(61 days)
This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix Local anesthetics such as electroexcision, electrofulguration, CO2 laser excision and vaporization, and in some patients, endocervical curettage and cervical blopsies
The needle is 27g, 3 ½ª long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal lube that is sharpened at one end and at the other end joined to a female connector (Luer lock) designed to mate with a male connector (Nozzle) of a piston syringe or an intravascular administration set. Over 3 ¼" of its proximal end a 21 gauge metal tube is added to strengthen the shaft
I am sorry, but I cannot provide a detailed description of acceptance criteria and a study proving device performance based on the provided text. The document is a 510(k) summary for a medical device (Endocervical Block Needle) and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific performance metrics and acceptance criteria as you've requested.
Here's why I cannot fulfill your request based on the given information, and what I can extract:
What the document does provide:
- Acceptance Criteria (Implicit via Equivalence): The implicit acceptance criterion for the Endocervical Block Needle is substantial equivalence to the Potocky Needle™ Disposable Injection Needle. The device is deemed acceptable if it can be shown to be as safe and effective as the predicate device.
- Study That Proves the Device Meets Acceptance Criteria: The "study" is a comparison of technological characteristics between the Endocervical Block Needle and the Potocky Needle™. This comparison, presented as a table, claims equivalence across multiple attributes.
Why the specific details you requested are not present:
- Table of Acceptance Criteria and Reported Device Performance: The document does not provide predefined numerical acceptance criteria (e.g., "device must achieve X accuracy" or "Y tensile strength") and then report specific performance results against those. Instead, it states "Equivalent" for various characteristics when compared to the predicate.
- Sample Size for Test Set and Data Provenance: There is no mention of a test set, statistical sample sizes, or data provenance (e.g., country of origin, retrospective/prospective). The assessment is based on a comparative analysis of specifications, not a new clinical or performance study with a distinct test set.
- Number of Experts and Qualifications for Ground Truth: Since no new performance study is described, there's no mention of experts establishing ground truth for a test set. The "ground truth" for equivalence is essentially derived from the established safety and efficacy of the predicate device.
- Adjudication Method: Not applicable as no new performance data requiring adjudication is presented.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant to a hypodermic needle's 510(k) submission.
- Standalone Performance Study (Algorithm Only): Not applicable. This is a physical medical device, not an algorithm. Its performance is assessed through equivalence to a physically similar device, not a standalone algorithm.
- Type of Ground Truth Used: The "ground truth" implicitly used is the established safety and efficacy profile of the predicate device (Potocky Needle™) as accepted by the FDA. There's no pathology, outcomes data, or expert consensus specifically generated for this new device's performance claims, beyond the general understanding that the predicate performs as intended.
- Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
- How Ground Truth for Training Set Was Established: Not applicable for the same reason as above.
In summary, the provided document demonstrates substantial equivalence through a comparative analysis of technological characteristics to a legally marketed predicate device, which is a common pathway for 510(k) clearance. It does not describe a performance study with specific acceptance criteria, test sets, or ground truth establishment in the way you've outlined for a new device's performance validation.
The table showing the comparison is:
Comparison of Technological Characteristics (Predicate vs. New Device)
| Characteristic | Endocervical Block Needle (Reported Performance) |
|---|---|
| 2-Target Population | Equivalent |
| 3-Design | Equivalent |
| 4-Materials | Equivalent |
| 5-Performance | Equivalent |
| 6-Sterility | Equivalent |
| 7-Biocompatibility | Equivalent |
| 8-Mechanical Safety | Equivalent |
| 9-Chemical Safety | Not Applicable |
| 10-Anatomical Sites | Equivalent |
| 11-Human Factors | Equivalent |
| 12-Energy used and/or delivered | Not Applicable |
| 13-Compatibility with Environment & other devices | Equivalent |
| 14-Where used | Equivalent |
| 15-Standards met | Equivalent |
| 16-Electrical Safety | Not Applicable |
| 17-Thermal Safety | Not Applicable |
| 18-Radiation Safety | Not Applicable |
Acceptance Criteria: For each characteristic, the acceptance criterion is "Equivalent" to the predicate device (Potocky Needle™ Disposable Injection Needle). The reported performance across all relevant characteristics is that the Endocervical Block Needle is "Equivalent" to the predicate.
§ 884.5100 Obstetric anesthesia set.
(a)
Identification. An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.(b)
Classification. Class II (performance standards).