(164 days)
Used to obtain gamete from the body
The Double Lumen Needle is intended to obtain gametes from the bodv. The catalog number is GNDL-632. The basic design is two concentric stainless steel needle tubing of 32 cm in exposed length, forming the "dual lumen". The outer tubing has the point, the inner is flat. They are attached to a hub of polycarbonate designed especially for this purpose. The outer diameter of the outer needle tube is 16 gauge. Attached to the hub are two lengths of tubing. One is attached to the rear of the needles. which allows the gametes to be aspirated into a collection test tube, and the second length is attached to the flush port on the side. This second port is attached to a syringe, which allows the operator to inject media into the follicle to allow "flushing".
This 510(k) submission describes a medical device called the " Double Lumen Needle." It is a device for assisted reproductive procedures, specifically for obtaining gametes from the body.
Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific acceptance criteria or quantitative performance metrics for the device. Instead, it relies on a demonstration of "substantial equivalence" to existing legally marketed devices.
Acceptance Criteria (Implicit from 510(k) context):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition | Made of two concentric stainless steel needle tubing (32 cm exposed length), attached to a polycarbonate hub. Outer diameter of 16 gauge. |
| Purity/Sterility Assurance | Gamma Irradiated. Dosage: 2.5 Mrad. Sterility Assurance Level (SAL): 10^-6. Validation in accordance with ANSI/AAMI/ISO 11137-1994 Standards. |
| Functional Design | Dual lumen design: one for aspiration of gametes into a collection test tube (rear of needles), another for injecting media into the follicle for "flushing" (flush port on the side, attached to a syringe). |
| Indications for Use | "Used to obtain gametes from the body." |
| Substantial Equivalence | "The Double Lumen Needle is substantially equivalent to several products currently marketed in the US." (Section 2, not provided, would contain specific comparisons) |
2. Sample size used for the test set and the data provenance
The document does not mention any specific test set, sample size, or data provenance (country of origin, retrospective/prospective) for proving performance. The submission relies on demonstrating substantial equivalence rather than explicit performance testing data from new studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided. There is no mention of a test set requiring expert ground truth establishment in this 510(k) submission.
4. Adjudication method for the test set
This information is not applicable or provided. There is no mention of a test set or an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of an MRMC study, AI assistance, or human readers in this submission. This device is a manual instrumental tool, not an AI-assisted diagnostic or therapeutic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical needle, not an algorithm.
7. The type of ground truth used
The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) is not directly applicable to this 510(k) submission. The "ground truth" for this device's acceptance is its physical and functional characteristics, and its demonstrated substantial equivalence to predicate devices, implying that if it functions similarly to already approved devices, it is safe and effective for its intended use.
8. The sample size for the training set
This is not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable. There is no training set mentioned.
Summary of the 510(k) Approach:
The core of this 510(k) submission rests on demonstrating "Substantial Equivalence" to legally marketed predicate devices. This means that the device is shown to be as safe and effective as a legally marketed device that does not require premarket approval. Instead of presenting new clinical performance data from studies, the manufacturer typically provides:
- A detailed description of the device's design, materials, and manufacturing process.
- Laboratory testing (e.g., sterility testing as described).
- Bench testing to compare physical and functional characteristics (e.g., flow rates, material compatibility) with predicate devices.
- A comparative analysis showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as the predicate devices.
The FDA's letter essentially confirms that based on the provided information, the device is considered substantially equivalent, allowing it to be marketed.
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).