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510(k) Data Aggregation
(30 days)
Safety Winged Blood Collection Sets
The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
This document is a 510(k) summary for a medical device called "Safety Winged Blood Collection Sets" (K243806) from Promisemed Hangzhou Meditech Co., Ltd. It declares substantial equivalence to a predicate device (K211293).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria and reported device performance in the format usually seen for AI/ML performance. This is because the device is a physical medical device (blood collection set), not an AI/ML diagnostic system. The "acceptance criteria" here are implied by adherence to recognized international standards and successful completion of non-clinical tests.
However, based on the provided text, we can infer some "acceptance criteria" and "performance" statements related to the modifications made (specifically the addition of model RBC and changes in needle sizes/materials).
| Acceptance Criteria (Implied by Standards & Testing) | Reported Device Performance (as stated in the document) |
|---|---|
| Compliance with ISO 6009:2016 for needle color coding. | "Color system is in accordance with ISO 6009 requirement." |
| Compliance with ISO 8536-4:2019 for infusion sets (gravity feed). | Not explicitly stated for performance, but listed as an "Applicable standard," implying compliance. |
| Compliance with ISO 9626:2016 for stainless steel needle tubing. | Not explicitly stated for performance, but listed as an "Applicable standard," implying compliance. |
| Compliance with ISO 23908:2011 for sharps injury protection. | Not explicitly stated for performance, but listed as an "Applicable standard," implying compliance. The device's "safety mechanism" is a key feature and its function is maintained. |
| Model RBC visual inspections for correct labeling. | "Visual inspections were conducted on unit packaging to ensure RBC labeling is correct." |
| Full performance testing (appearance, dimension, safety mechanism, labeling) for new needle sizes, colors, and schematic diagrams. | "Full performance was tested, including appearance, dimension, safety mechanism, labeling, etc. and found to comply with drawing requirements." |
| Biocompatibility of new material (PP for safety protective mechanism in RBC model). | "Material of RBC is PP which it is only contact intact skin as limited exposure (A), does not introduce new risks about biocompatibility safety." It also references K230715's biocompatibility testing per ISO 10993-1 (External communicating device, in contact with circulating blood with prolonged exposure B) to support this change, including In vitro cytotoxicity testing in accordance with ISO 10993-5:2009. |
| Overall device safety and effectiveness equal to predicate. | "All verification and validation tests passed without deviations, confirming that the subjective device meet the necessary design specifications and regulatory requirements. The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample size: The document does not specify a numerical sample size for any of the non-clinical tests conducted. Statements like "Visual inspections were conducted on unit packaging" and "Full performance was tested" indicate tests were performed but don't provide the number of units tested.
- Data provenance: The data provenance is from the manufacturer's internal non-clinical testing. It is implicitly "prospective" in the sense that the tests were conducted specifically to demonstrate the performance of the modified device for this 510(k) submission. No specific country of origin for the data is mentioned other than the manufacturer's location in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as this is a 510(k) for a physical medical device (blood collection set), not an AI/ML device that generates diagnostic outputs requiring expert interpretation or ground truth labeling in that sense. The "ground truth" for these types of devices is established by adherence to engineering specifications and international performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reason as above. No "adjudication" or consensus reading by experts is required for the non-clinical performance and design verification tests reported.
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 is not applicable as the device is not an AI/ML system, nor does it involve human readers or cases in an interpretive diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device is adherence to established technical specifications, engineering drawings, and relevant international performance standards (ISO 6009, ISO 8536-4, ISO 9626, ISO 23908). Biocompatibility is "ground-truthed" by ISO 10993 series testing (e.g., in vitro cytotoxicity).
8. The sample size for the training set
This is not applicable as there is no AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no AI/ML algorithm requiring a training set or its associated ground truth establishment.
