(51 days)
The Pre-Implantation Genetic Diagnosis Pipettes are used for the aspiration of blastomeres for pre-implantation genetic diagnosis. These devices are intended for one-time use and will be marketed sterile.
"This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PIGD) on the genetic material in the biopsied cell(s). Tests for PGD are currently developed and their performance characteristics are determined by the individual laboratories for their own use. The performance of these tests may vary depending on the particular assay and disease evaluated. Currently these tests have not been cleared or approved by the Food and Drug Administration.
The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are used for the aspiration of blastomeres for Pre-Implantation genetic diagnosis. These devices are intended for one-time use and will be marketed sterile.
These devices are manufactured entirely from borosilicate glass. Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests.
The provided document is a 510(k) summary for a medical device called Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes). This document asserts substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or a comprehensive study demonstrating performance against specific criteria in the way one would expect for a more complex diagnostic or therapeutic device.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) does not explicitly state quantitative acceptance criteria in a dedicated table format. Instead, it relies on demonstrating substantial equivalence to a predicate device.
The reported "performance" is primarily related to material safety and manufacturing quality rather than diagnostic accuracy or clinical efficacy.
| Feature / Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate device for aspiration of blastomeres. | "The Pre-Implantation Genetic Diagnosis Pipettes are used for the aspiration of blastomeres for Pre-Implantation genetic diagnosis." This is stated as being similar to predicate devices. |
| Design, Construction, Material | Substantially equivalent to predicate device. | "The Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) are substantially equivalent to other pipettes in terms of indications for use, design, construction and material equivalence." Devices are "manufactured entirely from borosilicate glass." |
| Sterility | Marketed sterile. | "These devices are intended for one-time use and will be marketed sterile." Compliance to unspecified sterilization standards is implied for marketed sterile devices. |
| Material Biocompatibility (Mouse Embryo Toxicity) | Material meets requirements of the test. | "Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests." |
| Material Biocompatibility (Endotoxin) | Material meets requirements of the test. | "Mouse Embryo Toxicity testing and Endotoxin testing have been performed on the borosilicate glass. Results show the material meets the requirements of these tests." |
| Manufacturing Process & Quality | Manufactured according to specified process controls and a Quality Assurance Program. | "This device will be manufactured according to specified process controls and a Quality Assurance Program." (No specific metrics provided). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) submission primarily focuses on substantial equivalence based on design, materials, and intended use to existing devices, and biocompatibility testing. There isn't a "test set" of clinical cases or data in the context of diagnostic accuracy for this type of basic microtool. The data provenance for the biocompatibility tests (Mouse Embryo Toxicity and Endotoxin testing) is not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this device is a microtool for cell manipulation rather than a diagnostic algorithm, there is no "ground truth" derived from expert consensus on clinical cases. The "ground truth" would be the verified safety of the materials and the functional design for its intended purpose.
4. Adjudication Method for the Test Set
Not applicable.
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 device is not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical microtool, not an algorithm or software.
7. The Type of Ground Truth Used
For the biocompatibility claims:
- Mouse Embryo Toxicity and Endotoxin Testing Results: These tests in laboratories define the "ground truth" for material safety as per established biological evaluation standards. The "results show the material meets the requirements of these tests," indicating a pass/fail ground truth based on the specific test's criteria.
For the substantial equivalence claim:
- Comparison to Predicate Device: The "ground truth" for substantial equivalence is the existing, legally marketed predicate device (Cook Australia's pipettes) in terms of its indications for use, design, construction, and materials.
8. The Sample Size for the Training Set
Not applicable. There is no machine learning or AI component requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 884.6120 Assisted reproduction accessories.
(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.