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510(k) Data Aggregation
(154 days)
The proposed device is intended for the injection of contrast media or saline. This syringe use with US legally marketed angiographic injectors.
The proposed devices are available in packs, which may include different configurations of syringes and accessories. The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1. The connection tubes, which is used to connect the syringe and the catheter. The tubes are available in two configurations, which are Type Y and Type T tube. The different between these tubes is tube shape, which is available in Y shape for Y tube and T shape for T tube. J shape tube, which is used to draw contrast media/ saline into the syringe barrel. Spikes, which are used to draw contrast media/saline into the syringe barrel.
The provided document is a 510(k) premarket notification for a medical device: "Sterile High-pressure Angiographic Syringes for Single-use". This type of submission focuses on demonstrating "Substantial Equivalence" to a legally marketed predicate device, rather than proving novel effectiveness or safety through extensive clinical trials.
As such, the document does not describe a study to prove the device meets acceptance criteria in the way you've outlined for an AI-powered diagnostic device. Instead, it details non-clinical tests to show the proposed device performs comparably to the predicate and meets relevant engineering standards.
Therefore, many of your requested points regarding Acceptance Criteria and Study Proof (especially related to AI, MRMC, expert consensus, and ground truth establishment) are not applicable to this 510(k) submission for a non-AI medical device.
However, I can extract the relevant information from the document regarding the "acceptance criteria" (in the sense of standards compliance and comparative performance) and the "study" (non-clinical tests) that proves these criteria are met.
Here's a breakdown based on the provided document:
Device: Sterile High-pressure Angiographic Syringes for Single-use
Device Type: Non-AI Medical Device (Angiographic Syringes)
Study Purpose: To demonstrate Substantial Equivalence (SE) to a predicate device (Shenzhen BaoAn Medical Supplies Co., Ltd. Sterile High-pressure Angiographic Syringes for Single-use, K151960) through non-clinical testing and comparison.
1. A table of acceptance criteria and the reported device performance
For a non-AI device like this syringe, "acceptance criteria" primarily refer to adherence to recognized international standards and demonstration of comparable performance to a predicate device. "Reported device performance" is the outcome of non-clinical tests demonstrating compliance.
| Acceptance Criteria (Standard / Property) | Basis / Test Method | Reported Device Performance (Result & SE Justification) |
|---|---|---|
| Performance | ||
| Compliance with Syringe Standards | ISO 7886-1 (Sterile hypodermic syringes for single use), ISO 594-1 (Conical fittings with a 6% (Luer) taper), ISO 594-2 (Lock Fitting) | Complied with ISO 7886-1, ISO 594-1, and ISO 594-2. This demonstrates performance equivalent to the predicate. |
| Seal Strength | ASTM F88/F88M-15 (Standard test method for seal strength of flexible barrier materials) | Test results met the standard. |
| Seal Leaks (Porous Medical Package) | ASTM F1929-15 (Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration) | Test results met the standard. |
| Connection Tube Performance | ISO 594-1 and ISO 594-2 | Performance test results of connection tube meet the criteria. Even with more product specifications (various lengths), the performance is maintained. |
| J-shape Tube Leakage | Non-standardized test, implied to ensure functionality. | Performance test results showed no leaks. |
| Biocompatibility | ||
| Biocompatibility Assessment | ISO 10993-1: 2018 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | Overall biocompatibility demonstrated; differences in materials (e.g., Piston, Filter membrane) from predicate are deemed not to affect SE due to successful biocompatibility testing (Analysis 2). |
| Cytotoxicity | ISO 10993-5:2009 (Tests for In Vitro cytotoxicity) | No Cytotoxicity. (Same as predicate) |
| Irritation | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | No Irritation. (Same as predicate) |
| Sensitization | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | No Sensitization. (Same as predicate) |
| Systemic Toxicity | ISO 10993-11:2017 (Tests for systemic toxicity) | No Acute Toxicity. (Same as predicate) |
| Hemolysis | ASTM F 756-17 (Standard practice for assessment of hemolytic properties of material) | No Hemolysis. (Same as predicate) |
| Pyrogenicity | USP 41-NF36:2018 (Pyrogen Test (USP Rabbit Test)) | No Pyrogen. (Same as predicate) |
| Sterility & Particulate Matter | ||
| Bacterial Endotoxins Limit | USP 41-NF36 2018 (Bacterial Endotoxins Limit) | Test results met the standard. |
