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510(k) Data Aggregation
(101 days)
BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.
BD pen needles are single use, sterile, medical devices designed to be use in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G and 31G) and lengths (5mm, 8mm and 12.7mm). BD Pen Needles are sterile (gamma irradiation sterilization), nontoxic and non-pyrogenic. The pen needle assembly consists of a doubled-ended cannula that is assembled into an injection-molded hub using adhesive. The hub has internal threads, which allows it to be screwed onto the pen-injector device. This allows the Non Patient (NP) end of the cannula to penetrate through the rubber septum of the cartridge. The Patient end and NP end of the cannula are lubricated using a silicone based lube for ease of injection and rubber septum penetration. An injection-molded inner shield is assembled over the Patient end of the Cannula to protect the point from damage and accidental needlesticks. This needle assembly is inserted into a protective injection-molded outer cover and sealed with a peel-away (tear drop) label to provide sterility barrier and tamper evidence. The Outer cover is also used to remove the hub and cannula from the pen. The peel-away label is pre-printed with information, which includes the lot number and needle gauge / length. The individual needle assemblies are packaged in bags and / or cartons, and placed into shippers with appropriate labeling. The shipper cases are palletized and sterilized. The purpose of this 510(k) Premarket Notification is to expand the product offering to include a 32G x 4mm Pen Needle. The intended use for the modified device remains the same as the predicate device.
This document describes the regulatory submission for the BD 32G x 4mm Pen Needle, demonstrating its substantial equivalence to predicate devices. The primary study presented is a clinical evaluation of glycemic control.
1. Acceptance Criteria and Reported Device Performance
| Performance Characteristic/Test Description | Acceptance Criteria (Implicit from ISO 11608-2) | Reported Device Performance |
|---|---|---|
| Clinical Performance: Comparison of Glycemic Control among Diabetics using the 4mm x 32G BD Pen Needle vs. the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle. | Equivalent glycemic control and a similar safety profile to predicate pen needles. (Implicit) | This study demonstrated that the 4 mm x 32G pen needle tested provides equivalent glycemic control and a similar safety profile to two predicate pen needle products - the 5mm x 31G and 8 mm x 31G pen needles. The clinical study summary can be found in Section XV, Clinical Performance. |
| Bench Testing (per ISO 11608-2): | ||
| Tubing diameters | Section 4.3.1 (tubing dimensions meet OD and ID requirements) | Tubing dimensions meet OD and ID requirements. |
| Patency of lumen | Section 4.4 (stylet, having a diameter equivalent to 80% ±2% of lumen ID passes through freely) | Stylet, having a diameter equivalent to 80% ±2% of lumen ID, passes through freely. |
| Needle points | Section 4.5 (visually sharp at 2.5X magnification) | Visually sharp at 2.5X magnification. |
| Needle dislocation (angularity) | Section 4.8 (4 mm patient end needle length meets needle dislocation requirements) | 4 mm patient end needle length meets needle dislocation requirements. |
| Type A needles (length) | Section 4.3 (patient end within indicated length ± 1.25 mm and cartridge end within 3.5-7.25 mm) | Patient end within indicated length ± 1.25 mm and cartridge end within 3.5-7.25 mm. |
| Cannula load test (No pre-conditioning) | Section 4.9 (cannula holds force of 22N for 5 seconds) | Cannula holds force of 22N for 5 seconds. |
| Cannula load test (with pre-conditioning) | Section 4.9 (cannula holds force of 22N for 5 seconds) | Cannula holds force of 22N for 5 seconds. |
| Siliconization (lubrication) | Section 4.7 (no visible droplets inside/outside surfaces of cannula) | No visible droplets inside/outside surfaces of cannula. |
| Universal Fit Compatibility Testing | Section 4.1 (connectivity (torque) and dose accuracy testing) | Connectivity (torque) and dose accuracy testing were successfully met for all pen families. The full set of insulin pen families available in the U.S. were tested with the BD 32G x 4mm Pen Needle for compatibility. Connectivity acceptance criteria per ISO 11608-2 were successfully met for all pen families. (From Section 7) |
2. Sample Size and Data Provenance
- Test Set (Clinical Study): The document does not explicitly state the sample size (number of subjects) for the clinical study "BDDC-08-011". It only mentions "subjects' glycemic control".
- Data Provenance: The document does not specify the country of origin for the clinical study data. It is a "clinical study conducted on the BD 32G x 4mm Pen Needle," indicating it was prospective.
- Test Set (Bench Testing): The document does not specify sample sizes for each bench test performed according to ISO 11608-2.
3. Number of Experts and Qualifications for Ground Truth
This type of submission (510(k) for a medical device like a pen needle) does not typically involve "experts" establishing ground truth in the way it would for AI/diagnostic algorithms.
- For the Clinical Study: The "ground truth" for glycemic control would be established through objective laboratory measurements (fructosamine levels) and clinical observation of safety profiles. While medical professionals (e.g., endocrinologists, nurses) would oversee the study, their role is not to establish a "ground truth" in the diagnostic sense, but to collect and interpret data against pre-defined clinical endpoints. No specific number or qualification of experts for "ground truth establishment" is provided or expected.
