(114 days)
ICSI injection micropipettes are used for injecting spermatozoa into the . cytoplasm of an oocyte during intracytoplasmic sperm injection (ICSI). -
- Holding micropipettes are used to anchor the oocyte under vacuum during . intracytoplasmic sperm injection (ICSI).
- Assisted hatching micropipettes are used to direct Tyrode's solution onto the . zona of an oocyte, thus creating a hole and enabling the oocyte to hatch.
- Denuding pipettes are used to strip the cumulus from oocytes prior to . intracytoplasmic sperm injection (ICSI).
ICSI injection micropipette (spiked and non-spiked) ICSI holding micropipette Assisted hatching / zona drilling micropipette Denudation pipette
There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text. The document is a 510(k) clearance letter from the FDA for a set of micropipettes, confirming that the devices (K991261) are substantially equivalent to legally marketed predicate devices. It discusses regulatory classification, general controls, and good manufacturing practices, but does not include any performance data or study details.
Therefore, I cannot provide the requested information.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 1999
Mr. Ben Murdock Quality Manager Research Instruments Limited Kernick Road Penryn, Cornwall TR10 9DQ United Kingdom
Re: K991261 ICSI Injection Pipettes, Holding Micropipettes, Denudation Pipettes, Assisted Hatching/Zona Drilling Pipettes Dated: July 16, 1999 Received: July 21, 1999 Requlatory Class: II 21 CFR §884.6130/Procode: 85 MQH
Dear Mr. Murdock:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumplions. Failure to comply with the GMP regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ 1_of 1
510(k) Number (if known): K991261
Device Name: ICSI injection micropipette (spiked and non-spiked) ICSI holding micropipette Assisted hatching / zona drilling micropipette Denudation pipette
Indications for Use:
...
ICSI injection micropipettes are used for injecting spermatozoa into the . cytoplasm of an oocyte during intracytoplasmic sperm injection (ICSI). -
- Holding micropipettes are used to anchor the oocyte under vacuum during . intracytoplasmic sperm injection (ICSI).
- Assisted hatching micropipettes are used to direct Tyrode's solution onto the . zona of an oocyte, thus creating a hole and enabling the oocyte to hatch.
- Denuding pipettes are used to strip the cumulus from oocytes prior to . intracytoplasmic sperm injection (ICSI).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David L. Seppman
(Optional Format 3-10-98)
(Division Sign-Off) Division of Reproductive. Abdominal, E and Radiological I 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
§ 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.