(422 days)
The BD Vacutainer® Push Button Blood Collection Set is a sterile, multi-sample, single-use fixed winged blood collection set intended for use in the general population by healthcare professionals experienced with venipuncture to obtain blood specimens from patients, including those patients with difficult vein access who may have small, fragile, and or non-palpable veins, into evacuated blood collection tubes and/or bottles. When used without the male Luer adapter, the device allows the clinician to obtain a blood specimen from the female Luer connector with a syringe, if necessary. The device can be used by healthcare professionals with infusion experience for short-term, single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and is to remain under the direct supervision of a clinician.
The recommended use of the device is to activate the needle safety feature prior to removal from the venipuncture site. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
The BD Vacutainer® Push Button Blood Collection Set is a sterile, multiple-sample, single-use device used for venipuncture to obtain blood specimens from patients and may be used for the short-term intravenous administration of fluids. The BD Vacutainer® Push Button Blood Collection Set is a winged blood collection set with flexible tubing, a female luer connector and an optional male luer adapter. The BD Vacutainer® Push Button Blood Collection Set also contains a needle protector. The wingset is designed with a safety mechanism to protect against needlesticks. When the button is depressed by the user, the needle fully retracts and is enclosed and locked within the barrel of the device. The retraction of the intravenous (IV) end of the needle aids in the prevention of accidental needlestick injury.
The BD Vacutainer® Push Button Blood Collection Set consists of:
- Stainless steel cannula (Intravenous end and non-patient end of cannula)
- Stainless steel spring
- Hub, front and rear barrel
- Wings (color coded according to needle gauge)
- Tubing
- Female luer connector and an optional male luer adapter
- Intravenous (IV) needle protector (covers the needle before use)
- Pre-attached holder (connected by male luer adapter in some models)
The intravenous needle of the blood collection set is bonded to one end of the hub. The other end of the hub is bonded to the blood collection set tubing, the end of which is then bonded to a female luer connector with an optional attached male luer adapter. Some models come with a pre-attached holder connected to the male luer adapter for user convenience. A spring is loaded onto the front barrel of the hub. Once the sample is collected, and without removing the needle from the patient vein, the user depresses the raised push button on top of the hub which activates the spring mechanism to automatically retract the needle from the device. In this retracted (locked) position, the IV point of the needle is fully contained within the body of the device. This will prevent the needle from coming out of the front barrel once it has retracted as well as preventing accidental overriding of the safety feature.
The blood collection set with a male luer adapter contains threads for attachment to a Vacutainer® Brand Needle Holder, and a non-patient cannula for blood collection into evacuated blood collection tubes and/or blood culture bottles. For models without the pre-attached holder, the user is instructed to attach a holder before using the device. The pre-attached holder models come with the BD Vacutainer® Brand Holder pre-attached for user convenience. The non-patient end cannula of the luer adapter has a sleeve that recovers over the cannula to stop blood flow in between collection of multiple tubes.
When used without the male adapter, the device allows the clinician to obtain a blood specimen from the female hub with a syringe, if necessary. The device can be used for short-term, single infusions (up to 2 hours) with consideration given to patient size and appropriateness for the solution being infused.
The provided text describes a 510(k) premarket notification for a medical device, the BD Vacutainer® Push Button Blood Collection Set. A 510(k) notification aims to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets a new set of defined acceptance criteria in the way a novel AI/ML device would.
Therefore, the structure of the provided document doesn't align with the typical "acceptance criteria" and "study that proves the device meets the acceptance criteria" framework seen with AI/ML systems where performance metrics (e.g., sensitivity, specificity, AUC) are rigorously tested against pre-defined thresholds.
Instead, this document focuses on demonstrating that the subject device (BD Vacutainer® Push Button Blood Collection Set, K220212) is substantially equivalent to a predicate device (BD Vacutainer® Push Button Blood Collection Set, K030573) and performs as intended through a series of non-clinical bench tests, biocompatibility, and sterilization testing. Clinical literature is cited to support the expanded indications for use, rather than a de novo clinical study with a control group and specified primary endpoints designed to meet quantitative performance acceptance criteria.
