(86 days)
This needle is designed for injection of solutions (such as 2% lidocaine with or without 1:100,000 epinephrine) into the cervix. The application includes local anesthetics such as electro-excision, electro-fulguration, CO2 laser excision, and vaporization, and when required, endocervical curettage and cervical biopsies.
The Wallach Endocervical Block Needle is a Sterile, Disposable, Single Use device. The needle is 27ga., 3 1/2" long. It is used for uterine anesthesia prior to Ob/Gyn procedures. It consists of a metal tube 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 intra-vascular administration set. Over 3 1/4" of its proximal end a 21 gauge metal tube is added to strengthen the shaft.
This document, a 510(k) Premarket Notification Submittal for the "Wallach Endocervical Block Needle," primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that defines and meets specific acceptance criteria based on quantitative performance metrics.
However, based on the provided text, we can infer the implicit acceptance criteria are for the device to be functionally equivalent and safe as compared to existing, legally marketed predicate devices. The study conducted is a comparative analysis, rather than a performance study with defined numerical acceptance thresholds.
Here's an attempt to structure the information based on your request, highlighting what is provided and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Intended Use Equivalence: Designed for injection of solutions (e.g., 2% lidocaine +/- epinephrine) into the cervix for local anesthesia prior to Ob/Gyn procedures, including electro-excision, electro-fulguration, CO2 laser excision and vaporization, endocervical curettage, and cervical biopsies. | Equivalent. The Wallach Endocervical Block Needle's intended use is identical to or consistent with the intended uses of the predicate devices: Coopersurgical 'Potocky Needle', Avid Medical 'Avid-Nit Cervical Regional Anesthesia Needle', Terumo Medical 'Terumo 30 Gauge Hypodermic Needle', and Nipro Medical Crop 'Nipro Hypodermic Needle'. |
| (Explicitly stated as "Equivalent" or consistent with predicate devices' intended use definitions for Class II, Product Code HEE & FMI). | |
| Sterility & Disposable Use Equivalence: Sterile, Disposable, Single Use. | Equivalent. The Wallach Endocervical Block Needle is described as "Sterile, Disposable, Single Use," which is explicitly stated as "Yes" and compared as "Yes" to all four predicate devices. |
| Design Equivalence (Needle Dimensions & Components): 27 gauge, 3 ½" long metal tube, sharpened at one end, joined to a female Luer lock connector, with a 21 gauge metal tube over 3 ¼" of its proximal end for shaft strengthening. | Equivalent/Similar. |
- Coopersurgical 'Potocky Needle': Described as "Equivalent" in design.
- Avid Medical 'Avid-Nit Cervical Regional Anesthesia Needle': Described as "Equivalent" in design.
- Terumo Medical 'Terumo 30 Ga. Hypodermic Needle': Described as "Similar" in design.
- Nipro Medical Corp 'Nipro Hypodermic Needle': Described as "Similar" in design.
(The full description of the Wallach needle design is provided, and the predicates are compared against it). |
| Material Equivalence: Stainless Steel Tubing, Plastic Hub. | Equivalent. All predicate devices are noted as "Equivalent" in material. |
| Safety: No new hazards presented compared to predicate devices. | Met. "Hazard analysis evaluations performed on the Wallach Endocervical Block Needle indicated that there were no new hazards presented with the use of the Wallach Endocervical Block Needle as compared to the predicated devices." |
| Performance: Device performance is substantially equivalent to predicate devices. | Met. "Testing that was performed on the Wallach Endocervical Block Needle indicates that the devices are substantially equivalent in the performance and design of operation." (Specific performance metrics or test results are not detailed) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This document does not describe a "test set" in the context of a clinical study or a statistically defined, independent dataset to evaluate a machine learning algorithm. The "testing" mentioned refers to hazard analysis and performance evaluations that deemed it substantially equivalent to existing devices, but no sample sizes for such tests are provided.
- Data Provenance: Not applicable, as there's no defined "test set" of patient data or images. The evaluation is based on a comparison of design, materials, intended use, and a generic statement about performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is not a study involving expert-established ground truth for a test set in the context of an AI/ML device. The "ground truth" for substantial equivalence is derived from regulatory classifications, established safety profiles, and intended uses of existing predicate devices.
4. Adjudication Method for the Test Set
- Not applicable, as there is no independent "test set" requiring adjudication by experts.
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 submission is for a physical medical device (needle), not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this 510(k) submission is the established regulatory status, safety, design characteristics, and intended uses of legally marketed predicate devices. The Wallach Endocervical Block Needle's characteristics are compared against these established predicates to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device, and thus there is no "training set" in that context.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no training set mentioned or implied.
Summary of the "Study" that Proves the Device Meets Acceptance Criteria:
The "study" presented here is a substantive equivalence comparison to legally marketed predicate devices as per 510(k) requirements. The manufacturer, Wallach Surgical Devices, Inc., claims that the Endocervical Block Needle is "substantially equivalent" to the following predicates:
- Coopersurgical 'Potocky Needle', K910252
- Avid Medical 'Avid-Nit Cervical Regional Anesthesia Needle', K000117
- Terumo Medical 'Terumo 30 Gauge Hypodermic Needle', K012646
- Nipro Medical Corp 'Nipro Hypodermic Needle', K013293
The comparison is based on:
- Intended Use: Identical.
- Technological Characteristics (Design, Materials, Operation): Found to be equivalent or similar.
- Performance: General statement that "Testing... indicates that the devices are substantially equivalent in the performance and design of operation." No specific test reports or data are included in this summary.
- Safety: "Hazard analysis evaluations... indicated that there were no new hazards presented with the use of the Wallach Endocervical Block Needle as compared to the predicated devices."
The FDA's letter (K021224 dated July 12, 2002) confirms this and states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This regulatory finding serves as the "proof" that the device meets the implied acceptance criteria for market entry under a 510(k) pathway.
§ 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).