- For Bench Testing: The "ground truth" is based on adherence to the specified International Standard ISO 11608-2. This is based on objective, quantifiable measurements and visual inspections against defined criteria within the standard. The "experts" involved would be qualified technicians and engineers performing these standardized tests, but their qualifications are not detailed in the summary.
4. Adjudication Method
- Clinical Study: Not applicable in the context of diagnostic AI. Clinical endpoints are typically adjudicated by an independent committee (e.g., Clinical Events Committee) if there are subjective elements, but the document does not specify any such process. For glycemic control, the primary data (fructosamine levels) are objective.
- Bench Testing: Not applicable. Measurements are objective and compared against ISO standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is more relevant for diagnostic imaging or interpretation tasks where human readers might be assisted by AI. For a pen needle, the focus is on physical and functional performance and direct clinical outcomes like glycemic control, not AI-assisted interpretation.
6. Standalone (Algorithm Only) Performance Study
- No standalone (algorithm only) performance study was done. This device is a physical medical device (pen needle), not an AI algorithm. Therefore, "algorithm only performance" is not applicable.
7. Type of Ground Truth Used
- Clinical Study (BDDC-08-011): The ground truth for the clinical study was based on outcomes data, specifically "fructosamine levels" to assess glycemic control, and an evaluation of the "safety profile." Fructosamine is an objective biochemical marker indicating average blood glucose levels over a period.
- Bench Testing: The ground truth for bench tests was adherence to specified objective criteria and measurements as defined by the international standard ISO 11608-2.
8. Sample Size for the Training Set
- Not applicable. This device is a physical medical device and does not involve AI/machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it is irrelevant in this context.
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(59 days)
The BD Phoenix™ Automated Microbiology System is intended for the rapid identification and in vitro antimicrobial susceptibility testing of isolates from pure culture of most aerobic and facultative anaerobic gram-negative and gram-positive bacteria of human origin.
The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Nonand ractive and most gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus and Enterococcus.
This premarket notification is for the addition of the antimicrobial agent Piperacillin at concentrations of I this premarks normounter is to the SST only Phoenix panels. Piperacillin has been shown to 0.5-120 pg miro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent.
The BD Phoenix Automated Microbiology System (Phoenix System) is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The system includes the following components:
- BD Phoenix instrument and software. .
- BD Phoenix panels containing biochemicals for organism ID testing and antimicrobial agents . for AST determinations.
- BD Phoenix ID Broth used for performing ID tests and preparing AST Broth inoculum. .
- BD Phoenix AST Broth used for performing AST tests only. .
- BD Phoenix AST Indicator solution added to the AST Broth to aid in bacterial growth . determination.
The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. Organisms for susceptibility testing must be a pure culture and preliminarily identified as a gram-negative or gram-positive isolate. For each isolate, an inoculation equivalent to a 0.5 McFarland standard is prepared in Phoenix ID Broth.
The Phoenix AST method is a broth based microdilution test. The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as well as bacterial turbidity are used in the determination Macterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations.
The instrument houses the panels where they are continuously incubated at a nominal temperature of 35°C. The instrument takes readings of the panels every 20 minutes. The readings are interpreted to give an identification of the isolate, minimum inhibitory concentration (MIC) values and category interpretations, S, I, or R (sensitive, intermediate, or resistant).
The provided text describes the acceptance criteria and study results for the BD Phoenix™ Automated Microbiology System with Piperacillin 0.5-128 µg/mL.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by FDA Guidance Document) | Reported Device Performance (BD Phoenix™ System) |
|---|---|
| Site Reproducibility: | |
| Overall intra-site reproducibility > 90% | Overall intra-site reproducibility > 90% |
| Overall inter-site reproducibility > 95% | Overall inter-site reproducibility > 95% |
| Clinical Performance: | |
| Essential Agreement (EA) | 94.3% (n=1781) |
| Category Agreement (CA) | 93.8% (n=1701) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Site Reproducibility: A panel of gram-negative isolates (specific number not given, but tested in triplicate on three different days).
- Clinical Studies: 1781 isolates for Essential Agreement (EA) and 1701 for Category Agreement (CA).
- Data Provenance: Clinical, stock, and challenge isolates were tested across multiple geographically diverse sites across the United States. This indicates a prospective study design using diverse US data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth. The ground truth was established by the NCCLS reference broth microdilution method.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for disagreements. The Phoenix System results were directly compared to the NCCLS reference method.
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. The BD Phoenix™ Automated Microbiology System is an automated system for antimicrobial susceptibility testing, not an imaging device or AI assistant that improves human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted. The performance of the BD Phoenix™ Automated Microbiology System (device only) was compared directly to the NCCLS reference broth microdilution method for both site reproducibility and clinical studies. There is no mention of a human-in-the-loop component in the evaluation of the system's performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was the NCCLS reference broth microdilution method (AST panels prepared according to NCCLS M7). This is considered a gold standard or reference method in antimicrobial susceptibility testing.
8. The Sample Size for the Training Set
The document does not explicitly state a "training set" sample size. The description pertains to the validation of the device's performance against a reference method. It's an automated system, and the "training" (if any, in a machine learning sense) would have occurred during the development of the system itself, prior to this validation study.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct "training set" with ground truth establishment for this specific submission is not described. The study focuses on the validation of the automated system against a established reference method.
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