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The SunmedTM disposable angio-closure pads is to assist in obtaining and maintaining hemostasis.

disposable angio-closure pads is composed of compression bulb, The compression band and infusion mouth. Compression bulb is made from medical Polyurethane. Compression band is made from medical adhesive tape. Infusion mouth is made from medical Polycarbonate.

The provided text describes a medical device called "SunmedTM Disposable Angio-Closure Pads" and its 510(k) submission to the FDA. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics typically associated with AI/ML or diagnostic devices.

The document primarily focuses on the device's substantial equivalence to a predicate device (Safeguard™ 24cm pressure assisted dressing) based on:

• Intended Use: Both assist in obtaining and maintaining hemostasis.
• Technological Characteristics: Equivalent in terms of fundamental scientific technology, operating principle, sterility assurance level, and method of sterilization.

The non-clinical testing performed includes biocompatibility, package penetration, asepsis, aging, EtO and ECH residue, and bench testing. These are primarily related to safety, sterility, and material properties, not performance metrics like accuracy, sensitivity, or specificity.

Therefore, I cannot provide the requested information in bullet points 1 through 9 because the provided document does not contain data on acceptance criteria, reader studies, ground truth establishment, or performance statistics typically found for diagnostic or AI-enabled medical devices.

The relevant sections of your request that are explicitly or implicitly addressed as "not applicable" in this document are:

• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Evaluation was not applicable."
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: "Clinical Evaluation was not applicable." (implies no standalone performance study in a clinical context)
• 7. The type of ground truth used: Not applicable as no clinical performance study was done.
• 8. The sample size for the training set: Not applicable as this is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.

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The Sunmed Control Syringes is intended to inject contrast media or saline for angiographic procedures.

The Sunmed™ Control Syringes using dynamics principle, by means of the interference fit between the plunger with piston and the barrel, using the aspirating or driving force generated by manual function to draw or inject angiography medicament or saline for clinical disposable use.
The Sunmed™ Control Syringes is a single-use device that consists of two different structures: one is the standard type; the other is locking plunger type.
The volume of two type control syringes that to be offered in 10ml, 12ml.
The sunmed™ Control Syringes are available with rotating male luer and fixed male luer.
The sterilization method of the Sunmed™ Control Syringes is Ethylene Oxide sterilization.

This document is a 510(k) premarket notification for the Sunmed™ Control Syringes. It describes the device and claims substantial equivalence to predicate devices, but it does not describe a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

The document discusses "acceptance criteria" only in a very general sense, referring to standard non-clinical tests for medical devices like biocompatibility, sterility, and bench testing, to demonstrate substantial equivalence to a predicate device. There is no mention of an algorithm, AI, or software performance evaluation.

Therefore, I cannot provide the requested information regarding AI device performance, sample sizes, ground truth establishment, or expert involvement, as these elements are not present in the provided text.

Here's a breakdown of why I cannot fulfill the request based on the provided text:

• No AI or Algorithm: The device is a "Sunmed™ Control Syringes," a physical medical device intended to inject contrast media or saline. This is not an AI or algorithm-based device.
• No "Device Performance" in the AI sense: The document assesses physical characteristics (pressure rating, clarity, sterility, etc.) against predicate devices, not AI performance metrics like sensitivity, specificity, or AUC.
• No Study Design for AI: There's no mention of training sets, test sets, ground truth, expert adjudication, or MRMC studies, all of which are relevant to AI device evaluations.

The document's purpose is to demonstrate substantial equivalence for a physical device, not to evaluate an AI's diagnostic or predictive capabilities.

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The SunmedTM Haemostatic Valves is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 Fr, 8 Fr or 9 Fr; The insertion tool facilitates introduction of guide wire through the haemostatic valves to reach the guiding catheter; The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.

Hemostatic valves is composed of single Y connector, insertion tool and torquer. There are four models of the Hemostatic valves: Push-pull Y Connector, Screw Y Connector, Y click Connector and Double Screw Y Connector. Each single Y connector has two different structures: one is that the end of sideon is female luer; Another is that the end of sideon is the tubing and a stopcock. The Sunmed TM Hemostatic Valvesis designed to three external diameter of 7F, 8F, 9F for through different specifications of guide wire or catheter according to clinical need.

I am unable to provide a description of acceptance criteria and a study proving device meets acceptance criteria, as the document does not contain information on device performance or clinical study results for the Sunmed™ Haemostatic Valves.

The document is a 510(k) premarket notification for a medical device (Sunmed™ Haemostatic Valves) and primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility. It explicitly states in section 8 that "Clinical Evaluation was not applicable." Therefore, there is no information about acceptance criteria for device performance or a study proving the device meets said criteria.

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The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.

The Sunmed™ High Pressure Line is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.

The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.

