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510(k) Data Aggregation
(331 days)
Intended for flushing and/or aspiration of oocytes from ovarian follicles.
Follicle Aspiration Sets included in this submission are intended for ultrasound-guided transvaginal aspiration and flushing of oocytes from ovarian follicles. Four types of Follicle Aspiration Sets are included in this submission, and are described in more detail below.
The Follicle Aspiration Sets are radiation sterilized and are for single use only. The materials used in these devices include: stainless steel, TPE-O tubing, silicone, medical grade adhesive, polypropylene, and methyl methacrylate acrylonitrile butadiene styrene.
Follicle Aspiration Set, Single Lumen: This device consists of a single-lumen stainless steel needle, aspiration tubing, and a silicone rubber cork for attachment to a collection tube. One version (17132) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. This device also includes an adapter for flushing of ovarian follicles and removal of blockages. The needles for the majority of the versions of this device type include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.
Follicle Aspiration Set, Double Lumen: This device consists of a double lumen stainless steel needle, tubing for flushing of ovarian follicles and removal of blockages, tubing for aspiration, and a silicone rubber cork for attachment to a collection tube. One version (17129) also includes vacuum tubing attached to the silicone rubber cork for attachment to the vacuum pump used for aspiration. The needles for these versions of the device include echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.
Follicle Aspiration Set, Single Lumen Luer with Tubing: This device consists of a single lumen stainless steel needle, and aspiration tubing with a luer connection at the end. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.
Follicle Aspiration Set, Single Lumen, Luer: This device consists of a single lumen stainless steel needle with a luer connection at the base of the needle. The needle is provided with echogenic markings at the tip of the needle to aid in visualization during aspiration procedures.
The provided text describes the Follicle Aspiration Set, outlining its design, intended use, and comparison to a predicate device. It also includes information about performance testing to establish substantial equivalence.
Here's a breakdown of the requested information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mouse Embryo Assay (MEA): ≥ 80% expanded blastocysts within 96 hours (1-Cell MEA) | Met: > 80% expanded blastocysts within 96 hours (1-Cell MEA) |
| Endotoxins: < 1.2 EU/device | Met: ≤ 1.2 EU/device |
| Vacuum Testing: Operate as intended under -500 mmHg vacuum without signs of damage | Met: Devices were shown to operate as intended without signs of damage. |
| Flow Testing: Flow rates within anticipated ranges under intended use conditions | Met: Testing was conducted to assess that flow rates were within anticipated ranges under intended use conditions. |
| Sterilization Validation per ISO 11137-2:2013 | Met: Confirmed by Sterilization Validation per ISO 11137-2:2013. |
| Biocompatibility: Non-cytotoxic | Met: Device extracts assessed were non-cytotoxic. |
| Biocompatibility: Non-sensitizing | Met: Device extracts assessed were non-sensitizing. |
| Biocompatibility: Non-irritating | Met: Device extracts assessed were non-irritating. |
| Mechanical Testing (Breakage, Bend, Stiffness per ISO 9626:2016) | Met: Testing conducted per ISO 9626:2016. (Specific results not detailed but implied to be sufficient for a substantial equivalence determination). |
| Tensile Strength Testing | Met: Testing conducted. (Specific results not detailed but implied to be sufficient for a substantial equivalence determination). |
| Shelf-life (3 years): 1-cell MEA ≥80% expanded blastocysts within 96 hours | Met: Conducted to ensure acceptance criteria are met over 3 years shelf-life. (Implied to meet the criterion). |
| Shelf-life (3 years): Standard Test Method for Seal Strength of Flexible Barrier Materials per ASTM F88 / F88M - 09 | Met: Conducted to ensure acceptance criteria are met over 3 years shelf-life. (Implied to meet the criterion). |
| Shelf-life (3 years): Dye Penetration per ASTM F1929 12 | Met: Conducted to ensure acceptance criteria are met over 3 years shelf-life. (Implied to meet the criterion). |
| Shelf-life (3 years): Visual Inspection per ASTM F1886 / F1886M 09 | Met: Conducted to ensure acceptance criteria are met over 3 years shelf-life. (Implied to meet the criterion). |
| Shelf-life (3 years): Tensile Strength Testing | Met: Conducted to ensure acceptance criteria are met over 3 years shelf-life. (Implied to meet the criterion). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify human test subjects or clinical data for the "test set" in the context of typical AI/software studies. The testing described is primarily non-clinical, involving laboratory and mechanical evaluations of the physical device. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature is not applicable here.
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 information is not applicable. The device is a physical medical instrument (Follicle Aspiration Set), and the testing performed relates to its physical, chemical, and biological properties (e.g., sterilization, endotoxins, MEA, mechanical strength, biocompatibility). It does not involve the interpretation of data by human experts in the way an AI diagnostic tool would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. The testing methods described are objective laboratory or standardized mechanical tests, not subjective assessments requiring expert 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic or assistive technologies, where human performance is measured with and without AI. The Follicle Aspiration Set is a physical medical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation (as typically understood for an algorithm) was not conducted because the device is a physical instrument, not an algorithm. The "standalone" performance here refers to the device's intrinsic mechanical, chemical, and biological properties, which were evaluated through the performance testing listed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing is based on established scientific and engineering standards and methods:
- Mouse Embryo Assay (MEA): The development of mouse embryos to the expanded blastocyst stage is a biological endpoint widely accepted in ART for assessing the embryotoxicity of materials.
- Endotoxin testing (USP<85>, LAL): Standardized biochemical tests for the presence and quantity of endotoxins.
- Sterilization Validation (ISO 11137-2:2013): International standard for radiation sterilization.
- Mechanical Testing (ISO 9626:2016, Tensile Strength): International and industry standards for needle properties and material strength.
- Biocompatibility Testing (ISO 10993-5, 10, 1): International standards for evaluating the biological effects of medical devices.
- Packaging Testing (ASTM F88/F88M, F1929, F1886/F1886M): American Society for Testing and Materials standards for package integrity.
These are objective, quantitative, and qualitative measures against defined standards or biological responses, rather than subjective ground truths established by human experts or outcomes data in a clinical trial.
8. The sample size for the training set
This information is not applicable. The device is a manufactured medical instrument, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this physical device.
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