| Sterility Assurance (Post-sterilization) | ISO 11737-2:2009 (Sterilization of medical devices- Microbiological methods- Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process) | Test results met the standard. (EO sterilized, same as predicate). |
| Ethylene Oxide Sterilization Residuals | ISO 10993-7:2008 (Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals) | Test results met the standard. (EO sterilized, same as predicate). |
| Particulate Matter | USP (Particulate matters) | Complied with USP 788. (Same as predicate) |
| Material & Physical Compatibility | ||
| Syringe Volume & Configuration Range Compatibility with Predicate's Performance | Comparison of various single and dual shot volumes (50ml to 200ml) and accessory types (connection tubes, J-shape tube, spikes) with the predicate device. | While the proposed device has a wider range of sizes/configurations than the predicate, non-clinical tests confirmed that all these configurations meet the performance criteria of relevant ISO standards. This difference is deemed not to affect SE. (Analysis 1) |
| Patient-Contact Material Compatibility | Comparison of materials used for various components (Barrel, Piston, Connection Tube, Luer Connectors, Spike, Filter Membrane, J-shape tube) with the predicate. Explicitly, changes in Piston (Medical rubber vs. Polyisoprene rubber) and Filter Membrane (Medical rubber vs. Polypropylene) from the predicate. | Differences in Piston and Filter Membrane materials exist. However, the contact classification (blood path, indirect limited contact) remains the same as the predicate. Extensive biocompatibility testing (Cytotoxicity, Irritation, Sensitization, Acute Toxicity, Hemolysis, Pyrogen) on the |
| proposed device's materials showed no adverse effects. Therefore, these material differences are not considered to affect substantial equivalence. (Analysis 2) | ||
| Labeling | 21 CFR Part 801 (Medical Device Labeling) | Complied with 21 CFR Part 801. (Same as predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not explicitly state the number of units/samples used for each non-clinical test (e.g., how many syringes were tested for seal strength, or how many batches for endotoxin). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The specific number of test replicates/samples would typically be detailed in the full test reports, which are not part of this summary document.
- Data Provenance: The tests are non-clinical (laboratory/bench testing) performed to verify compliance with standards. The company "Youwo (Guangzhou) Medical Device Co., Ltd." is based in Guangzhou, P.R. China, implying the testing was conducted in China, likely at their own facilities or certified labs in China. The data is entirely lab-generated, not from human subjects. The nature of the testing is prospective, in the sense that the tests were performed specifically for this submission on new device samples.
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 a non-AI, non-diagnostic medical device. There is no concept of "ground truth" established by human experts in the context of diagnostic interpretation. The "ground truth" for the performance of these syringes is defined by the objective pass/fail criteria of the recognized engineering and biocompatibility standards (e.g., is the seal strong enough? Is there pyrogen presence?). Compliance is measured by laboratory equipment and established protocols, not expert human review of an image or signal.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As per point 3, there's no human diagnostic interpretation to adjudicate. Test results are objective measurements against pre-defined thresholds 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 not an AI diagnostic tool, nor is it intended to assist human readers in interpreting medical cases. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device. Standalone performance refers to the device's ability to meet its specifications independently, which is what the non-clinical tests implicitly demonstrate (e.g., a syringe's seal strength is measured independently of human operation).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Standards-Defined Ground Truth: The "ground truth" here is the adherence to internationally recognized performance and safety standards (e.g., ISO, ASTM, USP). The device is "true" if it passes the specified tests according to the criteria defined within those standards. For example, a "true" biocompatible device produces no cytotoxicity according to ISO 10993-5. This is determined by laboratory measurements and chemical/biological assays, not clinical outcomes or expert diagnostician consensus.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device. There is no training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device. No ground truth for a training set was established.