The Sunmed™ High Pressure Line is single use and supplied sterile by Ethylene Oxide.

Package: Material: Dupont Tyvek package for medical use.

This document is a 510(k) premarket notification for a medical device called the "Sunmed™ High Pressure Line." It seeks to demonstrate substantial equivalence to previously marketed predicate devices, rather than establishing de novo acceptance criteria and proving performance through a clinical study. Therefore, much of the requested information about acceptance criteria for a novel device and specific study types (like MRMC or standalone performance) is not applicable or present in this filing.

However, I can extract the relevant information regarding the non-clinical testing performed to support substantial equivalence.

Here's a breakdown based on your request, explaining why some sections are not applicable to this type of regulatory submission:

Acceptance Criteria and Device Performance (Non-Clinical)

Since this is a 510(k) submission, the "acceptance criteria" are primarily established by demonstrating the device performs comparably to legally marketed predicate devices, especially through non-clinical testing. The "reported device performance" refers to the successful completion of these non-clinical tests.

Study Details

Given this is a 510(k) for a device like a high-pressure line, the "study" is primarily a non-clinical bench and lab testing program designed to demonstrate substantial equivalence, not a clinical trial.

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

   • Sample Size: Not explicitly stated for each non-clinical test. These tests typically use a defined number of device units as per specific test standards (e.g., ISO or ASTM standards).
   • Data Provenance: The tests were performed by or for Sunny Medical Device (Shenzhen) Co., Ltd. The physical location of testing is not specified beyond the company's address in Shenzhen, China. This would be considered retrospective data in the context of this submission, as the tests were completed prior to the FDA review.

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

   • This is not applicable for this type of non-clinical device testing. "Ground truth" and expert consensus are concepts typically applied to diagnostic algorithms or subjective assessments in clinical settings. Here, "ground truth" is defined by adherence to established testing standards and objective measurements (e.g., passing a sterility test or showing no toxicity).

4. Adjudication method for the test set:

   • Not applicable. Adjudication relates to resolving discrepancies in human expert opinions, which isn't part of non-clinical bench testing. The results of these tests are objective measurements against predefined acceptance criteria from standards.

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 passive high-pressure line, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant.

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

   • Not applicable. There is no "algorithm" in this device. Its performance is mechanical and biocompatibility-based.

7. The type of ground truth used:

   • For the non-clinical tests, the "ground truth" is established by objective scientific standards and measurements (e.g., absence of bacterial growth, specific chemical residue levels, lack of a toxic response in biological assays, structural integrity under pressure). It's not based on expert consensus, pathology, or outcomes data in the traditional sense, but adherence to recognized test methodologies and their pass/fail criteria.

8. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" as it's not an AI/machine learning product. Performance is based on physical and biological testing of manufactured units.

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

   • Not applicable. As there is no training set, this question is not relevant.

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The Sunmed The Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is intended for use in PTCA or PTA procedures to create and monitor pressure (by connecting the rotating male luer of inflation device with the balloon catheter's female luer) in the balloon and to deflate the balloon. The hemostatic valve is recommended for use during PTCA or PTA procedures in conjunction and/or diagnostic device (e.g. balloon dilatation catheters).Stopcock is used to release and purge any trapped air (if used).

The Sunmed The Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is 30ml disposable device capable of producing a maximum pressure of 40ATM. Pressure can be monitored via a pressure gauge. The manually operation of the device is achieved by the manipulation of a large handle to drive a piston housed within the body of the device.

Hemostatic valve is a single Y connector, and may be composed of an insertion tool, and a torquer. The hemostasis valve is designed to provide a port for interventional system. The insertion tool is used to facilitate placement of a guide wire tip through the hemostasis valve. The torque device is designed to hold the guide wire and provide a handle for manipulating.

This FDA 510(k) summary for the Sunmed™ Inflation Device (K133795) describes a device intended for use in PTCA or PTA procedures. However, it does not contain the detailed information required to fill out the user's requested template regarding acceptance criteria and a study proving those criteria are met.

Here's why and what information is available:

The document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to prove the device meets specific acceptance criteria through a clinical study in the way a PMA (Premarket Approval) might require.

Information NOT available in the provided text:

• A table of specific numerical acceptance criteria (e.g., specific thresholds for pressure accuracy, deflation time, etc.) and the reported device performance against those criteria. The document mentions "non-clinical testing" but does not provide results or specific criteria.
• Details about a specific study proving acceptance criteria:
  • Sample size used for the test set.
  • Data provenance (country of origin, retrospective/prospective).
  • Number of experts, qualifications, or adjudication method for ground truth.
  • Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
  • Standalone (algorithm only) performance.
  • Type of ground truth used (expert consensus, pathology, outcomes data).
  • Sample size for the training set (if applicable to an AI/algorithm-based device, which this is not).
  • How ground truth for the training set was established.

