(89 days)
The Swemed Blastomere Biopsy Pipette is intended to conduct a blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).
The Swemed Blastomere Biopsy Pipette is indicated to aspirate blastomeres containing genetic material for the purpose of preimplantation genetic diagnosis.
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 Swemed Blastomere Pipette is manufactured by Swemed of borosilicate glass. The pipette has an inner diameter ranging from 0.030 mm to 0.049 mm and an outer diameter of either 0.053 mm or 0.060 mm. The pipette's length ranges from 55 to 65 mm. The Blastomere Pipette has a 20-35° beveled tip. The pipette is packaged in a silicone holder together with a glass tube. The tubes are then provided in seals made of aluminum foil. The pipette is dry heat sterilized by Swemed Lab International. The pipette is intended for single use only.
The provided text is a 510(k) summary for a medical device called the Swemed Blastomere Biopsy Pipette. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study.
Therefore, the document does not contain information typically found in a study proving a device meets acceptance criteria, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details on ground truth establishment.
- Information on expert panels, adjudication methods, or MRMC studies.
- Details on standalone algorithm performance.
- Sample sizes or ground truth establishment for training sets (as this is not an AI/ML device).
The document focuses on demonstrating that the Swemed Blastomere Biopsy Pipette is "substantially equivalent" to existing predicate devices (Swemed's Assisted Hatching/Zona Drilling Pipette, Cook OB/GYN's Pre-Implantation Genetic Diagnosis Pipette, and Humagen Fertility Diagnostics, Inc.'s Blastomere Biopsy Micropipette) based on:
- Identical intended use and indications for use.
- Substantially equivalent technological characteristics, with minor variations in diameter ranges that do not raise new safety or effectiveness issues because the new device's diameter ranges are encompassed by the predicate's.
No specific acceptance criteria or a study designed to prove the device meets those criteria are described in this document. The entire submission acts as the "study" to prove substantial equivalence through comparison to predicates, rather than performance against defined metrics.
§ 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.