASTM standards. These tests demonstrate the device's safety and effectiveness as a disposable insulin syringe, but not as an AI/ML system.

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The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. They are in infection control practices to reduce the potential exposure to blood and body fluids.

The Disposable Medical Masks are single use, three-layer, flat-folded masks with ear loops and nose clamp. The Disposable Medical Masks are manufactured with three layers, the inner and outer layers are made of non-woven fabric, and the middle layer is made of melt blown Fabric. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the face mask. The ear loops are made of Polyamide & Spandex. The nose clamp in the layers of face mask is to allow the user to fit the face mask around their nose, which is made of galvanized iron wire wrapped with PE material. The Disposable Medical Masks will be provided in white, blue, and purple which are sold non- sterile and are intended to be single use, disposable devices.

This document describes the acceptance criteria and the results of a study demonstrating that the "Disposable Medical Masks" device, manufactured by Hantech Medical Device Co., Ltd., meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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The Disposable Medical Safety Hypodermic Needle is intended for use in the aspiration and injection of fluids for medical purposes. The Disposable Medical Safety Hypodermic Needle is compatible for use with standard luer slip and luer lock syringes.

Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.

The Disposable Medical Safety Hypodermic Needle is composed of a needle hub, a needle tube, a needle cap and a sharp injury protection feature. The sharp injury protection feature is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The sharp injury protection feature is activated with one-hand operation by pressing the sharp injury protection feature either with the finger or thumb, or by surface activation. The locking mechanism is positioned within the center and proximal end of the sharp injury protection feature. The hinge feature(sharp injury protection feature) allows the medical practitioner the flexibility to adjust the sharp injury protection feature to its desired position for use.

This document describes the FDA's 510(k) clearance for the Hantech Medical Device Co., Ltd.'s Disposable Medical Safety Hypodermic Needle. The clearance is based on the device being substantially equivalent to a legally marketed predicate device (TK Safety Needle, K191644).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through adherence to various international ISO standards, indicating it meets the acceptance criteria defined within those standards. The document doesn't provide specific numerical targets for "acceptance criteria" but rather states conformity to the clauses of these standards, which implicitly define the acceptance thresholds.

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