(173 days)
Biopsy micropipets are used to aspirate polar bodies or blastomeres containing genetic material for the purpose or pre-implantation genetic diagnosis. These devices are intended for single use and will be supplied sterile. The labeling will contain the following statement, in prominent and boxed format:
"This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic material in the biopsied cell(s). Tests for PGD are currently developed and their performance characteristics are determined by individual laboratories for their own use. The enafactoriance of these tests may vary depending on the particular assay and disease performance of ammy these tests have not been cleared or approved by the Food and Drug Administration."
Biopsy Micropipets are used to remove polar bodies from the zygote (polar body) or blastomeres from the embryo (blastomere biopsy) for the purpose of preimplantation genetic diagnosis. These devices are manufactured from borosilicate glass on which 2 cell mouse embryo and endotoxin testing are performed. They are manufactured following procedures of the Humagen Quality System. The pipets are manufactured to specific sizes or the size may be modified to meet customer specifications.
The provided text is a 510(k) summary for Humagen Fertility Diagnostics, Inc.'s Polar Body and Blastomere Biopsy Micropipets. It does not contain information about acceptance criteria or a study proving the device meets said criteria as typically found for complex medical devices with performance claims (e.g., diagnostic accuracy, sensitivity, specificity).
The document is primarily a declaration of substantial equivalence to a predicate device (K990847), focusing on the device's physical characteristics, intended use, and manufacturing processes rather than its performance in biopsy procedures. The key aspects that would usually be covered in a performance study for AI/diagnostic devices are explicitly stated as being determined by individual laboratories, not by the manufacturer for this submission.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The submission focuses on substantial equivalence based on manufacturing, material, and general dimensions to a previously cleared predicate device, rather than performance metrics related to the biopsy procedure itself.
- Reported Device Performance: Not reported. The document states: "Individual laboratories currently develop and determine performance characteristics for their own use. It is understood that the FDA has not currently cleared or approved these procedures." This indicates that the manufacturer is not providing performance data for the biopsy function of the pipets in this 510(k).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. No performance study data is presented for the biopsy function in this document. The document mentions "2 cell mouse embryo and endotoxin testing" performed on the materials, but details of such testing (sample size, criteria, results) are not provided in this summary.
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)
- Not applicable/Not provided. No ground truth establishment related to the biopsy procedure's efficacy or outcomes is discussed in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
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/Not provided. This device is a physical microtool, not an AI or diagnostic algorithm requiring reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided, for the reasons mentioned above. The only "testing" mentioned is for the materials ("2 cell mouse embryo and endotoxin testing"), but details are not elaborated to define a ground truth methodology.
8. The sample size for the training set
- Not applicable/Not provided. No training set is mentioned as this is not an AI/algorithm device.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Summary of Device-Specific Information from the Text:
- Device Name: Blastomere Biopsy Micropipet, Polar Body Biopsy Micropipet
- Intended Use: For polar body or blastomere biopsy, which may be done to perform pre-implantation genetic diagnosis (PGD) on the genetic material in the biopsied cell(s).
- Manufacturing: Made from borosilicate glass, manufactured following Humagen Quality System procedures.
- Testing Mentioned (without details): 2 cell mouse embryo and endotoxin testing performed on the materials.
- Substantial Equivalence Claim: Similar to other micropipets manufactured by Humagen and approved under K990847, varying only by size and shape of the tip. Testing and controls are stated to be the same as the predicate.
- Key Disclaimer: "Individual laboratories currently develop and determine performance characteristics for their own use. It is understood that the FDA has not currently cleared or approved these procedures." This is reiterated in the Indications for Use statement in a prominent, boxed format.
§ 884.6130 Assisted reproduction microtools.
(a)
Identification. Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.