(172 days)
The HSW NORM-JECT®- syringes are intended to be used to inject into, or withdraw fluids from the body. The 1 ml- syringe with a purple plunger, labeled with BOTOX® is exclusively produced for use with BOTOX® Cosmetic (onabotulinumtoxinA).
The purpose of this request is for marketing clearance of Henke-Sass, Wolf piston syringe because we have added a new purple-colored plunger for a new version of the syringe. The piston syringes covered by this submission will have the same performance as already marketed devices. The only difference will be the coloring of the plunger in adding a master batch to the original material.
The provided text describes a 510(k) submission for a piston syringe, focusing on demonstrating substantial equivalence to predicate devices rather than a study with acceptance criteria and device performance in the context of diagnostic accuracy or AI assistance.
Therefore, many of the requested elements for describing such a study (e.g., acceptance criteria for diagnostic performance, sample size for test sets with data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document.
The document primarily focuses on bench testing and compliance with recognized standards to show that the new syringe, with a color change to its plunger, performs identically to existing, cleared devices.
Here's the information that can be extracted from the provided text, with the understanding that it pertains to a medical device clearance for a syringe rather than a diagnostic algorithm study:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard Reference) | Reported Device Performance (Summary) |
|---|---|---|
| Biological Evaluation | ISO 10993-1:2009 (General) | Complies (implied by substantial equivalence claim and listing of standards) |
| ISO 10993-4:2002 (Hemocompatibility) | Complies | |
| ISO 10993-5:2009 (Cytotoxicity) | Complies | |
| ISO 10993-10:2002 (Sensitization) | Complies | |
| ISO 10993-10:2002 (Irritation/Intracutaneous Reactivity) | Complies | |
| ISO 10993-11:2006 (Acute Systemic Toxicity) | Complies | |
| Physical Performance | ISO 7886-1:1993 (Sterile hypodermic syringes for single use) | Complies |
| ISO 594-1:1986 (Conical fittings with 6% taper) | Complies | |
| Sterilization & Packaging | ISO 10993-7:2008 (EtO-Residuals) | Complies |
| ISO 11135-1:2007 (Sterilization Validation EtO) | Complies | |
| ISO 11607-1:2006 (Packaging for terminally sterilized medical devices - materials, systems) | Complies | |
| ISO 11607-2:2006 (Packaging for terminally sterilized medical devices - validation) | Complies | |
| Overall Comparison | Substantial Equivalence to Predicate Devices (K821537, K063280) | Device has identical operating principles and same intended uses as predicate devices. The only difference is the coloring of the plunger, which does not affect performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references international ISO standards for testing but does not detail the specific sample sizes or provenance of data for each test. For a syringe, testing would typically involve a predefined number of units per lot to meet standard requirements, but these specifics are not included in this summary.
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)
This is not applicable as the document describes a physical medical device (syringe) and its compliance with engineering and biological safety standards, not a diagnostic device relying on expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as above.
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 as this submission is for a physical syringe, not an AI-assisted diagnostic device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this submission is for a physical syringe, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on compliance with established international standards (ISO standards) for material safety, physical performance, sterilization, and packaging, as well as demonstrating identical operating principles and intended uses to legally marketed predicate devices. There wouldn't be a "ground truth" in the diagnostic sense (like pathology or expert consensus).
8. The sample size for the training set
This is not applicable as this submission is for a physical syringe, not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as above.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).