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(25 days)
The ELPH Injection System is a contrast delivery system which is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.
The ELPH Injection System will deliver radiographic contrast media at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The ELPH is made up of the following major components: Power Head, Power Pack, Remote Console (Optional), Syringes.
The provided document is a 510(k) summary for the ELPH Injection System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (CT 8000 Digital Injection System, later marketed as CT 9000ADV).
However, this document does not contain acceptance criteria or detailed study information that would typically be found in a performance evaluation or clinical study report. It is a regulatory submission focused on demonstrating equivalence rather than proving performance against specific criteria through a dedicated study.
Therefore, many of your requested points cannot be answered from the provided text. The document primarily focuses on a comparison of features between the new device and the predicate device to argue for substantial equivalence.
Here's how much can be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for the ELPH Injection System in the way a performance study would. Instead, it compares the features and performance specifications of the ELPH system to its predicate device, the CT 8000 Digital Injection System. The "reported device performance" is essentially the listed specifications for the ELPH.
| Feature | Acceptance Criteria (Implied by Predicate - CT 8000) | Reported Device Performance (ELPH) |
|---|---|---|
| Multi-phasic Injections | 4 phases per protocol | Single phase |
| Protocol Storage | 12 protocols | 1 protocol |
| X-ray Scan Delay Timer | 99 seconds | Manual, 20 minutes |
| Syringe Sizes | Mallinckrodt 125-ml; Liebel-Flarsheim 200-ml | Mallinckrodt 125-ml; 130-ml (L-F # 600172) |
| Syringe Drive System | Electromechanical | Electromechanical |
| Syringe Heater | Yes | No |
| Syringe Fill Rate | 2 to 15-ml/sec | 1 to 8-ml/sec |
| Flow Rate | 0.1 to 8-ml/sec | 0.1 to 6-ml/sec |
| Max Pressure Limit | 300 psi | 250 psi |
| Pressure Limit Control | User settable | Automatic based on flow rate |
| Flushing System | Manual | Manual; Automatic with interface option |
| Remote Start | Yes | Yes |
| Display Technology | LCD | LED |
| Program Memory | Yes | Yes |
| Number of Control Panel Buttons | 8 | 5 |
| Post Injection Readout | Yes | Yes |
| Printer Option | Yes | No |
| Interface | Relays & Optical Couplings | Relays & Optical Couplings |
| Safety Stop Mechanism | Electrical Stop when injection parameters are out of spec. | Electrical Stop when injection parameters are out of spec. |
| Remote Control | Yes | Yes |
| Fill/Expel Control | Push buttons on Power Head and Manual Knob | Purge/Retract trigger |
| Programming Injections | Buttons on Console | Buttons on Console and Powerhead |
| Volume Remaining Display | Display on Powerhead and Console | Display on Powerhead and Console |
| Materials | Plastic and metal | Plastic and metal |
| Anatomical Injection Site | Injection into venous system | Injection into venous system |
| Function and Purpose | Injection of X-ray contrast agents for enhanced diagnostic CT imaging | Injection of X-ray contrast agents and flushing solutions for enhancing diagnostic imaging |
| Target Population | Humans | Humans |
| Sterility (Syringe) | Injectors not sterile, Syringes/Disposables sterile | Injectors not sterile, Syringes/Disposables sterile |
Note: The "acceptance criteria" here are implied by the performance of the predicate device. The submission makes a case that the ELPH system is "less expensive, smaller and less complicated to operate" and meets "only the ordinary needs," which sometimes results in lower specifications compared to the predicate, but is still considered substantially equivalent for its intended, more focused purpose.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document presents a comparison of device features and specifications, not data from a test set or provenance of 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)
This information is not provided in the document, as it does not detail a study involving expert assessment or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device is an injection system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a hardware injection system and does not appear to involve algorithms in the context of diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document, as it does not detail a study where ground truth would be established for evaluating diagnostic performance.
8. The sample size for the training set
This information is not provided in the document. The device is a hardware injection system and the submission does not mention a training set in the context of machine learning.
9. How the ground truth for the training set was established
This information is not provided in the document.
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