(490 days)
The intended use is to be used with a syringe to pierce a pre-split rubber injection site.
B. Braun Medical Inc. intends to introduce into interstate commerce the Blunt Syringe Cannula. These have the same design and performance characteristics as the InterLink Syringe Cannnula currently marketed by Becton Dickinson and covered under K920422. It is also similar to McGaw's SafeLine System covered under K913177. The intended use is to be used with a syringe to pierce a pre-split rubber injection site.
This document is a 510(k) premarket notification for a medical device called the "Blunt Syringe Cannula." It focuses on demonstrating substantial equivalence to already marketed devices, rather than establishing specific performance acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, many of the requested elements for a study proving device adherence to acceptance criteria are not applicable to this type of regulatory submission. The submission relies on comparative claims and standard manufacturing/release testing.
Here's an breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Same design and performance characteristics as predicate devices. | "These have the same design and performance characteristics as the InterLink Syringe Cannula..." |
| Intended Use Equivalence: Used with a syringe to pierce a pre-split rubber injection site. | "The intended use is to be used with a syringe to pierce a pre-split rubber injection site." |
| Material Equivalence: Equivalent materials to predicate device. | "The Blunt Syringe Cannula is equivalent in materials..." |
| Biocompatibility: Meet recommendations in the Tripartite Guidance for contact duration. | "B. Braun Medical certifies that the biocompatibilty tests 'recommended... will be completed for all the materials..." |
| Safety and Effectiveness: No new issues of safety or effectiveness compared to predicate devices. | "There are no new issues of safety or effectiveness raised by the Blunt Syringe Cannula." |
| Manufacturing Release Specifications: Sterility, pyrogenicity, physical testing, visual examination. | "All finished products are tested and must meet all required release specifications before distribution... include... sterility, pyrogenicity (endotoxin/ LAL Method), physical testing, visual examination (in process and finished product)." |
| Physical Testing: Conform to product design specifications. | "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission does not describe a test set or study of this nature. The "testing" referred to is manufacturing quality control and comparison to existing predicate 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. No external expert panel was used to establish ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No external adjudication method for a test set was 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 is a physical medical device (cannula), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the performance and characteristics of the predicate devices (InterLink Syringe Cannula K920422 and SafeLine System K913177), as well as established industry standards and regulatory requirements for medical devices (e.g., sterilization, biocompatibility, physical integrity for the stated use).
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an AI/machine learning study for this device. The "training" for the device's design implicitly comes from existing medical device design principles and predicate devices.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set mentioned, this question is not relevant.
Summary of the "Study" (or justification) for K971924:
The provided document describes a 510(k) Premarket Notification submission for the Blunt Syringe Cannula. The "study" proving the device meets acceptance criteria is fundamentally a comparative analysis and declaration of compliance with manufacturing standards, rather than a clinical trial or performance study as might be seen for a novel therapeutic or diagnostic device.
The core argument for acceptance is substantial equivalence to predicate devices already on the market (K920422 and K913177). The manufacturer asserts that the Blunt Syringe Cannula has the "same design and performance characteristics" and is "equivalent in materials, form, and intended use" to these predicate devices. Furthermore, they state that "There are no new issues of safety or effectiveness raised."
In addition to this comparative claim, the document mentions adherence to routine quality control and manufacturing release specifications, including:
- Sterility
- Pyrogenicity (endotoxin/LAL Method)
- Physical testing (defined by Quality Control Test Procedure documents which conform to product design specifications)
- Visual examination (in process and finished product)
They also certify that biocompatibility tests "recommended in the Tripartite Guidance for this category of contact duration will be completed for all the materials used."
Essentially, the device is deemed to meet acceptance criteria because it is demonstrated to be fundamentally the same in function and safety as existing, approved devices, and it will undergo standard rigorous manufacturing quality control.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).