However, I can extract the relevant information and present it in a similar structure, focusing on what was demonstrated for substantial equivalence rather than a detailed "acceptance criteria" table for novel device performance.
Device: BD Vacutainer® Push Button Blood Collection Set (K220212)
Predicate Device: BD Vacutainer® Push Button Blood Collection Set (K030573)
1. Table of Acceptance Criteria and Reported Device Performance (or Demonstration of Substantial Equivalence)
Since this is a 510(k) focusing on substantial equivalence, the "acceptance criteria" are generally that the subject device performs as intended and is as safe and effective as the predicate device, despite minor differences. The performance is demonstrated through various bench and materials testing, and by referencing clinical literature.
| Category | Acceptance Criteria (Demonstrated Equivalence/Performance Goal) | Reported Device Performance / Evidence of Meeting Criteria |
|---|---|---|
| Intended Use | Predicate: For venipuncture to obtain blood specimens; intravenous administration of fluids. Subject Device Expansion: Intended for general population by healthcare professionals experienced with venipuncture to obtain blood specimens, including those patients with difficult vein access (DVA) who may have small, fragile, and/or non-palpable veins, into evacuated blood collection tubes and/or bottles. Can also obtain blood specimens with a syringe (when without male Luer adapter). Short-term, single infusions (up to 2 hours), not to be left in place, under direct clinician supervision. Both: activate needle safety feature prior to removal, aiding in accidental needlestick injury prevention. The expansion to DVA patients and syringe use should not raise new questions of safety/effectiveness. | Similarity/Difference and Justification: |
- Intended Population: Subject device explicitly adds "including patients with difficult vein access (DVA)". Justified by CLSI guideline GP41 and WHO Guidelines stating winged blood collection sets are recommended for difficult veins. This is considered a subset of 'General Use' and does not affect safety/effectiveness.
- Syringe Use: Re-inclusion of syringe use (unintentionally omitted from predicate IFU) is not a new intended use and does not raise new questions of safety/effectiveness.
- Overall intended use similar, with minor clarifications supported by existing clinical literature. |
| Technological Characteristics | Materials, dimensions, and design features should be substantially equivalent to the predicate, or any differences should not raise new questions of safety or effectiveness. | Comparison (See Table 1 in document, abridged): - Same: Needle Diameter OD/ID, Needle Point Geometry, Needle Length, Wing material, Hub material, Button Ink, Barrels (Front/Rear) material, Rear Barrel Lubricant, Spring material, IV Protector/Cannula/NP Cannula material, Tubing material, Cannula Lubricant/Adhesive, Hub-Tubing Adhesive, Female Luer Adapter/Luer Adapter Hub material, NP Sleeve, Luer Adhesive/Cannula Lubricant/Cap, Top Web, Blister material.
- Different (and Justified): Presence/absence of viscous fluid (not part of subject device – no impact on safety/effectiveness). Pre-attached holder (user convenience, legally marketed holder used – no impact on safety/effectiveness). |
| Performance (Non-Clinical Bench Testing) | The device must pass a comprehensive suite of bench tests to verify its design specifications and performance standards, demonstrating it is as safe and effective as the predicate. This includes mechanical properties, safety features, fluid dynamics, and packaging integrity. Compliance to applicable standards (e.g., ISO, ASTM). | Passed Tests (Partial List provided): - IV Protector Pull Test
- IV Cannula Removal Test
- Flow Rate
- Torque to Rotate Wing
- Wing Removal Test
- Front Barrel/Rear Barrel Separation Test
- Tubing to Female Luer Adapter Pull Test
- Tubing to Hub Pull Test
- Product (safety feature) Pre-Activation
- Retraction and Lock-out
- Force to Override Lock Mechanism
- Luer Cap Removal Torque
- Luer Separation Test
- NP Cannula Pull Test
- Male Luer Adapter Spin Out from Holder Test
- Torque to Unseat
- NP Sleeve Function
- Tube Push Off
- IV Cannula Penetration Test
- Submerged Leak Test (Device)
- Air Leakage Test
- Package Integrity Test
- Luer Compatibility (ISO 594-1/2)
- Sharps Injury Protection (ISO 23908)
- Stainless Steel Needle Tubing (ISO 9626)
Conclusion: Results demonstrate acceptable performance for the subject device and complies to applicable parts of the listed standards. |
