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510(k) Data Aggregation
(197 days)
The IMPROSAFE® Blood Collection Sets with Pre-attached to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROSAFE® Multi-Sample Needles are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood.
The IMPROSAFE® Blood Collection Sets are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Blood Collection Sets with Pre-attached holder are intended to be used with evacuated blood collection tube for the collection of venous blood.
The IMPROSAFE® Multi-Sample Needles (Flashback) are intended to be used with evacuated blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The IMPROVACUTER® Multi-Sample Needles are used with holder and vacuum blood collection tube for the venous blood collection.
The proposed devices are blood collection sets form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood. They are available in different configurations as follows:
IMPROSAFE® Blood Collection Set with Pre-attached holder: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, Pre-attached Holder, Safety Mechanism, Visible Flash Back
IMPROSAFE® Blood Collection Set: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, N.A., Safety Mechanism, Visible Flash Back
IMPROVACUTER® Blood Collection Set with Pre-attached Holder: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, Pre-attached Holder, N.A., Visible Flash Back
IMPROVACUTER® Blood Collection Set: Patient-End Needle, Non-Patient End Needle, Flexible Tubing, N.A., N.A., Visible Flash Back
IMPROSAFE® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A., Pre-attached Holder, Safety Mechanism, N.A.
IMPROSAFE® Multi Sample Needle (Flashback): Patient-End Needle, Non-Patient End Needle, N.A., Pre-attached Holder, Safety Mechanism, Visible Flash Back
IMPROVACUTER® Multi Sample Needle: Patient-End Needle, Non-Patient End Needle, N.A., N.A., N.A., N.A.
The provided text is a 510(k) Summary for several blood collection devices. It aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving a device meets specific acceptance criteria through an independent clinical study for AI software.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable or not provided in this document, as it pertains to medical hardware (needles and collection sets) and not AI software.
However, I can extract information related to non-clinical tests and the general equivalence claims.
Here's the breakdown of the information provided in the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, pre-defined manner for performance metrics. Instead, it refers to conformity with established international and ASTM standards. The "reported device performance" is essentially that the device "conforms" to these standards.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Conformity) |
|---|---|
| Material (Stainless steel needle tubing): Conforms to ISO 9626:1991+AMENDMENT 1 2001 | Conforms to ISO 9626:1991 AMD 2001 (and ISO 7864:1993 for sterile hypodermic needles) |
| Sterile Hypodermic Needles: Conforms to ISO 7864: 1993 | Conforms to ISO 7864: 1993 (and ISO 9626:1991 AMD 2001 for needle tubing) |
| Ethylene Oxide Sterilization residuals: Conforms to ISO 10993-7:2008 | Conforms with ISO 10993 |
| Seal Strength of Flexible Barrier Materials: Conforms to ASTM F 88/F88M-09 | Conforms to ASTM F 88/F88M-09 |
| Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration: Conforms to ASTM F1929-12 | Conforms to ASTM F1929-12 |
| Bacterial Endotoxins Limit: Conforms to USP38-NF33 <85> | Conforms to USP38-NF33 <85> |
| Tests for in vitro cytotoxicity: Conforms to ISO 10993-5:2009 | Conform with ISO 10993 |
| Tests for irritation and delayed-type hypersensitivity: Conforms to ISO 10993-10:2010 | Conform with ISO 10993 |
| Tests for systemic toxicity: Conforms to ISO 10993-11:2006 | Conform with ISO 10993 |
| Assessment of hemolytic properties of materials: Conforms to ASTM F 756-13 | Conform to ASTM F 756-13 |
| Sharps Injury Prevention Features: Conforms to Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features | Conforms to Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features |
| Labeling Requirements: Conforms to 21 CFR Part 801 | Conform with 21 CFR Part 801 |
| Sterility: EO sterilized | EO sterilized |
| Single Use: Single Use | Single Use |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. This document does not detail specific sample sizes for non-clinical tests or data provenance. The tests are general compliance tests for medical devices.
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/Not provided. This is not an AI device or a diagnostic device relying on expert interpretation for "ground truth." The tests are for physical/biological properties and compliance with engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This concept is not relevant to the non-clinical testing of blood collection devices described.
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 blood collection set/needle, not an AI-powered diagnostic tool, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this type of device is compliance with specific material, sterility, performance (e.g., seal strength, endotoxin limits), and biocompatibility standards, as measured by established laboratory test methods.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or corresponding ground truth for this type of device.
Summary of the Study (Non-Clinical Test Conclusion) from the document:
The non-clinical tests were conducted to verify that the proposed devices met all design specifications and were Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
- ISO 9626:1991+AMENDMENT 1 2001 (Stainless steel needle tubing)
- ISO 7864: 1993 (Sterile hypodermic needles for single use)
- ISO 10993-7:2008 (Biological evaluation - Ethylene oxide sterilization residuals)
- ASTM F 88/F88M-09 (Seal strength of flexible barrier materials)
- ASTM F1929-12 (Detecting seal leaks in porous medical packaging by dye penetration)
- USP38-NF33 <85> (Bacterial Endotoxins Limit)
- ISO 10993-5:2009 (Biological evaluation - Tests for in vitro cytotoxicity)
- ISO 10993-10:2010 (Biological evaluation - Test for irritation and delayed-type hypersensitivity)
- ISO 10993-11:2006 (Biological evaluation - Tests for systemic toxicity)
- ASTM F 756-13 (Assessment of hemolytic properties of materials)
- Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features
Clinical Test Conclusion:
"No clinical study is included in this submission."