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(60 days)
Safety Winged Blood Collection Sets
The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adaper and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
This document describes the premarket notification (510(k)) for the Promisemed Safety Winged Blood Collection Set. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (K170276). It does not involve AI or algorithms, but rather a physical medical device. Therefore, many of the requested elements regarding AI/algorithm performance are not applicable.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are demonstrated through adherence to various international and national standards, showing the device's conformance to established safety and performance benchmarks. The reported device performance is indicated by "passing results" for all tests.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Physical Performance | |
| Needle appearance and cleanliness (ISO 7864:2016, clause 4.3) | Meets requirements |
| Needle Size color code (ISO 6009:2016) | Meets requirements |
| Needle Particulate contamination (USP , METHOD 1, Test 1.B) | Meets requirements |
| Bonding strength: Needle and hub (ISO 7864:2016, clause 4.12) | Meets requirements |
| Bonding strength: Tubing and hub (ISO 8536-4:2019, clause 7.3) | Meets requirements |
| Bonding strength: Tubing and double wings luer adapter (ISO 8536-4:2019, clause 7.3) | Meets requirements |
| Infusion set leakage (ISO 8536-4:2019, clause 7.2) | Meets requirements |
| Needle patency of lumen (ISO 7864:2016, clause 4.13, a) | Meets requirements |
| Dimension: Blood collection needle (ISO 9626:2016, clause 5.6, table 1, (TW)) | Meets requirements |
| Dimension: Puncturing needle (ISO 9626:2016, clause 4.10.2, table1) | Meets requirements |
| Needle point (ISO 7864:2016, clause 4.11) | Meets requirements |
| Needle Lubrication: Appearance (ISO 7864:2016, clause 4.10.4) | Meets requirements |
| Needle Lubrication: Quantity (ISO 7886-1:2017, Annex F) | Meets requirements |
| Luer Connector (ISO 80369-7:2016, ISO 80369-20:2015) | Meets requirements |
| Tubing kink stability (ISO 20696:2018, clause 6.7) | Meets requirements |
| Puncture force of needle (ISO 7864:2016, clause 4.11) | Meets requirements |
| Safety protection mechanism (ISO 23908:2011) | Meets requirements |
| Stiffness of needle (ISO 9626:2016, clause 5.8, table 2 (TW)) | Meets requirements |
| Toughness of needle (ISO 9626:2016, clause 5.9) | Meets requirements |
| Resistance to corrosion of needle (ISO 9626:2016, clause 5.10) | Meets requirements |
| Chemical Performance | |
| Reducing matter (ISO 8536-4:2019, clause 8.1) | Meets requirements |
| Metal ions (ISO 8536-4:2019, clause 8.2) | Meets requirements |
| Limits for acidity or alkalinity (ISO 8536-4:2019, clause 8.3) | Meets requirements |
| Residue on evaporation (ISO 8536-4:2019, clause 8.4) | Meets requirements |
| Ethylene oxide residue (EO&ECH) (ISO 10993-7:2008, clause 4.3.4) | Meets requirements |
| Biological Performance (Biocompatibility) | |
| Bacterial endotoxin (USP ) | Passing results |
| Sterility (USP ) | Passing results |
| Pyrogen Test (Rabbit) (USP ) | Passing results |
| Hemolytic Properties (ASTM F756-17) | Passing results |
| Hematology (ISO 10993-4:2017) | Passing results |
| Platelet Count | Passing results |
| Partial Thromboplastin Time | Passing results |
| Cytotoxicity (ISO 10993-5:2009) | Passing results |
| Skin Sensitization (ISO 10993-10:2010) | Passing results |
| Intracutaneous Reactivity | Passing results |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Passing results |
| Safety Mechanism Activation (Sharps Injury Protection) | |
| Safety mechanism activation requirements (ISO 23908, internal protocol and test results) | Meets requirements |
| Safety overriding/unlocking force after activation requirements (ISO 23908, internal protocol and test results) | Meets requirements |
| Sterilization | |
| Sterility Assurance Level (SAL) of 10-6 (ISO 11135:2014 for Ethylene Oxide) | Validated |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test listed, but it indicates "Non-Clinical bench testing" was performed. The data provenance is implied to be from the manufacturer's internal testing in China (Promisemed Hangzhou Meditech Co., Ltd., Hangzhou City, Zhejiang, China). The tests are retrospective, as they are part of the device development and verification process before submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical medical device. Ground truth is established through adherence to international standards and validated laboratory testing procedures for physical, chemical, and biological properties, not through expert consensus on images or interpretations.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reading images) where disagreement might occur. For physical device testing, the results are typically quantitative or pass/fail based on established 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 product is a physical blood collection device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and human reader improvement are irrelevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This product is a physical blood collection device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by the specified international and national consensus standards (e.g., ISO, USP, ASTM) for medical devices, which define acceptable physical, chemical, and biological properties. This includes:
- Physical performance metrics: Bond strength, needle dimensions, patency, kink stability, puncture force, safety mechanism activation.
- Chemical properties: Absence of harmful residues or leaching.
- Biological properties: Biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, bacterial endotoxin) and sterility.
- Outcomes: The device is designed to prevent needlestick injuries, and its safety mechanism is tested to meet this outcome requirement.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning model. There is no "training set" in the context of this 510(k) submission.
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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