| Biocompatibility | Device materials must be biocompatible for intended use and contact (externally communicating device, direct contact with circulating blood for ≤ 24 hours). Compliance to ISO 10993 series. | Passed Tests: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility (Coagulation, Platelet Activation, Complement Activation, Hemolysis), Particulates. All compliant with ISO 10993 series and USP standards. |
| Sterilization, Package Integrity, Shipping & Shelf Life | The device must be sterile (SAL 10-6), maintain sterility through its shelf life, and withstand shipping. Compliance to relevant ISO and ASTM standards. | Demonstrated Compliance: Sterilized via gamma irradiation, with validations for sterilization, package integrity, shipping, and shelf life (2 years) according to ISO 11137 series, ISO 11737 series, ISO 11607 series, ASTM F1980, ASTM D4169, ASTM F2096, ASTM F88. |
2. Sample Sizes Used for the Test Set and Data Provenance
As this is a 510(k) for a physical device, not an AI/ML diagnostic, there isn't a "test set" in the sense of a distinct dataset of medical images or patient records used to evaluate an algorithm's performance against a gold standard. Instead, performance is demonstrated through:
- Non-Clinical Bench Testing: Tests were performed on a sufficient number of device samples to ensure reproducibility and statistical validity, though specific sample numbers for each test are not detailed in this summary. These are laboratory-based tests on manufactured devices.
- Clinical Literature Review: Two literature articles are cited to support the expanded indications for use.
- Ibarra AF and Villanueva, 2019: Clinical study showing phlebotomist preference and increased patient/phlebotomist satisfaction in a Mexican general hospital. The sample size for this specific study is not detailed, but it relates to the preference of the device rather than a ground truth for a diagnostic output.
- Merrill, V.D. et al., 2021: Study on venipuncture blood draws for oncology outpatients. Sample size: 89 oncology outpatients (≥18 years of age).
- Data Provenance: The Merrill study was conducted in an oncology outpatient clinic, implying a prospective collection of data for the purpose of the study. The location (country) is not specified but generally these studies would be in the US or similar developed healthcare systems given the context of FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no "ground truth" derived from expert consensus in the context of an AI/ML device output for this 510(k). The clinical literature cited supports the usability and effectiveness for patient populations (e.g., DVA patients) and specimen quality, rather than establishing a diagnostic "ground truth."
For the Merrill study (2021), clinical outcomes (successful blood collection, specimen quality based on LDH, K, and plasma free hemoglobin levels) served as the "ground truth" or evaluative criteria, not expert interpretations. The healthcare professionals performing the venipuncture are the "experts" in the practical application.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" requiring adjudication by multiple experts in the context described (e.g., for diagnostic AI device output). The clinical literature referenced presents outcomes data or user preference data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this is a physical blood collection device, not an AI/ML diagnostic system that assists human readers. The clinical summaries provided support the use and safety of the device for a broader patient population (DVA) and user preference, rather than an aid to diagnostic interpretation.
6. Standalone Performance (Algorithm Only)
Not applicable. This is a physical medical device. There is no standalone algorithm.
7. Type of Ground Truth Used
For the clinical literature cited:
- Merrill et al., 2021: The "ground truth" for the device's performance in DVA patients was based on physiological outcomes data:
- Successful blood collection from each patient.
- Specimen quality assessed by laboratory measurements of LDH, K, and plasma free hemoglobin levels, compared against normal and acceptable analyte reference ranges.
- Ibarra AF and Villanueva, 2019: The "ground truth" was user (phlebotomist) preference and patient/phlebotomist satisfaction data.
For the non-clinical bench testing, the "ground truth" is adherence to engineering specifications and performance standards (e.g., force required for retraction, flow rate, leak integrity).
8. Sample Size for the Training Set
Not applicable. This is a physical medical device; there is no AI/ML model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.