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510(k) Data Aggregation
(124 days)
THE STRIPPER PGD
The transfer of the removed blastomere from a holding vessel to a transport vessel. This device is NOT intended for blastomere biopsy from an embryo.
Stripper PGD® Micropipette and associated tip
This document is a 510(k) clearance letter from the FDA for a medical device called "Stripper PGD® Micropipette and associated tip." It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the information requested in the prompt regarding acceptance criteria, device performance, study details, or ground truth.
The letter is a regulatory approval document and focuses on the administrative aspects of device clearance rather than the detailed technical performance or the studies that would demonstrate compliance with acceptance criteria.
Therefore, I cannot extract the requested information from this provided text.
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(196 days)
THE STRIPPER
"THE STRIPPER®" MICROPIPET FAMILY'S INDICATION FOR USE IS T0 MANIPULATE AND TRANSFER ZYGOTES AND EMBRYOS DURING IVF AND ICSI PROCEDURES.
"THE STRIPPER®" MICROPIPETS ARE USED IN THE TISSUE CULTURE TECHNIQUES PERFORMED BY EMBRYOLOGISTS WHEN PREPARING OOCYTES FOR IVF, ICSI AND ASSISTED HATCHING TECHNIQUES PRIOR TO RE-IMPLANTATION.
"THE STRIPPER®" MICROPIPETS ARE TOOLS USED IN PROCEDURES THAT HAVE BEEN DEVELOPED TO AID INFERTILE COUPLES ACHIEVE PREGNANCY.
REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE FOR CONFIRMATION OF FERTILITY DURING IVF.
REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE PRIOR TO ICSI PROCEDURES.
USED TO TRANSFER EMBRYOS AND OOCYTES THROUGH VARIOUS MEDIA AND SOLUTIONS DURING THE IVF PROCEDURE.
"THE STRIPPER®" micropipetter is a hand held device used to create the vacuum necessary for "THE STRIPPER®" micropipetter tips to aspirate and dispense fluid and cellular material. Its' components include an aluminum barrel that houses a stainless steel plunger and spring, an aluminum plunger shaft with finger pad, o-rings, washer and collet for securing "THE STRIPPER®" tips.
"THE STRIPPER®" micropipette tips are fabricated from polycarbonate tubing wherein one end of the tube is pulled to a much smaller dimension to produce tips of varying internal dimensions.
The provided document describes the "THE STRIPPER®" Micropipetter and Micropipetter Tips, a device used in In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) procedures. The document includes information on the device's testing procedures and, by extension, its acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mouse Embryo Bioassay (Toxicity Testing) | |
| % Development to Blastocyst at 96 hours (Test Article) | > 70% |
| % Development to Blastocyst at 96 hours (Control Medium) | > 70% (Indicates a valid assay) |
| Sterility Testing | |
| Sterility Assurance Level (SAL) | 10⁻⁶ |
| Minimum Radiation Dose (for sterilization) | 15 kGy (Established by AAMI Method I, SIP) |
| Maximum Radiation Dose (for sterilization) | 25 kGy |
| Endotoxin Testing (Limulus Amebocyte Lysate Assay) | |
| Endotoxin Level per device |
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