What can be extracted and inferred from the document regarding testing:

1. Nature of Testing: The document states "Summary of Non-Clinical Testing" and explicitly says "Clinical Evaluation was not applicable." This indicates that the device's performance was evaluated through bench testing and biocompatibility studies, not human clinical trials against specific performance endpoints.

2. Types of Non-Clinical Tests Performed (as listed in section 7):

   • Biocompatibility Testing:
     • Pyrogen Test
     • Endotoxin Test
     • Acute Systemic Toxicity Test (two kinds of solvent)
     • Intracutaneous Reactivity Test
     • In Vitro Cytotoxicity Test
     • Skin sensitization Test (two kinds of solvent)
     • In Vitro Hemolysis Study
     • Complement Activity Test (C3a, SC5b-9)
     • In Vivo Thrombogenicity
   • Package Penetrate Testing
   • Asepsis Testing
   • Aging Testing
   • EtO and ECH Residue Testing
   • Bench Testing

3. Lack of Reported Performance Data: While these tests were performed, the document does not report the results of these tests or the specific acceptance criteria (e.g., "Pyrogen test result must be

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Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and mav be used to reach and cross a target lesion.

The Sunmed Guide Wires are available in three versions with a variety of tips:

Stainless steel guide wire Hydrophilic coated quide wire PTFE (Teflon®) coated guide wires

The Seldinger technique is used with these quidewires.

The stainless steel guide wires are standard wires with various tip configurations. The guide wire construction consists of a safety wire, a core wire, and a wound spring for flexibility. The features that distinguish individual wires consist of the core type (fixed or moveable), a straight or "J" tip configuration, diameters and lengths.

The Hydrophilic coated guide wires are constructed from the stainless steel core wire, with varying core lengths and diameters for each design.

The PTFE (Teflon®) coated guide wires are also manufactured from stainless steel wire, with PTFE (Teflon®) coating, or Benzalkonium Heparin (BH) coating applied over the PTFE (Teflon®) coating.

These guide wires are radiodetectable and fluoroscopy may be used to confirm position.

These medical devices are single use and supplied sterile by EQ.

The Sunny Medical Device (Shenzhen) Co., Ltd. (K120119) describes the performance testing and technological characteristics of its Sunmed Guide Wires to establish substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a direct table format. Instead, it lists various tests performed and states that the device was found to have "identical technological characteristics and to be equivalent" to the predicate devices. This implies that the acceptance criteria for each test were met sufficiently to demonstrate equivalence.

Here's a breakdown of the tests performed, which inherently serve as the areas where the device needed to perform comparably to its predicates:

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the "Performance Testing." It broadly lists the types of tests conducted. As this is a 510(k) submission for a Class II medical device, the studies would primarily be bench and material testing rather than clinical trials with human subjects. The data provenance is not specified, but it's assumed to be from internal testing conducted by Sunny Medical Device (Shenzhen) Co., Ltd. or its contracted laboratories, likely in China (given the company's address). The studies are retrospective in the sense that they are conducted on manufactured devices as part of the submission process, not prospective clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable in the context of this 510(k) submission. The performance testing described consists of objective, quantifiable physical and chemical tests (e.g., degradation, resistance, sterility) rather than diagnostic accuracy studies requiring expert interpretation of results to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the tests are objective and do not involve human interpretation or adjudication for ground truth establishment.

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

No, an MRMC comparative effectiveness study was not done. These types of studies are typically for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Sunmed Guide Wires are interventional devices, and their evaluation focuses on physical and material properties, not diagnostic interpretation.

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

Not applicable. This device is not an algorithm or an AI-enabled device. Its performance is hardware-based and evaluated through physical and chemical testing.

7. Type of Ground Truth Used:

The "ground truth" for the performance tests would be defined by established engineering standards, material specifications, and regulatory requirements for guide wires. For example:

• Physical Performance: Mechanical properties (e.g., tensile strength, flexibility, lubricity) would be compared against predetermined specifications or the properties of the predicate devices.
• Sterility: Absence of viable microorganisms, confirmed by validated sterilization methods and sterility testing.
• Chemical Residues: Levels of ETO and ECH residues within acceptable regulatory limits.
• Biocompatibility: Demonstrated compliance with ISO 10993 standards.

The comparison is primarily against the performance of the legally marketed predicate devices, K993000 (Bard Hydrophilic Coated Guide Wires) and K082094 (PTFE (Teflon) Coated Guide Wires), as well as pre-amendment devices for the stainless steel versions. The statement "found to have identical technological characteristics and to be equivalent" suggests that the Sunmed Guide Wires met or exceeded the performance characteristics of these predicates.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.

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

Not applicable for the same reason as above.

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