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(202 days)
IMPROVACUTER Gel & Clot Activator Tube is a single used to collect, transport, separate, and process venous blood specimens to obtain serum for clinical chemistry and immunology assays. It is used in settings where a venous blood sample is collected by a trained healthcare worker. For in vitro diagnostic use.
The IMPROVACUTER® Gel & Clot Activator Tube is sterile, plastic, evacuated blood collection tube. The tube consists of (1) a closure assembly, (2) a silica clot activator, (3) a Barrier Gel and (4) a plastic tube. The specimens are used for clinical laboratory assays involving the use of patient serum.
The provided text describes a 510(k) submission for the IMPROVACUTER® Gel & Clot Activator Tube, a medical device for blood collection, and focuses on demonstrating its substantial equivalence to a predicate device, the BD Vacutainer® Gel & Clot Activator Tube. The study outlined is a method comparison study, which is a common approach for demonstrating equivalence for in vitro diagnostic (IVD) devices.
Here's an breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text doesn't explicitly state quantitative acceptance criteria in a dedicated table. Instead, it describes the acceptance as demonstrating "no major differences" or "clinically equivalent" results compared to the predicate device. The performance is summarized qualitatively.
| Criterion Type | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Clinical Equivalence | The IMPROVACUTER® Gel & Clot Activator Tube should provide clinically equivalent chemistry and immunology analyte results compared to the predicate BD Vacutainer® tubes. | "The clinical evaluation demonstrated that the IMPROVACUTER® Gel & Clot Activator Tube provide clinically equivalent chemistry analyte results when compared to the BD Vacutainer® tubes." "All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes." (This statement is repeated for Method Comparison, Stability, Shelf-life, Same-Lot Repeatability, and Lot-to-Lot Reproducibility studies) |
| Analyte Stability (Refrigerated) | Analytes should be stable for 24 hours at 2-8°C. | Demonstrated for all analytes. "All results showed no significant different from BD Vacutainer® stored under the same condition." and "Stability for 24 hours at room temperature and refrigerated temperature has been demonstrated for all the analytes except TBIL." |
| Analyte Stability (Room Temperature) | Analytes should be stable for 24 hours at 22-25°C. | Demonstrated for most analytes. "TBIL is stable at room temperature for up to 20 hours." and "All results showed no significant different from BD Vacutainer® stored under the same condition." |
| Shelf-life | The device should not show significant differences from newly manufactured devices over its shelf life. | "All results showed no significant different from these [newly manufactured devices]." |
| Same-Lot Repeatability | No major differences from the method comparison study results within the same lot. | "All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes." (Implies meeting the criterion by finding no major differences compared to the predicate, which serves as the reference for acceptable performance). |
| Lot-to-Lot Reproducibility | No major differences from the method comparison study results across different lots. | "All comparison studies results demonstrate that there are no major differences between IMPROVACUTER® tubes and BD Vacutainer® tubes." (Implies meeting the criterion by finding no major differences compared to the predicate, which serves as the reference for acceptable performance). |
The document refers to CLSI Guideline, EP9-A2: Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline Second edition, which would contain the specific statistical methods and criteria (e.g., allowable total error, bias, correlation coefficients) used to determine "no major differences" or "clinically equivalent." However, these specific numerical criteria are not detailed in the provided summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The exact number of individual patient samples (N) for the "clinical evaluations" (method comparison studies) is not explicitly stated in the provided text. It mentions comparing devices "in total 28 chemistry assays and 13 Immunology assays," but this refers to the number of analytes tested, not the number of samples.
- Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective. It only states "Clinical evaluations were performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided in the context of this device and study. The "ground truth" for these types of studies (blood collection tubes for chemistry and immunology assays) is based on the analytical measurements from a legally marketed and accepted predicate device, rather than expert judgment or interpretation of images/clinical findings. The "truth" is the measured analyte concentration.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication typically refers to resolving discrepancies between multiple human readers or between human readers and an AI system, especially in image interpretation tasks. For a method comparison study of blood collection tubes, the "readings" are objective laboratory measurements, so there is no human interpretation or adjudication process in the same way.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the impact of a diagnostic aid (often AI) on human reader performance, usually in image-based diagnostics. This submission is for a blood collection device, which is an in vitro diagnostic (IVD) rather than an AI-powered diagnostic imaging tool. The study compares the performance of the device itself to a predicate device, not the performance of human readers using or not using the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, effectively. The "clinical evaluations were performed to determine the safety and efficiency of the IMPROVACUTER® Gel & Clot Activator Tube" by comparing its analytical results directly to those obtained from the predicate device. This is a standalone performance assessment of the device (or the "algorithm" in the context of a non-AI device, meaning its functional performance) without human interpretation influencing the primary outcome measures (i.e., analyte concentrations). The device itself is the "algorithm" being evaluated.
7. The Type of Ground Truth Used
The "ground truth," in this context, is the analyte concentration obtained from the legally marketed predicate device (BD Vacutainer® tubes). The study design is a method comparison where the predicate device serves as the reference standard. The results from the IMPROVACUTER® tubes are compared against the results from the BD Vacutainer® tubes to demonstrate "no major differences" or "clinical equivalence."
8. The Sample Size for the Training Set
Not applicable. This submission is for a traditional medical device (blood collection tube), not an AI algorithm. Therefore, there is no "training set" in the machine learning sense. The device's performance is inherent to its design and materials, not learned from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.
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