Search Results
Found 1 results
510(k) Data Aggregation
(30 days)
The BD SafeAssist™ Pen Needle is intended for use with pen injector devices for the injection of drugs, including insulin and exenatide.
Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.
The BD SafeAssist" safety pen needle is designed for use with pen injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. The BD SafeAssist™ features a 30G needle gauge size and is offered in needle lengths of 5mm and 8mm. It is a single-use disposable device that is provided sterile (gamma irradiation sterilization). BD SafeAssist™ is non-toxic and non-pyrogenic.
The BD SafeAssist is designed to reduce occurrence of accidental needle sticks from the patient end of the needle by providing a shield that locks over the needle after use. Prior to injection, the user will attach the BD SafeAssist" to the pen injector. The shield of the BD SafeAssist" will hide the needle prior to use. As the user presses the BD SafeAssist against the skin at a 90° angle, the shield retracts to expose the needle and allows it to penetrate the skin. After injection is completed and the BD SafeAssist" is removed from the skin, the shield extends automatically and locks in place to cover the needle. The locked shield is designed to reduce the occurrence of accidental needle stick injuries. The device also features a red band indicator which provides the user visual confirmation the needle's safety mechanism has been activated. The BD SafeAssist ""should be removed from the pen and discarded after use.
The BD SafeAssist™ device comprised of modifications to the BD AutoShield™ predicate cleared under K060007. These modifications consist of design, material and labeling changes.
This document is a 510(k) Pre-Market Notification for the "BD SafeAssist™ Pen Needle". It seeks to demonstrate substantial equivalence to legally marketed predicate devices. The information provided is for regulatory clearance, not a study evaluating human reader performance with or without AI assistance. Therefore, many of the requested fields are not applicable.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance data in the traditional sense of a clinical study assessing diagnostic accuracy or similar metrics for an AI device. Instead, it outlines non-clinical performance testing to demonstrate that the device meets requirements for its intended use and is substantially equivalent to predicate devices. The "acceptance criteria" are implied by the standards and tests performed.
| Acceptance Criteria (Implied by Standards/Tests) | Reported Device Performance |
|---|---|
| Functional Performance: Conformance to ISO 11608-2: Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles | Met requirements for its intended use and demonstrated substantial equivalence to its predicate devices. |
| Sterilization: Conformance to ISO 11137-2 (Sterilization of Health Care Product - Radiation Part 2: Establishing the Sterilization Dose) | Met requirements for its intended use and demonstrated substantial equivalence to its predicate devices. |
| Material Biocompatibility: Conformance to ISO 10993-1 (Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process) for the following tests: | Met requirements for its intended use and demonstrated substantial equivalence to its predicate devices. |
| - Cytotoxicity in Cell Culture | (Implicitly passed) |
| - Hemolysis | (Implicitly passed) |
| - Acute Systemic Toxicity | (Implicitly passed) |
| - Intracutaneous Reactivity | (Implicitly passed) |
| - Primary Dermal Irritation | (Implicitly passed) |
| - Pyrogenicity | (Implicitly passed) |
| - Sensitization | (Implicitly passed) |
| - Genotoxicity (Bacterial and Mammalian) | (Implicitly passed) |
| - Subchronic Toxicity | (Implicitly passed) |
| - Leachable Colorant | (Implicitly passed) |
| - Bacterial Endotoxin | (Implicitly passed) |
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 a "test set" in the context of an AI study (i.e., a dataset of images/cases for evaluating algorithm performance). The testing mentioned is for the physical device's functional, sterilization, and biocompatibility properties. Therefore, "sample size" would refer to the number of physical devices or materials tested for these engineering and biological properties, not a set of clinical data. This information (specific numbers of needles tested) is not provided in the summary.
Data provenance (country of origin, retrospective/prospective) is not applicable as this is not a study using patient data.
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. "Ground truth" in the context of an AI system's performance on clinical data is not relevant here. The ground truth for the tests performed would be established by standard accredited laboratory testing methods for functional performance, sterility, and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies or studies involving human interpretation of data. This document describes non-clinical laboratory testing.
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. This is not an AI device or a diagnostic device where human reader performance would be a relevant metric. The device is a "Hypodermic Single Lumen Needle" with a safety shield.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed are objective measurements based on established scientific and engineering standards (e.g., ISO standards for injection systems, sterilization, and biocompatibility). It is determined by the results of controlled laboratory experiments and chemical/biological assays, rather than expert consensus on clinical findings or pathology.
8. The sample size for the training set
Not applicable. This device does not involve AI/machine learning, and therefore there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
Ask a specific question about this device
Page 1 of 1