(52 days)
This winged needle holder is indicated for use in securing and positioning a hypodermic needle during the administration of a peribulbar nerve block.
The winged needle holder is fabricated from polyethylene.
This document describes a 510(k) submission for a "Removable Wings" device, also referred to as a "Winged needle holder." The submission focuses on demonstrating substantial equivalence to a predicate device already on the market. Consequently, the study described does not involve performance criteria and a study to prove they are met in the manner of a typical medical device with measurable outcomes (e.g., accuracy, sensitivity, specificity for a diagnostic device, or efficacy for a therapeutic device).
Instead, the "acceptance criteria" here are based on the comparison of attributes to a legally marketed predicate device. The "study" is a comparison table rather than a clinical trial or performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Attribute for Substantial Equivalence) | Reported Device Performance (Submitted Device) |
|---|---|
| Material of construction | Polyethylene |
| Wing shape | Curved |
| Needle fit | Needle hub through holder |
| Reusability | Disposable |
| Sterility | Sterile |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the traditional sense for this type of submission. There is no "test set" of patient data or clinical samples. The "test" is a direct comparison of physical and functional attributes of the submitted device against a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The "ground truth" for this substantial equivalence submission is the attributes of the legally marketed predicate device. No expert consensus on a test set was required.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring adjudication.
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 not an AI-assisted device, nor is it a diagnostic imaging device that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this submission is the characteristics and functionality of a legally marketed predicate device (Becton Dickinson and Company's removable winged needle holder). This is a regulatory "ground truth" for substantial equivalence rather than a clinical one.
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an algorithm or AI-powered device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set. The "ground truth" for the comparison was established by the existence and characteristics of the predicate device, presumably through manufacturer specifications and its established market use.
§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
(a)
Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.