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510(k) Data Aggregation
(38 days)
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients.
The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Surshield Safety Winged Blood Collection Set manufactured by Terumo Medical Products in Hangzhou, China is a sterile, single-use device consisting of a needle attached to a winged type hub, tubing, female connector with a multi-sample luer adapter attached for blood collection.
A hinged shield cover is attached to the wing just below the needle-to-wing junction. The shield cover can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a one- or two- handed technique. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needle stick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it.
Here's a breakdown of the acceptance criteria and study information for the TERUMO® SURSHIELD™ Safety Winged Blood Collection Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for each test. Instead, it states that the performance tests were performed and the conclusion is that the device is "substantially equivalent" to a predicate device, which implies the test results either met the predicate's performance or fell within acceptable manufacturing tolerances. For some tests, the document describes the design intent or functionality, which implicitly forms the basis of acceptance.
| Test Performed | Implied Acceptance Criteria (Based on Substantial Equivalence and Design) | Reported Device Performance |
|---|---|---|
| Shield cover/Needle Locking Strength | The shield cover must effectively and securely lock the needle after activation, preventing accidental exposure. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Break strength of the shield cover joint | The joint must withstand normal handling during activation without breaking, ensuring the safety mechanism remains intact. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Force to lock the needle in the shield cover (Force to activate safety feature) | The activation force should be reasonable for user operation while ensuring positive locking. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Puncture Resistance of Shield Cover | The shield cover must adequately resist needle puncture once locked, preventing accidental needlesticks. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Flow Rate | The device should allow for efficient blood collection and fluid administration. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Wing to Tubing Connection Strength | Connections must be robust to prevent leaks or detachment during use. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Tubing to Connector Connection Strength | Connections must be robust to prevent leaks or detachment during use. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Needle to Wing Connection Strength | Connections must be robust to prevent leaks or detachment during use. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Needle Penetration Resistance | Not explicitly defined for the safety feature (likely applies to the needle itself, ensuring proper venipuncture efficacy). | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Wing Needle Protector Fit | The protector must fit securely on the wing, likely referring to the design and integration of the safety feature. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Leak Test | The device must not leak during normal use for blood collection or fluid administration. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Blockage Test | The device must remain unblocked, allowing for proper fluid flow. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Connection Strength of Winged Infusion Set and Luer Adaptor Joint | The connection between the set and luer adaptor must be secure. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Valve Protector Fit | Likely refers to the fit and function of any valve mechanisms, ensuring proper seal and operation. | Not explicitly quantified, but considered "substantially equivalent" to predicate. |
| Sterility Assurance Level (SAL) | SAL of 10^-6 (implied by EN550 validation to 10^-9 means it meets this common standard). | Validated to provide a Sterility Assurance Level (SAL) of 10^-9. |
| Ethylene Oxide Residual Levels | Ethylene Oxide: 25 ppm; Ethylene Chlorohydrin: 25 ppm. | Ethylene Oxide: Does not exceed 25 ppm; Ethylene Chlorohydrin: Does not exceed 25 ppm. |
| Biocompatibility | Materials must be biocompatible according to ISO-10993 Part-1. | Blood contacting materials are biocompatible. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for any of the performance tests.
- Data Provenance: The tests were performed on the "Surshield Safety Winged Blood Collection Set manufactured by Terumo Medical Products in Hangzhou, China." The data is thus prospective for this specific device model from that manufacturing location.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study described is primarily a device performance and substantial equivalence assessment, not one relying on expert interpretation of results. Physical and chemical tests were performed.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the tests (mechanical, chemical, flow rates), an adjudication method as typically used for clinical or imaging data (e.g., 2+1) would not be applicable. The tests likely involved standardized methods with objective pass/fail criteria or measurements.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document is for a physical medical device (blood collection set), not an AI-powered diagnostic or interpretive system. Therefore, the concept of "human readers" or "AI assistance" is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, this is not an algorithm-only or AI-based device. It is a physical medical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests was based on engineering specifications, industry standards (e.g., EN550, ISO-10993), and the performance characteristics of the predicate device. For example, the ground truth for "Shield cover/Needle Locking Strength" would be defined by the predicate device's measured locking strength or a specific force threshold required by relevant standards for safety features.
8. The Sample Size for the Training Set
Not Applicable. This is a physical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As above, no training set was used.
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(24 days)
SURSHIELD SAFETY WINGED BLOOD COLLECTION SET
The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients.
The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.
Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The Surshield Safety Winged Blood Collection Set is a sterile, single-use device consisting of a needle attached to a winged type hub, tubing, a female connector with a multi-sample luer adapter attached for blood collection. The Surshield Safety Winged Blood Collection Set is the same as the Surshield Safety Winged Infusion Set (K010104) except for the attached luer adapter (K983490).
A hinged safety shield, previously cleared under K010103, is attached to the wing just below the needle-to-wing junction. The safety shield can be turned 180 degrees on the hinge. As the needle is removed from the patient's vessel, the user's finger actively pushes the shield cover until it latches onto needle using a single-handed technique. The shield cover is designed to allow the user's finger to remain behind the needle point so that the risk of needlestick injury is minimized. The shield cover is transparent for easy confirmation of the needle held in it.
The provided document describes a 510(k) premarket notification for the TERUMO® SURSHIELD™ Safety Winged Blood Collection Set. This submission is for a medical device and not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML studies are not applicable.
Here's an analysis of the provided text in relation to the prompt:
1. A table of acceptance criteria and the reported device performance:
The document states that "The following performance tests were performed on the Surshield Safety Winged Blood Collection Set:
- Leakage at connector to luer adapter junction
- Blockage
- Connection strength of luer adapter to connector
- Valve Protector Fit"
It also explicitly states, "Additionally, a risk analysis was conducted and any potential issues were addressed through design modification, and/or labeling as appropriate. None of the data raises any new issues of safety and effectiveness."
This indicates that the device met the acceptance criteria for these tests, implicitly defined by "not raising any new issues of safety and effectiveness." However, specific numerical acceptance criteria or performance metrics for these tests are not detailed in the provided text. For example, it doesn't state "Leakage less than X mL/hr" or "Connection strength greater than Y Newtons."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| No new issues of safety and effectiveness for: | Met, as "None of the data raises any new issues of safety and effectiveness." |
| - Leakage at connector to luer adapter junction | Met (Implied by the overall statement) |
| - Blockage | Met (Implied by the overall statement) |
| - Connection strength of luer adapter to connector | Met (Implied by the overall statement) |
| - Valve Protector Fit | Met (Implied by the overall statement) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for the performance tests mentioned (Leakage, Blockage, Connection strength, Valve Protector Fit). It also does not explicitly state the country of origin of the test data or whether the tests were retrospective or prospective. Given that the manufacturer, Terumo Corporation, is in Tokyo, Japan, it is highly likely the testing was conducted there.
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 question is not applicable as the submission is for a physical medical device (blood collection set), not an AI/ML diagnostic or predictive algorithm that relies on expert interpretation for ground truth. The performance tests described are physical engineering tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for a physical device's engineering performance tests. Adjudication methods are typically relevant for human interpretation of data, as in clinical studies or AI algorithm evaluations.
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. The device is a physical blood collection set, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical blood collection set, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance tests would be defined by engineering specifications and standards (e.g., maximum allowable leakage, minimum required connection strength). These are objective measurements rather than subjective human interpretations or clinical outcomes in the context of an AI/ML study.
8. The sample size for the training set:
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML algorithm that requires a training set.
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